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An Open Label, Phase 2 Trial Comparing Sorafenib And TACE in Advanced Hepatocellular Carcinoma With Portal Vein Invasion

Phase 2
18 Years
79 Years
Open (Enrolling)
Hepatocellular Carcinoma

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Trial Information

An Open Label, Phase 2 Trial Comparing Sorafenib And TACE in Advanced Hepatocellular Carcinoma With Portal Vein Invasion

TACE is an established therapy for patients with unresectable hepatocellular carcinoma (HCC)
and has been shown to significantly improve survival in these patients compared to no
treatment. Moreover, TACE can be performed safely and may improve the overall survival of
patients with HCC and major branch of portal vein invasion. Sorafenib, already approved for
HCC, could lead to significantly improvement in tumor control and survival in patients with
advanced stage HCC. So far there are no head to head comparison reports about the efficacy
of Sorafenib and TACE. Here the investigators evaluate the efficacy of sorafenib and TACE in
advanced HCC with major branch of portal vein invasion.

Inclusion Criteria:

1. 80 > Age >= 18 years.

2. Child-Pugh class A (class B could be included when Childs score is 7).

3. Hepatocellular carcinoma with major branch of portal vein invasion on dynamic CT or

- not only newly diagnosed treatment-naive patients,

- but also HCC patients previously treated with other therapies in case of
development of major branch of portal vein invasion

4. Adequate bone marrow, liver and renal function as assessed by the following
laboratory requirements:

- White blood cell counts (WBC) >= 2,000 /μl, Absolute neutrophil count (ANC) >

- Hemoglobin >= 8.0 g/dl

- Platelet count > 50,000/μl

- Serum creatinine < 1.7 mg/dl

- Total bilirubin =< 3.0 mg/dl

- Prothrombin Time (PT)-international normalized ratio (INR) =< 2.3 or Prothrombin
Time (PT)-sec =< 6 sec

5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.

Exclusion Criteria:

1. Child-Pugh score >= 8.

2. Age < 18 or >= 80 years.

3. ECOG Performance Status >= 3.

4. Recipient of living donor or deceased donor liver transplantation

5. Patients unable to understand the contents of informed consent or refuse to sign the
informed consent.

6. Patients with evidence of uncontrolled or severe medical conditions requiring

Type of Study:


Study Design:

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

Outcome Measure:

Time to Progression (Efficacy)

Outcome Time Frame:

every 6 weeks up to 3 years

Safety Issue:


Principal Investigator

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

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Hospital


South Korea: Korea Food and Drug Administration (KFDA)

Study ID:




Start Date:

June 2012

Completion Date:

December 2016

Related Keywords:

  • Hepatocellular Carcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular