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.
Ovarian cancer is the third most common gynecological malignancy,just less than endometrial cancer and cervical cancer. Because most patients with advanced ovarian cancer can not get the ideal tumor cell reduction surgery, and multi-drug resistance often emerges after repeated chemotherapy,recurrent and metastatic ovarian cancer has become one of the major diseases that threaten women's health. There is strongly necessary to explore effective therapeutic drugs and means to improve prognosis of these patients and improve the quality of life. The study,as a double blind clinical trial ,is to investigate the efficacy and safety of apatinib in patients with advanced ovarian cancer,who has received second-line chemotherapy regimens and failed. A total of 60 patients with performance status 0-2 were enrolled in this study, and were randomly divided into two groups--one group of 40 patients receiving apatinib,and another of 20 patients receiving placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Sichuan Cancer Hospital
Chengdu, Sichuan, China
RECRUITINGProgression-free survival (PFS)
Time from randomization until disease progression or death
Time frame: approximately 2 years
Overall survival (OS)
Time from randomization until death from any cause of death
Time frame: approximately 2 years
Objective response rate (ORR)
Proportion of patients with reduction in tumor burden of a predefined amount
Time frame: approximately 2 years
disease control rate (DCR)
the total proportion of patients who demonstrate a response to treatment
Time frame: approximately 2 years
Quality of life (QoL)
As measured by the European Organization for Research and Treatment of Cancer questionnaire (EORTC QLQ C30)
Time frame: approximately 2 years
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