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

Phase 3

Withdrawn

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: transarterial chemoembolization (TACE); Procedure: transarterial radioembolization (TARE)

• Registration Number: NCT02004210
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-10-01
• Study First Submitted QC: 2013-12-02
• Study First Posted: 2013-12-09
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-26
• Last Update Posted: 2016-04-27
• Primary Completion: 2018-04
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The TACE group	transarterial chemoembolization (TACE)	Transarterial chemoembolization group
The TARE group	transarterial radioembolization (TARE)	transarterial radioembolization group

Primary Outcome Measures

Name	Time	Method
Overall survival	every 12 weeks, up to the time of death, up to 12 months	From date of randomization until the date of death

Secondary Outcome Measures

Name	Time	Method
Progression-Free Survival in the Liver	every 12 weeks, up to the time of death or first documented intrahepatic tumor progression, up to 12 months	From date of randomization until the date of first documented intrahepatic tumor progression or death
Progression-Free Survival Overall	every 12 weeks, up to the time of death or first documented progression, up to 12 months	From date of randomization until the date of first documented progression or death
Overall tumor response assessment	every 12 weeks, up to the time of death or 12 months	(CR, PR, SD, PD)by modified RECIST criteria

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of