Actively Recruiting
Phase 2 Study of Adebrelimab and Fuzuloparib for Treating Women With Recurrent Platinum-Resistant Ovarian Cancer
Led by Fujian Cancer Hospital · Updated on 2024-02-06
37
Participants Needed
1
Research Sites
104 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of adebrelimab and fuzuloparib in people with recurrent platinum-resistant ovarian cancer who have not received previous systemic antitumor therapy for this cancer. This exploratory, single-arm Phase 2 study focuses on assessing the effectiveness and safety of this drug combination in women with this condition. The study is led by Fujian Cancer Hospital and aims to measure outcomes over a 3-year period. Participants receive adebrelimab at 20 mgkg intravenously every three weeks and take fuzuloparib orally at 100 mg twice daily. The study does not include a comparator group and follows a single treatment approach. Treatment continues under medical supervision while researchers monitor the participants response and safety. During the study, participants undergo regular evaluations including scans to measure tumor response using RECIST1.1 criteria, blood tests, and physical assessments. Researchers track the primary outcome of objective response rate over three years, along with secondary outcomes like overall survival, progression-free survival, and disease control rate. Safety monitoring and adherence to study procedures are maintained throughout the study, with participation lasting up to three years.
CONDITIONS
Brief Title
Adebrelimab Combined With Fuzuloparib in the Treatment of Patients With Recurrent Platinum-resistant Ovarian Cancer.
Research Team
Y
Yang Sun, Doctor
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