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

NCT04996914 | Not Yet Recruiting DMC

• 1 other identifier: 20-341
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 1-year local control rate

  After one year from the treatment, the precentage with alive subjects with no signs of local progression (the irradiated lesion). Local progression defined as more than 20% increase in diameter of enhancing tumor on contrast-enhanced CT scan in arterial phase or a new tumor mass within the original tumor volume according to modified RECIST criteria (mRECIST)

  12 Months

Secondary Outcomes (3)

• Qualtiy of life based on EORTC QLQC30

  12 Months

• 1- year progression free survival

  12 Months

• Quality of life based on EORTC QLQ-HCC18

  12 Months

Study Arms (1)

TACE+SBRT.

EXPERIMENTAL

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 .

Procedure: TACE; Radiation: SBRT

Interventions

TACE 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.

TACE+SBRT.

SBRT 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)

TACE+SBRT.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Officials

• Michael J. Eble, Professor Dr. med.

  University medical center RWTH Aachen

  STUDY CHAIR

• Philipp Bruners, Professor Dr. med.

  University medical center RWTH Aachen

  STUDY CHAIR

• Ahmed Allam Mohamed, MBBS, MSc, MD

  University medical center RWTH Aachen

  STUDY CHAIR

• Oliver Beetz, Prof. Dr.med . MHBA

  University medical center RWTH Aachen

  STUDY CHAIR

• Marie-Luise Berres, Prof. Dr.med.

  University medical center RWTH Aachen

  STUDY CHAIR

Central Study Contacts

Ahmed Allam Mohamed, MBBS,MSc, MD

CONTACT

+49241 80-8926; amohamed@ukaachen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: August 9, 2021
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: May 21, 2025

Record last verified: 2025-05