NCT05753826 Adebrelimab Combined With Fuzuloparib in the Treatment of Patients With Recurrent Platinum-resistant Ovarian Cancer.
| NCT ID | NCT05753826 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Fujian Cancer Hospital |
| Condition | Ovarian Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 37 participants |
| Start Date | 2023-08-01 |
| Primary Completion | 2025-12-31 |
Trial Parameters
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Brief Summary
This is a single-arm, exploratory study. People with recurrent platinum-resistant ovarian cancer who have not received any previous systemic antitumor therapy for ovarian cancer were selected to evaluate the efficacy and safety of adebrelimab combined with fuzuloparib.
Eligibility Criteria
Inclusion Criteria: 1. Age 18-70;Female; 2. Pathologically (including histologically) confirmed epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer (hereinafter referred to as ovarian cancer), recurrence within less than 6 months after the last treatment with platinum-containing chemotherapy; 3. Patients have at least one target lesion with measurable dimensions according to RECIST1.1 criteria; 4. HRR gene mutation confirmed by testing tissue or blood samples; 5. ECOG PS 0-1; 6. Major organ functions are normal and meet the following criteria:(1) Blood routine inspection standards must meet: (no blood transfusion within 14 days)a.HB≥100g/L, b. WBC≥3×10\^9/L c. ANC≥1.5×10\^9/L, d.PLT≥100×10\^9/L; (2) Biochemical examination must meet the following standards: a. BIL ≤1.5 times the upper limit of normal (ULN); b. ALT and AST≤2.5×ULN, ALT and AST≤5×ULN in patients with liver metastases; c. Serum Cr≤1.5×ULN 7. Activated partial thromboplastin time (APTT) ≤ 1.5 time