Actively Recruiting
Study of Adebrelimab Combined with Apatinib for Maintenance Treatment in Extensive-Stage Small Cell Lung Cancer
Led by Tang-Du Hospital · Updated on 2024-06-26
60
Participants Needed
1
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Adebrelimab combined with Apatinib as a maintenance treatment for patients with extensive-stage small cell lung cancer SCLC. This phase 2 clinical trial uses a single-arm design to observe how well this drug combination works in preventing cancer progression after initial chemotherapy and immunotherapy. The study is planned to enroll 60 patients in Shaanxi Province, China, beginning in June 2024 and expected to finish by December 2026. Participants receive treatment cycles lasting three weeks each. Adebrelimab is given intravenously at 1200 mg on day 1 of each cycle, every three weeks. Apatinib is taken orally at 250 mg daily for the first 14 days of the cycle, followed by a one-week break. Treatment timing allows for a window of plus or minus 15 days. Patients undergo regular assessments including vital signs, physical exams, laboratory tests, and performance status evaluations to monitor tolerability and decide on treatment continuation. Throughout the study, researchers will track progression-free survival, overall survival, response rates, and duration of response up to several years. Patients will be followed until tumor progression is confirmed by imaging or other criteria. Safety and side effects will also be monitored closely. The total participation duration varies but is expected to continue until disease progression or other study stopping criteria, with follow-up assessments occurring at regular intervals.
CONDITIONS
Brief Title
Adebrelimab + Apatinib in SCLC Maintenance Therapy
Research Team
J
Jie Min, Dr
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