Ovarian Cancer
Conditions
Interventions
Experimental group A:Anlotinib
Experimental group B:Bevacizumab
Sponsors
West China Second University Hospital,Sichuan University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in this study and sign an informed consent form; 2. Female aged =18 years old, ECOG performance status 0-1, expected survival time > 3 months; 3. Histopathology confirmed epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer; 4. Patients with FIGO III stage who did not achieve R0 resection, or any FIGO IV stage, or those with ascites, or those who have received neoadjuvant chemotherapy and are HRD-negative in advanced stages. 5. Patients who reached CR/PR after receiving first-line treatment with platinum-taxane chemotherapy plus bevacizumab; 6. The main organ functions are good, and the laboratory test indicators meet the following criteria (correction and supportive treatment of the parameters below are allowed one week before enrollment): (1) Blood routine: ? Hemoglobin (HB) = 90g/L; ? Absolute neutrophil count (ANC) = 1.5×10^9/L; ? Platelets (PLT) = 1×10^11/L; (2) Blood biochemistry: ? Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 × ULN (liver metastasis = 5 × ULN); ? Total bilirubin (TBIL) = 1.5 × ULN or direct bilirubin = 1.0 × ULN; ? Serum creatinine (Cr) = 1.5×ULN or creatinine clearance = 60 ml/min; (3) Coagulation function test: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) = 1.5×ULN; (4) Cardiac function: left ventricular ejection fraction (LVEF) = 50%; 7. Female subjects should have a negative urine or blood HCG (except for postmenopausal and hysterectomized women). Women of childbearing potential and their partners should use effective contraception during the trial and for 6 months after the last dose of the study drug (e.g., combined hormonal contraception with suppression of ovulation, progestin-only contraception with suppression of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal ligation, vasectomy, abstinence, etc.).
Exclusion criteria
Exclusion criteria: 1. Patients with other non-epithelial ovarian tumors (such as germ cell tumors, sex cord-stromal tumors, etc.) or borderline ovarian epithelial tumors; 2. Patients who have had or currently have other malignant tumors within the past 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors; 3. Patients with a history of gastrointestinal perforation or undergoing major surgery within 28 days prior to enrollment; 4. Patients with active ulcers, intestinal perforation, intestinal obstruction, or non-healed fractures; 5. Other conditions as determined by the investigator that may cause gastrointestinal bleeding or perforation; 6. Tumors invading major blood vessels such as the pulmonary artery, superior vena cava, or inferior vena cava, with a high risk of bleeding as determined by the investigator during screening. 7. Patients currently receiving thrombolytic or anticoagulant therapy, with the exception of prophylactic use of low-dose aspirin (=100mg/d) and low molecular weight heparin (=40mg/d). 8. Patients with various factors affecting oral medication (such as inability to swallow, gastrointestinal resection, chronic diarrhea, and intestinal obstruction); 9. Patients who have experienced unstable angina, myocardial infarction, or class III-IV heart failure (according to NYHA criteria) within 6 months prior to enrollment; 10. Patients with active uncontrolled infections; 11. Patients with a history of significant peripheral neuropathy; 12. Patients whose blood pressure control is not ideal (systolic pressure >=150 mmHg and/or diastolic pressure >=90 mmHg); 13. Urine routine indicated urinary protein >=++, and confirmed 24-hour quantitative urinary protein >1.0g; 14. Patients with human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); active hepatitis (hepatitis B, defined as HBV-DNA = 500 copies/ml; hepatitis C, defined as HCV-RNA higher than the detection limit of the assay) or concurrent HBV and HCV infection; 15. Patients with psychiatric disorders or other conditions such as uncontrolled heart or lung disease, diabetes, etc., who cannot comply with the requirements of the study treatment and monitoring; 16. Patients known to be allergic to the investigational drug or any of its excipients; 17. Pregnant or lactating female patients; female subjects of childbearing potential who refuse to use contraception; 18. Patients who have received other investigational anti-tumor interventions within 4 weeks prior to the first dose of study drug; 19. Patients deemed inappropriate to participate in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Safety;Quality of life score (EORTC QLQ-C30); | — |
Countries
China
Contacts
Public ContactRutie Yin / Qingli Li
West China Second University Hospital, Sichuan University
Outcome results
None listed