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

Completed

• Conditions: Non-metastatic Hepatocellular Carcinoma
• Interventions: Other: TACE + hypofractionated EBRT; Procedure: Surgical resection

• Registration Number: NCT04823715
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Patients with non-metastatic unresectable hepatocellular carcinoma

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2020-10-15
• Primary Completion: 2021-01-15
• Study Completion: 2021-01-15
• Status Verified: 2021-03
• Study First Submitted: 2021-03-26
• Study First Submitted QC: 2021-03-26
• Last Update Submitted: 2021-03-26
• Study First Posted: 2021-04-01
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 163

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TACE- hypofractionated radiation therapy	TACE + hypofractionated EBRT	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.
Surgical resection	Surgical resection	Surgical resection by open-laparotomy or laparoscopy of hepatocellular carcinoma

Primary Outcome Measures

Name	Time	Method
Disease-free survival of the patient after start of treatment	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.

Trial Locations

Locations (1)

Croix-Rousse Hospital, Hospices Civils de Lyon; 🇫🇷 Lyon, France