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

NCT ID: NCT04823715

Last Updated: 2021-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

163 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-15

Study Completion Date

2021-01-15

Brief Summary

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Patients with non-metastatic unresectable hepatocellular carcinoma

Detailed Description

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Conditions

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Non-metastatic Hepatocellular Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

TACE + hypofractionated EBRT

Intervention Type 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

Surgical resection by open-laparotomy or laparoscopy of hepatocellular carcinoma

Surgical resection

Intervention Type PROCEDURE

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

Interventions

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TACE + hypofractionated EBRT

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.

Intervention Type OTHER

Surgical resection

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

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Croix-Rousse Hospital, Hospices Civils de Lyon

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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249

Identifier Type: -

Identifier Source: org_study_id

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