Status:
TERMINATED
Comparison Study of Sorafenib and 5-fluorouracil/Mitomycin for Metastatic Hepatocellular Carcinoma
Lead Sponsor:
Seoul National University Hospital
Conditions:
Carcinoma, Hepatocellular
Eligibility:
All Genders
20-80 years
Phase:
PHASE2
Brief 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 ther...
Detailed Description
Most HCC patients are diagnosed at advanced stages in Korea, but effective treatment strategies for advanced HCC have not been established. In particular, optimal treatment strategy for extrahepatic a...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01171482
Start Date
November 1 2015
End Date
April 1 2016
Last Update
April 26 2017
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea