This is a single center, nonrandom, open-label study aiming to evluate the efficacy and safety of lenvatinib for patients with pretreated advanced biliary tract cancer.
Lenvatinib targets VEGFR1, 2, and 3, PDGFRα, Fibroblast growth factor receptor (FGFR), and the KIT and RET tyrosine kinases and was initially developed for use in various tumor types. This is a single-center, non-random, open-label study in participants with unresectable BTC and disease progression or failure following at least one chemotherapy regimen. This study contains three procedures: a pre-treatment procedure that will last within 21 days; a treatment procedure that will consist of study treatment cycles and tumor assessment conducted every 6-8 weeks; and a follow-up procedure that will begin immediately after the off-treatment visit and will continue as long as the participant is alive, unless the participant withdraws consent, or until the terminal of the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Drug doses for BTC are identical, being orally administered at 8mg/d to patients weighing \<60 kg and 12mg/d to those ≥60 kg.
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Objective Response Rate (ORR)
Objective response rate
Time frame: Six months
Progression free survival (PFS)
Progression free survival
Time frame: Six months
Overall survival (OS)
Overall survival (OS) \[ Time Frame: From the date of first dose of study drug to the date of death from any cause, or up to approximately 2 years \]
Time frame: Two years
Disease control rate (DCR)
DCR is defined as the percentage of participants with complete response (CR) + partial response (PR) + stable disease (SD).
Time frame: Six months
The Rate of Treatment Related Adverse Events
Treatment related adverse events (AEs) were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (CTCAE 4.0). The study recorded the occurrence rate of treatment related AEs
Time frame: Three years
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