A Clinical Study To Evaluate Camrelizumab (SHR-1210) Plus Capecitabine and Oxaliplatin Followed by Sequential Treatment With Camrelizumab Plus Apatinib Mesylate in Advanced or Metastatic Gastric Cancer (GC) or Gastroesophageal Junction Cancer (GEJ) Without Prior Systemic Therapy

Summary

This is a randomized, open-label, multi-center, phase III trial to evaluate the efficacy and safety of SHR-1210 plus capecitabine and oxaliplatin sequenced by SHR-1210 plus apatinib versus capecitabine and oxaliplatin as first-line therapy in patients with locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Timeline

Start

2019-03-07

Primary completion

2023-06-07

Completion

2023-06-07

Outcome

Met primary endpoint

paper median 15.0 v 12.5 months; hazard ratio 0.80 (95% CI 0.65 to 0.98); one sided P=0.02 PMID 41819560 ↗

paper median 13.5 v 12.1 months; hazard ratio 0.80 (0.68 to 0.94); one sided P=0.004 PMID 41819560 ↗

Publications

• Peng Z, Zhang Y, Xu H, Yang Y, Yang M, Zhang M, Cheng Y, Chen X, Pan Y, Wang F, Li Q, Xu N, Liu L, Gu K, Xiao J, Zhang R, Zhao Q, Chen J, Lin L, Chen Y, Deng Y, Cai S, Bai B, Wang Y, Shen L. Camrelizumab plus CAPOX with camrelizumab based maintenance versus CAPOX alone as initial treatment for gastric or gastro-oesophageal junction adenocarcinoma: randomised phase 3 trial. BMJ. 2026 Mar 12;392:e086115. doi: 10.1136/bmj-2025-086115.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Camrelizumab	Monoclonal antibody	200 mg	Intravenous
Subject	Rivoceranib	Small molecule	250 mg	Oral
Background	Capecitabine	Small molecule	1000 mg/m2	Oral
Background	Oxaliplatin	Small molecule	130 mg/m2	Intravenous

Indications