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

Launched by RWTH AACHEN UNIVERSITY · Aug 6, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for patients with liver cancer, specifically hepatocellular carcinoma (HCC), who cannot undergo surgery or a liver transplant. The study will explore how effective a type of radiation therapy called Stereotactic Body Radiation Therapy (SBRT) is when given after a procedure called Trans-arterial Chemoembolization (TACE). TACE is a treatment that delivers chemotherapy directly to the tumor while blocking its blood supply. The trial aims to help patients with early to intermediate stages of HCC who have 1 to 3 tumors that are larger than 4 cm.

To participate in this trial, patients need to be aged between 18 and 80, have a confirmed diagnosis of HCC, and meet certain health criteria, including having enough healthy liver tissue. They should not have signs of cancer spreading outside the liver or previous treatments that might interfere with the study. Participants will undergo regular evaluations and treatment as part of the trial, and while the study is not yet recruiting, it aims to provide valuable insights into improving outcomes for liver cancer patients.

Gender

ALL

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