Clinical trial · Interventional
A Study of RC48-ADC Combination Therapies as First-line Treatment in Advanced Metastatic Gastric Cancer
A Study of RC48-ADC Combine With Toripalimab and Chemotherapy or RC48-ADC Combine With Toripalimab and Trastuzumab as First-line Treatment in Local Advanced or Metastatic Gastric Cancer With the HER2 Expression or Non-expression
- 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)
This is a Phase II/III, randomized, multicenter, open-label clinical trial designed to evaluate safety and efficacy of RC48-ADC combine with Toripalimab and chemotherapy or RC48-ADC combine with Toripalimab and Trastuzumab as first-line treatment in human epidermal growth factor receptor 2 (HER2)-expression or non-expression participants with locally advanced or metastatic gastric cancer.
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 Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine（1000mg/m2） | Drug | Capecitabine | ALIAS |
| Capecitabine（750mg/m2） | Drug | Capecitabine | ALIAS |
| Oxaliplatin（100mg/m2 ） | Drug | Oxaliplatin | ALIAS |
| Oxaliplatin（130mg/m2 ） | Drug | Oxaliplatin | ALIAS |
| RC48-ADC（2.0mg/kg） | Drug | — | UNRESOLVED |
| RC48-ADC（2.5mg/kg） | Drug | — | UNRESOLVED |
| Toripalimab | Drug | Toripalimab | ALIAS |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (8)
- type
- EXPERIMENTAL
- label
- RC48-ADC+Toripalimab+CAPOX (HER2-high expression)
- description
- Participants with HER2-high expression(IHC2+FISH+ or IHC3+) will receive of RC48-ADC every 2 weeks (Q2W), Toripalimab every 2 weeks (Q2W) and CAPOX every 3 weeks (Q3W) , as one treatment period until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first).
- interventionNames
- Drug: RC48-ADC（2.5mg/kg）
- Drug: Toripalimab
- Drug: Oxaliplatin（130mg/m2 ）
- Drug: Capecitabine（1000mg/m2）
- type
- EXPERIMENTAL
- label
- RC48-ADC+Toripalimab+Trastuzumab (HER2-high expression)
- description
- Participants with HER2-high expression(IHC2+FISH+ or IHC3+) will receive of RC48-ADC every 2 weeks (Q2W), Toripalimab every 2 weeks (Q2W) and Trastuzumab every 3 weeks (Q3W) , as one treatment period until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, 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: * Voluntary agreement to provide written informed consent. * Age:18-75 years（including 18 and 75）. * Predicted survival ≥ 12 weeks. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. * Adequate organ function. * All subjects must have inoperable, advanced or metastatic gastric or or gastroesophageal adenocarcinoma. * Subject must be previously untreated with systemic treatment; Subject that received neoadjuvant chemotherapy with recurrence \>6 months from completion of therapy are permitted; * HER2-expressing status determined by laboratory to be IHC 1+, 2+ or 3+ or IHC0. Exclusion Criteria: * Active central nervous system (CNS) metastases. * Known active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection. * History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, thyroid cancer ,etal. * Known hypersensitivity to antibody-drug conjugate(ADC) or PD-(L)1 or any of its components. * Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
References
Publications (0)
Data not yet available