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

Hepatocellular Carcinoma Clinical Trial

Official title:

A Randomized, Multi-center, Open Label, Phase 3 Trial Comparing Conventional TACE and Transarterial Radioembolization in Patients With Unilobar Advanced Hepatocellular Carcinoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02004210
• Other study ID #: TACE_TARE
• Status: Withdrawn
• Phase: Phase 3
• First received: October 1, 2013
• Last updated: April 26, 2016
• Start date: April 2013
• Est. completion date: April 2018

Study information

• Verified date: April 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• transarterial radioembolization (TARE)
transarterial radioembolization
• transarterial chemoembolization (TACE)
transarterial chemoembolization

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	From date of randomization until the date of death	every 12 weeks, up to the time of death, up to 12 months	No
Secondary	Progression-Free Survival in the Liver	From date of randomization until the date of first documented intrahepatic tumor progression or death	every 12 weeks, up to the time of death or first documented intrahepatic tumor progression, up to 12 months	No
Secondary	Progression-Free Survival Overall	From date of randomization until the date of first documented progression or death	every 12 weeks, up to the time of death or first documented progression, up to 12 months	No
Secondary	Overall tumor response assessment	(CR, PR, SD, PD)by modified RECIST criteria	every 12 weeks, up to the time of death or 12 months	No