Hepatocellular Carcinoma
Conditions
Keywords
hepatocellular carcinoma, portal vein invasion, transarterial chemoembolization, transarterial chemoinfusion
Brief summary
The aim of this study is to compare the efficacy of transarterial chemoembolization with adriamycin to transarterial chemoembolization with adriamycin/transarterial chemoinfusion with cisplatin combination in advanced hepatocellular carcinoma with portal vein invasion.
Detailed description
Potentially curative treatments for hepatocellular carcinoma (HCC) include surgical resection, liver transplantation, and local ablative therapy. However, HCC patients are diagnosed at advanced stages in Korea. Especially, HCCs with portal vein invasion are unresectable and they are not suitable for other curative therapies. For these patients, the optimal treatment remains largely controversial. As a palliative treatment, the benefit of transarterial chemoembolization (TACE) had been shown in patients with unresectable HCC and without portal vein invasion by several trials. In patients with main portal vein invasion, TACE is theoretically contraindicated because of the potential risk of hepatic failure resulting from ischemia after TACE. However, recent studies have revealed that TACE could safely be performed in these patients. The aim of this study is to compare the efficacy of transarterial chemoembolization (TACE) with adriamycin to transarterial chemoembolization with adriamycin/transarterial chemoinfusion (TACI) with cisplatin combination in advanced hepatocellular carcinoma with portal vein invasion.
Interventions
DRUGDoxorubicin
Transarterial chemoembolization (TACE) with adriamycin
DRUGCisplatin
transarterial chemoinfusion with cisplatin 50-100 mg
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 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with clinical or histological diagnosis of HCC based on the guidelines of the AJCC * Patients with advanced HCC with invasion of major branch(es) of portal vein in the arterial phase of dynamic CT or MRI * Patients who have received previous local therapy treatments (RFA, PEI, cryoablation, surgery, resection) are eligible * Age : 18 years to 80 years * ECOG Performance Status of 0 to 2 * Child-Pugh class A (Child-Pugh score 5-6) * Adequate bone marrow, liver function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening: * WBC count \> 2,000/mm3 * Absolute neutrophil count \> 1,000/mm3 * Hb ≧ 8.0 g/dL * Platelet count ≧ 50,000 /mm3 * Bilirubin ≦ 3 mg/dL * Adequate clotting function: INR \< 2.3 or \< 6sec
Exclusion criteria
* Child-Pugh score ≧ 7 * ECOG Performance Status ≧ 3 * Patients with chronic kidney disease or serum creatinine ≥ 1.2 mg/dL * History of organ allograft * Patients with uncontrolled co-morbidity which needs treatment * Patients who have received prior systemic chemotherapy * Patients with extrahepatic metastasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | every 12 weeks, up to 48 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Time-to-progression | every 12 weeks, up to 48 weeks |
| Progression-free survival | every 12 weeks, up to 48 weeks |
Countries
South Korea
Outcome results
None listed