Advanced HRP ovarian cancer
Conditions
Interventions
Senaparib Monotherapy group:Senaparli monotherapy
Senaparib in Combination with Bevacizumab group:Senaparib in Combination with Bevacizumab
Sponsors
Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences)
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily join this study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up; 2. Age 18–75 years (calculated as of the date of signing the informed consent); 3. Newly diagnosed patients with epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer confirmed by histopathology; 4. FIGO stage III–IV: Stage III subjects must have undergone one optimal debulking surgery (either primary cytoreductive surgery or interval cytoreductive surgery). Stage IV subjects must have undergone biopsy and/or primary cytoreductive surgery or interval cytoreductive surgery; 5. HRD-negative; 6. Achieved CR or PR after platinum-based therapy; CR is defined as no measurable and/or non-measurable lesions by imaging evaluation according to RECIST v1.1 and CA125 within the normal range. PR is defined as: after chemotherapy, imaging evaluation meets PR by RECIST v1.1 criteria, or imaging evaluation shows no measurable and/or non-measurable lesions by RECIST v1.1, with CA125 above the normal range but without persistent increase; 7. In the niraparib plus bevacizumab treatment group, patients are required to have completed at least 2–3 cycles of bevacizumab during first-line chemotherapy, and it must be combined with platinum-based chemotherapy in the last 3 cycles; 8. Pre-treatment CA125 test results must meet the following specific criteria: (1) If the first test value is ULN, a second assessment must be performed at least 7 days after the first test. If the second value is >=15% higher than the first, the subject is ineligible; 9. The interval from the last chemotherapy to administration does not exceed 12 weeks; 10. ECOG Score: 0–1; 11. Major organ functions are normal and meet the following requirements (no blood products or growth factors may be used within 14 days prior to enrollment): (1) Complete blood count: 1) Hemoglobin (HB) >= 100 g/L; 2) Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; 3) Platelets (PLT) >= 1 × 10^11/L; (2) Blood biochemistry: 1) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 60 ml/min; (3) Coagulation function: Activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) <= 1.5 × ULN; 12. Subjects of reproductive potential must use at least one medically approved contraceptive method (such as an intrauterine device or condom) during the study treatment and for 6 months after the last administration of the investigational drug; must have a negative serum HCG test within 72 hours prior to the first dose; and must not be breastfeeding.
Exclusion criteria
Exclusion criteria: 1. History of (within 5 years) or currently having other untreated malignant tumors, except for cured basal cell carcinoma of the skin, thyroid cancer, cervical carcinoma in situ, and breast cancer that has undergone radical surgery with no recurrence for more than 3 years; 2. Previously treated with PARP inhibitors; 3. Unable to swallow tablets normally, or having gastrointestinal abnormalities that, in the investigator's judgment, may affect drug absorption; 4. For the combination therapy group, history of gastrointestinal perforation or major surgery within 4 weeks before the first dose; patients with any bleeding event >= CTCAE grade 3, or having unhealed wounds, ulcers, or fractures; 5. Imaging (CT or MRI) showing tumor invasion of major blood vessels or unclear boundaries with blood vessels; 6. For the combination therapy group, patients with poorly controlled blood pressure (systolic >= 150 mmHg and/or diastolic >= 90 mmHg); 7. For the combination therapy group, urinalysis showing proteinuria >=2, and confirmed 24-hour urine protein >=1.0g; 8. History of intestinal obstruction within the recent 3 months; 9. Patients with clinically symptomatic malignant ascites or pleural effusion who require puncture and drainage, or those who have undergone ascites or pleural effusion drainage within 2 months before the first trial medication; 10. In the combination therapy group, patients with coagulation dysfunction (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds), those with a tendency to bleed, or those receiving thrombolytic or anticoagulant therapy are allowed to receive low-dose low-molecular-weight heparin or oral aspirin for prophylactic anticoagulation during the trial; 11. Patients who have used investigational drugs from other clinical trials within the past 4 weeks; 12. Patients who received strong CYP3A4 inhibitors or strong CYP3A4 inducers before the first dose of the study drug (eligible if at least 5 half-lives have passed since the last dose), and strong CYP3A4 inhibitors or inducers cannot be used during the study; 13. Subjects may receive other systemic antitumor treatments during the study; 14. Patients known to be allergic to the excipients of cenapalib or bevacizumab; 15. Patients who, in the investigator's judgment, have other factors that may lead to forced early termination of the study, such as other severe diseases (including psychiatric disorders) requiring concurrent treatment, severe laboratory abnormalities, or family or social factors that may affect patient safety, data, or sample collection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-Year Progression-Free Survival Rate;2-Year Progression-Free Survival Rate; | — |
Countries
China
Contacts
Public ContactHe Shanyang
Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences)
Outcome results
None listed