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

RWTH Aachen University

Status: Not yet enrolling

Conditions: Hepatocellular Carcinoma Non-resectable

Treatments: Procedure: TACE; Radiation: SBRT

Study type: Interventional

Funder types: Other

Identifiers

NCT04996914

20-341

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

TACE+SBRT.

Experimental group

Description:

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 .

Treatment:

Radiation: SBRT

Procedure: TACE