NCT03958890

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)

A Randomized, Double-blind, Multicenter, Phase III Clinical Trial Comparing HLX10 (Recombinant Anti-pd-1 Humanized Monoclonal Antibody Injection) With Placebo Combined With Chemotherapy (Cisplatin + 5-fu) in the First-line Treatment of Locally Advanced/Metastatic Esophageal Squamous Cell Carcinoma (ESCC)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 489 (estimated)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	HLX10 100 mg in 10 ml Injection	3mg/kg IV（HLX10+cis-platinum+5FU）
DRUG	Placebos	3mg/kg IV（placebo+cis-platinum+5FU）

Timeline

• Start date: 2019-06-19
• Primary completion: 2023-04-30
• Completion: 2023-12-30
• First posted: 2019-05-22
• Last updated: 2023-04-18

Locations

7 sites across 1 country: China