A Phase 3 Trial Comparing TACE and TARE in Unilobar Advanced Hepatocellular Carcinoma

Seoul National University

Status and phase: Withdrawn; Phase 3

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: transarterial chemoembolization (TACE); Procedure: transarterial radioembolization (TARE)

Study type: Interventional

Funder types: Other

Identifiers

NCT02004210

TACE_TARE

Details and patient eligibility

About

The aim of this study is to compare the efficacy of conventional transarterial chemoembolization(TACE) and transarterial radioembolization in patients with unilobar advanced hepatocellular carcinoma.

Full description

Potentially curative treatments for hepatocellular carcinoma (HCC) include surgical resection, liver transplantation, and local ablative therapy.

However, HCC patients are diagnosed at advanced stages in Korea. Unresectable advanced HCCs are not suitable for other curative therapies. For these patients, the optimal treatment remains largely controversial. As a palliative treatment, the benefit of transarterial chemoembolization (TACE) had been shown in patients with unresectable HCC by several trials. Recently,transarterial radioembolization (TARE) has been introduced for the treatment of advanced HCC. However, the efficacy of TARE compared to TACE is uncertain.

The aim of this study is to compare the efficacy of conventional transarterial chemoembolization(TACE) and transarterial radioembolization in patients with unilobar advanced hepatocellular carcinoma.

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with clinical or histological diagnosis of HCC based on the guidelines of the AJCC

• Patients with advanced HCC with unilobar advanaced involvement: right lobe ± S4 segment or left lobe ± S4 segment)

• Patients with single large HCC or multinodular HCC

  • Single & 5cm < size < 15cm
  • 2-5 nodules & maximal sized 4-15cm & sum of diameters ≦ 25cm
  • Infiltrative type & unilobular involvement on liver MRI
  • Segmental or lobar portal vein invasion can be included.

• Age : 20 years to 80 years

• ECOG Performance Status of 0 to 2

• Child-Pugh class A (Child-Pugh score 5-6), B (CP score 7)

• Adequate bone marrow, liver function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:

  • WBC count ≧ 1,000/mm3
  • Absolute neutrophil count > 500/mm3
  • Hb ≧ 7.0 g/dL
  • Platelet count > 100,000 /mm3
  • Bilirubin ≦ 3 mg/dL
  • Adequate clotting function: INR ≦ 2.3 or ≦ 6sec

Exclusion criteria

• Child-Pugh score ≧ 8
• ECOG Performance Status ≧ 3
• Patients with chronic kidney disease or serum creatinine ≥ 1.2 mg/dL
• History of organ allograft
• Patients with uncontrolled co-morbidity which needs treatment
• Patients who have received prior systemic chemotherapy
• Patients who have received Capecitabine within 8 weeks
• Patients with extrahepatic metastasis
• Main portal vein invasion
• Patients with lymph node metastasis
• Bilobar involvement
• Bulk disease(Tumor volume >70% of the target liver volume, or tumor nodules too numerous to count)
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

The TARE group

Experimental group

Description:

transarterial radioembolization group

Treatment:

Procedure: transarterial radioembolization (TARE)

The TACE group

Experimental group

Description:

Transarterial chemoembolization group

Treatment:

Procedure: transarterial chemoembolization (TACE)