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

N/ACompletedNCT04823715

Hospices Civils de Lyon163 enrolled

Overview

Patients with non-metastatic unresectable hepatocellular carcinoma

Study Type

OBSERVATIONAL

Enrollment

163

Conditions

Non-metastatic Hepatocellular Carcinoma

Interventions

TACE + hypofractionated EBRTOTHER

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 resectionPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Croix-Rousse Hospital, Hospices Civils de Lyon

Lyon, France

Outcomes

Primary Outcomes

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.

Time frame: Within 10 years after the treatment (surgical resection or TACE)

Data from ClinicalTrials.gov

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