Comparison Study of Sorafenib and 5-fluorouracil/Mitomycin for Metastatic Hepatocellular Carcinoma

• Status: Terminated
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to compare the efficacy of sorafenib to 5-fluorouracil/mitomycin in HCC patients with pulmonary metastasis whose intrahepatic tumors has been controlled with locoregional therapies.

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

Details

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

Criteria

Inclusion Criteria:

• Patients with clinical or histological diagnosis of HCC based on the guidelines of the AJCC

• Patients with at least one, bi-dimensionally measurable, pulmonary metastasis without intrahepatic viable tumor (Viable tumor is defined as uptake of contrast agent in the arterial phase of dynamic CT or MRI.)

• Patients who have received previous local therapy treatments (RFA, PEI, cryoablation, surgery, resection) to non-target lesions are eligible

• Age : 20 years to 80 years

• ECOG Performance Status of 0 to 1

• Child-Pugh class A or B (Child-Pugh score 7)

• Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:

• Hb ≧ 9 g/dL

• Absolute neutrophil count > 1000/mm3

• Platelet count ≧ 60,000 /mm3

• Adequate clotting function: INR < 1.5

• Hepatic: AST and ALT < 5 X ULN

• Renal: serum creatinine < 1.7mg/dL

• Bilirubin ≦ 3 mg/dL

Exclusion Criteria:

• Patients with diffuse infiltrative type of HCC that are poorly defined

• Presence of hepatic encephalopathy and intractable ascites

• Patients who are on a liver transplant list

• The patient has received prior systemic chemotherapy

• History of organ allograft

• Active clinically serious infections (> grade 2 NCI-CTC version 3.0), including spontaneous bacterial peritonitis

• History of cardiac disease: congestive heart failure > NYHA class 2; active coronary artery disease (myocardial infarction more than 6 months prior to study entry is allowed), cardiac arrhythmias requiring anti-arrhythmic therapy or uncontrolled hypertension and diabetes mellitus

• Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to entry is permitted

• HIV infection or AIDS-related illness or serious acute or chronic illness (based on medical history)