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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hepatocellular Carcinoma Non-resectable
• Intervention / Treatment: Procedure: TACE; Radiation: SBRT

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Allam Mohamed, MBBS,MSc, MD; Phone Number: +49-241 8036866; Email: amohamed@ukaachen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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
• 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 ≥ 60 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
• Active hepatitis B
• Previous SIRT
• Previous Sorafenib in the last 8 weeks
• Pregnant and lactating females

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: TACE+SBRT.; 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; 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.; Radiation: SBRT; 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) BED (α/β 10Gy) 5x 10 Gy @ 83% isodose = 50 Gy (100 Gy) 8 x 7.5 Gy @ 83% isodose = 60 Gy (105 Gy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualtiy of life based on EORTC QLQC30	alive subjects will fill quality of life questionnaires (EORTC QLQC30) before the treatment and after 3,6 and 12 months after. The results before and after the treatment will be presented in comaprsion to the reference data.	12 Months
1- year progression free survival	After one year from the end of the treatment, the percentage of alive subjects without the apperance of new hepatic and/or extra-heaptic new lesions outside the SBRT-field. This will be measured using contrast-enhanced CT scan Liver/Abdomen and Thorax	12 Months
Quality of life based on EORTC QLQ-HCC18	alive subjects will fill quality of life questionnaires (EORTC QLQ-HCC18) before the treatment and after 3,6 and 12 months after. The results before and after the treatment will be presented in comaprsion to the reference data.	12 Months

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Investigators: Principal Investigator: Michael J. Eble, Professor Dr. med., University Medical Center Rwth Aachen; Principal Investigator: Philipp Bruners, Professor Dr. med., University Medical Center Rwth Aachen; Study Chair: Ahmed Allam Mohamed, MBBS, MSc, MD, University Medical Center Rwth Aachen

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: July 2, 2021
• First Submitted That Met QC Criteria: August 6, 2021
• First Posted (Actual): August 9, 2021

Study Record Updates

• Last Update Posted (Actual): August 9, 2021
• Last Update Submitted That Met QC Criteria: August 6, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: 20-341

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No