NCT07315750

A Study of Disitamab Vedotin Combined With Trastuzumab and Tislelizumab Versus Chemotherapy Combined With Trastuzumab With or Without Pembrolizumab in HER2-high Expression Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.

A Randomized Controlled Phase III Study to Evaluate the Combination of Disitamab Vedotin, Trastuzumab, and Tislelizumab Versus Chemotherapy (CAPOX) Combined With Trastuzumab With or Without Pembrolizumab as First-Line Treatment for Advanced Gastric/Gastroesophageal Junction Adenocarcinoma With HER2-high Expression

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 555 (estimated)
• Sponsor: RemeGen Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin combined with Trastuzumab and Tislelizumab Versus Chemotherapy Combined with Trastuzumab with or without Pembrolizumab as First-Line Treatment for Advanced Gastric/Gastroesophageal Junction Adenocarcinoma with HER2-high Expression.

Conditions

• Gastric Carcinoma

Interventions

Type	Name	Description
DRUG	Disitamab Vedotin	Disitamab Vedotin: 2.5 mg/kg, IV, D1, Q2W;
DRUG	Tislelizumab	Tislelizumab: 200 mg, IV, D1, Q3W
DRUG	CAPOX (oxaliplatin/capecitabine)	Oxaliplatin: 130 mg/m², IV, D1, Q3W; Capecitabine: 1000 mg/m², po, BID, D1-D14, Q3W;
DRUG	Trastuzumab	Trastuzumab: Initial dose of 8mg/kg, followed by 6 mg/kg, IV, D1, Q3W;
DRUG	Pembrolizumab	Pembrolizumab: 200mg, IV, D1, Q3W

Timeline

• Start date: 2026-01-01
• Primary completion: 2029-06-30
• Completion: 2030-12-31
• First posted: 2026-01-02
• Last updated: 2026-01-21

Locations

1 site across 1 country: China