NCT03829969

Toripalimab or Placebo With Paclitaxel and Cisplatin in Esophageal Squamous Cell Carcinoma

A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Compare Toripalimab Injection (JS001) Combined With Standard Chemotherapy Versus Placebo Combined With Standard Chemotherapy in Treatment of Advanced or Metastatic Esophageal Squamous Cell Cancer (ESCC) Without Previous Systemic Chemotherapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 514 (actual)
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is one randomized, double-blind, multi-center, placebo-controlled phase III study. The objective of this study is to compare the effectiveness and safety of JS001 combined with paclitaxel and cisplatin(TP regimen )with placebo combined with TP regimen in patients with advanced or metastatic Esophageal Squamous Cell Carcinoma(ESCC )who have not received systemic chemotherapy previously.

Conditions

• Advanced or Metastatic Esophageal Squamous Cell Cancer Without Previous Systemic Chemotherapy

Interventions

Type	Name	Description
BIOLOGICAL	Toripalimab	TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy

Timeline

• Start date: 2019-01-31
• Primary completion: 2021-03-22
• Completion: 2023-09-30
• First posted: 2019-02-04
• Last updated: 2025-07-23
• Results posted: 2024-05-02

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study