SBRT or TACE for Advanced HCC

  • End date
    Dec 31, 2023
  • participants needed
  • sponsor
    University of Aarhus
Updated on 9 December 2021
neutrophil count
stereotactic body radiation therapy
radiofrequency ablation
ethanol injection


Randomized study of stereotactic body radiation therapy (SBRT) versus transarterial chemoembolization (TACE) in locally advanced hepatocellular carcinoma.

Condition Adenocarcinoma, HEPATOCELLULAR CARCINOMA, Malignant Adenoma, HEPATIC NEOPLASM, Liver Cancer, liver cell carcinoma
Treatment SBRT, DEB
Clinical Study IdentifierNCT03338647
SponsorUniversity of Aarhus
Last Modified on9 December 2021


Yes No Not Sure

Inclusion Criteria

HCC (biopsy or radiological diagnostic (>1 cm, enhancing in arterial phase and wash-out in later phases)
Number of lesions: not more than 3 lesions
Lesion size: up to 10 cm for a single lesion (and up to 10 cm cumulative diameter, if there is more than 1 lesion)
Child-Pugh A or B (<7) on examination within 6 weeks prior to study entry
BCLC Stage A/B
Must be fit (eligible) for SBRT and TACE
Unsuitable/unwilling for resection or transplant or radiofrequency ablation (RFA) or if these options are not available
Distance between GTV (lesion) and luminal structures (including esophagus, stomach, duodenum, small or large bowel) is >10 mm
All blood work obtained within 2 weeks prior to study entry with adequate organ function defined as follows
Absolute neutrophil count (ANC) 1,500 cells/mm3
Platelets 50,000 cells/mm3
Hemoglobin 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb 8.0 g/dl is acceptable.)
Total bilirubin < 2 mg/dL
Prothrombin time/INR < 1.4 (unless on Coumadin/Warfarin)
Albumin 28 g/L
AST (and ALT) < 5 times ULN
Serum creatinine ULN or creatinine clearance 60 mL/min
Left-ventricular ejection fraction >50% (cardiac ejection fraction should be measured in case of history of cardio-vascular disease
May have had previous surgery, ethanol injection and RFA to the liver

Exclusion Criteria

Not suitable for clinical trial or follow-up
Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (Note that carcinoma in situ of the breast, oral cavity, or cervix are all permissible). No active cancer therapy
Unsuitable for or refractory to transarterial hepatic chemo-embolization (TACE)
Non-enhancing HCC on CT or CT-angio or
Portal vein thrombosis/macroscopic venous invasion
Arterio-portal and arterio-venous fistulas observed on pre-study imaging (if it is found during the TACE, the fistula may be embolized before injection of the drug)
Evidence of metastatic disease including nodal or distant metastases
Previous TACE or radiation to the liver (including SIRT)
Life-threatening condition (including untreated HIV and active hepatitis B/C)
Detectable HBeAg and HBV viral load > 20,000 IU/mL or
HBeAg-negative chronic hepatitis B and HBV viral load >2,000 IU/mL
If HBV-DNA copy is higher than 500 copies/ml, anti-viral therapy, such as Entecavir followed by observation for 2 weeks
If anti-HCV antibody is positive (may be false positive) and increased HCV viral load indicating active disease. Active HCV should be treated sufficiently before inclusion in the study. Below 2 million copies per milliliter (mL) is related to chronic hepatitis C that does not need antiviral therapy
Patients with active hepatitis B or C should be on treatment for at least 4 weeks before inclusion in the trial
On sorafenib or other antineoplastic drug therapy within 7 days before inclusion (not accepted until time of progression)
Pregnancy or women of childbearing potential require a negative pregnancy test within 28 days
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