ovarian cancer
Conditions
Interventions
treatment group:Sapanapali combined with bevacizumab for maintenance treatment, with a 21-day treatment cycle. The dosage is as follows: sapanapali 100mg once daily
Sponsors
Women’s Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Voluntarily participate in the study, sign the informed consent form, and cooperate with follow-up; 2.Aged 18–75 years (calculated on the date of signing the informed consent form); 3.Newly diagnosed patients with histopathologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; 4.FIGO Stage III–IV: - Stage III subjects must have undergone optimal debulking surgery (primary cytoreductive surgery or interval cytoreductive surgery); - Stage IV subjects must have undergone biopsy and/or primary cytoreductive surgery or interval cytoreductive surgery; 5.Clinically confirmed as BRCAwt; 6.Achieved complete remission (CR) or partial remission (PR) after completion of first-line platinum-containing chemotherapy: - CR: No measurable and/or non-measurable lesions per RECIST v1.1 criteria by imaging assessment, and CA125 within the normal range; - PR: Either achievement of PR per RECIST v1.1 criteria by imaging assessment after chemotherapy, or no measurable and/or non-measurable lesions per RECIST v1.1 criteria by imaging assessment with CA125 above the normal range (without sustained elevation); 7.Minimum requirement for bevacizumab use in prior first-line chemotherapy: Completed at least 2 cycles of bevacizumab treatment before enrollment, and the treatment must have been combined with platinum-based chemotherapy in the last 2 cycles; 8.CA125 test results before treatment must meet the following specific criteria: - If the first test value ULN, a second assessment must be conducted at least 7 days after the first test. If the second assessment value is >=15% higher than the first, the subject is ineligible; 9.Must be enrolled and start study treatment within 8–12 weeks after the last chemotherapy administration; 10.ECOG performance status score of 0–1; 11.Normal major organ function, meeting the following requirements (no use of blood components or cell growth factors within 28 days before enrollment is allowed): 1.Routine blood test: - Hemoglobin (HB) >=100 g/L; - Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; - Platelets (PLT) >= 1 × 10^11/L; 2. Blood biochemistry test: - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 60 ml/min; 3. Coagulation function test: - Activated partial thromboplastin time (APTT), international normalized ratio (INR), and prothrombin time (PT) <= 1.5 × ULN; 12.Fertile subjects must use at least one medically approved contraceptive method (e.g., intrauterine device or condom) during the study treatment period and within 6 months after the last administration of study drugs; they must also have a negative serum HCG test result within 72 hours before the first dose and be non-lactating; 13.Life expectancy of at least 16 weeks;
Exclusion criteria
Exclusion criteria: 1.A history of other untreated malignant tumors (within 5 years) or concurrent malignant tumors, except for cured basal cell carcinoma of the skin, thyroid cancer, carcinoma in situ of the cervix, and breast cancer with no recurrence for > 3 years after radical resection; 2.Prior treatment with PARP inhibitors; 3.Inability to swallow tablets normally, or presence of gastrointestinal dysfunction that may affect drug absorption (as judged by the investigator); 4.A history of gastrointestinal perforation or major surgery within 4 weeks before the first dose; patients with any bleeding event >= Grade 3 (per CTCAE), or presence of unhealed wounds, ulcers, or fractures; 5.Poorly controlled blood pressure (systolic blood pressure >= 140 mmHg and/or diastolic blood pressure = 90 mmHg), or a history of hypertensive crisis or hypertensive encephalopathy; 6.Urine protein >=2+ (by urine routine test) with confirmed 24-hour urine protein >=1.0 g; 7.Intestinal obstruction occurring within 3 months; 8.Clinically significant malignant ascites or pleural effusion requiring puncture/drainage, or patients who received ascites/pleural effusion drainage within 2 months before the first dose of study drugs; 9.Coagulation disorders (INR > 1.5 or PT > ULN + 4 seconds), bleeding tendency, or receiving thrombolytic or anticoagulant therapy; low-dose low-molecular-weight heparin, rivaroxaban, or oral aspirin for prophylactic anticoagulation is allowed during the study; 10.Clinically significant cardiovascular diseases, including: a. Myocardial infarction or unstable angina within =2; c. Arrhythmia poorly controlled by medication (well-rate-controlled atrial fibrillation is acceptable), or any clinically significant abnormality on resting electrocardiogram; d. Peripheral vascular disease of Grade >=3 (e.g., obvious symptoms affecting daily activities and requiring surgical repair or reconstruction); e. Cerebrovascular accident (CVA), transient ischemic attack (TIA), or subarachnoid hemorrhage (SAH) within 6 months before enrollment; 11.Use of drugs from other clinical trials within 4 weeks before enrollment; 12.Use of strong CYP3A4 inhibitors or strong CYP3A4 inducers before the first dose of study drugs (eligible for enrollment if washed out for >=5 half-lives before the first dose of study drugs); use of strong CYP3A4 inhibitors or inducers is not allowed during the study (see Appendix IV for details); 13.Potential receipt of other systemic anti-tumor therapy during the study; 14.Known hypersensitivity to senaparib, bevacizumab, or their excipients; 15Other factors (judged by the investigator) that may force early termination of the study, such as severe concurrent diseases (including mental illness) requiring combined treatment, severe laboratory abnormalities, or family/social factors that may affect the subject’s safety or the collection of data and samples;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1y-PFS %; | — |
Secondary
| Measure | Time frame |
|---|---|
| AE/SAE;OS;2y-PFS %;PFS; | — |
Countries
China
Contacts
Public ContactXiaodong Cheng
Women’s Hospital, Zhejiang University School of Medicine
Outcome results
None listed