Actively Recruiting
Fluzoparib Combined With Bevacizumab in PSROC Previously Treated With PARPi
Led by Chongqing University Cancer Hospital · Updated on 2022-09-22
42
Participants Needed
1
Research Sites
367 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
There are more and more PARPi(PARP inhibitors) resistance for ovarian cancer patients after previous use of PARP inhibitors. Basic studies have found that there is synergistic effect of bevacizumab combined with PARPi. Therefore we designed the study to include 42 ovarian cancer patients who had PARPi for at least half a year and then relapsed (platinum-sensitive, previously 1-3 lines of chemotherapy). After getting complete remission or partial remission with chemotherapy containing platinum and bevacizumab, fluzopanib and bevacizumab were used for maintenance treatment. The progression-free survival, ORR, DCR, DoR, and safety were evaluated based on RECIST V1.1.
CONDITIONS
Official Title
Fluzoparib Combined With Bevacizumab in PSROC Previously Treated With PARPi
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 75 years with ovarian cancer diagnosed as low/high grade serous carcinoma or endometrioid carcinoma
- Received 1 to 3 lines of platinum-based chemotherapy after primary cytoreductive surgery
- At least one measurable lesion by RECIST V1.1 criteria
- More than 6 months since last chemotherapy cycle to relapse or progression
- ECOG performance status score of 0 or 1
- Negative serum or urine pregnancy test within 7 days before enrollment for women of childbearing age and agreement to use contraception during the study
- Blood counts: hemoglobin 6 g/L, absolute neutrophil count 1.5 x 10^9/L, platelets 100 x 10^9/L
- Liver enzymes: ALT and AST less than or equal to 3 times upper limit of normal
- Serum creatinine less than or equal to 1.5 times upper limit of normal
You will not qualify if you...
- Use of bevacizumab within 6 months before enrollment
- Diagnosis of other malignant tumors within 5 years or untreated central nervous system metastases
- Recent intestinal obstruction or gastrointestinal perforation within 3 months
- Uncontrolled high blood pressure (systolic 140 mmHg or diastolic 90 mmHg)
- Moderate to severe cerebrovascular accident, deep vein thrombosis, or pulmonary embolism within 6 months before enrollment
- Blood clotting disorders
- History of myocardial infarction, severe arrhythmia, or congestive heart failure NYHA class 2 or higher
- Active or uncontrolled severe infections
AI-Screening
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Trial Site Locations
Total: 1 location
1
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030
Actively Recruiting
Research Team
Z
Zou Dongling, PH.D.
CONTACT
L
Lin Zhong, M.D.
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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