RecruitingPhase 3NCT07315750

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


Sponsor

RemeGen Co., Ltd.

Enrollment

555 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a new combination of cancer drugs (disitamab vedotin plus trastuzumab and tislelizumab) against standard chemotherapy with trastuzumab for people with HER2-positive advanced stomach or gastroesophageal junction cancer that cannot be removed surgically. **You may be eligible if...** - You have confirmed advanced or metastatic stomach or gastroesophageal junction cancer with high HER2 expression - You have not previously had treatment for advanced or metastatic disease (or your cancer came back more than 6 months after finishing earlier treatment) - You have at least one measurable tumor - You are in good physical condition (ECOG 0 or 1) and have an expected survival of more than 12 weeks **You may NOT be eligible if...** - You have cancer that has spread to the brain or fluid around the brain - You have significant nerve damage (peripheral neuropathy above grade 1) - You have serious lung, liver, or gastrointestinal conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDisitamab Vedotin

Disitamab Vedotin: 2.5 mg/kg, IV, D1, Q2W;

DRUGTislelizumab

Tislelizumab: 200 mg, IV, D1, Q3W

DRUGCAPOX (oxaliplatin/capecitabine)

Oxaliplatin: 130 mg/m², IV, D1, Q3W; Capecitabine: 1000 mg/m², po, BID, D1-D14, Q3W;

DRUGTrastuzumab

Trastuzumab: Initial dose of 8mg/kg, followed by 6 mg/kg, IV, D1, Q3W;

DRUGPembrolizumab

Pembrolizumab: 200mg, IV, D1, Q3W


Locations(1)

Beijing Cancer Hospital

Beijing, BJ-Beijing, China

View Full Details on ClinicalTrials.gov

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NCT07315750


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