Chiauranib in Combination With Chemotherapy in Patients With Ovarian Cancer

Exclusion Criteria

• •1. Patients with prior invasive malignancies in the past five years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ;
• •2. Patients with allergic to Chiauranib, Etoposide and Paclitaxel;
• •3. Patients received vascular endothelial growth factor(VEGF)/vascular endothelial growth factor receptor(VEGFR) inhibitor, like Apatinib, Anlotinib, Fruquintinib, Bevacizumab, etc., or Aurora kinase inhibitors;
• •4. Patients received Etoposide therapy;
• •5. Patients received weekly Paclitaxel therapy ;
• •6. Clinical evidence of central nervous system involvement;
• •7. Have uncontrolled or significant cardiovascular disease, including:
• •1. Congestive heart failure, unstable angina pectoris, myocardial infarction within 6 months prior to study entry; arrhythmia, or Left Ventricular Ejection Fraction (LVEF) \< 50% requiring treatment with agents during screening stage.
• •2. primary cardiomyopathy(dilated cardiomyopathy, hypertrophic cardiomyocyte, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, et,al)
• •3. History of significant QT interval prolongation, or Corrected QT Interval (QTc) \> 470 ms prior to study entry
• •4. Symptomatic coronary heart disease requiring treatment with agents
• •5. Uncontrolled hypertension (≥ 140/90 mmHg) by single agent.
• •8. Have active bleeding current thrombotic disease, patients with bleeding potential ,or receiving anticoagulation therapy; within 2 months prior to screening;
• •9. Proteinuria positive (≥1g/24h).
• •10. History of deep vein thrombosis or pulmonary embolism;
• •11. Have unsolved toxicities (\> grade 1) from prior anti-cancer therapy;
• •12. Have clinical significant gastrointestinal abnormality, e.g., unable to swallow, chronic diarrhea, ileus, that would impair the ingestion, transportation or absorption of oral agents, or patients undergone gastrectomy;
• •13. History of organ transplantation;
• •14. Major surgery within 6 weeks and minor surgery within 2 weeks prior to screening;
• •15. Serologically positive for HIV, hepatitis B or C, or other serious infectious diseases (positive infectious diseases refer to that needed systemic therapy; HIV, hepatitis B or C: qualitative detection priority, quantitative detection if needed).
• •16. History of interstitial lung disease (ILD).
• •17. Any mental or cognitive disorder, that would impair the ability to understand the informed consent document or the operation and compliance of study;
• •18. Candidate with drug and alcohol abuse (alcohol abuse: alcohol consumption is no more than 5040ml beer or 2100ml wine or 630ml strong wine with alcohol content tops out at 40 percent each week).
• •19. Patients participated in other clinical trials in 4 weeks before enrollment, or washout period less than 5 half-life after received other clinical trial drugs (whichever is the longest);
• •20. Participants of reproductive potential not willing to use adequate contraceptive measures for the duration of the study (both male and female participants).Pregnant or breastfeeding women. Female participants must have a negative urinary or serum pregnancy test when done or have evidence of post-menopausal status (Defined as absence of menstruation for greater than 12 months, bilateral oophorectomy or hysterectomy).
• •21. Any other condition which is inappropriate for the study in the opinion of the investigators.