RecruitingPhase 3NCT05608200

Lenvatinib+Sintilimab+TACE vs. Lenvatinib+TACE for Advanced HCC

Lenvatinib, Sintilimab Plus TACE Versus Lenvatinib Plus TACE for Patients With Advanced Hepatocellular Carcinoma: a Prospective, Multicenter, Randomized Controlled Trial

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Enrollment

427 participants

Start Date

Nov 2, 2022

Study Type

INTERVENTIONAL

Conditions

Hepatocellular Carcinoma Non-resectable

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).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study compares two treatment approaches for people with advanced liver cancer (hepatocellular carcinoma, or HCC): one group receives lenvatinib (a targeted drug) plus sintilimab (an immunotherapy) plus a procedure called TACE (which delivers chemotherapy directly into the liver tumor), and the other receives lenvatinib plus TACE without immunotherapy. **You may be eligible if...** - You have advanced liver cancer (BCLC stage C or CNLC IIIa/IIIb) confirmed by biopsy or clinical criteria - You have at least one measurable liver tumor - Your liver function is acceptable (Child-Pugh class A or B) - Your performance status is ECOG 0 or 1 - Your life expectancy is at least 3 months - You had tumor recurrence after surgery or ablation (allowed) **You may NOT be eligible if...** - The main portal vein (the large blood vessel feeding the liver) is blocked by tumor on both sides - You have vascular invasion of certain major vessels - You have other serious health conditions (check full criteria with your doctor) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLenvatinib, 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.

DRUGLenvatinib 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.