Hepatocellular Carcinoma
Conditions
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.
Interventions
DRUGSorafenib
Sorafenib 400mg po bid
PROCEDURETACE for HCC with portal vein invasion
The volume of iodized oil ranged from 2 to 12 mL, and the amount of doxorubicin ranged from 10 to 60 mg. Gelatin sponge particles were mixed with mitomycin and contrast material.Cisplatin was infused at the tumor feeder vessels as a solution with a concentration of 0.5 mg/mL at a rate of 5-10 mL/min. The total amount of cisplatin used ranged from 50 to 100 mg depending on the patient's body weight and the level of infusion.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Progression (Efficacy) | every 6 weeks up to 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| objective tumor response rate | every 6 weeks up to 3 years | Determined by dynamic-perfusion CT scan at the end of each cycle |
| objective tumor control rate | every 6 weeks up to 3 years | Determined by dynamic-perfusion CT scan at the end of each cycle |
| progression-free survival | every 6 weeks up to 3 years | — |
| overall survival | every 6 weeks up to 3 years | — |
| Change of perfusion parameter | every 6 weeks up to 3 years | — |
| Alpha feto protein (AFP) responsiveness | every 6 weeks up to 3 years | AFP responder : 20% reduction from baseline AFP level after 6 weeks of treatment |
| the adverse event rate and examine the toxicities | every 6 weeks up to 3 years | The investigators will evaluate the adverse event according to Common Toxicity Criteria(version 4.0)by National Cancer Institute of National Institutes of Health |
Countries
South Korea
Outcome results
None listed