Clinical trial NCT01480817: Sorafenib VS TACE in HCC Patients With Portal Vein Invasion
Official title: An Open Label, Phase 2 Trial Comparing Sorafenib And TACE in Advanced Hepatocellular Carcinoma With Portal Vein Invasion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-11-29
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, 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.

Eligibility 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.

Primary outcomes:
measure: Time to Progression (Efficacy)
timeFrame: every 6 weeks up to 3 years
Secondary outcomes:
measure: overall survival
timeFrame: every 6 weeks up to 3 years
measure: objective tumor response rate
timeFrame: every 6 weeks up to 3 years
measure: objective tumor control rate
timeFrame: every 6 weeks up to 3 years
measure: progression-free survival
timeFrame: every 6 weeks up to 3 years
measure: the adverse event rate and examine the toxicities
timeFrame: every 6 weeks up to 3 years
measure: Change of perfusion parameter
timeFrame: every 6 weeks up to 3 years
measure: Alpha feto protein (AFP) responsiveness
timeFrame: every 6 weeks up to 3 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jung-Hwan Yoon, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: