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OpenTrials
Completed

NCT Number: NCT04823715

Transarterial Chemoembolization Plus Hypofractionnated Radiotherapy vs. Surgery in Locally Advanced Hepatocellular Carcinoma: an IPTW Comparison

Patients with non-metastatic unresectable hepatocellular carcinoma

Completed

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Key information

Conditions

Non-metastatic Hepatocellular Carcinoma Carcinoma Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Croix-Rousse Hospital, Hospices Civils de Lyon

Lyon, 69004, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TACE + hypofractionated EBRT

Other

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

Procedure

Surgical resection by open-laparotomy or laparoscopy of hepatocellular carcinoma by a highly experienced liver surgeon

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: TACE-hypoRT

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 1, 2021
Registry last updated
Apr 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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