The Impact on Hepatic Recurrence After Adjuvant Chemotherapy With Intraarterial Infusion of Idarubicin-Lipiodol

NCT04178642 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-12-14

No results posted yet for this study

Summary

The aim of this study is to test whether the realization of 3 courses of intra-arterial chemotherapy of idarubicin-lipiodol without embolization, administered non-selectively in the hepatic artery, following the percutaneous tumour ablation of a hepatocellular carcinoma, could constitute an effective adjuvant treatment to reduce the rates of local and intrahepatic distant recurrence and thus improve the survival without hepatic progression.

Conditions

Interventions

DRUG

percutaneous destruction of the tumor + Idarubicin-Lipiodol treatment

Patients will receive the standard treatment protocol consisting of a percutaneous destruction of the tumor. In addition they will receive an adjuvant treatment by hepatic arterial chemo-infusion of Idarubicin (Zavedos®, Pfizer), which is an anthracycline antineoplastic agent, mixed with Lipiodol (Lipiodol Ultra-Fluid®, Guerbet), which is a contrast agent.

PROCEDURE

Percutaneous destruction of the tumor

Patients will received the standard treatment protocol consisting of a percutaneous destruction of the tumor.

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Christophe CASSINOTTO · University Hospital, Montpellier

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-09-22
Primary Completion
2021-07-14
Completion
2021-07-14

Countries

  • France

Study Locations

More Related Trials

Entities

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 NCT04178642 on ClinicalTrials.gov