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


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

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


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)

- ECOG performance status ≤2

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 >2

- 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 exclusion criteria)

- Esophageal bleeding during the last 3 months

- Hepatic encephalopathy

- Transjugular intrahepatic portosystemic shunt (TIPS)

- Infiltration or occlusion of the main portal vein

- Hepatofugal blood flow in the portal vein

- Hepatopulmonary shunt ≥ 20% in the macroaggregated albumin scan

- Contraindications against angiography

- Gravidity

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free-Survival

Outcome Time Frame:

up to three years

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

SIRT-TACE-HCC-Mainz-1

NCT ID:

NCT01798160

Start Date:

February 2010

Completion Date:

March 2013

Related Keywords:

  • Hepatocellular Carcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular

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