Fluzopari Combined With Apatinib for the Neoadjuvant Treatment of Unresectable Ovarian Cancer
- Sponsor
- Fujian Cancer Hospital
- Study ID
- NCT05597527
- Phase
- PHASE2
- Status
- Unknown
Conditions
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Fluzopari and apatinib — DRUGFluzopari was used as 100mg capsules orally twice a day (one time in the morning and one time in the evening), every four weeks as a cycle, a total of 3-4 cycles. Apatinib was used as 250 mg orally once a day, every 4 weeks as a cycle, 2-3 cycles in total, and stop 4 weeks before operation.
Study Details
This is a single arm, multi center, exploratory clinical study to evaluate the efficacy and safety of fluzoparide combined with alpatinib as neoadjuvant therapy in patients with BRCA1/2 gene mutation or HRD gene mutation, advanced ovarian cancer, primary peritoneal cancer, fallopian tube cancer ((FIGO stage III or IV), who can not achieve R0 tumor reduction surgery after imaging evaluation or laparoscopic evaluation .
Key Dates
- Start date
- Nov 1, 2022
- Status verified
- Oct 2022
- Primary completion
- May 31, 2025
- Completion
- May 31, 2025
Study Design
- Enrollment
- 35 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Fluzopari and Apatinib groupFluzopari and Apatinib were used in patients with newly diagnosed ovarian cancer before any treatment. The daily dose should be strictly controlled according to the experimental design.
Primary Outcome Measure
R0 resection rate [ Time Frame: 3-month ]
Central Contacts
- Lin An13805015679
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