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NCT Number: NCT04996914

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

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

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Key information

Conditions

Hepatocellular Carcinoma Non-resectable

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RWTH Aachen University Hospital

Aachen, North Rhine-Westphalia, 52074, Germany

Location status: Recruiting

Location contact

Ahmed Allam Mohamed, PD. Dr. MSc. MBBCh.

CONTACT

[email protected]

+492418089260

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TACE

Procedure

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.

SBRT

Radiation

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) EQD2 (α/β 10Gy) 5x 8-6 Gy @ 83% isodose = 40-30 Gy (60-40 Gy) 8 x 6-4.5 Gy @ 83% isodose = 48-36 Gy (64-43.5 Gy)

Primary outcomes

  1. 1-year local control rate

    Time frame: 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 outcomes

  1. 1- year progression free survival

    Time frame: 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

  2. Qualtiy of life based on EORTC QLQC30

    Time frame: 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.

  3. Quality of life based on EORTC QLQ-HCC18

    Time frame: 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.

  4. Possibility of a secondary resection/organ transplant

    Time frame: 3 Years

    Possibility of a secondary resection/organ transplant (Yes/ No)

  5. Side effects

    Time frame: 6 months

    will be reported based on Common Terminology Criteria for Adverse Events (CTCAE) Version 5 and Child Pugh Score change till 6 months after the study

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Allam Mohamed, MBBS,MSc, MD

CONTACT

[email protected]

+49241 80-8926

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Acronym: ASTrH

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 9, 2021
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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