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TACE Combined With Lenvatinib and Sintilimab for Advanced HCC

NCT04599790 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-11-10

No results posted yet for this study

Summary

This study will evaluate the efficacy and safety of transcatheter arterial chemoembolization (TACE) combined with lenvatinib and sintilimab in patients with unresectable advanced hepatocellullar carcinoma (HCC).

Conditions

  • Hepatocellular Carcinoma Non-resectable

Interventions

DRUG

TACE combined with lenvatinib and sintilimab

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.

Sponsors & Collaborators

  • Second Affiliated Hospital of Guangzhou Medical University

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2021-11-29
Completion
2022-10-31

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 NCT04599790 on ClinicalTrials.gov