NCT03691090

Study of SHR-1210 in Combination With Chemotherapy in Advanced Esophageal Cancer

PD-1 Antibody SHR-1210 Combined With Paclitaxel and Cisplatin Versus Placebo Combined With Paclitaxel and Cisplatin as First-line Therapy for Advanced Esophageal Cancer: a Randomized, Double-blinded, Controlled, Multi-center Phase III Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 596 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomised, double-blinded, placebo-controlled, multi-center phase III trial, comparing the efficacy and safety of SHR-1210 + paclitaxel + cisplatin vs placebo+paclitaxel +cisplatin as 1L therapy for advanced esophageal cancer patients in China. SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.

Detailed description

In this study, eligible subjects will be randomized into study arm or control arm. Treatment cycles of chemotherapy will be at most 6 cycles which would be decided by the investigators. Progression-free survival (PFS) assessed by the Independent Review Committee (IRC) and overall survival (OS) will be the primary outcomes.

Conditions

• Advanced Esophageal Cancer

Interventions

Type	Name	Description
DRUG	SHR-1210	SHR-1210 200mg
DRUG	Placebo	Placebo
DRUG	paclitaxel	paclitaxel 175mg/m2
DRUG	cisplatin	cisplatin 75mg/m2

Timeline

• Start date: 2018-12-03
• Primary completion: 2020-10-30
• Completion: 2022-04-30
• First posted: 2018-10-01
• Last updated: 2022-12-07

Locations

1 site across 1 country: China