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

Not Applicable

Not yet recruiting

• Conditions: Hepatocellular Carcinoma Non-resectable
• Interventions: Procedure: TACE; Radiation: SBRT

• Registration Number: NCT04996914
• Lead Sponsor: RWTH Aachen University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-02
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-06
• Last Update Submitted: 2021-08-06
• Study First Posted: 2021-08-09
• Last Update Posted: 2021-08-09
• Study Start: 2022-01-01
• Primary Completion: 2024-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TACE+SBRT.	TACE	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 .
TACE+SBRT.	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 .

Primary Outcome Measures

Name	Time	Method
1-year local control rate	12 Months	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)

Secondary Outcome Measures

Name	Time	Method
Qualtiy of life based on EORTC QLQC30	12 Months	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.
Quality of life based on EORTC QLQ-HCC18	12 Months	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.
1- year progression free survival	12 Months	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