drugset / Trial / NCT05180734

PD1 Combined With Chemotherapy for Adjuvant Treatment of Gastric Cancer

NCT05180734

Phase 3 Active not recruiting 878 enrolled Shanghai Junshi Bioscience Co., Ltd.
RandomizedSequentialQuadruple-blindTreatment

Summary

This multicenter, randomized, double-blind phase III study intends to recruit about 878 patients, including PD-L1 positive 660 patients, who have received radical gastrectomy (R0 resection, D2 or more extended lymphadenectomy) with postoperative pathological stage IIB or III (AJCC Cancer Staging Manual, 8th Edition) gastric or EGJ adenocarcinoma to evaluate the efficacy and safety of JS001 combined with postoperative adjuvant chemotherapy versus placebo combined with postoperative adjuvant chemotherapy.

Timeline

Start
2022-02-10
Primary completion
2027-03-31
Completion
2028-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Toripalimab Monoclonal antibody 240 mg Intravenous

Indications