Selective Internal Radiation Therapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Hepatocellular Carcinoma (HCC).

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01798160

Enrollment

Registered

2013-02-25

Start date

2010-02-28

Completion date

2013-05-31

Last updated

2015-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Brief summary

Selective Internal Radiation Therapy is superior to Transarterial Chemoembolisation for the treatment of intermediate stage hepatocellular carcinoma.

Interventions

PROCEDUREDEB TACE

DEB TACE every 6 weeks until either no viable tumor or endpoint reached.

PROCEDURESIRT

Selective Internal Radiation Therapy once at the beginning of the study. Follow up until endpoint.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* ≥18 years * HCC, proven by histology or according to EASL criteria * Intermediate stage HCC (stage B according to BCLC) * At least one measurable lesion in magnetic resonance imaging (MRI) * Tumor load ≤ 50% * preserved liver function (Child Pugh A and B)

Exclusion criteria

* Patients feasible for curative treatment (e.g. resection or local ablation) * Previous TACE or SIRT * Chemotherapy during the last 4 weeks * Child Pugh stage C * BCLC stage D * ECOG Performance Status \>0 * Tumor involvement \>50% of the liver * Extrahepatic tumor * Serum Bilirubin \>2.0 mg/dl; Serum Albumin 2.8 g/dl, Serum Creatinine \>2 mg/dl; Leukocytes \<3000/ml; Thrombocytes \<50000/ml * Clinically apparent ascites (ascites only in CT/MRI is no

Design outcomes

Primary

Measure	Time frame
Overall-Survival	up to three years
Progression-free-Survival	up to three years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026