Adjuvant Stereotactic Body Radiation Therapy After Trans-arterial Chemoembolization in Hepatocellular Carcinoma
RWTH Aachen University
30 participants
May 5, 2026
INTERVENTIONAL
Conditions
Summary
The study investigates the adjuvant SBRT following TACE in early and intermediate stages HCC not amenable for surgical resection.
Eligibility
Inclusion Criteria13
- 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 Criteria7
- 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
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Interventions
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 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)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04996914