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

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

Recruiting
18-80 years
All
Phase N/A

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Overview

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

Eligibility

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

Study details
    Hepatocellular Carcinoma Non-resectable

NCT04996914

RWTH Aachen University

13 May 2026

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