CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 457 enrolled
Drug / intervention
camrelizumab +2 morebiological
Likely dose
camrelizumab 200mgfrom 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/NCT03099382
NCT03099382Phase 3Completed

A Randomized, Open-Label, Active-Controlled, Multi-Center, Phase III Clinical Study of Anti-PD-1 Antibody SHR-1210 vs. Investigator's Choice of Chemotherapy in Subjects With Locally Advanced or Metastatic Esophageal Cancer

Jiangsu HengRui Medicine Co., Ltd.·interventional·Posted Apr 4, 2017·Updated Jan 22, 2024

In Brief

A Phase 3 clinical trial evaluating camrelizumab, Docetaxel, and 1 other intervention for Esophageal Carcinoma. Completed, enrolled 457 participants across 2 sites.

Detailed Summary

In this study, participants with advanced or metastatic squamous cell carcinoma of the esophagus that has progressed after first-line standard therapy will be randomized to receive either single agent SHR-1210 or the Investigator's choice of standard therapy with docetaxel or irinotecan. The primary study hypothesis is that treatment with SHR-1210 will prolong overall survival (OS) as compared to treatment with standard therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 4, 2017
Enrollment StartMay 5, 2017
Primary CompletionMay 6, 2019
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 9.2 years ago

Interventions

camrelizumabbiological

Subjects receive camrelizumab intravenous infusion at the dose 200mg on Day 1 every 2 weeks

Docetaxeldrug

Subjects receive Docetaxel intravenous infusion at the dose 75mg/m2 on Day 1 every 3 weeks

Irinotecandrug

Subjects receive Irinotecan intravenous infusion at the dose 180mg/m2 on Day 1 every 2 weeks