Progress on clinical drug trials of esophageal squamous cell carcinoma in China from 2012 to 2021_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

WU Dawei ¹ , HUANG Huiyao ¹ , ZHU Qi ^1,2 , YU Yue ¹ , LI Ziwei ^1,2 , MENG Xinyu ³ , DU Jingting ¹ , GA Man ¹ , MIAO Shuangman ¹ , XING Shujun ¹ , TANG Yu ¹ ,  LI Ning ¹

1. 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, P. R. China;
2. Department of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, Nanjing, 211198, P. R. China;
3. University of Melbourne, Faculty of Medicine, Dentistry and Health Sciences, Melbourne, 3010, Australia;

Corresponding?author：

LI Ning, Email: ncctrials@cicams.ac.cn

Keywords：

Esophageal neoplasms; squamous cell carcinoma; China; drug; clinical trial

DOI：

10.7507/1007-4848.202203044

Video：

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Abstract Full text Figures/Tables Video References Cited by

Objective To summarize the progress and trend on clinical drug trials of esophageal squamous cell carcinoma in China. Methods Based on the clinical drug trial registration and information disclosure platform and the drug data query system of the National Medical Products Administration, the characteristics of clinical trials, investigational drugs and listed drugs of esophageal squamous cell carcinoma in China from 2012 to 2021 were analyzed. Results From 2012 to 2021, a total of 49 clinical drug trials of esophageal squamous cell carcinoma were registered in China, accounting for 1.6% of all clinical trials of anticancer drugs. Among them, there were 39 (79.6%) trials initiated by domestic pharmaceutical enterprises, 6 (12.2%) for adjuvant and neoadjuvant treatment, and 9 (18.4%) for local treatment. There were differences in the treatment line distribution between global and domestic enterprise-initiated trials (P=0.032). The above trials covered 29 investigational drugs, including 23 (79.3%) targeted drugs, most of which targeted programmed death-1, programmed death-ligand 1 and epidermal growth factor receptor. From 2012 to 2021, there were 2 drugs for esophageal squamous cell carcinoma listed in China, both of which were approved for the first-line and second- line treatment. Conclusion Great achievements have been made in the clinical development of esophageal squamous cell carcinoma drugs in China. It is suggested that domestic enterprises increase the investment of esophageal squamous cell carcinoma, pay attention to adjuvant and local treatment, explore novel targets and drug categories, and focus on the details of pivotal trials.

Citation： WU Dawei, HUANG Huiyao, ZHU Qi, YU Yue, LI Ziwei, MENG Xinyu, DU Jingting, GA Man, MIAO Shuangman, XING Shujun, TANG Yu, LI Ning. Progress on clinical drug trials of esophageal squamous cell carcinoma in China from 2012 to 2021. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2022, 29(12): 1601-1606. doi: 10.7507/1007-4848.202203044 Copy

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23.	余琦瑤, 李斌, 馮海明, 等. PD-1/PD-L1在食管鱗狀細胞癌中的表達及其與腫瘤預后相關性的系統評價與Meta分析. 中國胸心血管外科臨床雜志, 2021, 28(11): 1352-1359.

1. Zhang S, Sun K, Zheng R, et al. Cancer incidence and mortality in China, 2015. J Natl Cancer Cent, 2021, 1(1): 2-11.
2. Zeng H, Chen W, Zheng R, et al. Changing cancer survival in China during 2003-15: A pooled analysis of 17 population-based cancer registries. Lancet Glob Health, 2018, 6(5): e555-e567.
3. Sung H, Ferlay J, Siegel RL, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin, 2021, 71(3): 209-249.
4. Gao YB, Chen ZL, Li JG, et al. Genetic landscape of esophageal squamous cell carcinoma. Nat Genet, 2014, 46(10): 1097-1102.
5. 中國臨床腫瘤學會指南工作委員會. 中國臨床腫瘤學會(CSCO)分化型甲狀腺癌診療指南2021. 腫瘤預防與治療, 2021, 34(12): 1164-1200.
6. Ajani JA, D'Amico TA, Bentrem DJ, et al. Esophageal and esophagogastric junction cancers, version 2. 2019, NCCN clinical practice guidelines in oncology. J Natl Compr Canc Netw, 2019, 17(7): 855-883.
7. Li N, Huang HY, Wu DW, et al. Changes in clinical trials of cancer drugs in mainland China over the decade 2009-18: A systematic review. Lancet Oncol, 2019, 20(11): e619-e626.
8. Yang YM, Hong P, Xu WW, et al. Advances in targeted therapy for esophageal cancer. Signal Transduct Target Ther, 2020, 5(1): 229.
9. Akin Telli T, Bregni G, Camera S, et al. PD-1 and PD-L1 inhibitors in oesophago-gastric cancers. Cancer Lett, 2020, 469: 142-150.
10. 黃欽, 王玉珠, 范乙, 等. 藥物臨床試驗登記與信息公示平臺介紹及常見問題分析. 中國新藥雜志, 2014, 23(23): 2721-2724.
11. 莊潔, 王莉文, 王景田. 建立藥品說明書數據庫查詢系統的方法. 首都醫藥, 2005, 2: 38.
12. 吳大維, 黃慧瑤, 唐玉, 等. 2020年中國腫瘤藥物臨床試驗進展. 中華腫瘤雜志, 2021, 43(2): 218-223.
13. 王書航, 方元, 黃慧瑤, 等. 2019中美肺癌藥物臨床試驗橫斷面比較研究. 中國胸心血管外科臨床雜志, 2020, 27(3): 327-331.
14. Luo H, Lu J, Bai Y, et al. Effect of camrelizumab vs. placebo added to chemotherapy on survival and progression-free survival in patients with advanced or metastatic esophageal squamous cell carcinoma: The ESCORT-1st randomized clinical trial. JAMA, 2021, 326(10): 916-925.
15. Huang J, Xu J, Chen Y, et al. Camrelizumab versus investigator's choice of chemotherapy as second-line therapy for advanced or metastatic oesophageal squamous cell carcinoma (ESCORT): A multicentre, randomised, open-label, phase 3 study. Lancet Oncol, 2020, 21(6): 832-842.
16. Sun JM, Shen L, Shah MA, et al. Pembrolizumab plus chemotherapy versus chemotherapy alone for first-line treatment of advanced oesophageal cancer (KEYNOTE-590): A randomised, placebo-controlled, phase 3 study. Lancet, 2021, 398(10302): 759-771.
17. Kojima T, Shah MA, Muro K, et al. Randomized phase Ⅲ KEYNOTE-181 study of pembrolizumab versus chemotherapy in advanced esophageal cancer. J Clin Oncol, 2020, 38(35): 4138-4148.
18. Wu D, Huang H, Zhang M, et al. The global landscape of neoadjuvant and adjuvant anti-PD-1/PD-L1 clinical trials. J Hematol Oncol, 2022, 15(1): 16.
19. Kelly RJ, Ajani JA, Kuzdzal J, et al. Adjuvant nivolumab in resected esophageal or gastroesophageal junction cancer. N Engl J Med, 2021, 384(13): 1191-1203.
20. Wu H, Minamide T, Yano T. Role of photodynamic therapy in the treatment of esophageal cancer. Dig Endosc, 2019, 31(5): 508-516.
21. Wu DW, Huang HY, Tang Y, et al. Clinical development of immuno-oncology in China. Lancet Oncol, 2020, 21(8): 1013-1016.
22. Yamamoto S, Kato K. JUPITER-06 establishes immune checkpoint inhibitors as essential first-line drugs for the treatment of advanced esophageal squamous cell carcinoma. Cancer Cell, 2022, 40(3): 238-240.
23. 余琦瑤, 李斌, 馮海明, 等. PD-1/PD-L1在食管鱗狀細胞癌中的表達及其與腫瘤預后相關性的系統評價與Meta分析. 中國胸心血管外科臨床雜志, 2021, 28(11): 1352-1359.

Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Progress on clinical drug trials of esophageal squamous cell carcinoma in China from 2012 to 2021

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