Comparison of TACE Versus TACE/TACI Combination in Advanced Hepatocellular Carcinoma With Portal Vein Invasion

Hepatocellular Carcinoma Clinical Trial

Official title:

A Randomized Open Label Pilot Study Comparing Transarterial Chemoembolization Versus Transarterial Chemoembolization/Transarterial Chemoinfusion Combination in Advanced Hepatocellular Carcinoma With Portal Vein Invasion

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01857726
• Other study ID #: PVT_TACE/TACI
• Status: Withdrawn
• Phase: N/A
• First received: May 13, 2013
• Last updated: April 27, 2016
• Start date: July 2013
• Est. completion date: December 2016

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 transarterial chemoembolization with adriamycin to transarterial chemoembolization with adriamycin/transarterial chemoinfusion with cisplatin combination in advanced hepatocellular carcinoma with portal vein invasion.

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. Especially, HCCs with portal vein invasion are unresectable and they 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 and without portal vein invasion by several trials. In patients with main portal vein invasion, TACE is theoretically contraindicated because of the potential risk of hepatic failure resulting from ischemia after TACE. However, recent studies have revealed that TACE could safely be performed in these patients.

The aim of this study is to compare the efficacy of transarterial chemoembolization (TACE) with adriamycin to transarterial chemoembolization with adriamycin/transarterial chemoinfusion (TACI) with cisplatin combination in advanced hepatocellular carcinoma with portal vein invasion.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 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 invasion of major branch(es) of portal vein in the arterial phase of dynamic CT or MRI

• Patients who have received previous local therapy treatments (RFA, PEI, cryoablation, surgery, resection) are eligible

• Age : 18 years to 80 years

• ECOG Performance Status of 0 to 2

• Child-Pugh class A (Child-Pugh score 5-6)

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

• WBC count > 2,000/mm3

• Absolute neutrophil count > 1,000/mm3

• Hb ? 8.0 g/dL

• Platelet count ? 50,000 /mm3

• Bilirubin ? 3 mg/dL

• Adequate clotting function: INR < 2.3 or < 6sec

Exclusion Criteria:

• Child-Pugh score ? 7

• 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 with extrahepatic metastasis

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Doxorubicin
Transarterial chemoembolization (TACE) with adriamycin
• Cisplatin
transarterial chemoinfusion with cisplatin 50-100 mg

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		every 12 weeks, up to 48 weeks	No
Secondary	Time-to-progression		every 12 weeks, up to 48 weeks	No
Secondary	Progression-free survival		every 12 weeks, up to 48 weeks	No