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RECRUITING
NCT07315750
PHASE3

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.

Sponsor: RemeGen Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

555

Start Date

2026-01-01

Completion Date

2030-12-31

Last Updated

2026-01-21

Healthy Volunteers

No

Interventions

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

Locations (1)

Beijing Cancer Hospital

Beijing, BJ-Beijing, China