A Clinical Trial Comparing HLX10 With Placebo Combined With Chemotherapy (Cisplatin + 5-fu) in the First-line Treatment of Locally Advanced/Metastatic Esophageal Squamous Cell Carcinoma (ESCC)

Summary

This study is a randomized, double-blind, multi-center, phase III clinical study comparing the clinical efficacy and safety of HLX10 or placebo combined with chemotherapy in first-line treatment of locally advanced/metastatic esophageal squamous cell carcinoma (ESCC) patients.This study consists of three periods, screening period (28 days), treatment period and follow-up period (including safety follow-up, survival follow-up).Subjects can be enrolled into this study only if they meet inclusion criteria and do not meet exclusion criteria.

Timeline

Start

2019-06-19

Primary completion

2023-04-30

Completion

2023-12-30

Publications

• Liu S, Jiang N, Dou L, Li S. Cost-effectiveness analysis of serplulimab plus chemotherapy in the first-line treatment for PD-L1-positive esophageal squamous cell carcinoma in China. Front Immunol. 2023 May 4;14:1172242. doi: 10.3389/fimmu.2023.1172242. eCollection 2023.
• Song Y, Zhang B, Xin D, Kou X, Tan Z, Zhang S, Sun M, Zhou J, Fan M, Zhang M, Song Y, Li S, Yuan Y, Zhuang W, Zhang J, Zhang L, Jiang H, Gu K, Ye H, Ke Y, Li J, Wang Q, Zhu J, Huang J; ASTRUM-007 investigators. First-line serplulimab or placebo plus chemotherapy in PD-L1-positive esophageal squamous cell carcinoma: a randomized, double-blind phase 3 trial. Nat Med. 2023 Feb;29(2):473-482. doi: 10.1038/s41591-022-02179-2. Epub 2023 Feb 2.

Drugs

Indications