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

NCT05608200 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 427

Last updated 2023-05-31

No results posted yet for this study

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).

Conditions

  • Hepatocellular Carcinoma Non-resectable

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • Second Affiliated Hospital of Guangzhou Medical University

    lead OTHER

Principal Investigators

  • Kangshun Zhu, MD · Second Affiliated Hospital of Guangzhou Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-02
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05608200 on ClinicalTrials.gov