Ovarian Cancer
Conditions
Interventions
Experimental group:Fuzuloparib: 150 mg, twice daily, orally, 28 days as a treatment cycle
Famitinib: 15 mg, once daily, orally, 28 days as a treatment cycle
Treatment continues until disease progression, unacceptable toxicity, or other reasons specified in the protocol.
Sponsors
Tianjin Medical University Cancer Institute & Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary participation and signed informed consent; 2. Age between 18 and 70 years; 3. Histopathologically confirmed malignant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; 4. Achievement of no evidence of disease (NED) or complete response/partial response (CR/PR) after the last platinum-based chemotherapy; 5. Prior maintenance therapy with a PARP inhibitor as a single agent; 6. CA125 level >= 2 times the upper limit of normal (ULN) or >= 2 times the patient's nadir value (for patients whose CA125 was not elevated prior to treatment or had returned to normal after initial treatment, elevation is defined as >= 2× ULN; for patients with elevated CA125 at initial diagnosis that did not normalize after treatment, elevation is defined as >= 2× the nadir value), with no evidence of tumor recurrence on imaging; 7. Life expectancy >= 3 months; 8. Adequate major organ function, with results from tests performed within 7 days prior to the first dose meeting the following criteria: 1) Hematology (without blood transfusion or use of hematopoietic growth factors within 7 days prior to screening): Hemoglobin (Hb) >= 90 g/L; absolute neutrophil count (ANC) >= 1.5×10?/L; lymphocyte count (LC) >= 0.5×10?/L; platelet count (PLT) >= 75×10?/L; white blood cell count (WBC) >= 3.0×10?/L and = 60 mL/min (Cockcroft-Gault formula); prothrombin time (PT) and activated partial thromboplastin time (APTT) = 2+, 24-hour urine protein quantification must show protein <= 1 g; 4) Thyroid function: Thyroid-stimulating hormone (TSH) within normal range, or abnormal but with normal free T3 (FT3)/free T4 (FT4) levels and asymptomatic (stable doses of thyroid hormone replacement therapy permitted); 5) 12-lead electrocardiogram: Fridericia-corrected QT interval (QTcF) < 470 ms in females. 9. Wound healing: At least 4 weeks have passed since the last major surgery (e.g., laparotomy, thoracotomy), and the wound is fully healed. 10. The subject voluntarily agrees to participate in this study, signs the informed consent form, demonstrates good compliance, and is able to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with other malignant tumors (except those with carcinoma in situ that has been completely treated with no evidence of disease, thyroid cancer that has undergone curative treatment, and other malignancies for which curative treatment has been completed and the time from the last tumor-related treatment to screening exceeds 5 years); 2. Clear evidence of tumor recurrence or progression on imaging evaluation; 3. History of major organ transplantation; 4. History of severe psychiatric illness or brain dysfunction; history of substance abuse or drug addiction; 5. Any active autoimmune disease or history of autoimmune disease (including but not limited to autoimmune hepatitis, interstitial pneumonia, hepatitis, enteritis, nephritis, hypophysitis, vasculitis, uveitis), or patients requiring systemic corticosteroid therapy and/or immunosuppressive therapy (e.g., asthma requiring bronchodilators); the following are excluded: vitiligo, alopecia, Graves’ syndrome, psoriasis or eczema that has not required systemic treatment in the past 2 years, stable immune thyroiditis that is controlled after treatment, type I diabetes mellitus requiring only stable insulin therapy, and childhood asthma that has completely resolved; 6. Current use of immunosuppressants or systemic corticosteroids for immunosuppressive purposes (dose > 10 mg/day of prednisone or equivalent), with continued use within 2 weeks prior to enrollment. Topical use and systemic use of = 2.5 mL within 3 months prior to screening; 8. History of thrombosis or embolic events within the past 6 months, such as cerebrovascular accident (including transient ischemic attack); 9. Severe cardiovascular disease or history including but not limited to: NYHA Class 3 and 4 congestive heart failure within 6 months prior to enrollment; unstable angina pectoris or newly diagnosed angina pectoris or myocardial infarction within 12 months prior to screening; arrhythmias requiring therapeutic intervention (patients receiving beta-blockers or digoxin may be enrolled); family history of long QT syndrome or corrected QT interval (QTc) > 470 ms (female); if the patient has a prolonged QTc interval but the cause is assessed by the investigator to be a pacemaker (and there are no other cardiac abnormalities), the patient may still be included; CTCAE >= Grade 2 valvular heart disease; uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg); 10. Patients with active ulcers, active gastrointestinal fistula or intra-abdominal abscess (unless drained with no evidence of infection), intestinal perforation, unresolved intestinal obstruction, or history of gastrointestinal perforation within 28 days prior to enrollment; 11. Active inflammatory bowel disease, uncontrolled nausea and vomiting, inability to swallow study medication, or any gastrointestinal disease that may interfere with drug absorption and metabolism; 12.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (CA-125 response);Progression Free Survival,PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first subsequent anti-cancer treatment,TFST;Overall survival,OS;Safety endpoints (adverse events, etc.); | — |
Countries
China
Contacts
Public ContactWenxin Liiu
Tianjin Medical University Cancer Institute & Hospital
Outcome results
None listed