Ovarian Clear Cell Carcinoma
Conditions
Interventions
Experimental group:Anlotinib combined with Niraparib Dual Therapy
Sponsors
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years (inclusive), female; 2. Histologically confirmed ovarian clear cell carcinoma; 3. The patient has received platinum-containing regimen treatment after the initial cytoreductive surgery, and the disease recurrence/progression during the platinum-containing regimen treatment or the time from platinum-containing treatment (at least 4 cycles) to disease recurrence/progression is less than 6 months, that is platinum refractory ovarian cancer; or the patient relapsed within 6 months after the last platinum-containing chemotherapy ended, that is, platinum resistance recurrence; 4. Life expectancy> 16 weeks; 5. The patient's ECOG physical state score is 0-1; 6. Good organ function, including neutrophil count >=1500/µL, platelet >=100,000/µL, hemoglobin >=10g/dL, serum creatinine =60mL/min (according to Cockcroft Gault formula calculation), total bilirubin <= 1.5 times the upper limit of normal or direct bilirubin <= 1.0 times the upper limit of normal, AST and ALT <= 2.5 times the upper limit of normal, and liver metastasis must be <= 5 times the upper limit of normal; 7. Women of childbearing age who had a negative pregnancy test result at the time of enrollment and promised to take adequate and effective contraceptive measures or abstinence during the period from the beginning of the study to the end of the study, and within 3 months after the last administration of the study medication, can join the study. Or the women enrolled in this study are women without potential fertility; 8. Any previous toxic and side effects of chemotherapy have returned to <= CTCAE level 1 or baseline level, except for sensory neuropathy or alopecia with stable symptoms <= CTCAE level 2; 9. According to the RECIST 1.1 standard, there is at least one measurable lesion before enrollment.
Exclusion criteria
Exclusion criteria: 1. Have received any PARP inhibitor treatment in the past; 2. Those who are known to be allergic to niraparib or the active or inactive ingredients of drugs with similar chemical structure to niraparib and those who are known to be allergic to anlotinib or the active or inactive ingredients of drugs with similar chemical structure to anlotinib; 3. Symptomatic, uncontrollable brain metastases or pial metastases, no imaging scan is needed to confirm no brain metastases; patients with spinal cord compression can still be considered for inclusion if they have received targeted treatment and have evidence of clinically stable disease for at least > 28 days (Controlled central nervous system metastasis must have received treatment such as radiotherapy or chemotherapy at least 1 month before entering the study; 4. Have received major surgery within 3 weeks before the start of the study, or any surgical effect that has not recovered after the operation, or received chemotherapy; 5. Received palliative radiotherapy with >20% bone marrow 1 week before enrollment; 6. Suffered from invasive cancers other than ovarian cancer (except for fully treated basal or squamous cell skin cancer) within 2 years before enrollment; 7. The patient has previously or currently diagnosed myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML); 8. Suffer from serious or uncontrollable disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Carbohydrate antigen 125; | — |
Countries
China
Contacts
Public ContactZhang Bingzhong
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Outcome results
None listed