This is a single-arm, open-label study performed at our hospital, patients with progression hepatocellular carcinoma (HCC) met inclusion criteria will be enrolled. Patients received oral lenvatinib 12mg/day (for patients≥60 kg) or 8 mg/day (for patients\<60kg ) before local radiotherapy 4 weeks, large lesions were treated with IMRT for 40-60gy / 20-30f. Combined therapy will be taken until unacceptable treatment-related toxicities occurred or disease progression.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Radiotherapy with IMRT or VMAT with 40-60Gy/20-30f; Concurrent Lenvatinib 12mg/day (for patients≥60 kg) or 8 mg/day (for patients\<60kg ) qd po. (Note: Levatinib can be given to patients in four weeks before Radiotherapy is applied, so that it can control disease during waiting for Radiotherapy). Maintenance Lenvatinib 12mg/day (for patients≥60 kg) or 8 mg/day (for patients\<60kg ) qd po until disease progress or unacceptable adverse events; six months is recommended but not mandatory.
Bo Chen
Beijing, Beijing Municipality, China
MST
Median Survival Time (MST) was defined as the duration from the date of patient recruited to the date of death from any cause
Time frame: 24 months
ORR
Overall Response Rate (ORR) was defined as the total of CR (Complete Response) and PR (Partial Response). CR and PR were assessed by independent reviewers according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. ORR evaluated in 1 to 3 months after the completion of radiotherapy.
Time frame: Assessment in 1 to 3 months after radiotherapy
TTP
Time to Progression (TTP) was defined as the duration from the date of patient recruited to the first progress at any site or the date of death
Time frame: 24 months
Rate of III-IV grade adverse events
Adverse events was evaluated during received protocol therapy according to CTCAE 4.03
Time frame: up to 24 months
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