Clinical trial · Interventional
RC48 Plus AK105 and Cisplatin in Advanced Gastric Cancer
Disitamab Vedotin Plus Penpulimab and Cisplatin in Advanced Gastric Cancer
NCT05313906CI-TRIAL-00057619unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To explore the safety and clinical efficacy of cisplatin combined with RC48 and anti-PD-1 antibodies AK105 in Her-2 positive advanced gastric cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Gastric Carcinoma | Gastric Carcinoma | CURATED_BROADER | 0.78 |
| HER2-positive Gastric Cancer | HER2-Positive Gastric Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RC48+AK105+cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- exprimental group
- description
- RC48 plus AK105 and cisplatin
- interventionNames
- Drug: RC48+AK105+cisplatin
Primary outcomes (1)
- measure
- ORR
- timeFrame
- three months
- description
- the proportion of patients who got CR and PR
Secondary outcomes (2)
- measure
- PFS
- timeFrame
- six months and twelve months
- description
- the duration of diseases stable or better
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years old, ≤75 years old, regardless gender * Pathologically confirmed gastric adenocarcinoma, Her2 immunohistochemical examination of 2+ or 3+ * ECOG PS scores 0-1 * Stage IV according to AJCC 8.0 and no systemic therapy previously * Expected lifespan ≥ 3 months * Adequate organ function * At least one measurable lesion according to RECIST 1.1 * Asymptomatic intracranial metastasis * No history of other malignancies * Women of childbearing age must have a negative blood pregnancy test within 7 days, and subjects of childbearing age must use appropriate contraception during the trial and for 6 months after the trial * Agreed to participate in this clinical study and signed the Informed Consent Exclusion Criteria: * Currently participating in an interventional clinical investigational treatment, or have received other investigational drugs or treatment with an investigational device within 4 weeks prior to the first dose * Received anti-PD-1, anti-PD-L1, anti-CTLA-4, and other checkpoint inhibitor * Received traditional Chinese medicines or immunomodulatory drugs with anti-gastric cancer indications within 2 weeks before the first administration * Active autoimmune diseases or immunodeficiency diseases * Allergy to any test drug and its excipients, or a history of severe allergy, or contraindication to the test drug * Severe mental disorder * Receiving systemic corticosteroids within 7 days prior to the first dose of the study * Clinically apparent cardiovascular and cerebrovascular disease * Others investigators evaluated not meet the inclusion criteria
References
Publications (0)
Data not yet available
No reference posted for this study.