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A Trial on SBRT After Incomplete TAE or TACE Versus Exclusive TAE or TACE For Treatment of Inoperable HCC

I

Istituto Clinico Humanitas

Status

Terminated

Conditions

Hepatocellular Carcinoma

Treatments

Radiation: SBRT
Procedure: TACE

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

The trial is a multicentre, prospective, randomised controlled, unblinded, parallel-group superiority trial of SBRT versus standard TAE/TACE for the curative treatment of inoperable HCC treated with a TAE/TACE incomplete cycle.

Full description

In this phase III study patients with inoperable HCC single nodule no more 5 cm or 1- 3 nodules no more 3 cm in diameter after incomplete TAE or TACE, are randomized to stereotactic radiotherapy in 3 or 6 daily fractions or to a new cycle of TAE or TACE. A total of 80 patients (40 in each arm) will be recruited into the trial over a 2 years period and will be randomised on an equal basis to either SBRT or TAE/TACE. The follow-up period will be finished 1.5 years after the final patient is randomised.

Enrollment

41 patients

Sex

All

Ages

18 to 95 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Age >18 years
  • Karnofsky index >70%
  • Child-Turgotte-Pugh A or B liver score.
  • An initial diagnosis of primary HCC or recurrence.
  • A technically unresectable lesion or medically contraindicated surgery or a case in which surgery was declined.
  • HCC (single nodule ≤ 5 cm or max 3 nodules ≤ 3 cm) diagnosed by histology or non-invasive EASL criteria
  • Baseline CT or MRI and bone scan without evidence of radiologically definable major vascular invasion or extrahepatic disease
  • Hb >10.5.0 g/%, WBC >3.000 cells/mm3, platelets >50.000 cells/mm3, bilirubin <2 mg/dl, aspartate and alanine aminotransferase levels <5 times upper normal limit, and prothrombin time-international normalized ratio ≤ 2;
  • Serum creatinine <1.7 mg/dl
  • Previously incomplete TAE or TACE with radiologically defined residual disease.
  • Informed consent

Exclusion criteria

  • Extrahepatic disease and refractory ascites.
  • Previous abdominal radiation therapy (RT)
  • Hemorrhage/bleeding event = Grade 3 within 4 weeks of enrollment in the study.
  • Pregnant or breastfeeding patients.
  • Patients with uncontrolled infections or HIV seropositive patients.
  • Mental conditions rendering the patient incapable to understand the nature, scope, and consequences of the study.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

41 participants in 2 patient groups

Stereotactic body radiation therapy
Experimental group
Description:
HCC after incomplete TAE or TACE treated by SBRT
Treatment:
Radiation: SBRT
TACE/TAE
Active Comparator group
Description:
HCC after incomplete TAE or TACE treated by a new cycle of TAE or TACE
Treatment:
Procedure: TACE

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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