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

NCT ID: NCT04996914

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2028-08-01

Brief Summary

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

Conditions

Hepatocellular Carcinoma Non-resectable

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TACE+SBRT.

If a patient is eligible to participate in the project according to the in- and exclusion criteria, the patient will assigned to 1-2 sessions of TACE followed by SBRT within one month from last TACE session .

Group Type: EXPERIMENTAL

TACE

Intervention Type: PROCEDURE

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.

SBRT

Intervention Type: RADIATION

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)

Interventions

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.

Intervention Type: PROCEDURE

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)

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• HCC (diagnosis: histological or radiological)
• Age: 18-80
• Number of lesions 1-3 lesions
• Size of the lesion (or sum of 2-3 lesions) ≥ 4 cm
• Sufficient non-tumorous liver volume (≥ 800 cm3)
• Child Pugh Score: A5-6 or B7-8
• BCLC A or B
• Patient is illegible or refused surgical resection or orthotopic liver transplant
• Blood work (within 2 weeks before registration):
• Absolute neutrophil count (ANC) ≥ 1,500 cells/mm³)
• Platelets ≥50,000 cells/mm³
• AST (and ALT) < 5 times ULN
• Serum creatinine ≤ ULN or creatinine clearance ≥ 50 mL/min

Exclusion Criteria

• Evidence of extrahepatic disease (lymph node or distant metastases)
• Evidence of macroscopic vascular invasion
• Evidence of an arterio-portal or arterio-venous fistulas
• History of previous malignancy
• Previous SIRT
• Previous Sorafenib in the last 8 weeks
• Pregnant and lactating females

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael J. Eble, Professor Dr. med.

Role: STUDY_CHAIR

University medical center RWTH Aachen

Philipp Bruners, Professor Dr. med.

Role: STUDY_CHAIR

University medical center RWTH Aachen

Ahmed Allam Mohamed, MBBS, MSc, MD

Role: STUDY_CHAIR

University medical center RWTH Aachen

Oliver Beetz, Prof. Dr.med . MHBA

Role: STUDY_CHAIR

University medical center RWTH Aachen

Marie-Luise Berres, Prof. Dr.med.

Role: STUDY_CHAIR

University medical center RWTH Aachen

Central Contacts

Ahmed Allam Mohamed, MBBS,MSc, MD

Role: CONTACT

amohamed@ukaachen.de

+49241 80-8926

Other Identifiers

20-341

Identifier Type: -

Identifier Source: org_study_id