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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.

NCT07315750 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 555

Last updated 2026-01-21

No results posted yet for this study

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

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

Sponsors & Collaborators

  • RemeGen Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2029-06-30
Completion
2030-12-31

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07315750 on ClinicalTrials.gov