drugset / Trial / NCT04367025

Efficacy and Safety of Perioperative Chemotherapy Plus PD-1 Antibody in Gastric Cancer

NCT04367025 ↗

Phase 2 Unknown 70 enrolled Chinese PLA General Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

For locally advanced gastric cance, neoadjuvant chemotherapy can increase the resectability of tumor, and finally improve the long-term survival. Combination of perioperative PD-1 antibody and chemotherapy for locally advanced gastric cancer could be a novel therapy to increase response rate and resectability and reduce recurrence rate. Camrelizumab(SHR-1210) in this study is a Chinese anti-PD-1 monoclonal antibody for injection which has been approved for melanoma and Hepatocellular carcinoma. This study is a single center, open-label, randomized comparative phase II clinical trial to evaluate safety and efficacy of Camrelizumab in combination with perioperative chemotherapy in locally advanced adenocarcinoma of stomach or gastroesophageal junction. Differences in T cell expression were detected by single cell RNA sequencing to screen people who were more sensitive to immunotherapy.

Timeline

Start
2020-05
Primary completion
2022-05
Completion
2023-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Camrelizumab Monoclonal antibody 200 mg Intravenous
Background Oxaliplatin Small molecule 130 mg/m2 Intravenous
Comparator S1 [arm: active_comparator] — S-1:40\~60mg Bid, d1\~14, q3w; Unknown 40 mg —
Comparator S1 [arm: active_comparator] — S-1:40\~60mg Bid, d1\~14, q3w; Unknown 60 mg —

Indications