Trials / Not Yet Recruiting
Not Yet RecruitingNCT07266025
Adebrelimab Combined With Induction Chemotherapy or SHR-8068 for Mismatch Repair-Deficient/Microsatellite Instability-High (dMMR/MSI-H) Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma：A Randomized, Non-comparative Phase 2 Study
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Shanghai Zhongshan Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, non-comparative, open-label, two-arm phase II clinical trial designed to evaluate the efficacy and safety of neoadjuvant therapy with adebrelimab plus induction chemotherapy versus adebrelimab plus SHR-8086 in patients with dMMR/MSI-H gastric or gastroesophageal junction adenocarcinoma.
Conditions
- Gastric Adenocarcinoma
- Gastroesophageal Adenocarcinoma
- Mismatch Repair Deficient or MSI-High Solid Tumors
- Immunotherapy
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Adebrelimab | Participants in both arms will receive neoadjuvant adebrelimab 1200mg intravenously on day 1 of a 21-day cycle for four cycles. |
| DRUG | XELOX | Participants assigned to arm 1 will receive neoadjuvant XELOX (capecitabine 1000 mg/m² orally twice daily on days 1-14 plus oxaliplatin 130 mg/m² intravenously on day 1) for one cycle. |
| DRUG | SHR-8068 | Participants assigned to arm 2 will receive SHR-8068 280 mg administered intravenously on day 1 for one cycle. |
| PROCEDURE | D2 radical gastrectomy | Curative-intent D2 radical gastrectomy is scheduled 4-6 weeks after completion of the fourth cycle. |
Timeline
- Start date
- 2026-01-30
- Primary completion
- 2030-06-30
- Completion
- 2030-06-30
- First posted
- 2025-12-05
- Last updated
- 2026-01-27
Source: ClinicalTrials.gov record NCT07266025. Inclusion in this directory is not an endorsement.