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Lenvatinib+Sintilimab+TACE vs. Lenvatinib+TACE for Advanced HCC
Sponsor: Second Affiliated Hospital of Guangzhou Medical University
Summary
This study is conducted to evaluate the efficacy and safety of lenvatinib, sintilimab plus TACE (Len-Sin-TACE) compared with lenvatinib plus TACE (Len-TACE) for patients with advanced hepatocellular carcinoma (HCC).
Official title: Lenvatinib, Sintilimab Plus TACE Versus Lenvatinib Plus TACE for Patients With Advanced Hepatocellular Carcinoma: a Prospective, Multicenter, Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
427
Start Date
2022-11-02
Completion Date
2026-10-31
Last Updated
2023-05-31
Healthy Volunteers
No
Conditions
Interventions
Lenvatinib, sintilimab plus TACE
Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. qd and sintilimab (200mg I.V. q3w) will be started at 3-7 days after the first TACE. TACE will be repeated if clinically indicated. Treatment of sintilimab will last up to 24 months. Patients will be allowed to have lenvatilib or sintilimab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.
Lenvatinib plus TACE
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 if clinically indicated. The interruption, dose reduction and discontinuation of lenvatinib depended on the presence and severity of toxicities according to the drug directions.
Locations (1)
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China