ovarian cancer
Conditions
Interventions
Treatment group:Niraparib 200mg po QD day1~21, Anlotinib 12mg po QD day1~14
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Subjects understand the trial process, sign informed consent, agree to participate in the study, and have the ability to follow the protocol; 2. 18 ~ 70 years old (inclusive), female; 3. Histologically diagnosed ovarian, fallopian tube, or primary peritoneal cancer; 4. Subjects were initially treated with platinum, and the disease recurrence occurred within 6 months after the end of the previous platinum-containing chemotherapy, that is, platinum resistance relapsed; 5. Life expectancy > 16 weeks; 6. Patient's ECOG physical status score is 0-1; 7. Subject agrees to take blood samples for gBRCA mutations; 8. Can provide formalin-fixed, paraffin-embedded tumor tissue samples for sBRCA and homologous recombination repair-related genes detection (optional); 9. Good organ function, including: – Neutrophil count >= 1500 / µL; – Platelets >= 100,000 / µL; – Hemoglobin >= 10g / dL; – Serum creatinine = 60mL / min (calculated according to Cockcroft-Gault formula); – Total bilirubin <= 1.5 times the upper limit of normal value or direct bilirubin <= 1.0 times the upper limit of normal value; – AST and ALT <= 2.5 times the upper limit of normal value. When liver metastases are present, it must be <= 5 times the upper limit of normal value. 10. The toxic side effects of any previous chemotherapy have recovered to <= CTCAE level 1 or baseline levels, except for sensory neuropathy or hair loss with stable symptoms <= CTCAE level 2.
Exclusion criteria
Exclusion criteria: 1. People who are known to be allergic to Niraparib or Anlotinib (or active or inactive ingredients of drugs with similar chemical structure); 2. Symptomatic, uncontrolled brain or pia mater metastases; 3. Underwent major surgery within 3 weeks before the study began or has not recovered after surgery; 4. Received palliative radiotherapy of > 20% bone marrow 1 week before enrollment; 5. Have invasive cancer other than ovarian cancer (except fully treated basal or squamous cell skin cancer) within 2 years before enrollment; 6. Patients with central lung squamous cell carcinoma or at risk for large hemoptysis; 7. Previous or currently diagnosed myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML); 8. Severe or uncontrolled diseases, including but not limited to: uncontrollable nausea and vomiting, inability to swallow or gastrointestinal diseases that may interfere with drug absorption and metabolism; active viral infections; mental illnesses that affect patients' signed informed consent History of bleeding tendency and thrombosis; history of severe cardiovascular disease; 9. Laboratory abnormalities: hyponatremia; hypokalemia; uncontrollable nail function abnormalities; 10. Receive platelet or red blood cell transfusions within 4 weeks; 11. Patients who are pregnant or nursing, or who plan to become pregnant during study treatment; 12. Have previously received any PARP inhibitor treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Platinum-free interval;Duration of treatment response; | — |
Countries
China
Contacts
Public ContactJihong Liu
Sun Yat-Sen University Cancer Center
Outcome results
None listed