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

NCT04823715 | Completed

• 1 other identifier: 249
• Study Type: observational
• Target: 163
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with non-metastatic unresectable hepatocellular carcinoma

Conditions

Non-metastatic Hepatocellular Carcinoma

Keywords

Liver neoplasms; Carcinoma; Hepatocellular; Radiation therapy; TACE; Transarterial Chemoembolization

Outcome Measures

Primary Outcomes (1)

• Disease-free survival of the patient after start of treatment

  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)

Study Arms (2)

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

Surgical resection

Surgical resection by open-laparotomy or laparoscopy of hepatocellular carcinoma

Procedure: Surgical resection

Interventions

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.

TACE- hypofractionated radiation therapy

Surgical resection PROCEDURE

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

Surgical resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Croix-Rousse Hospital, Hospices Civils de Lyon

Lyon, 69004, France

Location

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 1, 2021
• Study Start: October 15, 2020
• Primary Completion: January 15, 2021
• Study Completion: January 15, 2021
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

FR (1)