Phase II Study Evaluating the Efficacy of 5-fluorouracil/Mitomycin for the Patients With Pulmonary Metastasis of Hepatocellular Carcinoma Who Had Progressive Disease With Sorafenib
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- Time-to-progression(TTP)of lung metastasis
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
The 5-fluorouracil/mitomycin group
Systemic chemotherapy with 5-fluorouracil/mitomycin 5-fluorouracin 15mg/kg/day D1-6 civ + Mitomycin 4mg/day iv push D1,4 till progression, every 4 weeks
Intervention: 5-fluorouracil (Drug)
The 5-fluorouracil/mitomycin group
Systemic chemotherapy with 5-fluorouracil/mitomycin 5-fluorouracin 15mg/kg/day D1-6 civ + Mitomycin 4mg/day iv push D1,4 till progression, every 4 weeks
Intervention: Mitomycin (Drug)
Outcomes
Primary Outcomes
Time-to-progression(TTP)of lung metastasis
Time Frame: every 12 weeks, up to 36 weeks
Secondary Outcomes
- Response rates(CR + PR)of lung metastasis(every 12 weeks, up to 36 weeks)
- progression free survival(every 12 weeks, up to 36 weeks)
- Overall survival(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)
Investigators
Jung-Hwan Yoon
Professor
Seoul National University Hospital