NCT03099382

Study of SHR-1210 Versus Investigator's Choice of Chemotherapy for Participants With Advanced Esophageal Cancer

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 457 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophageal Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	camrelizumab	Subjects receive camrelizumab intravenous infusion at the dose 200mg on Day 1 every 2 weeks
DRUG	Docetaxel	Subjects receive Docetaxel intravenous infusion at the dose 75mg/m2 on Day 1 every 3 weeks
DRUG	Irinotecan	Subjects receive Irinotecan intravenous infusion at the dose 180mg/m2 on Day 1 every 2 weeks

Timeline

• Start date: 2017-05-05
• Primary completion: 2019-05-06
• Completion: 2019-05-06
• First posted: 2017-04-04
• Last updated: 2024-01-22
• Results posted: 2024-01-22

Locations

2 sites across 1 country: China