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

Seoul National University

Status: Withdrawn

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Cisplatin; Drug: Doxorubicin

Study type: Interventional

Funder types: Other

Identifiers

NCT01857726

PVT_TACE/TACI

Details and patient eligibility

About

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.

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. 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.

Sex: All

Ages: 18 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 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

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 TACE/TACI combination group

Experimental group

Description:

Transarterial chemoembolization with doxorubicin/transarterial chemoinfusion with cisplatin combination

Treatment:

Drug: Cisplatin

Drug: Doxorubicin

The TACE-only group

Active Comparator group

Description:

Transarterial chemoembolization with doxorubicin

Treatment:

Drug: Doxorubicin