drugset
drugset / Trial / NCT04997837

Study of Adjuvant Chemotherapy With or Without PD-1 Inhibitors and Chemoradiotherapy in Resected pN3 Gastric (G) or GEJ Adenocarcinoma

NCT04997837 ↗

Phase 3 Recruiting 433 enrolled Fudan University
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to evaluate the efficacy and safety of postoperative adjuvant chemotherapy with PD-1 inhibitors and chemoradiotherapy, in comparison with adjuvant chemotherapy only, in D2/R0 resected pN3 gastric or gastroesophageal junction adenocarcinoma. PD-1+CRT cohort: A total of 216 patients will receive 6 weeks of PD-1 inhibitors and chemotherapy, then receive concurrent chemoradiotherapy, followed by 6 weeks of PD-1 inhibitors and chemotherapy, finally receive maintenance treatment of PD-1 inhibitors until (maximum 1year after radiotherapy). CT cohort: A total of 217 patients will receive 6 months of chemotherapy. The disease-free survival(DFS), overall survival(OS) and adverse effects will be analyzed.

Timeline

Start
2021-07-21
Primary completion
2027-07-21
Completion
2027-10-21

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Camrelizumab Monoclonal antibody 200 mg Intravenous
Subject Nivolumab Monoclonal antibody 240 mg Intravenous
Subject Nivolumab Monoclonal antibody 360 mg Intravenous
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Subject Sintilimab Monoclonal antibody 200 mg Intravenous
Subject Tilelizumab Unknown 200 mg Intravenous
Subject Toripalimab Monoclonal antibody 240 mg Intravenous
Subject Toripalimab Monoclonal antibody 360 mg Intravenous
Background Capecitabine Small molecule 625 mg/m2 Oral
Background Capecitabine Small molecule 1000 mg/m2 Oral
Background Oxaliplatin Small molecule 85 mg/m2 Intravenous
Background Oxaliplatin Small molecule 130 mg/m2 Intravenous
Background S-1 Small molecule 40 mg Oral
Background S-1 Small molecule 60 mg Oral
Background fluorouracil Small molecule 2400 mg/m2 Intravenous
Background fluorouracil Small molecule 2800 mg/m2 Intravenous

Indications

gastric cancer