Clinical trial · Interventional
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
NCT07315750CI-TRIAL-00101243recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Carcinoma | Gastric Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAPOX (oxaliplatin/capecitabine) | Drug | CAPOX Regimen | ALIAS |
| Disitamab Vedotin | Drug | Disitamab Vedotin | ALIAS |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Disitamab Vedotin Combined with Trastuzumab and Tislelizumab
- description
- Participants will receive Disitamab Vedotin, Trastuzumab and Tislelizumab until the occurrence of intolerable toxicity, disease progression (investigator-assessed), initiation of new anti-tumor therapy, loss to follow-up, withdrawal of informed consent, or death (whichever occurs first).
- interventionNames
- Drug: Disitamab Vedotin
- Drug: Tislelizumab
- Drug: Trastuzumab
- type
- ACTIVE_COMPARATOR
- label
- Chemotherapy (CAPOX) Combined with Trastuzumab With or Without Pembrolizumab
- description
- Participants will receive CAPOX, Trastuzumab and Trastuzumab. Only subjects whose PD-L1 expression is confirmed as CPS ≥1 by the central laboratory will receive pembrolizumab. Treatment will continue until the occurrence of intolerable toxicity, disease progression (investigator-assessed), initiation of new anti-tumor therapy, loss to follow-up, withdrawal of informed consent, or death (whichever occurs first).
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.