This study is conducted to evaluate the efficacy and safety of lenvatinib plus SIRT (LEN+SIRT) compared with lenvatinib (LEN) alone for patients with hepatocellular carcinoma (HCC) refractory to transarterial chemoembolization (TACE).
This is a prospective, non-randomized controlled trial to evaluate the efficacy and safety of LEN+SIRT versus LEN alone for patients with TACE-refractory HCC. 78 patients (39 in each arm) with TACE-refractory HCC will be enrolled in this study. The patients will receive either LEN+SIRT or LEN. Lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight \< 60 kg, 8mg P.O. QD) will be administered to the patients and last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. For patients in the LEN+SIRT arm, lenvatinib will be started at 3-7 days after SIRT. The primary end point of this study is objective response rate (ORR). The secondary endpoints are disease control rate (DCR), progression-free survival (PFS), time to response (TTR), duration of response (DOR), overall survival (OS), and adverse events (AEs).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
78
Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. QD will be started at 3-7 days after the first SIRT.
Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. QD.
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGObjective response rate (ORR)
The percentage of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR) according to mRECIST
Time frame: 3 years
Disease control rate (DCR)
The percentage of patients who had a tumor response rating of CR, PR, or stable disease (SD) according to mRECIST.
Time frame: 3 years
Progression free survival (PFS)
The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.
Time frame: 3 years
Time to response (TTR)
The time from treatment initiation to first tumour remission (mRECIST)
Time frame: 3 years
Duration of response (DOR)
Time from first tumor response to first disease progression (mRECIST) or death from any cause (whichever occurs first)
Time frame: 3 years.
Overall survival (OS)
The time from date of treatment initiation to death due to any cause
Time frame: 4 years.
Adverse Events (AEs)
Number of patients with AEs assessed by NCI CTCAE v5.0.
Time frame: 3 years.
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