NCT07315750 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.
| NCT ID | NCT07315750 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | RemeGen Co., Ltd. |
| Condition | Gastric Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 555 participants |
| Start Date | 2026-01-12 |
| Primary Completion | 2029-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 555 participants in total. It began in 2026-01-12 with a primary completion date of 2029-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07315750 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Gastric Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07315750 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 555 participants.
Is NCT07315750 currently recruiting?
Yes, NCT07315750 is actively recruiting participants. Contact the research team at hongfang.li@remegen.com for enrollment information.
Where is the NCT07315750 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07315750 clinical trial?
NCT07315750 is sponsored by RemeGen Co., Ltd.. The trial plans to enroll 555 participants.