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

Study Overview
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Brief Summary
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Patients with non-metastatic unresectable hepatocellular carcinoma

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

Conditions
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Non-metastatic Hepatocellular Carcinoma

Intervention / Treatment
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* Other: TACE + hypofractionated EBRT
* Procedure: Surgical resection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TACE- hypofractionated radiation therapy<br>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<br>* 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.<br>|
| Surgical resection<br>Surgical resection by open-laparotomy or laparoscopy of hepatocellular carcinoma | Procedure: Surgical resection<br>* Surgical resection by open-laparotomy or laparoscopy of hepatocellular carcinoma by a highly experienced liver surgeon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver neoplasms, Carcinoma, Hepatocellular, Radiation therapy, TACE, Transarterial Chemoembolization