Hepatocellular Carcinoma
Conditions
Keywords
transarterial chemoembolization, transarterial radioembolization, advanced hepatocellular carcinoma
Brief summary
The aim of this study is to compare the efficacy of conventional transarterial chemoembolization(TACE) and transarterial radioembolization in patients with unilobar advanced hepatocellular carcinoma.
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. Unresectable advanced HCCs 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 by several trials. Recently,transarterial radioembolization (TARE) has been introduced for the treatment of advanced HCC. However, the efficacy of TARE compared to TACE is uncertain. The aim of this study is to compare the efficacy of conventional transarterial chemoembolization(TACE) and transarterial radioembolization in patients with unilobar advanced hepatocellular carcinoma.
Interventions
transarterial radioembolization
transarterial chemoembolization
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 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 unilobar advanaced involvement: right lobe ± S4 segment or left lobe ± S4 segment) * Patients with single large HCC or multinodular HCC * Single & 5cm \< size \< 15cm * 2-5 nodules & maximal sized 4-15cm & sum of diameters ≦ 25cm * Infiltrative type & unilobular involvement on liver MRI * Segmental or lobar portal vein invasion can be included. * Age : 20 years to 80 years * ECOG Performance Status of 0 to 2 * Child-Pugh class A (Child-Pugh score 5-6), B (CP score 7) * Adequate bone marrow, liver function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening: * WBC count ≧ 1,000/mm3 * Absolute neutrophil count \> 500/mm3 * Hb ≧ 7.0 g/dL * Platelet count \> 100,000 /mm3 * Bilirubin ≦ 3 mg/dL * Adequate clotting function: INR ≦ 2.3 or ≦ 6sec
Exclusion criteria
* Child-Pugh score ≧ 8 * 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 who have received Capecitabine within 8 weeks * Patients with extrahepatic metastasis * Main portal vein invasion * Patients with lymph node metastasis * Bilobar involvement * Bulk disease(Tumor volume \>70% of the target liver volume, or tumor nodules too numerous to count) * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | every 12 weeks, up to the time of death, up to 12 months | From date of randomization until the date of death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival in the Liver | every 12 weeks, up to the time of death or first documented intrahepatic tumor progression, up to 12 months | From date of randomization until the date of first documented intrahepatic tumor progression or death |
| Progression-Free Survival Overall | every 12 weeks, up to the time of death or first documented progression, up to 12 months | From date of randomization until the date of first documented progression or death |
| Overall tumor response assessment | every 12 weeks, up to the time of death or 12 months | (CR, PR, SD, PD)by modified RECIST criteria |
Countries
South Korea
Outcome results
None listed