Ovarian Cancer
Conditions
Interventions
Trial group:Fruquintinib 100mg, twice daily, oral
Famicitinib 20mg, once daily, oral
Sponsors
Yantai Yuhuangding Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Participants must voluntarily join this study, sign the informed consent form, demonstrate good compliance, and be able to cooperate with follow-up; 2. Female, aged 18–75 years (calculated on the day of signing the informed consent form); 3. Pathologically confirmed high-grade (or poorly differentiated) serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; 4. HRD-negative (confirmed by central laboratory next-generation sequencing [NGS], including BRCA1/2 wild-type with low genomic loss of heterozygosity [LOH] score or low genomic instability index); 5. Underwent primary tumor debulking surgery or intermediate tumor debulking surgery after neoadjuvant therapy, regardless of residual disease status post-surgery; tumor debulking must include bilateral salpingo-oophorectomy and partial omentectomy; 6. Completed 6–9 cycles of platinum-based combination chemotherapy; for those intolerant to chemotherapy due to specific reasons, at least 4 cycles of combination chemotherapy must be completed; for patients who underwent intermediate tumor debulking surgery, at least 2 cycles of combination chemotherapy must be completed post-surgery, totaling 6–9 cycles; intravenous or intraperitoneal chemotherapy is permitted, but hyperthermic intraperitoneal chemotherapy (HIPEC) is not allowed; 7. Assessed by the investigator as having achieved disease response after platinum-based chemotherapy, and must complete randomization within 12 weeks after the last chemotherapy; disease response is defined as follows: complete response (CR): no lesions on imaging evaluation, and CA125 within the upper limit of normal (=90% during first-line chemotherapy; if there are no measurable lesions, CA125 must decrease to within the upper limit of normal (=90% during first-line chemotherapy; 8. Maintenance therapy with bevacizumab is not allowed after chemotherapy completion; if a patient has received bevacizumab during first-line platinum-based chemotherapy but is unsuitable for continued maintenance therapy with it, enrollment may be considered; concurrent use of other investigational drugs and antitumor agents (except endocrine therapy and traditional/modern Chinese herbal preparations) is prohibited during or after platinum-based chemotherapy; 9. Two CA125 tests must be completed during the screening period, with an interval of >=7 days between tests; if the first CA125 test result is >ULN, participants with a second test result showing an increase of >10% from the previous test are ineligible; 10. Must be able to provide formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens for biomarker testing at the designated central laboratory; 11. ECOG performance status: 0–1; 12. Organ function must meet the following criteria (no use of blood components or growth factors within 14 days prior to medication): absolute neutrophil count >=1.5×10^9/L; platelet count >=100×10^9/L; hemoglobin >=10 g/dL; serum albumin >=3 g/dL; bilirubin <=1.5×ULN; ALT and AST <=3×ULN; serum creatinine <=1.5×ULN; 13. Female patients of childbearing potential must use at least one medically approved contraceptive method (e.g., intrauterine device or condom) during the
Exclusion criteria
Exclusion criteria: 1. Patients with a history of or concurrent other malignancies within the past 5 years, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and breast cancer with no recurrence for >3 years after radical surgery; 2. Patients who have previously received PARP inhibitors or small-molecule antiangiogenic TKI drugs, including but not limited to olaparib, niraparib, and rucaparib; 3. Patients with untreated central nervous system metastases; those who have received systemic or radical treatment (radiotherapy or surgery) for brain or meningeal metastases, with imaging-confirmed stability for >=1 month, and who have discontinued systemic hormonal therapy (dose >10 mg/day prednisone or equivalent) for >2 weeks and are asymptomatic may be included; 4. Patients who have experienced intestinal obstruction or gastrointestinal perforation within 3 months prior to treatment; 5. Patients unable to swallow tablets normally or with gastrointestinal abnormalities that, in the investigator's judgment, may affect drug absorption; 6. Patients with clinically symptomatic cancerous ascites or pleural effusion requiring puncture or drainage, or those who have undergone ascites or pleural effusion drainage within 3 months prior to treatment; 7. Patients with poorly controlled cardiac clinical symptoms or diseases, including: (1) NYHA Class II or higher heart failure; (2) Unstable angina; (3) Myocardial infarction within the past year; (4) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; (5) QTc interval >470 ms; 8. Patients with hypertension that remains poorly controlled despite antihypertensive medication (systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg); 9. Patients who have experienced any bleeding event of CTCAE 5.0 Grade 2 or higher within 4 weeks prior to treatment; 10. Patients with a history of or currently diagnosed with interstitial pneumonia, drug-induced pneumonia, or active pneumonia during the screening period; 11. Patients with coagulation abnormalities (international normalized ratio [INR] >1.5 or prothrombin time [PT] >ULN+4 seconds) and a bleeding tendency; or those receiving thrombolytic or anticoagulant therapy (low-dose low-molecular-weight heparin or oral aspirin for prophylactic anticoagulation is permitted); 12. Patients who have experienced arterial/venous thrombotic events within 6 months prior to treatment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, or pulmonary embolism; patients with lower extremity intermuscular venous thrombosis assessed as not requiring anticoagulation or with catheter-related mural thrombosis resolved without medication may be considered for inclusion; 13. Patients with a history of hereditary or acquired bleeding disorders or coagulation dysfunction; or those with clinically significant bleeding symptoms or a clear bleeding tendency within 3 months prior to treatment, such as gastrointestinal bleeding or hemorrhagic gastric ulcer; 14. Patients with active infections or unexplained fever (body temperature >=38.5°C) within 7 days prior to treatment; 15. Patients with congenital or acquired immunodeficiency (e.g., HIV infection) or active hepatitis (for hepatitis B: HBsAg positive and HBV DNA >=500 IU/mL; for hepatitis C: HCV antibody positive and HCV viral copy number > upper limit of normal); 16. Patients wi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) assessed by investigators; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Time to Future Treatment (TFST);Time to Progression (TTP);Changes in tumor markers; | — |
Countries
China
Contacts
Public ContactCong Jianglin
Yantai Yuhuangding Hospital
Outcome results
None listed