If you are dying of 4th stage cancer, Chinese Plasmodium Trial Program may let you live on. FULL HOUSE!

[tun_dr_m]

http://www.sohu.com/a/294759690_260616?spm=smpc.home.top-news4.1.1550171686156j7Yq715




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疟原虫治晚期癌症志愿者招募已满：疗法处早期阶段，理性就医

2019-02-14 22:46

春节刷屏至今的“疟原虫治疗晚期癌症”项目有了新的动态，该项目由中科院广州生物医药与健康研究院研究员陈小平主导。

2月14日，澎湃新闻记者（www.thepaper.cn）在广州中科蓝华生物科技有限公司（下称“中科蓝华”）官网看到，网站发布一则通知：疟原虫免疫疗法治疗晚期癌症临床研究招募志愿者名额已满。

中国临床试验注册中心官网显示，中科蓝华为三项疟原虫治疗癌症相关项目的申请人所在单位、研究实施负责单位。该公司成立于2013年1月，注册资本1900万元，最大股东及实际控制人为柯宗贵，柯宗贵也是上市公司蓝盾信息安全技术股份有限公司（300297）的最大股东。陈小平为中科蓝华创始人，现任首席执行官（CEO）。

疟原虫免疫疗法临床研究项目组在通知中表示，疟原虫免疫疗法临床研究还处在早期阶段，仍然需要不断探索，目前本期志愿者招募名额已满。下期临床研究需求及招募志愿者的相关信息，请密切关注“中科蓝华生物科技”官网的更新。项目组将在系统中筛选条件符合的志愿者。

通知还写道，希望各位家属考虑患者身体状况，根据患者健康状况确定是否参与本临床研究，请大家理性就医。

另外，项目组称，由于医务人员和科研人员工作繁忙，请各志愿者或家属不要到现场进行咨询。并且，为了不耽误患者治疗，建议其先寻求其他方法治疗。

澎湃新闻还获悉，原定于2月14日、2月15日在广州复大肿瘤医院的两场疟原虫科研项目咨询也全部取消。

目前名额已满的这轮招募信息最早于1月31日在中科蓝华官网发布。患者招募信息称，疟原虫免疫疗法治疗晚期肺癌的临床研究目前已经在广州医科大学附属第一医院与钟南山院士的团队合作开展，取得了初期研究进展，现扩展到其它癌症中。

新招募患者的临床试验地点广州医科大学附属第一医院、云南昆钢医院（云南省昆明市第四人民院）、广州复大肿瘤医院。

澎湃新闻记者2月13日从患者家属中曾获悉，或将有第四家医院实施疟原虫治疗。陈小平团队称即将在广州医科大学附属第五医院启动疟原虫免疫疗法治疗中晚期实体瘤的临床研究。

中科蓝华方面的工作人员向家属介绍，计划是广州医科大学附属第一医院招收30例受试者，广州复大肿瘤医院招收20例受试者，云南昆钢医院招收90例受试者，广州医科大学附属第五医院招收30例受试者。

在中科蓝华患者招募网站上看到，志愿者年龄需在18-70岁，生活能够自理，饮食良好，癌症类别为非小细胞肺癌、肝/胆癌、胃癌、乳腺癌、结直肠癌这五种。 接受治疗的志愿者需要住院治疗2个月左右。

陈小平团队所谓的“疟原虫治疗晚期癌症”，即向符合入组条件的晚期癌症患者注射含有疟原虫（间日疟原虫）的红细胞。团队此前在小鼠动物实验看到，疟原虫感染能显著抑制小鼠肺癌（Lewis肺癌）的生长和转移，显著延长荷瘤小鼠的生存时间。团队随后还发文解释背后机制：癌症小鼠感染疟原虫之后，其免疫细胞会被激活，这些免疫细胞激活之后会杀死肿瘤细胞。与此同时，肿瘤组织中起到抑制抗肿瘤免疫反应的细胞也会被疟原虫感染所抑制，因而解放了肿瘤组织中的免疫抑制微环境，并促进T细胞进入到肿瘤中去，从而有效杀死肿瘤细胞。

陈小平团队自2016年起在医院正式开展疟原虫免疫疗法治疗晚期实体肿瘤的临床试验。直到1月28日，中科院官方微博发布消息，在中科院SELF论坛的一场公开演讲里，陈小平介绍了上述疗法，并称，团队研究发现肿瘤死亡率与疟疾发病率呈现负相关关系，疟原虫对治疗癌症有帮助，目前临床试验发现，10名病人中，有5人治疗效果明显，其中2人可能被治愈。

随后，疟原虫治疗晚期癌症的消息在网络上刷屏至今。不过，这种“以毒攻毒”、直接向患者注射病原体的治疗方式，也陆续引发一些业内人士的质疑。返回搜狐，查看更多

声明：该文观点仅代表作者本人，搜狐号系信息发布平台，搜狐仅提供信息存储空间服务。



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Plasmodium treatment of advanced cancer volunteers has been recruited: early stage of therapy, rational medical treatment
2019-02-14 22:46

The “Plasmodium Treatment of Advanced Cancer” project has been updated in the Spring Festival. The project is led by Chen Xiaoping, a researcher at the Guangzhou Institute of Biomedicine and Health, Chinese Academy of Sciences.

On February 14th, the 澎湃 journalist (www.thepaper.cn) saw in the official website of Guangzhou Zhongke Lanhua Biotechnology Co., Ltd. (hereinafter referred to as “Zhongke Lanhua”) that the website issued a notice: Plasmodium immunotherapy treatment The number of volunteers recruited for advanced cancer clinical research is full.

According to the official website of the China Clinical Trial Registration Center, Zhongke Lanhua is the unit responsible for the three malaria parasites for cancer-related treatment projects and the responsible unit for research implementation. The company was established in January 2013 with a registered capital of 19 million yuan. The largest shareholder and actual controller is Ke Zonggui. Ke Zonggui is also the largest shareholder of the listed company Blue Shield Information Security Technology Co., Ltd. (300297). Chen Xiaoping is the founder of Zhongke Lanhua and the current CEO (CEO).

The Plasmodium Immunotherapy Clinical Research Project Team stated in the notice that the clinical study of Plasmodium immunotherapy is still in its early stages and still needs to be explored continuously. At present, the number of volunteer recruitment is full. For the next phase of clinical research needs and information on recruiting volunteers, please pay close attention to the update of the official website of Zhongke Lanhua Biotechnology. The project team will screen the volunteers who meet the criteria in the system.

The notice also wrote that I hope that all family members will consider the patient's physical condition and determine whether to participate in this clinical study according to the patient's health status. Please seek medical advice rationally.

In addition, the project team said that due to the busy work of medical staff and scientific researchers, volunteers or their families should not go to the site for consultation. Moreover, in order not to delay the treatment of patients, it is recommended to seek other methods of treatment.

The news also learned that the consultations on two malaria parasite research projects scheduled to be held at Guangzhou Fuda Cancer Hospital on February 14 and February 15 were all cancelled.

The current round of recruitment information has been published on the official website of Zhongke Lanhua on January 31. According to the patient recruitment information, the clinical study of Plasmodium immunotherapy for advanced lung cancer has been carried out in cooperation with the team of the First Affiliated Hospital of Guangzhou Medical University and Academician Zhong Nanshan, and has achieved initial research progress and is now expanding into other cancers.

The clinical trial site for newly recruited patients is the First Affiliated Hospital of Guangzhou Medical University, Yunnan Kunshan Iron and Steel Hospital (the Fourth People's Hospital of Kunming, Yunnan Province), and Guangzhou Fuda Cancer Hospital.

澎湃The journalist was informed on February 13 from the family of the patient that there would be a fourth hospital to implement the treatment of malaria parasites. Chen Xiaoping said that he will start the clinical study of Plasmodium immunotherapy in the treatment of advanced solid tumors in the Fifth Affiliated Hospital of Guangzhou Medical University.

The staff of Zhongke Lanhua introduced to the family that the plan is to enroll 30 subjects in the First Affiliated Hospital of Guangzhou Medical University, to recruit 20 subjects from Guangzhou Fuda Cancer Hospital, and to enroll 90 subjects in Yunnan Kunshan Iron and Steel Hospital. The fifth hospital affiliated to Guangzhou Medical University enrolled 30 subjects.

On the recruitment website of Zhongke Lanhua patient, the volunteers need to be 18-70 years old, and they can take care of themselves and have a good diet. The cancer categories are non-small cell lung cancer, liver/chosal cancer, stomach cancer, breast cancer and colorectal cancer. These five kinds. Volunteers receiving treatment need to be hospitalized for about 2 months.

Chen Xiaoping’s team called “Plasmodium to treat advanced cancer”, which is to inject red blood cells containing Plasmodium (P. vivax) into patients with advanced cancer who meet the enrollment criteria. The team previously observed in mouse animal experiments that Plasmodium infection significantly inhibited the growth and metastasis of mouse lung cancer (Lewis lung cancer), significantly prolonging the survival time of tumor-bearing mice. The team then issued a document explaining the underlying mechanism: after cancer mice are infected with Plasmodium, their immune cells are activated, and these immune cells activate tumor cells after activation. At the same time, cells that inhibit the anti-tumor immune response in tumor tissues are also inhibited by Plasmodium infection, thus liberating the immunosuppressive microenvironment in tumor tissues and promoting T cells to enter the tumor, thereby effectively killing Dead tumor cells.

Chen Xiaoping’s team has officially started clinical trials of Plasmodium immunotherapy for advanced solid tumors in hospital since 2016. Until January 28th, the official microblog of the Chinese Academy of Sciences released a message. In a public speech at the SELF Forum of the Chinese Academy of Sciences, Chen Xiaoping introduced the above therapy and said that the team study found a negative correlation between tumor mortality and malaria incidence, malaria parasites. It is helpful for the treatment of cancer. At present, clinical trials have found that 5 out of 10 patients have obvious treatment effects, and 2 of them may be cured.

Subsequently, the news that Plasmodium treats advanced cancer has been screened on the Internet to this day. However, this "drug-to-drug" treatment of direct injection of pathogens into patients has also raised questions from some insiders. Go back to Sohu and see more
Disclaimer: This article only represents the author himself, Sohu is the information publishing platform, and Sohu only provides information storage space services.

 

[tun_dr_m]

Traditional thousand years old Chinese philosophy says: 以毒攻毒 !

Use a Toxin to neutralize against another, it works all the time. Alkaline against Acid, Acid against Alkaline. Yeast eats Bacteria, Bacteria eats Yeast.

 

[syed putra]

Out of 5, 2 survived this ordeal.

 

[borom]

Nothing new-in use since 1917
I quote Wiki

" P. vivax was used between 1917 and the 1940s for malamalariotherapy , that is, to create very high fevers to combat certain diseases such as tertiary syphilis. In 1917, the inventor of this technique, Julius Wagner-Jauregg , received the Nobel Prize in Physiology or Medicine for his discoveries. However, the technique was dangerous, killing about 15% of patients, so it is no longer in use "
https://en.wikipedia.org/wiki/Plasmodium_vivax

 

[rushifa666]

Yes. The mainland chinks will kill you. And so you did not die of cancer. Technicality that should be ignored

 

[Ang4MohTrump]

Nothing new-in use since 1917
I quote Wiki

" P. vivax was used between 1917 and the 1940s for malamalariotherapy , that is, to create very high fevers to combat certain diseases such as tertiary syphilis. In 1917, the inventor of this technique, Julius Wagner-Jauregg , received the Nobel Prize in Physiology or Medicine for his discoveries. However, the technique was dangerous, killing about 15% of patients, so it is no longer in use "
https://en.wikipedia.org/wiki/Plasmodium_vivax

Initial discovery was made before WW2. But no viable medical solution came from that, because of failures, their discovery noticed some effects then, failed all the way to turn those effects into a medical solution, given up already. Chinese developed it now. They have new abilities that Chow Ang Moh are far far behind lagging further and further.

 

[Ang4MohTrump]

Yes. The mainland chinks will kill you. And so you did not die of cancer. Technicality that should be ignored

In this current world ALL 8 BILLION SUCKERS are PLAYED OUT by Modern Civilization. Con into a MASSIVE TOTAL EXTINCTION SUICIDE. The only way out which has very little time left for, is to ELIMINATED BILLIONS OF OTHERS and survive yourself. Your time will run out when the others ruin the planet to a state unrecoverable, or the remaining resources had been exhausted by the others squandering to pamper themselves. Chinese ancestors had been the most trained and proven on the right track of eliminations and carnage. They should nuke the rest now, and I can see even that is insufficient, because the remaining resources is below the level to sustain 1.4 Billion Chinese alone. They have to also nuke away at least 60% or more of their owns, if they want to last for eternity in balanced with the deeply ruined remains of Planet Earth. Only in millions (low millions) that is possible. Man already squandered within the last 100 years, thousands time more resources than human consumption since 5000 years of Chinese history.

 

[rushifa666]

Finally blocked the nut.

 

[tun_dr_m]

https://tech.sina.com.cn/scientist/2019-02-15/doc-ihqfskcp5149073.shtml

“以毒攻毒”疟原虫能治好癌症？这疗法真的靠谱吗？

“以毒攻毒”疟原虫能治好癌症？这疗法真的靠谱吗？

出品| 新浪科技《科学大家》
撰文| 王立铭 浙江大学生命科学研究院教授、研究员、博士生导师
这几天，有一个来自科学界的新闻刷屏了。中科院广州生物医药与健康研究院的陈小平研究员（下文均称陈小平），在中科院SELF论坛一场公开演讲里介绍了自己的研究工作——利用疟原虫成功治疗晚期癌症患者。
脑洞这么大的研究思路，又是如此重要的临床进展，网友们的评论也是花式赞美和支持。

如果你还没来得及看视频，我先帮助你简单总结一下相关的内容：
陈小平在早年学习期间，偶然发现世界范围内疟疾发病率和癌症死亡率的地理分布图，似乎存在负相关的关系，萌生了“疟疾也许能治癌”的初步想法；
后来，他们团队在小鼠模型中研究发现，引发疟疾的疟原虫能够显著抑制肿瘤生长，而且还研究了背后的机制，可能是通过激活小鼠的免疫系统机能；
过去两年，他们团队在几个医院开始了利用疟原虫治疗晚期癌症的临床试验。在演讲公开的十个病人的数据里，有五个“有效果“，两个“好像已经治好了”，成效可喜。
这么看是不是确实很靠谱？很激动人心？八竿子打不着的疟疾和癌症居然有着隐秘的关系，一位中国科学家借此产生了一个天外飞仙的抗癌思路，还取得了初步成功，这个思路居然还暗合“以毒攻毒”的古老智慧！
请容我说一句，
且慢。
在急忙欢欣鼓舞，甚至急忙前往寻医问药之前，我想，几个非常关键的问题值得先考虑下。我会花点时间，给你慢慢道来。
1 理论基础
首先，我们看看陈小平整个研究的理论基础是不是牢靠。
也就是说，疟疾发病率和癌症死亡率，真的存在负相关的关系么？
我看到，陈小平的演讲当中，用了这么一张图，来说明两者的负相关关系。

初看好像合理，左边图里颜色深的部分（也就是疟疾高发地区），往往在右边图里比较浅（癌症死亡率低）——特别看非洲、中东、印度那里，对比非常醒目。
好像确实疟疾发病率高的地方，癌症死亡率低！
但是我可以很有把握的说，陈小平的演讲，用了一张假图。
右边这个图我不知道本来是什么用途，但它偏偏完全不可能是癌症死亡率图。图上的颜色深浅也根本不代表癌症死亡率的高低（其实你放大看看就能看到，它代表的是20个不同的世界区域的划分）
请注意，全世界范围内，美欧澳那几个地方确实是癌症高发的热点区域（这主要是受人均寿命提高的影响，癌症的发病率随年龄增加快速上升）。但是考虑到这些国家医疗水平的因素，癌症死亡率远远不是全球最高的。
作为证据，下图是我找到的2008年全球癌症死亡率（年龄矫正后的数据，来自美国华盛顿大学健康指标与评估研究所IHME）。你自己可以看看和陈小平用的图，区别有多大。

从这个信息出发，我得到的第一个信息是，陈小平研究的最初开端，很可能是一个读图错误，一个历史的误会……
不过，话说回来，演讲用了一个完全错误的图，是不是就一定说明，陈小平所说的疟疾发病率和癌症死亡率的负相关关系，根本就不存在呢？
倒也不能。
严谨起见，我去阅读了陈小平2017年发表的论文（Qin L et al Infect Agent Cancer 2017）。他在演讲中提到过这个研究，认为这项统计学研究证明了两者之间的负相关性。

简单来说，上面这个表格呈现的是五十多个国家当中，疟疾发病率和癌症死亡率随时间变化的趋势，有没有负相关。
通俗来说就是，一个国家如果疟疾发病率持续下降，那癌症死亡率是不是持续上升，或者反过来。
顺便说一句，这个比较方法，其实比陈小平演讲中提到的，比较不同国家之间疟疾发病率/癌症死亡率的办法，要更可靠一些。因为相对来说，这个方法更好的控制了不同国家制度风俗卫生系统等因素的影响。在这里我还要澄清一下很多人的一个误解。陈小平的研究确实使用了年龄矫正过的癌症死亡率数据，已经排除了因为某些国家卫生和经济发展落后、疟疾发病率高、人均寿命低，所以相应的癌症死亡率也低的可能性。
但结论如何呢？
整体而言，两个趋势之间的负相关性是非常微弱的。疟疾发病率变成原来的2倍，癌症发病率只会降低10%左右；疟疾发病率就算是上升10倍（这是一个非常可怕的如果），癌症发病率降低到原来的60%多。两个数值分别取对数之后计算，就得到了上图所示的约-0.2的回归系数（具体计算方法可以查阅论文内容）。
但是请注意，有另外两个重要因素，我们是必须考虑在内的：

1. 在疟疾流行的地区，抗疟疾药物，比如奎宁和青蒿素的使用自然也更加广泛。而一直有人猜测这两种药物可能本身就有抗癌效果，也有一些相关的研究（可以参考这个新闻：https://www.fiercebiotech.com/resea...nt）。因此，陈小平观察到的微弱的负相关性，也可能不是疟疾高发、而是抗疟疾药物使用的结果；
2. 已经有充分研究证明疟疾可以显著增加某些癌症的发病，特别是Burkitt’s Lymphoma（可以参考：Moormann and Bailey Curr Opin Virol 2016）。这种淋巴癌的高发地区也确实和疟疾流行地区高度重合。考虑到这个更加确凿的致病风险，疟疾和癌症死亡率即便真的有微弱的负相关关系，利用起来也需要非常审慎才行。

总结上面的讨论，我想可以比较稳妥地推断：
陈小平演讲中提到世界各地疟疾发病率和癌症死亡率负相关的时候，使用了有错误的图表；
陈小平2017年的统计学论文，并不能很好的支持随着时间变化，疟疾发病率和癌症死亡率变化趋势相反的结论；
疟疾发病率和癌症死亡率即便真的存在微弱的负相关关系，也需要进一步考虑疟疾致癌、以及抗疟药治疗癌症的重要干扰因素；
因此，至少陈小平研究的理论基础，本身就是有问题的。
2 临床数据
理论基础有问题，是不是后面的整个研究都不值得一驳？
也不是。
必须承认，理论依据有瑕疵，本身并不必然说明研究内容就一定不对。科学史上阴差阳错的发现多的是，甚至极端一点，为了证明一件事展开研究、最后反而把它推翻了的例子也比比皆是（比如著名的迈克尔逊莫雷实验）。
在疟疾抗癌这个案例里，我们还是得针对研究内容本身展开分析才好。
我们继续追问。
在陈小平的临床研究里，疟原虫真的治疗癌症了么？
我的看法是，很可疑。
陈小平在演讲里声称，已经有三十多个病人在接受疟原虫治疗，并且“已经看到效果了”。最强有力的证据是，十个最早的患者当中，五个有效，两个甚至“好像已经治好”了。
是不是真的呢？
陈小平这项临床研究的数据尚未公开发表。不过，陈小平在演讲里公开了一张统计图。

必须说明，这张图不是严肃的临床试验结果分析，缺少很多必要数据。这一点当然可以理解，毕竟陈小平并不是在严肃的学术场合讨论数据、而是在进行公众演讲。
不过既然陈小平主动公开了部分信息，我们自然可以对此展开一些分析。而且你会看到，仅仅根据这点信息，我们也能看出很多东西了。
首先解释一下背景信息：怎么评估一种抗癌药物的有效性？
这个问题当然是非常专业的，一两句话很难概括完整。就简单说一点点吧，抗癌药物最重要的金标准，是看是不是能够有效延长患者的生存期，这就是所谓总生存期的指标（OVERALL SURVIVAL, OS）。大部分癌症药物最终获得上市批准，需要提供OS的信息。不过在很多临床试验里，OS难以快速衡量（毕竟很多患者会活好几年几十年，而临床试验一般也就几个月到几年）。所以在临床试验、特别是早期临床试验当中，研究人员会用一系列替代性的指标作为分析依据。
这其中可能最重要的一种叫做客观缓解率（OBJECTIVE RESPONSE RATE, ORR）。在较短的期限内衡量癌症药物的疗效，ORR是最常用的指标之一。
所谓ORR，衡量的是在临床试验过程中，有多少患者的肿瘤，在接受治疗后出现了完全的（完全缓解，COMPLETE RESPONSE, CR，一般标准是每个病灶都要缩小到1厘米直径下）或者是部分的缩小（部分缓解，PR，PARTIAL RESPONSE，一般标准是肿瘤直径缩小30%以上）。
与之相对应的，如果患者的肿瘤持续增大，超过20%，被认为是疾病进展（PD），也就是说治疗无效。如果患者的肿瘤变化的情况，在进展和缓解之间，叫做疾病稳定（SD）。
当然必须说明，这仅仅是最肤浅的一点背景信息。临床数据分析是个特别复杂的工程，什么时候测量肿瘤的尺寸，怎么测，测几次，用哪一次的数据，都是需要事先制定方案严格执行的。这样一刀切的操作当然会带来一些不可避免的误判。但真实世界里，每个病人的情况千变万化，必须有一个一碗水端平的客观评估标准，才能保证临床研究的有效性。
根据这些信息，我们再回头看看陈小平提供的表格。
十个患者，五个注明了PD（疾病进展），三个SD（疾病稳定）。还有两个标绿的患者，没有说明CR/PR/SD/PD的情况，是单独用文字解释的，就是陈小平演讲当中提到的“可能已经治好”的病人。
我们首先就来看这两个最鼓舞人心的案例。
我接下来会说明，这两个患者，根本不能被当做疟原虫治疗有效的案例看待，更不要说当作“可能治好”的案例来大肆宣传了。
先看左边那个标绿的患者。
陈小平演讲中解释，这个患者用疟原虫治疗之后，肿瘤形状变化，因此用手术切除，无病生存至今。

这当然是好消息！
但是这个案例的治疗，能归功于疟原虫疗法么？
不可以！
在正规的临床试验分析当中，这个患者在停止疟原虫治疗、接受肿瘤切除手术的时候，就已经不能看作是疟原虫临床试验的成员了（术语所谓的出组）。对他的疗效评估，正确的做法是在这之前就检查肿瘤尺寸，并且按照CR/PR/SD/PD的类别归类进行数据分析。（从上图非常有限的信息看，这位患者归类更大的可能性是SD）。
这是为什么呢？
道理其实不难理解。在真实世界里，癌症病人往往面临多种治疗方案的选择，而且往往需要多种方案组合治疗。这个当然无可厚非。但是这种操作给客观评估一种新疗法的作用增加了困难（很简单，功劳到底算哪一种方法的？）。
因此在早期临床试验中，一般会要求患者只接受一种治疗方案。陈小平他们的临床试验也有同样的要求，入组患者不能同时接受别的治疗。这一点在中国临床试验注册中心的数据库里也有体现。

所以当一个患者决定脱离这种待评估的治疗方法（疟原虫治疗），转而使用另一种疗法（微创手术）之后，就不能再作为一个有效的数据点了。否则以此类推，如果接受疟原虫治疗的患者，同时偷偷吃了别的化疗药、打了CAR-T、甚至是请了气功大师给自己发功，还真的看到肿瘤缩小了。。。
效果算谁的？
这个道理不难理解吧？
我们再说右边那位标绿的患者。
陈小平在演讲中也提到了，这位患者疟原虫治疗结束几个月后发现，虽然肿瘤大小没变，但是PET-CT结果提示肿瘤代谢活性消失。肿瘤代谢活性消失，提示癌细胞可能正在缓慢死亡，这当然也是非常大的好消息。

但是这个患者能算被疟原虫疗法“好像治好”了么？
对不起，这个例子也很成问题。
第一个问题是和上面一样的：这位患者在结束疟原虫治疗几个月之后看到的结果，你怎么就那么肯定是疟原虫导致的？这个患者在此期间接受别的治疗了么？根据演讲内容，这位患者之后回了老家生活，那疟原虫临床研究团队能对这位患者的用药情况精确追踪么？这些信息陈小平并没有提供，只能存疑。
第二个问题是，所谓“肿瘤代谢活性消失”，当然是一件好事，也是临床研究中应该追踪和分析的有效数据。但是请注意，在这10位患者的数据当中，其他八位患者是用SD/PD——也就是简单的肿瘤大小指标——进行衡量的。而如果套用同样的标准分析这位患者的PET-CT图，他大概率是属于SD类别。那问题就来了，为什么不同的患者没有使用同样的分析标准呢？
说到这里我们就可以小结一下了，至少从这非常有限的十个数据来看，疟原虫疗法的效果根本不是五个有明显的效果，两个可能治好！
首先，两个“可能已经治好”的案例，如果稍微严格一点评估，可能都属于SD（疾病稳定）的组别。那么这十位患者更应该被定义为五个PD（疾病进展），五个SD（疾病稳定）。如果真要较真一点计算治疗方案的有效性，也就是ORR，是0%……（当然，如此有限的数据信息是不足以支持任何ORR计算的，在早期临床当中也并不需要，仅给读者做个操作演示）
其次，即便我们放宽标准，认为疾病稳定也可能是治疗的结果，也不能简单粗糙的把五个SD患者直接叫做“有比较明显的效果”。在临床试验评估的短暂时间内，即便是晚期癌症患者，癌症病灶不持续快速增大的情况也比比皆是。因此需要追问的问题是，陈小平是根据什么比较，认定这五个SD患者是属于治疗有效的情形的？他们有没有和真实世界数据进行比较（也就是接受其他治疗、或者没有接受治疗的同类型癌症患者的数据）？
第三，特别要提醒的是，“治好”这两个字是无论如何不能随便使用的。在临床实践中，一般只有症状完全缓解（也就是上文提到的CR）、并持续五年的病例，才能成为临床治愈。在陈小平的故事里，这两位患者确确实实看到了曙光（暂且不论曙光到底是不是疟原虫的功劳），但是距离完全缓解尚且距离很远，更不要说临床治愈了！这种轻率的说法，会给患者带来虚假的希望和不必要的情绪负担。我们后面再展开讨论这一问题。
说到这里，陈小平提供的临床信息，我已经分析的差不多了。
但是你可能还有两个疑问：
十个病例太少了是不是不能说明问题？是不是可以多做一些再下结论？在批评之前，我们是不是应该给陈小平更大的耐心？
就算效果不太好，反正患者也已经走投无路，给他们一个死马当作活马医的选择行么？
这两个问题都很好。
我们先说第一个问题。
没错！评估一个癌症疗法，特别是一个革命性的新方法，十个数据点确实太少太少了。想要全面评估，更多的患者数据是必须的。这一点我们也讨论过了。
但是拿着远不足以说明问题的十个数据在大众平台上声明疗法有效，还出现了“可能已经治好”的患者案例，并且加上“杀死癌症”“癌症疫苗”美名引爆互联网的，不正是陈小平么？
需要更有耐心，需要更保守更稳妥，需要等更多数据再评价，再宣传，再公开招募更多的受试者的，不是批评者，而是陈小平，对不对？
反过来说，既然宣传已经是这么火热，那么给泼泼冷水，防止更多人被误导，是不是就特别必需了？
我们再说第二个问题：不管疗法到底如何，给走投无路的患者提供一个选择是不是好的？
这个看法不光你会有，陈小平本人其实也是这么说的。

但是这个说法其实是问题很大的。
用常识你就可以判断，世界上大多数医疗骗局都是这个套路：反正你也没办法了，干脆死马当成活马医。权健这么说，气功大师这么说，祖传神医也这么说。
平心而论这个说法的说服力是很强的。它很好的利用了癌症患者焦急无奈绝望的心理，和对医疗知识的不熟悉，趁虚而入。我扪心自问，真的有这么一天，我自己也不一定扛得住诱惑。
而这，恰恰也是为什么各个国家对医疗产品的上市和应用，都有严格的监管程序！
恰恰是因为患者在很多时候没有做出理性判断的知识和情绪，所以国家动用专业力量，来帮你做最后的把关。帮你评估这个产品是不是真的合法，是不是真的安全有效。是真的提供了最后的救济和希望，还是在利用你的恐惧谋财害命。
那么疟原虫疗法是不是这种情况呢？
我不想做任何没有根据的推断。从能查到的资料看，陈小平他们公司做的临床试验都是合法合规的，有伦理批件，在正规医院进行，临床试验有备案。这个必须要说明。
但是，有一个细节让我有点不太踏实。
他们临床研究招募病人的条件，根本不是陈小平所说的其他任何方法无效，走投无路！甚至，在他们2017年开始的一个临床研究中，还有这么一条（信息来自中国临床试验注册中心的数据库）：

也就是说，哪怕一个患者刚刚发病，任何正规治疗都没有进行（包括手术和化疗），只要他“强烈要求”，就可以进行疟原虫试验！（一个很有趣的对比是，在同一团队提交在www.clinicaltrials.gov的英文临床试验说明里，却没有“强烈要求”这一条。）
这是种非常让人难以理解的操作。
只需要用常识就可以判断，这个条件给诱导更多的患者加入临床试验留了多大的空子——甚至是那些刚发现疾病、本来应该接受各种正规治疗方案的患者。我很好奇，在目前接受疟原虫治疗的患者当中，有多少是这种情形？他们当中有多少，如果早点开始正规治疗，可能癌症真的已经治愈或者明显得到控制了？他们当中又有多少，可能被疟原虫疗法耽误了治疗？
3 生物学机制研究
讨论了原初的理论依据，讨论了最近的临床信息，我们最后再来看看这当中生物学机制的研究。这部分专业性更强，因此我留在最后一部分。
我们来审查一下，虽然立项依据存疑，临床结果存疑，那么这项研究彻头彻尾就是无稽之谈么？
公道说，也不一定。
陈小平的这项研究，从原理上说，是用疟原虫引发患者全身性的免疫反应（高烧就是一个证明），然后寄希望于这种免疫反应能够帮助人体杀伤肿瘤细胞，治疗癌症。
这部分工作，部分发表于2011年的PLOS ONE杂志（Chen et al PloS ONE 2011）。
简单来说，陈小平团队发现，如果给小鼠接种癌细胞的同时也注射一些携带疟原虫的红细胞，那么肿瘤的生长会受到明显的抑制。他们也分析了几个免疫学指标，发现这些小鼠体内的天然免疫和获得性免疫系统都被激活，因此推测免疫系统的激活杀伤了癌细胞。

这个现象本身其实并不奇怪。一种高毒性病原体的入侵理所当然的会激活动物身体的免疫系统；而免疫系统也确确实实能够杀伤癌细胞。
其实说白了，这就是最近几年火热的“癌症免疫”的思路嘛。
熟悉新闻的人应该还记得，2018年的诺贝尔生理或医学奖，就发给了开启”癌症免疫疗法“的两位科学家。他们的贡献，就是帮助人类找到了一条对抗癌症的革命性道路：通过重启免疫系统的功能，杀伤人体癌细胞，治疗癌症。
更重要的是，在他们的研究指引下，好几种癌症免疫药物（特别是著名的O药Opdivo和K药Keytruda）已经上市，并且在好多不同的癌症类型当中都取得了很好的效果。
这种癌症免疫药物，和疟原虫抗癌，有关系么？
不是没有可能。
癌症免疫疗法这个思路，最早的发轫，可以追溯到100多年前。
19世纪末，美国医生威廉·科利（William Coley）偶然发现某些癌症患者在出现细菌感染、严重高烧之后，癌症居然奇迹般地消失了。这个现象也把科利医生彻底带上了一条全新的治疗道路。他自己制备了很多治病细菌的培养液（所谓”科利毒素“），给不同的癌症患者接种，试图重现高烧杀死癌症的奇迹。据说，他可能在数百位患者身上做过类似的尝试，还颇有一些患者的肿瘤出现了缓解甚至治愈。
只是由于这种操作可控性非常差（每个患者需要注射的剂量次数都不一样），安全性也很差（持续高烧对于很多癌症患者是致命的），科利医生又始终无法解释他的治疗效果是因何而来，所以慢慢就被新兴的放射性治疗和化疗药物给取代了。直到最近二十年，人类才彻底搞清楚这背后的机理，并且开发出了全新的革命性药物——也就是上面提到的癌症免疫药物。
说到这，你可能已经意识到了：科利医生在100多年前的尝试，和陈小平如今的尝试，其实从现象上看，是非常相似的。
他们都是用病原体感染人体（细菌 vs 寄生虫），引发人体系统性的免疫反应（持续的高烧就是证明），然后期待这种系统性的免疫反应能够帮助杀死癌细胞。
那这么说，陈小平的研究，机制上靠谱？
先等等。
我们先问一个假设性的问题：
在人类已经发明了更加可靠、安全和有效的癌症免疫药物，能够更加特异的激活针对癌细胞的免疫机能，在不引发过度强烈的人体炎症反应的前提下有效杀伤癌细胞的时候，如果让你选择，你还会主动放弃O药和K药，专门去给自己打一针剧毒细菌，用其实历史更悠久、但是疗效和副作用都难以控制的科利毒素来治病么？
你会么？
我猜你不会。
那如果，把科利毒素换成不光副作用难以控制，而且直到现在都还缺乏有价值的临床疗效信息（“五个有效两个治好”的神话，我已经讨论过真实性了）的疟原虫，你的选择是什么？
这才是问题的关键。
陈小平关于疟原虫抗癌的小鼠模型研究，确有可能真实有效（尽管他们2011年的论文也有不少硬伤，我们下文提）。和科利毒素类似，疟原虫确实有可能恰好通过激发了某些患者体内的某种特殊的免疫反应，起到了治病的效果。
如果搞清楚这背后的机理加以利用，走出一条全新的对抗癌症的道路也不是不可能。
而不是：
急吼吼地把这种生物学机制仍然几乎是空白的研究推向临床；
急吼吼地在临床都还没有得到什么有意义的信息的时候，就对着全国人民喊话“已经有五个病人有效，两个病人好像治好了”；
急吼吼地在这个阶段借机放出临床试验负责人的联系方式，让没有太多医学知识储备的老百姓盲目的去加入其中！
这样不对，那应该怎么做？
我们来做一个简单的比较，看看真正的癌症免疫疗法是怎么一步步走到今天的吧。
看O药的发明历史，其中有几个非常重要的节点（为了简化讨论，我省略了一些比较曲折地历史变迁，请业内专家见谅）：
十九世纪末，科利医生发现细菌感染引起的高烧有时候能够治疗癌症，但并不理解原因；
在二十世纪，伴随着免疫学的研究，人类逐渐开始猜测，科利毒素的作用可能是激活人体免疫反应杀伤癌细胞；
上个世纪九十年代，日本人本庶佑发现小鼠如果缺乏一个名为PD-1的蛋白质，很容易患上自身免疫疾病。因此提示PD-1蛋白质抑制了免疫系统的功能；
世纪之交，华人科学家陈列平发现一个名为PD-L1的蛋白质也有类似功能，而且PD-L1在肿瘤组织高度富集，因此提示了一个可能性，就是癌症细胞可能是通过PD-L1抑制了免疫系统的杀伤从而存活的；
世纪之交，本庶佑和合作者发现PD-1和PD-L1相互结合恰为一对。因此理论上说，如果能够用一种药物抑制PD-1或者PD-L1，都能起到重新唤醒免疫系统、杀伤癌细胞的作用；
又历经超过10年的开发之后，2014年，一种针对PD-1的单克隆抗体药物Nivolumab上市，这就是鼎鼎大名的O药。
不知道你看到区别没有？
在研究开始的时候，研究者们面对的其实都是一个简单的、难以完全理解的现象——病原体引发的高烧可能能杀伤肿瘤。
但是从科利毒素到PD-1和PD-L1的发现，再到Nivolumab的开发和临床试验，人类用了一个多世纪时间，把一种复杂难解的、充满不可控因素的原始毒素，变成了如今可以大规模生产和广泛应用的革命性药物。
陈小平做的疟原虫抗癌的研究，从发表的数据来看，确实存在一种可能性，那就是疟原虫感染可能激活了人体的天然或者获得性免疫系统，从而对癌细胞产生了一定的杀伤效果。但是这种可能性仍然需要非常审慎的处理。比如说，他们2011年的研究并没有比较疟原虫感染的抗癌效果是不是就比简单的发一场高烧更好（如果不是，那为什么要用会带来严重副作用的疟原虫）；没有比较各种毒性不同的疟原虫是不是同样有效（如果确实是，那就没有比较选用对人体伤害较大的类型）；没有研究更多的肺癌动物模型、更没有测试其他的癌症模型（如果没有，怎么可以随便在人身上测试其他种类的癌症）…… 在这些机制问题得到严肃探究之前，轻率地开展人体实验不是一个合理的选择。
而且，退一万步说，即便这种可能性得到了严格证明，在科利毒素诞生100多年后的今天，在人类对抗癌症的技术、人类理解生命现象的能力已经鸟枪换炮的背景下，更应该做的，是就像上面讲述的O药发明历程一样，去深入去挖掘这背后的机理，搞清楚疟原虫究竟激活了人体的什么免疫细胞、如何激活、哪部分激活是有意义的而哪部分激活是非特异性的而需要避免的、最终引导我们开发出有效、安全的新药。
说的更直白点，就是一种模拟甚至加强疟原虫抗癌效果、同时规避疟原虫强烈副作用的药物。
而不是去简单粗暴的模仿100多年前的科利医生，直接把毒素往人体注射。
屠呦呦先生找出了青蒿素，那么今天的疟疾患者就不需要再去用成捆的青蒿泡水了——那个又麻烦又没有多少有效成分，可能还有植物毒素中毒的可能。
疟原虫的研究，难道不是应该也见贤思齐么？
最后的话
这些讨论文章在微博发出后，收获的主要是批评和谩骂，这个自不多说，我尽我的责任而已。在这里我吸收了几位业内专家的意见加以修改再次发出。如果还有纰漏和错误，请大家帮我指出。
我的目的不是为了打倒谁，批判谁。
我的目的很简单，希望对“疟疾抗癌”欢欣鼓舞甚至跃跃欲试的人们，再多看看，多想想。
希望疟疾抗癌的研究，如果真的有那么一点点希望，也可以有机会做的更好更确凿，而不是拔苗助长，杀鸡取卵。
而且，即便被骂得体无完肤，几条该说的警告，还是得说出来才好。
坚决反对将一项非常早期的、远未接近成功的研究加以包装，轻率的推向公众。就像我们已经看到的，这会极大地误导不具备太多医学知识的老百姓，给他们虚假的希望，甚至是不切实际的幻想。
作为当事人，陈小平在公众演讲中贸然宣称“五个有效两个可能治好”，通过大众媒体招募临床试验受试者，这是夸大宣传和误导最根本的推动力！我甚至查询得知，早在十几年前陈小平本人还在媒体宣扬过”疟疾抗艾滋病“的故事（参见2001年健康报的报道“疟疾疗法抗艾滋”。当然没有下文）。请问作为一个科学家，这种做法合适么？
媒体在报道专业性比较强的新闻的时候，请做好事实核查！特别是中科院SELF论坛和中科院官微。作为具有巨大公信力的研究机构代言人，在任何场合都不应该为一项如此早期的，缺乏可信数据的研究背书站台，甚至是帮助招募临床试验受试者。同时，我没有看到任何一个主流媒体的报道，采访了持反对意见的专业人士。
就生物学研究本身而言，陈小平团队当然有权利和自由，就疟原虫抗癌的可能机制进行持续研究，找出他们背后可能的机理，助力药物开发。但是根据上面的讨论，很明显，陈小平的研究团队，需要有更专业的研究人员参与。从他演讲中提到的信息来看，他们在流行病学、癌症生物学、免疫学、临床试验设计、药物开发等等方面的能力是有很大欠缺的。
最后，祝终有一天，天下无癌。
相关阅读
疟疾能治癌？连正式论文还没发表，疑似又是一波炒作
专家点评“疟疾治愈癌症”：使用“治愈”易误导大众
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"Through poisoning" Plasmodium can cure cancer? Is this therapy really reliable?
"Through poisoning" Plasmodium can cure cancer? Is this therapy really reliable?

Produced | Sina Technology "Science everyone"

Author | Wang Liming Professor, Researcher, Doctoral Supervisor, Institute of Life Sciences, Zhejiang University

In the past few days, there has been a news screen from the scientific community. Researcher Chen Xiaoping of the Guangzhou Institute of Biomedicine and Health of the Chinese Academy of Sciences (hereinafter referred to as Chen Xiaoping) introduced his research work in a public speech at the SELF Forum of the Chinese Academy of Sciences – using Plasmodium to successfully treat patients with advanced cancer.

Such a large research idea of the brain hole is such an important clinical progress, and the comments of netizens are also fancy praise and support.

If you haven't had time to watch the video yet, I will help you briefly summarize the relevant content:

During his early years of study, Chen Xiaoping accidentally discovered that the geographical distribution of malaria incidence and cancer mortality in the world seems to have a negative correlation, and the initial idea that "malaria may cure cancer" has emerged;

Later, their team found in a mouse model that malaria-causing Plasmodium can significantly inhibit tumor growth, and also studied the mechanism behind it, perhaps by activating the immune system function of mice;

In the past two years, their team has started clinical trials using Plasmodium to treat advanced cancer in several hospitals. Among the data of the ten patients who were publicly announced, there were five "effective" and two "it seems to have been cured", and the results were gratifying.

Is it really reliable to see it this way? Very exciting? Malaria and cancer, which cannot be beaten by gossip, have a secret relationship. A Chinese scientist has produced an anti-cancer idea of Feixian, and has achieved initial success. This idea actually coincides with the ancient wisdom of "to attack poison"!

Please let me say,

And slow.

Before rushing to rejoice and even rushing to seek medical advice, I think several key issues are worth considering. I will take some time to give you a little time.

1 Theoretical basis

First of all, let us see if the theoretical basis of Chen Xiaoping's entire research is not solid.

In other words, is there a negative correlation between malaria incidence and cancer mortality?

I saw that Chen Xiaoping’s speech used such a picture to illustrate the negative correlation between the two.

At first glance, it seems reasonable. The dark color in the left picture (that is, the high-risk area of malaria) is often shallow in the right picture (low cancer mortality) - especially in Africa, the Middle East, and India, the contrast is very eye-catching.

It seems that where the incidence of malaria is high, the cancer mortality rate is low!

But I can safely say that Chen Xiaoping’s speech used a fake picture.

I don't know what the original figure is on the right side of the picture, but it is completely impossible to be a cancer mortality chart. The color depth on the map does not at all represent the level of cancer mortality (in fact, you can see it by zooming in, it represents the division of 20 different world regions)

Please note that in the world, the United States, Europe and Australia are indeed hot spots for cancer (this is mainly due to the increase in life expectancy, and the incidence of cancer increases rapidly with age). But taking into account the medical level of these countries, cancer mortality is far from the highest in the world.

As evidence, the chart below shows the 2008 global cancer mortality rate I found (age-corrected data from the University of Washington Institute for Health Indicators and Assessment IHME). You can look at the picture used by Chen Xiaoping, and the difference is big.

Starting from this information, the first information I got was that the initial beginning of Chen Xiaoping’s research was probably a reading error, a historical misunderstanding...

However, in the end, the speech used a completely wrong picture. Does it necessarily mean that Chen Xiaoping’s negative correlation between malaria incidence and cancer mortality does not exist at all?

It can't be done.

Strictly speaking, I went to read the paper published by Chen Xiaoping in 2017 (Qin L et al Infect Agent Cancer 2017). He mentioned this study in his speech and concluded that this statistical study proved a negative correlation between the two.

Simply put, the above table shows the trend of malaria incidence and cancer mortality over time in more than 50 countries, with or without a negative correlation.

In layman's terms, if a country's malaria incidence continues to decline, then whether the cancer mortality rate continues to rise, or vice versa.

By the way, this comparison method is actually more reliable than the one mentioned in Chen Xiaoping's speech, comparing malaria incidence/cancer mortality among different countries. Because relatively speaking, this method better controls the influence of factors such as institutional customs and health systems in different countries. Here I would like to clarify a misunderstanding of many people. Chen Xiaoping’s research does use age-corrected cancer mortality data, which has ruled out the possibility of corresponding cancer deaths due to poor health and economic development in some countries, high malaria incidence, and low life expectancy.

But what about the conclusion?

Overall, the negative correlation between the two trends is very weak. The incidence of malaria has doubled, the incidence of cancer has only decreased by about 10%; the incidence of malaria has increased by 10 times (this is a terrible if), and the incidence of cancer has dropped to more than 60%. The two values are calculated after taking the logarithm, and the regression coefficient of about -0.2 shown in the above figure is obtained (the specific calculation method can refer to the paper content).

But please note that there are two other important factors that we must consider:

In areas where malaria is endemic, the use of anti-malarial drugs such as quinine and artemisinin is naturally more widespread. It has been speculated that these two drugs may have anti-cancer effects in themselves, and there are some related studies (refer to this news: https://www.fiercebiotech.com/research/new-insight-into-why-malaria-drugs -work-against-some-cancers-could-boost-drug-development). Therefore, the weak negative correlation observed by Chen Xiaoping may not be the result of high malaria, but the use of anti-malarial drugs;
There has been extensive research to show that malaria can significantly increase the incidence of certain cancers, especially Burkitt's Lymphoma (see: Moormann and Bailey Curr Opin Virol 2016). This high-risk area of lymphoma does coincide with malaria-endemic areas. Given this more rigorous risk of disease, even if there is a weak negative correlation between malaria and cancer mortality, it takes a lot of prudence to use it.

Summarizing the above discussion, I think it can be safely inferred:

When Chen Xiaoping mentioned the negative correlation between malaria incidence and cancer mortality in the world, he used the wrong chart;

Chen Xiaoping's 2017 statistical papers do not support the conclusion that the trend of malaria and cancer mortality changes in opposite directions over time;

Even if there is a weak negative correlation between malaria incidence and cancer mortality, further consideration needs to be given to malaria carcinogenesis and important interference factors for antimalarial treatment of cancer;

Therefore, at least the theoretical basis of Chen Xiaoping's research is inherently problematic.

2 clinical data

There is a problem with the theoretical foundation. Isn’t the entire study behind it worthy of a refutation?

Nor is it.

It must be acknowledged that the theoretical basis is flawed, and it does not necessarily indicate that the research content is necessarily wrong. There are many discoveries in the history of science that are, even more extreme, examples of proving one thing to be studied and eventually overthrowing it (such as the famous Michelson Morey experiment).

In the case of malaria anti-cancer, we still have to analyze the research content itself.

We continue to ask.

In the clinical study of Chen Xiaoping, did the malaria parasite really treat cancer?

My opinion is that it is very suspicious.

In his speech, Chen Xiaoping claimed that more than 30 patients have been treated for Plasmodium and “have seen results”. The strongest evidence is that five of the ten earliest patients are effective, and two even "seems to have been cured."

Is it true?

Chen Xiaoping's data on this clinical study has not been published. However, Chen Xiaoping published a chart in his speech.

It must be stated that this picture is not a serious analysis of clinical trial results and lacks a lot of necessary data. This is of course understandable. After all, Chen Xiaoping did not discuss data in serious academic situations, but was conducting public speeches.

However, since Chen Xiaoping has actively disclosed some information, we can naturally carry out some analysis. And you will see that we can see a lot of things based on this information alone.

First explain the background information: how to evaluate the effectiveness of an anticancer drug?

This problem is of course very professional, and it is difficult to summarize one or two sentences. To put it simply, the most important gold standard for anticancer drugs is to see if it can effectively prolong the survival of patients. This is the so-called overall survival index (OVERALL SURVIVAL, OS). Most cancer drugs are finally approved for marketing and need to provide information about the OS. However, in many clinical trials, OS is difficult to measure quickly (after all, many patients will live for several decades, and clinical trials are usually months to years). Therefore, in clinical trials, especially early clinical trials, researchers use a range of alternative indicators as a basis for analysis.

One of the most important ones is called OBJECTIVE RESPONSE RATE (ORR). Measuring the efficacy of cancer drugs in a short period of time, ORR is one of the most commonly used indicators.

The so-called ORR measures how many patients have tumors during the clinical trial, and after treatment, there is complete (complete remission, COMPLETE RESPONSE, CR, the general standard is to reduce each lesion to 1 cm diameter) Or partial reduction (partial relief, PR, PARTIAL RESPONSE, the general standard is that the tumor diameter is reduced by more than 30%).

Correspondingly, if the patient's tumor continues to increase, more than 20%, is considered to be disease progression (PD), which means that the treatment is ineffective. If the patient's tumor changes, between progression and remission, it is called disease stabilization (SD).

Of course, it must be stated that this is only the most superficial background information. Clinical data analysis is a particularly complicated project. When to measure the size of a tumor, how to measure it, how to measure it, and which data to use, it is necessary to strictly implement the plan in advance. Such a one-size-fits-all operation will certainly bring some unavoidable misjudgments. However, in the real world, the situation of each patient is ever-changing, and there must be a bowl of water-level objective assessment criteria to ensure the effectiveness of clinical research.

Based on this information, we will look back at the form provided by Chen Xiaoping.

Ten patients, five noted PD (disease progression), three SD (stable disease). There are also two patients with green color, which do not explain the CR/PR/SD/PD situation. They are explained in words alone, which is the patient who may have been cured in Chen Xiaoping's speech.

Let us first look at the two most inspiring cases.

I will explain next that these two patients cannot be treated as a case of effective treatment for malaria parasites, let alone publicized as a case of "possible cure."

First look at the green patient on the left.

Chen Xiaoping explained that after the patient was treated with Plasmodium, the shape of the tumor changed, so he was surgically removed and survived without disease.

This is of course good news!

But can the treatment of this case be attributed to malaria parasite therapy?

No!

In a formal clinical trial analysis, this patient was not considered a member of the Plasmodium clinical trial when the Plasmodium treatment was stopped and tumor resection was performed (the term so-called outgroup). For his efficacy evaluation, the correct approach is to check the tumor size before this, and to conduct data analysis according to the CR/PR/SD/PD classification. (From the very limited information in the picture above, this patient is more likely to be classified as SD).

Why is this?

The truth is not difficult to understand. In the real world, cancer patients often face a variety of treatment options, and often require multiple combinations of treatments. This is of course nothing wrong. But this kind of operation adds to the difficulty of objectively evaluating the role of a new treatment (very simple, which method is the best?).

Therefore, in early clinical trials, patients are generally required to receive only one treatment option. Chen Xiaoping has the same requirements in their clinical trials. Patients who are enrolled cannot receive other treatments at the same time. This is also reflected in the database of the China Clinical Trial Registry.

So when a patient decides to leave the treatment to be evaluated (malaria treatment) and switch to another treatment (minimally invasive surgery), it can no longer be a valid data point. Otherwise, if the patient receiving the Plasmodium treatment secretly ate other chemotherapy drugs, hit the CAR-T, or even invited the Qigong master to give himself a hard work, he really saw the tumor shrinking. . .

Who is the effect?

This truth is not difficult to understand?

Let's talk about the green patient on the right.

Chen Xiaoping also mentioned in the speech that this patient has been treated for a few months after the treatment of Plasmodium. Although the tumor size has not changed, the PET-CT results suggest that the tumor metabolic activity disappears. The disappearance of tumor metabolic activity suggests that cancer cells may be slowly dying, which is of course very good news.

But can this patient be considered "polished" by Plasmodium therapy?

Sorry, this example is also very problematic.

The first problem is the same as above: the result of this patient's treatment after the end of the malaria parasite treatment, how do you be so surely caused by the malaria parasite? Has this patient received any other treatment during this period? According to the content of the speech, the patient returned to his hometown. Can the Plasmodium clinical research team accurately track the patient's medication? Chen Xiaoping did not provide this information and could only be suspicious.

The second problem is that the so-called "metabolism of tumor metabolism" is of course a good thing and an effective data that should be tracked and analyzed in clinical research. But please note that among the data of these 10 patients, the other eight patients use SD/PD - that is, Jane

 

[halsey02]

Yes. The mainland chinks will kill you. And so you did not die of cancer. Technicality that should be ignored

The tiongbu will kill you first....in so many ways! ha ha ha ha ha