CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 514 enrolled
Drug / intervention
Toripalimabbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03829969
NCT03829969Phase 3Completed
CompareCT.gov

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

Shanghai Junshi Bioscience Co., Ltd.·interventional·Posted Feb 4, 2019·Updated Jul 23, 2025

In Brief

A Phase 3 clinical trial evaluating Toripalimab for Advanced or Metastatic Esophageal Squamous Cell Cancer Without Previous Systemic Chemotherapy. Completed, enrolled 514 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced or Metastatic Esophageal Squamous Cell Cancer Without Previous Systemic Chemotherapy
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedFeb 4, 2019
Enrollment StartJan 31, 2019
Primary CompletionMar 22, 2021
Study CompletionSep 30, 2023
TodayJul 1, 2026
Enrollment to primary: 2.1 yearsPosted 7.4 years ago

Interventions

Toripalimabbiological

TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy