This study is conducted to evaluate the efficacy and safety of sintilimab, bevacizumab plus TACE (Sin-Bev-TACE) compared with lenvatinib plus TACE (Len-TACE) for patients with advanced stage hepatocellular carcinoma (HCC).
This is a multicenter, prospective and randomized controlled trial to evaluate the efficacy and safety of Sin-Bev-TACE versus Len-TACE for patient with advanced HCC. 258 patients with advanced HCC (BCLC C stage) will be enrolled in this study. The patients will receive either sintilimab and bevacizumab (Sin-Bev) or lenvatinib (Len) after first TACE using an 1:1 randomization scheme. In the Sin-Bev-TACE arm, sintilimab (200mg I.V. q3w) and bevacizumab (7.5mg/kg I.V. q3w) will be started at 3-7 days after the first TACE. In the the Len-TACE arm, lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. qd will be started at 3-7 days after the first TACE. TACE will be repeated on demand based on the evaluation of follow-up laboratory and imaging examination. Sintilimab and bevacizumab will last up to 24 months, or 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. Lenvatinib will 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. In the Sin-Bev-TACE arm, patients will be allowed to have sintilimab or bevacizumab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity. The primary end point of this study is overall survival (OS). The secondary endpoints are progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and adverse events (AEs).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
258
Sintilimab (200mg I.V. q3w) and bevacizumab (7.5mg/kg I.V. q3w) are administered at 3-7 days after the first TACE. The study treatment of sintilimab and bevacizumab will last up to 24 months. TACE can be repeated on demand.
Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. qd will be started at 3-7 days after the first TACE. TACE will be repeated on demand.
the Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGOverall survival (OS)
The time from date of randomization to death due to any cause.
Time frame: 4 years
Progression free survival (PFS)
The time from date of randomization until the first occurrence of disease progression or death due to any cause, whichever occurs first.
Time frame: 4 years
Objective response rate (ORR)
The proportion of patients with the best response of complete response (CR) or partial response (PR).
Time frame: 4 years
Disease control rate (DCR)
The proportion of patients with the best response of CR, PR, or stable disease (SD).
Time frame: 4 years
Adverse Events (AEs)
Number of patients with AEs assessed by Common Terminology Criteria for Adverse Events v5.0.
Time frame: 4 years
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