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Adjuvant Stereotactic Body Radiation Therapy After Trans-arterial Chemoembolization in Hepatocellular Carcinoma

NCT04996914 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-11

No results posted yet for this study

Summary

The study investigates the adjuvant SBRT following TACE in early and intermediate stages HCC not amenable for surgical resection.

Conditions

  • Hepatocellular Carcinoma Non-resectable

Interventions

PROCEDURE

TACE

1-2 session TACE before SBRT according to the preference of the interventional radiologist. Goal of TACE is the complete emnbolization of the HCC-nodules. It is allowed to use both conventional TACE (cTACE) and drug-eluting beads TACE (DEB-TACE) according to the interventional radiologist preference.

RADIATION

SBRT

SBRT should be 1 month after last TACE. This can be extended till 2 months if indicated. However, prolongation of the gap between TACE and SBRT is not encouraged. Treatment center should choose one of fractionation schedule mentioned allowed in the study, in order to achieve a balance between dose applied for tumor control and constraints for OAR PTV Dose in 5 / 8 fractions (Gy) EQD2 (α/β 10Gy) 5x 8-6 Gy @ 83% isodose = 40-30 Gy (60-40 Gy) 8 x 6-4.5 Gy @ 83% isodose = 48-36 Gy (64-43.5 Gy)

Sponsors & Collaborators

  • RWTH Aachen University

    lead OTHER

Principal Investigators

  • Michael J. Eble, Professor Dr. med. · University medical center RWTH Aachen

  • Philipp Bruners, Professor Dr. med. · University medical center RWTH Aachen

  • Ahmed Allam Mohamed, MBBS, MSc, MD · University medical center RWTH Aachen

  • Oliver Beetz, Prof. Dr.med . MHBA · University medical center RWTH Aachen

  • Marie-Luise Berres, Prof. Dr.med. · University medical center RWTH Aachen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-05
Primary Completion
2028-05-05
Completion
2029-05-05

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04996914 on ClinicalTrials.gov