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TACE Combined With Lenvatinib for Unresectable Hepatocellular Carcinoma

NCT04490694 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2021-09-24

No results posted yet for this study

Summary

It is an exploratory clinical study aimed to evaluate the efficacy and safety of TACE combined with Lenvatinib in the treatment of patients with BCLC stage B and C HCC.Treatment will continue until the death or intolerable toxicity or patients withdrawal of consent,and the target sample size is 54 individuals.

Conditions

Interventions

DRUG

Lenvatinib

Intervention Description：lenvatinib will be administered daily (for patients \<60kg, lenvatinib 8mg bid po for patients ≥60kg, lenvatinib 12mg bid po) until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

PROCEDURE

TACE

Patients will be treated with TACE 2-4 weeks after randomization: the blood supply of the tumor will be evaluated by transradial / femoral artery approach, microcatheter will be inserted into the tumor feeding artery, and lipiodol plus epirubicin emulsifier will be injected (40mg epirubicin will be added to each 10ml lipiodol, the total amount should less than 20ml, epirubicin 40-60mg). Gelatin sponge particles / microspheres are used to strengthen embolization. Blood biochemical examination will be performed within 1 week before TACE, 3 days after operation and 1 month after operation.

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Principal Investigators

  • Zhiping Yan, M.D. · Fudan 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
2020-03-01
Primary Completion
2022-08-01
Completion
2023-08-01

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

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 NCT04490694 on ClinicalTrials.gov