Transarterial Chemoembolization Plus Hypofractionnated Radiotherapy vs. Surgery in Locally Advanced Hepatocellular Carcinoma: an IPTW Comparison (TACE-hypoRT)

March 26, 2021 updated by: Hospices Civils de Lyon
Patients with non-metastatic unresectable hepatocellular carcinoma

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

163

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69004
        • Croix-Rousse Hospital, Hospices Civils de Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients aged 18 or older, presenting Child-Pugh class A HCC treated in Hospices Civils de Lyon between 2004 and 2016

Description

Inclusion Criteria:

  • Age ≥18 years of age
  • ECOG 0-2
  • Histologically proven hepatocellular carcinoma or proven according to radiological and biochemical criteria (EASL-AASLD) in cirrhotic patients
  • Child-Pugh class A
  • Absence of truncular or lobar portal vein invasion, or suprahepatic vein invasion

Exclusion Criteria:

  • Uncontrolled replication of hepatitis B virus
  • Transplanted liver
  • Previous abdominal irradiation
  • Previous treatment of HCC with systemic therapy, or with surgical resection in the 2 previous years
  • Metastatic illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TACE- hypofractionated radiation therapy
Patients will receive one course of transarterial chemoembolization followed 1 to 4 weeks later by hypofractionated radiation therapy up to a total dose of 45 to 60 Gy, 3 Gy per fraction, 5 fractions per week, for an overall treatment time of 3 to 4 weeks.
Other: TACE + hypofractionated EBRT
One cure of doxorubicin or DC Beads transarterial chemoembolization by a highly experienced interventional radiologist, followed 1 to 4 weeks later by hypofractionated external beam radiation therapy up to a total dose of 45-60 Gy, 3 Gy per fraction, 5 fractions per week, for an overall treatment time of 3 to 4 weeks.
Surgical resection
Surgical resection by open-laparotomy or laparoscopy of hepatocellular carcinoma
Procedure: Surgical resection
Surgical resection by open-laparotomy or laparoscopy of hepatocellular carcinoma by a highly experienced liver surgeon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival of the patient after start of treatment
Time Frame: Within 10 years after the treatment (surgical resection or TACE)
Disease-Free Survival (DFS) defined as the time (in months) between the treatment (surgical resection or TACE) and the diagnostic of local, locoregional or distant recurrence, or date of death from any cause; patients who are alive or lost to follow-up at the time of the analysis will be censored on the last follow-up date; patients who have received a liver transplant for non-carcinologic reason will be censored on the date of transplantation.
Within 10 years after the treatment (surgical resection or TACE)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2020

Primary Completion (Actual)

January 15, 2021

Study Completion (Actual)

January 15, 2021

Study Registration Dates

First Submitted

March 26, 2021

First Submitted That Met QC Criteria

March 26, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 26, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 249

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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