Actively Recruiting
Pegylated Liposomal Doxorubicin Plus Adebrelimab With or Without Mirabegron in Relapsed Ovarian Cancer: a Randomized, Controlled, Open-label Trial
Led by Obstetrics & Gynecology Hospital of Fudan University · Updated on 2025-03-18
296
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief 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
- Eastern Cooperative Oncology Group (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 fresh biopsy at screening
- Adequate organ function
- Not recovered from adverse events to Grade 1 or prior treatment level due to previous agent
You will not qualify if you...
- Has 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 agents or other co-inhibitory T-cell receptor agents or participation in prior adebrelimab studies
- Received systemic anticancer therapy including radiation 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 required treatment 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 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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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Repeated 21-day cycles until intolerance or disease progression
Participants receive pegylated liposomal doxorubicin plus adebrelimab with or without mirabegron on Day 1 of each 21-day cycle until intolerance or disease progression.
Visits every 3 weeks for treatment administration
Duration - Up to 1 month after the end of treatment
Participants are monitored for safety and survival outcomes after treatment ends.
Approximately 1 follow-up visit after treatment completion
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
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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