Oral Topotecan Combined With Anlotinib in Patients With Platinum-resistant Recurrent Ovarian Cancer

Exclusion Criteria

• •1. Have other malignant tumors at the same time, except for malignant tumors that have been cured or stabilized;
• •2. Pregnant or lactating women;
• •3. Participated in clinical trials of other drugs within six months;
• •4. Have a variety of factors that affect oral drugs (such as inability to swallow, chronic diarrhea and intestinal obstruction, etc.);
• •5. Any bleeding event with a severe grade of 3 or above in CTCAE 4.0 within 4 weeks prior to screening;
• •6. Patients with known central nervous system metastases or history of central nervous system metastases before screening;
• •7. Patients with hypertension who cannot be well controlled by single antihypertensive drugs (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg); Patients with a history of unstable angina; Patients with a new diagnosis of angina within 3 months before screening or a myocardial infarction event within 6 months before screening; Arrhythmias require long-term use of antiarrhythmic drugs and New York Heart Association grade ≥ II cardiac insufficiency;
• •8. Long-term unhealed wounds or incompletely healed fractures;
• •9. Previous organ transplantation history;
• •10. Imaging shows that the tumor has invaded important blood vessels or the investigator judges that the patient's tumor has a high possibility of invading important blood vessels during treatment and causing fatal hemorrhage;
• •11. Coagulation dysfunction (prothrombin time\>16s, Activated partial thromboplastin\>43s, thrombin time\>21s, fibrinogen\<2g/L), with bleeding tendency (14 days before randomization must meet: INR within normal value without anticoagulant); Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; Under the premise of the international normalized ratio (INR) of prothrombin time (INR) ≤ 1.5, the use of low-dose warfarin (1 mg orally once daily) or low-dose aspirin (not exceeding 100 mg daily) for prophylactic purposes is permitted;
• •12. Screen for arteriovenous thrombotic events within one year before, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis (except for venous thrombosis caused by venous catheterization with chemotherapy in the early stage of chemotherapy and judged to have been cured by the investigator) and pulmonary embolism;
• •13. Those who have a history of psychotropic substance abuse and cannot quit or have mental disorders;
• •14. Have a history of immunodeficiency, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;
• •15. According to the judgment of the investigator, there are serious concomitant diseases that endanger the safety of patients or affect the completion of the study;
• •16. History of surgical procedures within 28 days;
• •17. History of abdominal fistula or gastrointestinal perforation within 28 days;
• •18. Those who may receive other systemic anti-tumor therapy or plan to undergo ovarian cancer debulking surgery during the study.