Actively Recruiting
Adebrelimab Combined With Fuzuloparib in the Treatment of Patients With Recurrent Platinum-resistant Ovarian Cancer.
Led by Fujian Cancer Hospital · Updated on 2024-02-06
37
Participants Needed
1
Research Sites
230 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-arm, exploratory study. People with recurrent platinum-resistant ovarian cancer who have not received any previous systemic antitumor therapy for ovarian cancer were selected to evaluate the efficacy and safety of adebrelimab combined with fuzuloparib.
CONDITIONS
Official 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
- Confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with recurrence less than 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 of 0 or 1
- Normal major organ function meeting specific blood and biochemical standards without recent transfusions
- Activated partial thromboplastin time, prothrombin time, and INR within 1.5 times the upper limit of normal unless on anticoagulation with expected ranges
- No severe heart, lung, liver, or kidney disorders
- Negative serum pregnancy test within 7 days before enrollment and willingness to use 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...
- Concurrent participation in other clinical drug trials using experimental drugs
- Known allergy to fuzuloparib or components chemically similar
- Known allergy to adebrelimab or components chemically similar
- Inability to swallow oral medication or gastrointestinal conditions affecting drug absorption
- Prior treatment with immune checkpoint inhibitors
- Active or history of autoimmune diseases needing intervention except certain stable or resolved conditions
- History of immunodeficiency, including positive HIV or organ/bone marrow transplantation
- Uncontrolled systemic diseases like hypertension or severe arrhythmias
- Pulmonary diseases including idiopathic pulmonary fibrosis or active pneumonia
- Uncontrolled cardiac conditions or significant arrhythmias
- Pregnant or breastfeeding or planning pregnancy during treatment
- Investigator's judgment deeming patient unsuitable for inclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fujian Cancer Hospital
Fujian, China
Actively Recruiting
Research Team
Y
Yang Sun, Doctor
CONTACT
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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