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

Not Applicable

Withdrawn

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Doxorubicin; Drug: Cisplatin

• Registration Number: NCT01857726
• Lead Sponsor: Seoul National University Hospital

Brief 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.

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. 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.

Study Timeline

• Study First Submitted: 2013-05-13
• Study First Submitted QC: 2013-05-15
• Study First Posted: 2013-05-20
• Study Start: 2013-07
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-27
• Last Update Posted: 2016-04-28
• Primary Completion: 2016-12
• Study Completion: 2016-12

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• Status: WITHDRAWN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 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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The TACE/TACI combination group	Doxorubicin	Transarterial chemoembolization with doxorubicin/transarterial chemoinfusion with cisplatin combination
The TACE/TACI combination group	Cisplatin	Transarterial chemoembolization with doxorubicin/transarterial chemoinfusion with cisplatin combination
The TACE-only group	Doxorubicin	Transarterial chemoembolization with doxorubicin

Primary Outcome Measures

Name	Time	Method
Overall survival	every 12 weeks, up to 48 weeks

Secondary Outcome Measures

Name	Time	Method
Time-to-progression	every 12 weeks, up to 48 weeks
Progression-free survival	every 12 weeks, up to 48 weeks

Trial Locations

Locations (1)

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