drugset
drugset / Trial / NCT07474324

Disitamab Vedotin Combined With SOX Regimen Versus SOX Alone as Adjuvant Therapy for HER2-Moderate/High Expressing Stage Ⅲ Gastric Cancer: A Prospective, Multicenter, Randomized, Phase Ⅱ Clinical Trial

NCT07474324 ↗

Phase 2 Recruiting 124 enrolled The First Affiliated Hospital with Nanjing Medical University
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a prospective, multicenter, randomized, phase II clinical trial intended to enroll patients with HER2-moderate/high-expressing, pathologically staged stage III gastric cancer who have undergone D2 or more extensive surgery. The study aims to evaluate the preliminary efficacy and safety of disitamab vedotin combined with the SOX regimen versus SOX alone as post-operative adjuvant therapy.

Timeline

Start
2026-03-15
Primary completion
2028-12-31
Completion
2030-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Disitamab Vedotin Other / unclassified 2.5 mg/kg Intravenous
Subject Oxaliplatin Small molecule 100 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 130 mg/m2 Intravenous
Subject S-1 Small molecule 40 mg/m2 Oral
Subject S-1 Small molecule 60 mg/m2 Oral

Indications

gastroesophageal junction adenocarcinoma