Actively Recruiting
Pegylated Liposomal Doxorubicin Plus Adebrelimab With or Without Mirabegron in Relapsed Ovarian Cancer
Led by Obstetrics & Gynecology Hospital of Fudan University · Updated on 2025-03-18
296
Participants Needed
1
Research Sites
256 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Pegylated Liposomal Doxorubicin Plus Adebrelimab With or Without Mirabegron in Relapsed Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided documented informed consent for the study
- ECOG performance status of 0 or 1
- Histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
- Received front line platinum-based regimen after primary or interval debulking surgery with documented disease recurrence
- Platinum-free interval less than 12 months if last regimen was platinum-based, or treatment-free interval less than 12 months if last regimen was non-platinum-based
- Measurable disease at baseline based on RECIST 1.1
- Life expectancy of at least 12 weeks
- Provided tumor tissue sample from prior surgery or newly obtained at screening
- Adequate organ function
- Not recovered from adverse events to Grade 1 or prior treatment level from previous therapy
You will not qualify if you...
- Nonepithelial cancers, borderline tumors, mucinous, seromucinous predominantly mucinous, malignant Brenner's tumor, or undifferentiated carcinoma
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or other co-inhibitory T-cell receptor agents, or prior participation in adebrelimab studies
- Received systemic anticancer therapy or maintenance therapy within 4 weeks before randomization
- Severe hypersensitivity (Grade 3 or higher) or uncontrolled hypertension to study drugs or their excipients
- Major surgery within 3 weeks before randomization or unresolved complications
- Additional malignancy progressed or treated within last 5 years
- Pregnant or breastfeeding
- History of allogenic tissue or solid organ transplant
- History of thrombotic disorders, hemorrhage, hemoptysis, or active gastrointestinal bleeding within 6 months
- History of active autoimmune disease
- Active infection requiring systemic therapy
- History of HIV infection
- History of Hepatitis B or C virus infection
- Any condition or therapy that might confound study results
- Known psychiatric or substance abuse disorder interfering with study cooperation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200090
Actively Recruiting
Research Team
C
Cao Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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