Sorafenib VS TACE in HCC Patients With Portal Vein Invasion

• Status: Terminated
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators are going to compare the therapeutic effect of sorafenib and transarterial chemoembolization in advanced hepatocellular carcinoma with major branch of portal vein invasion.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Niacinamide; Sorafenib

Criteria

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 MRI

• 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) > 1,200/μl

• 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 treatment.