The purpose of the study is to evaluate the efficacy and toxicity of anlotinib in patients with platinum resistant or refractory ovarian cancer
Ovarian cancer is the leading cause of death for patients with gynecologic malignancies. In most cases, the disease is diagnosed at an advanced stage and approximately 75% of patients will eventually experience disease recurrence. However, the overall response rates of second-line chemotherapy for recurrent ovarian cancer are only 20-27%. Therefore, it is important to seek alternative agent that can improve the outcome. Anlotinib is a new, orally administered tyrosine kinase inhibitor that targets VEGFR,FGFR,PDGFR,and c-kit,. The preclinical studies suggest anlotinib may be effective in other cancers such as ovarian cancer. Therefore, the purpose of this study is to test the efficacy and safety of the study drug anlotinib.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
The Second Affiliated hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGObjective response rate (ORR)
Objective response rate defined as confirmed complete response or partial response under RECIST 1.1 criteria. CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met.
Time frame: Up to three years
Progression-free survival (PFS)
Time frame: Up to three years
Duration of Response
Time frame: Up to three years
Frequency and severity of adverse effects as defined by CTCAE version 4.03
Time frame: 30 days after last dose
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