Disitamab vedotin plus trastuzumab and tislelizumab versus chemotherapy plus trastuzumab (± pembrolizumab) for HER2‑high advanced gastric or gastroesophageal junction adenocarcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 randomized interventional study enrolls patients with unresectable locally advanced or metastatic HER2‑high gastric or gastroesophageal junction adenocarcinoma who have not received prior systemic therapy for advanced disease. Participants are randomized to receive disitamab vedotin with trastuzumab and tislelizumab or to receive CAPOX chemotherapy with trastuzumab with or without pembrolizumab as first‑line therapy. Tumor response will be measured by RECIST v1.1 and safety will be closely monitored, with key efficacy endpoints likely including progression‑free and overall survival. Eligible patients must have ECOG 0–1, measurable disease, adequate organ function, and an expected survival over 12 weeks.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Voluntarily consent to participate in the study and sign the informed consent form
* Expected survival period \>12 weeks
* ECOG Performance Status 0 or 1
* Histologically confirmed unresectable locally advanced or metastatic --gastric/gastroesophageal junction adenocarcinoma
* No prior systemic therapy for locally advanced or metastatic gastric cancer; or disease progression or recurrence occurring ≥6 months after completion of neoadjuvant/adjuvant therapy
* HER2-high expression
* At least one assessable lesion according to RECIST v1.1 criteria
* Adequate organ function
* Female subjects of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first treatment, and agree not to breastfeed or donate ova from the signing of the informed consent form until 6 months after the last treatment. Male subjects must agree not to donate sperm from the signing of the informed consent form until 6 months after the last treatment.
* Able to understand the study requirements and willing to comply with the study and follow-up procedures

Exclusion Criteria:

* Presence of central nervous system (CNS) metastasis and/or carcinomatous meningitis
* Peripheral neuropathy \> Grade 1
* Tumor lesions with a tendency to bleed
* Severe gastrointestinal dysfunction that may affect drug intake, transport, or absorption
* Bone metastases with a risk of paraplegia
* Past or current interstitial lung disease, or severely impaired lung function
* Other malignancies within 5 years prior to randomization, except for those expected to be cured with treatment
* Pregnant or breastfeeding women

Where it's running

• Beijing Cancer Hospital
  Beijing, BJ-Beijing, China Recruiting

Study contacts

• Study coordinator: Hongfang Li
• Email: hongfang.li@remegen.com
• Phone: 86+010-65018841

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.