Ovarian Cancer
Conditions
Keywords
therapy
Brief summary
This is a single-arm, open-label, multicenter exploratory clinical study designed to evaluate the efficacy and safety of fluzoparib combined with famitinib malate as maintenance therapy in patients with newly diagnosed advanced (FIGO III-IV) high-grade serous or endometrioid ovarian cancer (including fallopian tube and primary peritoneal cancer) who have achieved a complete response (CR) or partial response (PR) after first-line platinum-based chemotherapy (with or without bevacizumab). Eligible women aged 18-75 years with ECOG 0-1 will start study treatment within \<9 weeks after the last platinum dose. Participants will receive fluzoparib 150 mg orally twice daily plus famitinib malate 10 mg orally once daily in 28-day cycles, continuing for up to 24 cycles or until disease progression, unacceptable toxicity, initiation of new anti-tumor therapy, withdrawal of consent, or investigator decision. The primary endpoint is progression-free survival (PFS); secondary endpoints include overall survival (OS), duration of response (DOR), time to response (TTR), and PFS-2.
Interventions
DRUGFluzoparib
Fluzoparib is administered orally at a dose of 150 mg twice daily, and famitinib malate is administered orally at a dose of 10 mg once daily. Treatment is given in 28-day cycles as maintenance therapy following complete or partial response to first-line platinum-based chemotherapy, and is continued until disease progression, unacceptable toxicity, withdrawal of consent, initiation of new anti-tumor therapy, or completion of up to 24 cycles.
Sponsors
Jinhua Zhou
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single-group assignment: all participants receive fluzoparib + famitinib as post-first-line platinum response maintenance therapy.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Female patients aged 18 to 75 years at the time of informed consent. Newly diagnosed, histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, including high-grade serous or high-grade endometrioid carcinoma. FIGO stage III-IV disease at initial diagnosis. Achieved complete response (CR) or partial response (PR) after completion of first-line platinum-based chemotherapy, with or without bevacizumab. Initiation of study treatment within 9 weeks after the last dose of platinum-based chemotherapy. ECOG performance status 0-1. Adequate bone marrow, liver, and renal function, as defined by protocol-specified laboratory criteria. Life expectancy of ≥12 weeks. Ability to swallow oral medications and comply with study requirements. Signed written informed consent prior to any study-specific procedures.
Exclusion criteria
Evidence of disease progression during or after first-line platinum-based chemotherapy. Prior treatment with any PARP inhibitor or anti-angiogenic tyrosine kinase inhibitor (except bevacizumab as part of first-line therapy). Prior systemic anti-cancer therapy for ovarian cancer other than first-line platinum-based chemotherapy. Uncontrolled or significant cardiovascular disease, including but not limited to uncontrolled hypertension, recent myocardial infarction, or clinically significant arrhythmia. Active or uncontrolled infection, or serious concomitant systemic disorders that may interfere with study participation. Known central nervous system metastases. History of other malignancies within the past 5 years, except for adequately treated carcinoma in situ of the cervix or non-melanoma skin cancer. Pregnant or breastfeeding women. Known hypersensitivity to fluzoparib, famitinib, or any of their excipients. Any condition that, in the investigator's judgment, would make the patient unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | From treatment initiation up to approximately 48 months | Progression-free survival is defined as the time from initiation of maintenance treatment with fluzoparib plus famitinib to the first documentation of disease progression according to RECIST v1.1 criteria or death from any cause, whichever occurs first. |
Contacts
CONTACTYing Zhou
Outcome results
None listed