Progress on clinical trials of common gastrointestinal cancer drugs in China from 2012 to 2021.
10.3760/cma.j.cn112152-20211207-00907
- VernacularTitle:中国胃癌临床试验10年进展
- Author:
Hui Yao HUANG
1
;
Da Wei WU
1
;
Qi ZHU
2
;
Yue YU
1
;
Hai Xue WANG
3
;
Jun WANG
3
;
Man GA
1
;
Xin Yu MENG
4
;
Jing Ting DU
1
;
Shuang Man MIAO
1
;
Zhi Xia ZHAO
5
;
Xin WANG
6
;
Pu SHANG
7
;
Min Jiang GUO
8
;
Li Hong LIU
5
;
Yu TANG
1
;
Ning LI
1
;
Cai CAO
9
;
Bing He XU
1
;
Yan SUN
1
;
Jie HE
10
Author Information
1. Department of Clinical Trials Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.
2. School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, Nanjing 211198, China.
3. National Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China.
4. The University of Melbourne, Faculty of Medicine, Dentistry and Health Sciences, Melbourne 3010, Australia.
5. Department of Clinical Trial Center, China-Japan Friendship Hospital, Beijing 100029, China.
6. Clinical Trials Research Center, Beijing Hoppital, National Center of Getrontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100730, China.
7. National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, China.
8. Department of Health Insurance Information Research, Institute of Medical Information, Chinese Academy of Medical Sciences, Beijing 100020, China.
9. Zhongguancun Jiutai Good Clinical Practice Union, Beijing 100027, China.
10. Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.
- Publication Type:Journal Article
- Keywords:
China;
Clinical trial;
Drug;
Gastric neoplasms
- MeSH:
China;
Gastrointestinal Agents/therapeutic use*;
Gastrointestinal Neoplasms;
Humans;
Pharmaceutical Preparations;
United States;
United States Food and Drug Administration
- From:
Chinese Journal of Oncology
2022;44(3):276-281
- CountryChina
- Language:Chinese
-
Abstract:
Objective: Systematically summarize the research progress of clinical trials of gastric cancer oncology drugs and the overview of marketed drugs in China from 2012 to 2021, providing data and decision-making evidence for relevant departments. Methods: Based on the registration database of the drug clinical trial registration and information disclosure platform of Food and Drug Administration of China and the data query system of domestic and imported drugs, the information on gastric cancer drug clinical trials, investigational drugs and marketed drugs from January 1, 2012 to December 31, 2021 was analyzed, and the differences between Chinese and foreign enterprises in terms of trial scope, trial phase, treatment lines and drug type, effect and mechanism studies were compared. Results: A total of 114 drug clinical trials related to gastric tumor were registered in China from 2012 to 2021, accounting for 3.7% (114/3 041) of all anticancer drug clinical trials in the same period, the registration number showed a significant growth rate after 2016 and reached its peak with 32 trials in 2020. Among them, 85 (74.6%, 85/114) trials were initiated by Chinese pharmaceutical enterprise. Compared with foreign pharmaceutical enterprise, Chinese pharmaceutical enterprise had higher rates of phase I trials (35.3% vs 6.9%, P=0.001), but the rate of international multicenter trials (11.9% vs 67.9%, P<0.001) was relatively low. There were 76 different drugs involved in relevant clinical trials, of which 65 (85.5%) were targeted drugs. For targeted drugs, HER2 is the most common one (14 types), followed by PD-1 and multi-target VEGER. In the past ten years, 3 of 4 marketed drugs for gastric cancer treatment were domestic and included in the national medical insurance directory. Conclusions: From 2012 to 2021, China has made some progress in drug research and development for gastric carcinoma. However, compared with the serious disease burden, it is still insufficient. Targeted strengthening of research and development of investment in many aspects of gastric cancer drugs, such as new target discovery, matured target excavating, combination drug development and early line therapy promotion, is the key work in the future, especially for domestic companies.
