A phase II trial of lenvatinib in patients with metastatic colorectal cancer after standard chemotherapy

Intervention type:DRUG
Name of intervention:Lenvatinib
Dose form / Japanese Medical Device Nomenclature:CAPSULE
Route of administration / Site of application:ORAL
Dose per administration:24mg
24mg
24mg
Dosing frequency / Frequency of use:QD
Planned duration of intervention:Treatment will continue until the discontinuation criteria are met.
Intended dose regimen:24mg of lenvatinib is orally taken once daily for 28 days each course
detailes of teratment arms:Treatment will continue with lenvatinib 24mg qd until the criteria of interruption, resuming, reduction and discontinuation of treatment are met.
Dose of lenvatinib will be reduced to 20mg, 14mg, 10mg, 8mg, and 4mg qd according to the reduction criteria, and treatment will be discontinued if unable to tolerate at 4mg qd.
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Primary outcome(s): Disease control rate
Study Design: Open-label, single-arm and single-center trial, no treatment control standard of care control, No, open(masking not used),