drugset
drugset / Trial / NCT06944496

A Study of Disitamab Vedotin Combined With Tislelizumab and Chemotherapy Versus Tislelizumab Combined With Chemotherapy in HER2-Low Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

NCT06944496 ↗

Phase 3 Not yet recruiting 616 enrolled RemeGen Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of \*\*Disitamab Vedotin combined with Tislelizumab and CAPOX versus Tislelizumab combined with CAPOX\*\* as first-line treatment for patients with HER2-low advanced gastric or gastroesophageal junction adenocarcinoma.

Timeline

Start
2025-05-15
Primary completion
2028-05-15
Completion
2030-05-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Capecitabine Small molecule 750 mg/m2 Oral
Comparator Capecitabine Small molecule 1000 mg/m2 Oral
Subject Disitamab Vedotin Monoclonal antibody 2.5 mg/kg Intravenous
Comparator Oxaliplatin Small molecule 100 mg/m2 Intravenous
Comparator Oxaliplatin Small molecule 130 mg/m2 Intravenous
Comparator Tislelizumab Monoclonal antibody 200 mg Intravenous

Indications

gastric carcinoma