In June this year, the New England Journal of Medicine published the results of a small clinical trial in which 14 patients with locally advanced rectal cancer with rare mutations (mismatch repair defects, dMMR) miraculously made the tumor "disappear" and all recovered after receiving experimental immunotherapy.
1. Unprecedented! 100% rehabilitation of patients with experimental cancer treatment
In this html phase 22 clinical trial, in order to verify the efficacy of immunotherapy drug Dostarlimab, a total of 14 locally advanced rectal cancer patients were recruited, and the patients were given medicine every 3 weeks for 6 months.
After follow-up 6-25 months after the experiment, all the patients participating in the study found no signs of cancer recurrence, and no further standard treatment such as surgery, radiotherapy and chemotherapy were required.
What is even more surprising is that no patient reported adverse reactions of grade 3 or above. It can be said that the drug has completely disappeared from the patients' tumors, and the cure rate reaches 100%.
Comparison between patients before and after taking medication
As soon as the news came out, many people were excited about it, and many cancer friends felt that they had medicine to cure it again. However, some people have raised questions: Isn’t this drug still in the clinical trial stage? If clinical trials say they are OK, they will do it? What if the effect is not good after clinical application?
clinical trial, some people regard it as the "last hope", while others think it is to be a "villain mouse" and feel a sense of resistance. Faced with some favorable results, how should cancer friends correctly view it? Xiao Ai will give you a good talk today.
2. Are the results of clinical trials reliable?
Innovative biopharmaceutical research and development is a difficult and long process. Carrying clinical trials is to collect clinical data to establish models, and then evaluate the efficacy and safety of the drug.
clinical trials are generally divided into phases I, II, III and IV.
- Phase I clinical trial mainly studies people's tolerance to new drugs. proposes a preliminary, safe and effective dosing regimen to guide the next phase of clinical trials.
- Phase II clinical trial is the preliminary evaluation stage of therapeutic effect. The purpose is to conduct a preliminary exploration of the effectiveness and other characteristics of , while observing the safety of drugs. is the weather vane of phase III clinical trials.
- Phase III clinical trial is the stage of confirming the therapeutic effect. This stage of will conduct a deeper study on the safety and effectiveness of the drug.
- Phase IV clinical trials mainly examine the efficacy and adverse reactions of drugs under widely used conditions, evaluate the relationship between benefits and risks of use in ordinary or special groups, and improve the dosage of drugs, etc.
In the mindset of many patients, "clinical trials" are just scientific research, and it is difficult to say whether the research results are reliable.
In fact, in clinical trials, through professional collaborative work, a professional team composed of specific research doctors, research nurses, and clinical coordinator will strictly control the trial process and carefully take care of the subjects. Patients were randomly assigned to the control group to receive existing standard therapy.
The so-called standard therapy is a solution that has been proven to be effective and widely used in clinical practice. Currently, most of the clinical trials of phase 2 and phase 3 of drugs are conducted in my country. Most of them are drugs that have been launched abroad, or new foreign drugs are copied from my country, and the technology is relatively mature. Therefore, clinical trials followed scientific principles, laws and regulations, and ethical principles, excluded some fraud. After the fourth phase of the trial, the final results were highly reliable.
3. When cancer is "no cure", will it be possible to "get your wish" after participating in clinical trials?
clinical trial should be one of the important options for the treatment of advanced tumor patients. But to become a drug tester, if you want to participate in clinical trials, you must know the following three things.
. Clinical trials are not when the "villain"
The treatment method for the first time, most patients have doubts or resistance. Some patients even if they are told to participate, they will have a question mark in their hearts. Do the doctor ask patients to be "villain"?
In fact, clinical trials are conducted in drug clinical trial institutions recognized by the State Food and Drug Administration. These drug clinical trial institutions generally have considerable reputation and scientific research capabilities. At the same time, if you participate in the drug test, you will sign a legal agreement . The trial of each drug will comply with strict operating procedures, and the entire process will be tested and cared for by professionals. does not just take a drug to the patient. There will also be many risk response measures during the experiment, so participating in clinical trials cannot be simply understood as "being a guinea pig".
. Participate in clinical trials and have a greater possibility of benefiting
"The Lancet" An analysis research paper based on the data of the National Cancer Institute (NCI) Cancer Treatment Evaluation Program (CTEP) in the past 20 years shows that the results of the current Phase 1 clinical trial of solid tumors have made great progress compared with the past. In different research stages of the Phase 1 clinical trial, the risk of treatment-related death in patients with different types of tumors remains below 1% (except pancreatic cancer ), and the degree of benefit of patients has significantly improved in the past 20 years. The treatment-related toxicity tends to decrease and remains stable with the extension of treatment time.
Specifically, patients participating in clinical trials may obtain:
① Understand and use the latest therapeutic drugs;
② Monitoring and prevention and control of professional medical teams;
③ Reduction and exemption of examination and treatment costs;
Some basic subsidies: blood collection, transportation, nutrition, etc.
. Participating in clinical trials may not necessarily lead to "full"
Of course, there are also some uncertain factors in clinical trials, and patients also need to bear corresponding risks. For example, the visit time of is complicated and rigid, and the patient may spend more time and energy; the new drug may not increase the efficacy but become toxic; it is assigned to the control group, and the treatment may be ineffective and does not achieve the expected effect.
However, if an unexpected emergencies really occur, researchers will deal with various adverse reactions as soon as possible. When the toxicity is intolerable or the drug is ineffective, the patient needs to withdraw from the trial treatment and replace other clinical treatment plans.
Therefore, overall, the positive significance of clinical trials is relatively great, especially for cancer patients, participating in clinical trials is actually one of the treatment methods.
4. How to obtain clinical trial-related information?
At present, there are hundreds of open clinical trial registration websites founded by governments, enterprises and hospitals in the world. The most influential ones are the US clinical trial registration and registration website (clinicaltrials.gov) founded by the US government and the International Clinical Trial Registration Platform (ICTRP) led by the World Health Organization (WHO).
"Drug Clinical Trial Registration and Information Disclosure Platform" is a clinical trial registration and registration website in my country. Sponsors should register on the drug clinical trial registration and information disclosure platform before conducting drug clinical trials, and disclose information such as clinical trial design content.
It should be noted that not everyone is suitable for participating in clinical trials. For example, the "unspoken rules" of frequently participating in drug testing to make money should be rejected. Since you are participating in clinical trials, you are using your own body to test the drugs. If all major matters related to the patient's life and death can be unspoken rules, it is tantamount to slaughtering money. And before participating, you must know its formality first.
Most patients with tumors who are initially diagnosed as uncurable. The first reaction of some attending doctors is to recommend clinical trials of screening drugs, actively create opportunities for patients to try new drugs, so that patients can obtain traditional or latest therapeutic drugs for free in the trial. The vast majority of subjects can benefit from treatment, generally gain more treatment opportunities, longer survival, and higher quality of life, and greatly reduce the financial burden of treatment.
Among the tumor patients in developed countries, more than 15% of the patients actively participate in various types of clinical studies, while in my country, this number is less than 3%. Foreign studies have shown that within 20 years, the response rate of patients after participating in clinical trials has been greatly improved, and the treatment-related mortality rate has not increased significantly. This is sufficient to show that the safety of clinical trials is relatively guaranteed.
Reference materials:
[1] "Research and enlightenment of drug clinical trial data disclosure system". China New Drug Journal. 2017-05-15
[2] "Analysis of the filing situation of Chinese drug clinical trial institutions". Chinese Journal of Clinical Pharmacology. 2021-02-28
[3] "Overview of the main program of clinical medical trials and its application". China Clinical Medicine. 2019-10-25
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