NCT04342910

Study to Evaluate the Efficacy and Safety of Camrelizumab and Apatinib in Patients With GC/GEJC

A Study of Camrelizumab (SHR-1210) Combined With Apatinib Versus Paclitaxel or Irinotecan in Participants With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma Progressed After First-line Chemotherapy

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 550 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a study for participants with advanced gastric or gastroesophageal junction adenocarcinoma who have had tumor progression after first-line platinum-contained therapy. The primary study hypotheses are that camrelizumab (SHR-1210) combined with apatinib prolongs overall survival (OS) for participants with tumors that show positive programmed cell death ligand 1 (PD-L1) expression.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	camrelizumab	200 mg intravenous (IV) camrelizumab on Day 1 and Day 15 of each 28-day cycle.
DRUG	Apatinib Mesylate	250 mg qd
DRUG	Paclitaxel	80 mg/m\^2 administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle.
DRUG	Irinotecan	180 mg/m\^2 administered as IV infusion on Days 1, and 15 of each 28-day cycle.

Timeline

• Start date: 2020-09-21
• Primary completion: 2026-04-01
• Completion: 2026-09-01
• First posted: 2020-04-13
• Last updated: 2026-01-20

Locations

1 site across 1 country: China