Hepatocellular Carcinoma, Lung Metastasis
Conditions
Keywords
hepatocellular carcinoma, lung metastasis, 5-fluorouracil/mitomycin
Brief summary
The aim of this study is to evaluate the efficacy of 5-fluorouracil + Mitomycin for the patients with pulmonary metastasis of hepatocellular carcinoma who had progressive disease with sorafenib.
Detailed description
Extrahepatic metastasis of hepatocellular carcinoma has recently been paradoxically increasing due to increased survival with effective locoregional therapies. Sorafenib is the first systemic agent that has demonstrated a significant survival benefit in patients with advanced HCC; however, the modest improvement of 3 months is far from satisfactory. There is no convincing evidence, to date, that systemic chemotherapy when tumor progresses after sorafenib therapy improves overall survival. The combination of anticancer agents is important to achieve favourable clinical results. For patients with metastatic liver cancer or HCC, some studies have discussed the effectiveness of 5-fluorouracil/mitomycin(FM). However, few studies have examined the actual FM regimen for HCC. The aim of this study is to evaluate the efficacy of 5-fluorouracil/mitomycin for the patients with pulmonary metastasis of hepatocellular carcinoma who had progressive disease with sorafenib.
Interventions
DRUG5-fluorouracil
5-fluorouracin 15mg/kg/day D1-6 civ till progression, every 4 weeks
DRUGMitomycin
Mitomycin 4mg/day iv push D1,4 till progression, every 4 weeks
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients who have received previous local therapy treatments for the intrahepatic hepatocellular carcinoma (RFA, PEI, cryoablation, surgery, resection) and who don't have any viable intrahepatic tumor within 3 months of imaging (dynamic liver CT or liver MRI) after the locoregional therapy * Patients who have measurable lung metastasis * Patients who have received their last dose of sorafenib more than 14 days before and who had progressive disease of lung metastasis with sorafenib * Patients who have risk factors of hepatocellular carcinoma (chronic hepatitis B, chronic hepatitis C, liver cirrhosis) * Age : 18 years to 80 years * ECOG Performance Status of 0 to 2 * Child-Pugh class A,B (Child-Pugh score 5-9) * 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 \> 50,000 /mm3 * Bilirubin \< 3 mg/dL * Adequate clotting function: INR \< 2.3 or \< 6sec
Exclusion criteria
* Child-Pugh score \> 10 * ECOG Performance Status \> 3 * History of organ allograft * Patients with uncontrolled co-morbidity which needs treatment * Patients who have received prior systemic chemotherapy except sorafenib
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time-to-progression(TTP)of lung metastasis | every 12 weeks, up to 36 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | every 12 weeks, up to 36 weeks |
| Response rates(CR + PR)of lung metastasis | every 12 weeks, up to 36 weeks |
| Time to recurrence of intrahepatic tumor | every 12 weeks, up to 36 weeks |
| Disease control rates (CR + PR + SD)of lung metastasis | every 12 weeks, up to 36 weeks |
| progression free survival | every 12 weeks, up to 36 weeks |
Other
| Measure | Time frame |
|---|---|
| Adverse Events | every 12 weeks, up to 36 weeks |
Countries
South Korea
Outcome results
None listed