Status:
TERMINATED
Sorafenib VS TACE in HCC Patients With Portal Vein Invasion
Lead Sponsor:
Seoul National University Hospital
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-79 years
Phase:
PHASE2
Brief 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.
Detailed Description
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, ...
Eligibility Criteria
Inclusion
- 80 \> Age \>= 18 years.
- Child-Pugh class A (class B could be included when Childs score is 7).
- 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
- 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
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
Exclusion
- Child-Pugh score \>= 8.
- Age \< 18 or \>= 80 years.
- ECOG Performance Status \>= 3.
- Recipient of living donor or deceased donor liver transplantation
- Patients unable to understand the contents of informed consent or refuse to sign the informed consent.
- Patients with evidence of uncontrolled or severe medical conditions requiring treatment.
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01480817
Start Date
June 1 2012
End Date
December 1 2015
Last Update
April 29 2016
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 110-744