Ovarian cancer
Conditions
Interventions
1:Niraparib
1: anlotinib
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to 75 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. aged 18 ~ 75years old (inclusive), female; 3. ECOG0-1 4. Histologically diagnosed Endometrial carcinoma includes endometrioid adenocarcinoma, serous carcinoma, clear cell carcinoma, and carcinosarcoma. -Life expectancy > 12 weeks; 5. Subject agrees to take blood samples for Biomarker test(eg.gBRCA mutationsHRRMMRTMB)(optional); 6. Good organ function, including: 7. Neutrophil count >= 1500/uL; Platelets >= 100,000/uL; Hemoglobin >= 10g/dL; Serum creatinine = 60mL / min (calculated according to Cockcroft-Gault formula); Total bilirubin <= 1.5 ULN or direct bilirubin <= 1.0 ULN; AST and ALT <= 2.5 ULN. When liver metastases are present, it must be <= 5 ULN; 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. Have invasive cancer other than Endometrial Cancer(except fully treated basal or squamous cell skin cancer) within 5 years before enrollment; 5. Patients with central lung squamous cell carcinoma or at risk for large hemoptysis; 6. Previous or currently diagnosed myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML); 7. 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; Laboratory abnormalities: hyponatremia; hypokalemia; uncontrollable nail function abnormalities; 8. Have previously received any PARP inhibitor treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective remission rate ; | — |
Secondary
| Measure | Time frame |
|---|---|
| TEAE;progression free survival ;overall survival;Disease control rate ; | — |
Countries
China
Contacts
Public ContactHuaying Wang
Fudan University Shanghai Cancer Center
Outcome results
None listed