This study is designed to see whether Apatinib is effective in treating patients with advanced refractory biliary tract cancers.
Biliary tract cancers (BTC) includes cholangiocarcinoma and gallbladder carcinoma (GBC). The systematic treatment based on gemcitabine plus cisplatin is recommended as the current standard chemotherapy for unresectable or metastatic BTC. There is no standard recommendation for second line therapy. Apatinib is a tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor 2(VEGFR-2). This study was conducted to assess the efficacy and safety of Apatinib in patients with advanced refractory BTC who had received first-line chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Apatinib 500mg, po, qd, every 4 weeks.
Foshan people's Hospital
Foshan, Guangdong, China
RECRUITINGCancer center of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGProgression-free survival (PFS)
the time from randomize to progression or death; RECIST guidelines were used to define all responses after patients had received every 4 weeks of therapy
Time frame: Approximately 1 year
Overall survival (OS)
Defined as the time from randomize to death
Time frame: Approximately 2 years
Disease control rate(DCR)
Defined as the rate of complete response , partial response and stable disease according to RECIST guidelines
Time frame: Approximately 1 year
Quality of life(QoL)
As measured by the European Organization for Research and Treatment of Cancer questionnaire (EORTC QLQ C30)
Time frame: Approximately 1 year
Safety (incidence of adverse events)
Incidence of adverse events
Time frame: Approximately 1 year
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