Trial intelligence / Profile preview

SHR-1210 combinations in advanced gastric cancer

NCT03472365Phase 2

Key facts

Status: Completed
Start: Apr 2018
Primary completion: Nov 2020
Countries: 1
Sponsor: Hengrui
Modality: Immune Checkpoint Inhibitors

Drugs: camrelizumab
Conditions: gastric adenocarcinomagastroesophageal junction adenocarcinoma

Overview

Phase 2, randomised, open-label trial of camrelizumab in gastric adenocarcinoma and gastroesophageal junction adenocarcinoma (2 arms), sponsored by Hengrui. Primary endpoint: Objective Response Rate at 6 months. Started Apr 2018; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

SHR-1210 + CAPOX -> SHR-1210 + Apatinib
Camrelizumab + Capecitabine + Oxaliplatin followed by Camrelizumab + Apatinib
SHR-1210 + Apatinib
Camrelizumab + Apatinib continuous

Who it enrols

Patients with locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma, HER2-negative, no prior systemic therapy for advanced disease, and adequate organ function.

Endpoints

Primary

Objective Response Rate6 months

Secondary

Progression-free Survival24 months
Duration of Response24 months
Disease Control Rate24 months
Adverse Events24 months

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