A Phase Ib/II Study of Adebrelimab in Combination with Capecitabine and Oxaliplatin in Cancer
NCT06776770 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 52
Last updated 2025-01-15
Summary
In this study, the combination of Adebrelimab (PD-L1 monoclonal antibody) on the basis of standard treatment (two-drug chemotherapy regimen of fluorouracil and platinum drugs) may enhance the immune response in order to enhance the killing effect on tumor cells and bring survival benefits to patients with advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma.
Conditions
Interventions
- DRUG
-
Adebrelimab
Phase I: Cohort 1: Adebrelimab 10 mg/kg Q3W plus capecitabine and oxaliplatin (XELOX regimen); 21-day treatment cycle; Cohort 2: Adebrelimab 1200 mg or 20 mg/kg Q3W plus capecitabine and oxaliplatin (XELOX regimen); 21-day treatment cycle. Phase II: Adebrelimab (RP2D, Q3W) + (XELOX regimen), with a 3-week (21-day) treatment cycle. XELOX regimen:Oxaliplatin 130 mg/m2 iv.gtt d1,Capecitabine 1,000 mg/m2 p.o.b.i.d.d1\~14.
Sponsors & Collaborators
-
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-08-03
- Primary Completion
- 2026-09-30
- Completion
- 2026-12-31
Countries
- China
Study Locations
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