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


N/A
18 Years
80 Years
Not Enrolling
Both
Hepatocellular Carcinoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall survival

Outcome Time Frame:

every 12 weeks, up to 48 weeks

Safety Issue:

No

Principal Investigator

Jung-Hwan Yoon, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Hospital

Authority:

Korea: Institutional Review Board

Study ID:

PVT_TACE/TACI

NCT ID:

NCT01857726

Start Date:

May 2013

Completion Date:

December 2016

Related Keywords:

  • Hepatocellular Carcinoma
  • hepatocellular carcinoma
  • portal vein invasion
  • transarterial chemoembolization
  • transarterial chemoinfusion
  • Carcinoma
  • Carcinoma, Hepatocellular

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