Disitamab vedotin plus trastuzumab and tislelizumab versus chemotherapy plus trastuzumab (± pembrolizumab) for HER2‑high 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
This trial tests whether combining disitamab vedotin with trastuzumab and the immunotherapy tislelizumab works better than standard chemotherapy with trastuzumab (with or without pembrolizumab) as first‑line treatment for people with HER2‑high advanced gastric or gastroesophageal junction cancer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 555 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | RemeGen Co., Ltd. Industry-sponsored |
| Drugs / interventions | Disitamab, Trastuzumab, Tislelizumab, Pembrolizumab, Chemotherapy |
| Locations | 1 site (Beijing, BJ-Beijing) |
| Trial ID | NCT07315750 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with unresectable or metastatic HER2‑high gastric or gastroesophageal junction adenocarcinoma who are treatment‑naive in the metastatic setting, have measurable disease, ECOG 0–1, and adequate organ function.
Not a fit: Patients with HER2‑low or negative tumors, ECOG ≥2, recent systemic therapy for metastatic disease, or significant organ dysfunction are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, the regimen could improve response rates and survival for HER2‑high patients and potentially offer a more targeted, less cytotoxic first‑line option.
How similar studies have performed: Other HER2‑targeted antibody‑drug conjugates and combinations with PD‑1 inhibitors have shown promising activity in earlier-phase studies, but definitive phase 3 proof for this exact combination is not yet established.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing, BJ-Beijing
- Beijing Cancer Hospital — Beijing, BJ-Beijing, China (Recruiting)
Study contacts
- Study coordinator: Hongfang Li
- Email: hongfang.li@remegen.com
- Phone: 86+010-65018841
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.