drugset / Trial / NCT03691454

Compare Neoadjuvant DOS Combined With Toripalimab Versus SOX Combined With Toripalimab in Locally Advanced Gastric Adenocarcinoma

NCT03691454 ↗

Phase 2/3 Active not recruiting 248 enrolled Peking University
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomized, multicenter, controlled, adaptive phase II/III clinical study. The aim is to compare neoadjuvant chemotherapy with docetaxel, oxaliplatin, and S-1 (DOS) plus toripalimab versus oxaliplatin and S-1 (SOX) plus toripalimab in patients with locally advanced gastric adenocarcinoma.

Timeline

Start
2018-06-28
Primary completion
2026-09-30
Completion
2027-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 50 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 85 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 130 mg/m2 Intravenous
Subject S-1 Small molecule 40 mg Oral
Subject S-1 Small molecule 50 mg Oral
Subject S-1 Small molecule 60 mg Oral
Subject Toripalimab Monoclonal antibody 3 mg/kg Intravenous
Subject Toripalimab Monoclonal antibody 240 mg Intravenous