Study of Pegylated Liposomal Doxorubicin and Adebrelimab With or Without Mirabegron for Treating Relapsed Ovarian Cancer in Adult Women

What this Trial Is About

Researchers are evaluating whether the drug combination of pegylated liposomal doxorubicin and adebrelimab, with or without mirabegron, can effectively treat relapsed ovarian cancer in adults. This trial aims to find out if this combination reduces tumor size and to learn about the safety and medical issues participants may experience. The study is a randomized, controlled, open-label trial sponsored by the Obstetrics & Gynecology Hospital of Fudan University and includes adults aged 18 to 75 years. Participants are randomly assigned to receive either pegylated liposomal doxorubicin plus adebrelimab with daily mirabegron or pegylated liposomal doxorubicin plus adebrelimab without mirabegron. The drugs are given by intravenous infusion every 21 days, with mirabegron taken orally daily in one group until intolerance or disease progression occurs. The study includes regular clinic visits every two months for checkups and tests, with participants also keeping a diary of their symptoms. During the trial, participants will have their tumor response measured by the objective response rate at 6 months. Additional outcomes include progression-free survival and overall survival at 6 and 12 months, as well as monitoring for serious adverse events up to one month after treatment ends. Safety, tumor measurements, laboratory tests, and symptom diaries will help researchers assess the treatments. The study is planned to continue until February 2030, with careful monitoring throughout.

Pegylated Liposomal Doxorubicin Plus Adebrelimab With or Without Mirabegron in Relapsed Ovarian Cancer