Actively Recruiting
Phase II Study Comparing Bevacizumab Plus Cisplatin to Cisplatin Alone for Treating Malignant Serous Effusions in Advanced Adenocarcinoma
Led by Qingdao Central Hospital · Updated on 2025-07-29
60
Participants Needed
1
Research Sites
21 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining bevacizumab with cisplatin compared to cisplatin alone for treating malignant serous effusion in patients with advanced adenocarcinoma. This is a phase II, three-center, randomized clinical study sponsored by Qingdao Central Hospital. The study focuses on overall response rates at 4 weeks to understand how well the treatments control serous effusion in this patient group. Participants will be randomly assigned to one of two treatment groups. One group receives an intracavity injection of bevacizumab at 7.5 mgkg combined with cisplatin at 40 mgm2, with a repeat dose on the 21st day if the serous effusion is not controlled. The other group receives cisplatin alone at 40 mgm2 via intracavity injection. Both treatments are administered directly into the cavity where the effusion is present. During the study, participants will be monitored for treatment response at 4 weeks to assess the overall response rate of the serous effusion. Safety and efficacy are carefully observed throughout the treatment period. Patients must meet specific health and laboratory criteria to participate, and their progress will be tracked to ensure their well-being and to gather important data on the treatments effects. The study is expected to run until May 2027.
CONDITIONS
Brief Title
Bevacizumab Combined With Cisplatin Versus Cisplatin Monotherapy in Malignant Serous Effusions
Research Team
Y
youxin ji director of oncology, md, phD
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