Endometrial carcinoma
Conditions
Interventions
single arm:niraparlib monotherapy
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The subjects understood the test process, signed the informed consent and agreed to participate in the study; 2. Women aged 18 or above; 3. Patients with endometrial carcinoma confirmed histologically, including endometrial adenocarcinoma, serous carcinoma and clear cell carcinoma, were excluded from carcinosarcoma; 4. The subjects received first-line or second-line platinum containing chemotherapy to achieve objective remission or disease stability (complete remission [Cr] or partial remission [PR] or disease stability [SD]), and were enrolled in the group within 8 weeks after chemotherapy; 5. Patients with previous radiotherapy or endocrine treatment history are allowed; 6. Patients with life expectancy > 16 weeks; 7. ECoG score of patients was 0-1; 8. The subjects agreed to collect blood samples to detect the HRR mutation; 9. Good organ function, including: Neutrophil count >= 1500 / µ L Platelets >= 100000 / µ L Hemoglobin >= 10g / dl Serum creatinine = 60ml / min (calculated according to Cockcroft Gault formula: CCR (ml / min) = (female) (140 age) x weight (kg) x 0.85/72 x SCR (mg / dl) or CCR (ml / min) = (female) (140 age) x weight (kg) x 0.85/0 .818 x Scr(umol/L)) Total bilirubin = 60, or women aged >= 40 and < 60, and menopause for more than 12 months; 11. Patients who are able to follow the program; 12. Patients whose side effects of any previous chemotherapy have recovered to <= CTCAE level 1, except for sensory neuropathy or alopecia with stable symptoms <= CTCAE Level 2.
Exclusion criteria
Exclusion criteria: 1. Patients who are known to be allergic to zl-2306 (nilaparil) or active or inactive components of drugs with similar chemical structure to zl-2306 (nilaparil); 2. Patients with symptomatic and uncontrollable brain metastasis or pial metastasis. No imaging scan is needed to confirm that there is no brain metastasis; patients with spinal cord compression who have received targeted treatment and have clinical stability of disease at least > the evidence of 28 days can still be considered into the group (the controlled central nervous system metastasis must have received treatment such as radiotherapy or chemotherapy at least 1 month before entering the study; the patient can not have new symptoms related to the focus of the central nervous system or symptoms indicating the progress of the disease, and the patient either takes a stable dose of hormone or does not need to take hormone); 3. Patients who have undergone major surgery within 3 weeks before the start of the study, or any surgical effect that has not been recovered after the operation, or who have received chemotherapy; 4. Patients who received > 20% bone marrow palliative radiotherapy one week before admission; 5. Patients with invasive cancer other than endometrial cancer (except basal or squamous cell skin cancer completely treated) within 2 years before admission; 6. The patient has MDS or AML which has been or is currently diagnosed; 7. Patients with serious or uncontrollable diseases, including but not limited to: (1) Uncontrollable nausea and vomiting, inability to swallow the study drug, and any gastrointestinal disease that may interfere with drug absorption and metabolism; (2) Active virus infection, such as human immunodeficiency virus, hepatitis B, hepatitis C, etc.; (3) Uncontrolled seizures, unstable spinal cord compression, superior vena cava syndrome or other mental disorders that affect the patient's signature of informed consent; (4) Immune deficiency (except splenectomy), or other diseases that researchers believe may expose patients to high-risk toxicity. 8. Any previous or current disease, treatment or laboratory abnormality that may interfere with the results of the study and affect the patient's full participation in the study, or the researcher thinks that the patient is not suitable to participate in the study; the patient is not allowed to receive platelet or RBC infusion within 4 weeks before the start of the treatment of the study drug; 9. Immune deficiency (except splenectomy), or other diseases that researchers think may expose patients to high risk; 10. Patients who are pregnant or nursing, or who plan to be pregnant during the study treatment; 11. Patients who have been previously treated with any PARP inhibitor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mPFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS; | — |
Countries
China
Contacts
Public ContactJianqing ZHU
Zhejiang Cancer Hospital
Outcome results
None listed