High Grade Serous Adenocarcinoma of Ovarian, Fallopian Tube and Peritoneum
Conditions
Interventions
Phase 1:Anlotinib
Phase 2:Anlotinib
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Signed informed consent form; 2. Histologically documented high-grade serous adenocarcinoma of ovary, fallopian tube and peritoneum; 3. Platinum resistant or refractory ovarian cancer had failed at least second line chemotherapy, no prior radiotherapy targeting abdominal and pelvic lesions; 4. Measurable disease, as defined by RECIST v1.1; 5. Women aged between 18-75 years; 6. ECOG performance status of 0 or 1; 7. Life expectancy >=12 weeks; 8. Adequate hematologic and end-organ function, defined by the following laboratory results obtained within 2 week prior to the first study treatment (Cycle 1, Day 1): 1) ANC >=1500 cells/uL (without granulocyte colony-stimulating factor [G-CSF] support within 2 weeks prior to Cycle 1, Day 1); 2) Lymphocyte count >=500/uL; 3) Platelet count >=100,000/uL (without transfusion within 2 weeks prior to Cycle 1, Day 1); 4) Hemoglobin >=9.0 g/dL (without transfusion within 2 weeks prior to Cycle 1, Day 1); 5) AST, ALT, and =60 mL/min or serum creatinine =50%; 10. The patients have good compliance to the therapy and follow-up to be scheduled and are able to understand the study protocol.
Exclusion criteria
Exclusion criteria: 1. Malignancies other than Ovarian caner within 5 years prior to treat, with theexception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer); 2. Patient with adverse effect worse than CTCAE(4.0) grade 2, with the exception of Alopecia; 3. Patient with a variety of factors that affect the oral administration and absorption of drugs; 4. Known CNS disease, except for treated asymptomatic CNS metastases; 5. Patient with known coagulopathy including: PT>16s, APTT>43s, TT>21s, Fbg150mmHg, DP>90mmHg); 2) grade 1 or worse myocardial ischemia or myocardial infarction, arrthyima (including QTC>=470ms) and NYHA grade 2 or worse congestive heart failure; 3) active or uncontrolled severe infection worse than CTCAE grade 2; 4) immunodeficiency: HIV positive, acquired or congential immunodeficiency; 5) uncontrolled diabetes (FBG>10mmol/l); 6) proteinuria( positive for urinalysis or >1.0g/24h); 7) uncontrolled epilepsy; 10. Any risk for hemorrahge; Any hemorraghe within 4 weeks; Uncontrolled wound, ucler or fracture; 11. Any embolic event within 6 months, including cario-cerebrovascular event like TIA, DVT and PVE; 12. Durg abuse and uncontrolled mental illness; 13. Attending another clinical trail within 4 weeks; 14. Patient with severe concomitant disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Respose Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;Progression Free Survival;Overall Survival;Quality of Life; | — |
Countries
China
Contacts
Public ContactHuaying Wang
Fudan University Shanghai Cancer Center
Outcome results
None listed