Angiogenesis Inhibitors,Ovarian Neoplasms Clinical Trial
Official title:
Efficacy and Safety of Apatinib As Third Line Therapy in Patients With Advanced Ovarian Cancer
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.
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | February 2021 |
| Est. primary completion date | August 2020 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 70 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Sichuan Cancer Hospital | Chendu | Sichuan |
| Lead Sponsor | Collaborator |
|---|---|
| Sichuan Cancer Hospital and Research Institute |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression-free survival (PFS) | Time from randomization until disease progression or death | approximately 2 years | |
| Secondary | Overall survival (OS) | Time from randomization until death from any cause of death | approximately 2 years | |
| Secondary | Objective response rate (ORR) | Proportion of patients with reduction in tumor burden of a predefined amount | approximately 2 years | |
| Secondary | disease control rate (DCR) | the total proportion of patients who demonstrate a response to treatment | approximately 2 years | |
| Secondary | Quality of life (QoL) | As measured by the European Organization for Research and Treatment of Cancer questionnaire (EORTC QLQ C30) | approximately 2 years |