Efficacy and Safety of Apatinib As Third Line Therapy in Patients With Advanced Ovarian Cancer

• Status: Unknown status
• Trial end date: 2021-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

The study is to investigate the efficacy and safety of apatinib in patients with advanced ovarian cancer,who has received second-line chemotherapy and failed.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sichuan Cancer Hospital and Research Institute
• Treatments: Apatinib

Criteria

Inclusion Criteria:

1. 18 years to 70 years;

2. Had a histologically or cytologically confirmed diagnosis of epithelial ovarian cancer；

3. unfit for radical surgery and had received second-line chemotherapy，the disease still progressed or can not tolerate the chemotherapy;

4. Had a disease status that was measurable or evaluable as defined by Response Evaluation Criteria in Solid Tumors (RECIST, version1.1);

5. Had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2;

6. Had a life expectancy of at least 12 weeks;

7. Adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥90g/L, platelets ≥ 80×10^9/L, neutrophils ≥ 1.5×10^9/L, total bilirubin within 1.5×the upper limit of normal (ULN), and b) ALT and AST≤2.5×the ULN (If liver metastases, serum creatine ≤ 1.5 x ULN);

8. Had not gastrointestinal diseases that lead to malabsorption or impact Drug absorption;

9. had good compliance;

10. Signed and dated informed consent.

Exclusion Criteria:

1. patients who had received anti-vascular therapy;

2. Allergic to any ingredients of Apatinib;

3. Participated in other drug clinical researchers within four weeks;

4. Have a variety of factors that affect oral medication (such as can not swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.)

5. Severe infection;

6. Patients with serious cardiovascular diseases,such as unstable angina, grade 3-4 heart dysfunction (NYHA Standard), congestive heart failure, poor-controlled arterial hypertension despite standard medical management;

7. Patients who received major surgical operations within 4 weeks before screening;

8. Patients who manifested arterial/venous thrombus events, e.g.cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism, etc., within 12 months before screening;

9. Past or concurrent with other malignancies, except for cured skin basal cell carcinoma and cervical in situ cancer;

10. Have a history of psychiatric abuse and can not quit or have mental disorders.