Primary objective: To determine the Tumor Response Rate of patients with hepatocellular carcinoma treated with the combination chemotherapy of Eloxatin+5-FU/LV Secondary objective: To evaluate time to progression, 6month survival, overall survival, safety and tolerability of patients with hepatocellular carcinoma treated with the combination chemotherapy of Eloxatin+5-FU/LV
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
85mg/m², 2 hours IV infusion, Day 1; Every 2 weeks
400mg/m², 2 hours IV bolus, Day 1; 22 hours continuous IV infusion 600mg/m², Day 1 and Day 2; Every 2 weeks
200mg/m², Day 1 and Day 2; Every 2 weeks
Sanofi-Aventis Administrative Office
Seoul, South Korea
Tumor Response Rate evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) by physical examination, chest X-ray, abdomen-pelvis CT (Computed tomography) scan
Time frame: every 6 weeks
Time to Progression (TTP), 6 month survival, overall survival, AFP
Time frame: from the signature of Informed Consent up to end of the study
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