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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01171482
• Date of registration: 22/07/2010
• Primary sponsor: Seoul National University Hospital
• Public title: Comparison Study of Sorafenib and 5-fluorouracil/Mitomycin for Metastatic Hepatocellular Carcinoma
• Scientific title: An Open Label, Phase 2 Trial Comparing Sorafenib and 5-fluorouracil/Mitomycin in Hepatocellular Carcinoma With Pulmonary Metastasis
• Date of first enrolment: November 2010
• Target sample size: 40
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01171482
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Korea, Republic of

Contacts

• Name: Jung-Hwan Yoon

Key inclusion & exclusion 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)



Age minimum: 20 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Carcinoma, Hepatocellular

Intervention(s)

Drug: 5-FU

Drug: Mitomycin

Drug: sorafenib

Primary Outcome(s)

Progression free survival (PFS) [Time Frame: every 8 weeks]

Secondary Outcome(s)

Adverse event rates and the toxicities [Time Frame: every 4 weeks]

Objective tumor response rate [Time Frame: Determined by CT scan at the end of every 2 cycles until progressive disease is documented or intolerable toxicity occurs]

Overall survival [Time Frame: every 8 weeks]

Time-to-progression (TTP) [Time Frame: every 8 weeks]

Secondary ID(s)

07-2010-010

Source(s) of Monetary Support

Please refer to primary and secondary sponsors