Actively Recruiting
Adebrelimab Combined With Fuzuloparib for Recurrent Platinum-resistant Ovarian Cancer Treatment in a Single-arm Exploratory Study
Led by Fujian Cancer Hospital · Updated on 2024-02-06
37
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of adebrelimab and fuzuloparib in people with recurrent platinum-resistant ovarian cancer who have not received previous systemic antitumor therapy for this cancer. This exploratory, single-arm Phase 2 study focuses on assessing the effectiveness and safety of this drug combination in women with this condition. The study is led by Fujian Cancer Hospital and aims to measure outcomes over a 3-year period. Participants receive adebrelimab at 20 mg/kg intravenously every three weeks and take fuzuloparib orally at 100 mg twice daily. The study does not include a comparator group and follows a single treatment approach. Treatment continues under medical supervision while researchers monitor the participants' response and safety. During the study, participants undergo regular evaluations including scans to measure tumor response using RECIST1.1 criteria, blood tests, and physical assessments. Researchers track the primary outcome of objective response rate over three years, along with secondary outcomes like overall survival, progression-free survival, and disease control rate. Safety monitoring and adherence to study procedures are maintained throughout the study, with participation lasting up to three years.
CONDITIONS
Brief Title
Adebrelimab Combined With Fuzuloparib in the Treatment of Patients With Recurrent Platinum-resistant Ovarian Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 70 years
- Diagnosed with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer within 6 months after last platinum chemotherapy
- At least one measurable target lesion by RECIST1.1 criteria
- Confirmed HRR gene mutation by tissue or blood testing
- ECOG performance status 0 or 1
- Normal major organ functions meeting specified blood and biochemical standards
- Coagulation times within acceptable limits unless on anticoagulation therapy
- No severe heart, lung, liver, or kidney disorders
- Negative pregnancy test for women of childbearing age and agree to contraception during and 8 weeks after treatment
- Estimated survival of at least 12 weeks
- Signed informed consent and ability to comply with study visits and procedures
You will not qualify if you...
- Participation in other clinical trials with experimental drugs concurrently
- Known allergy to fuzuloparib or similar compounds
- Known allergy to adebrelimab or similar compounds
- Inability to swallow oral medication or gastrointestinal disorders affecting drug absorption
- Prior treatment with immune checkpoint inhibitors
- Active or history of autoimmune diseases except certain stable or resolved conditions
- History of immunodeficiency, including HIV or organ/bone marrow transplantation
- Uncontrolled systemic diseases like hypertension or severe arrhythmias
- Previous or current serious lung diseases or active pneumonia
- Uncontrolled cardiac conditions including recent heart attack or significant arrhythmias
- Pregnant or breastfeeding, or planning pregnancy during treatment
- Investigator's judgment of unsuitability for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 3-week cycles until disease progression or discontinuation
Participants receive Adebrelimab and Fuzuloparib as treatment for recurrent platinum-resistant ovarian cancer.
Dosing every 3 weeks with daily oral medication; visit cadence as per treatment cycles
Trial Site Locations
Total: 1 location
1
Fujian Cancer Hospital
Fujian, China
Actively Recruiting
Research Team
Y
Yang Sun, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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