The Efficacy of 5-fluorouracil/Mitomycin for the Patients With Pulmonary Metastasis of Hepatocellular Carcinoma

• Status: Withdrawn
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Fluorouracil; Mitomycin; Mitomycins

Criteria

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