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

NANot yet recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

August 1, 2027

Study Completion Date

August 1, 2028

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)"

All Listed Sponsors
lead

RWTH Aachen University

OTHER

NCT04996914 - Adjuvant Stereotactic Body Radiation Therapy After Trans-arterial Chemoembolization in Hepatocellular Carcinoma | Biotech Hunter | Biotech Hunter