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Safety and Efficacy of Radiation Plus TACE and Lenvatinib in Advanced HCC With PVTT

NCT05592197 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-02-16

No results posted yet for this study

Summary

This is a multicentri prospective cohort study to investigate the safety and efficacy of external beam radiation (RT) combined with transarterial chemoembolization (TACE) and lenvatinib vs TACE and lenvatinib in the treatment of advanced hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT).

Conditions

Interventions

DRUG

Lenvatinib

Lenvatinib will be initially provided to patients first (dose: 8 mg qd for patients \< 60 kg, and 12 mg qd for patients ≥ 60 kg)

PROCEDURE

TACE

TACE will be performed one day after oral administration of lenvatinib. Either cTACE or DEB-TACE can be used, depending on the condition of each center.

RADIATION

External beam radiation (RT)

RT will be given within 4 weeks after the first TACE with linear accelerator-based photon beams. Gross tumor volume is defined as intrahepatic tumor and vascular invasion including a 1-cm margin into the contiguous HCC. Prescription dose will be 4500-6000 cGy in 25 fractions.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Ming Kuang, Ph.D. · First Affiliated Hospital, Sun Yat-Sen University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2023-03-31
Completion
2023-03-31

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 NCT05592197 on ClinicalTrials.gov