RecruitingPhase 2Phase 3NCT06791460

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

Pegylated Liposomal Doxorubicin Plus Adebrelimab With or Without Mirabegron in Relapsed Ovarian Cancer: a Randomized, Controlled, Open-label Trial


Sponsor

Obstetrics & Gynecology Hospital of Fudan University

Enrollment

296 participants

Start Date

Mar 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if drug regimen pegylated liposomal doxorubicin and adebrelimab with or without mirabegron works to treat relapsed ovarian cancer in adults. It will also learn about the safety of drug regimen pegylated liposomal doxorubicin and adebrelimab with or without mirabegron. The main questions it aims to answer are: Does drug pegylated liposomal doxorubicin and adebrelimab with or without mirabegron reduce tumor volume? What medical problems do participants have when taking drug pegylated liposomal doxorubicin and adebrelimab with or without mirabegron? Researchers will compare drug regimen pegylated liposomal doxorubicin and adebrelimab with mirabegron to a drug regimen pegylated liposomal doxorubicin and adebrelimab without mirabegron to see which drug regimen works better to treat relapsed ovarian cancer. Participants will: Take drug pegylated liposomal doxorubicin and adebrelimab every 21 days with or without everyday mirabegron Visit the clinic once every 2 months for checkups and tests Keep a diary of their symptoms


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding mirabegron (a drug used for overactive bladder that may also affect the immune system) to a combination of pegylated liposomal doxorubicin (a targeted chemotherapy) and adebrelimab (an immunotherapy drug) improves outcomes for women with relapsed ovarian cancer — cancer that came back after initial treatment. **You may be eligible if...** - You have been diagnosed with epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer confirmed by tissue test - Your cancer has come back and your last platinum-based chemotherapy ended less than 12 months ago - You received a standard first-line platinum-based treatment following surgery - Your performance status is good (ECOG 0-1) **You may NOT be eligible if...** - You have not received first-line platinum-based chemotherapy - Your cancer is still responding very well to platinum-based drugs (platinum-free interval of 12 months or more from the last platinum therapy) - You have serious health conditions that would prevent you from tolerating the treatment - Your organ function does not meet the required minimums Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPegylated liposomal doxorubicin plus adebrelimab with mirabegron

Participants receive pegylated liposomal doxorubicin at a dose of 20mg/m2 plus adebrelimab at a dose of 20 mg/kg via intravenous (IV) infusion plus on Day 1 of each 21-day cycle orally with daily mirabegron until intolerance or disease progression.

DRUGPegylated liposomal doxorubicin plus adebrelimab

Participants receive pegylated liposomal doxorubicin at a dose of 20mg/m2 plus adebrelimab at a dose of 20 mg/kg via intravenous (IV) infusion plus on Day 1 of each 21-day cycle until intolerance or disease progression.


Locations(1)

Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, China

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NCT06791460


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