The purpose of this study is to evaluate the efficacy of sorafenib in combination with low dose cisplatin /fluorouracil hepatic arterial infusion chemotherapy in patients with advanced hepatocellular carcinoma.
Sorafenib with Low-dose FP Group Sorafenib will be administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) for 28 days. Cisplatin at the dose of 20mg/m2 will be administered at day 1 and day8, and fluorouracil at the dose of 330mg/m2 will be administered continuously at day1-day5, and day8-day12 via the implanted catheter system. Sorafenib Group Sorafenib will be administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) for 28 days. The treatment regimen will be continued until radiographic or symptomatic progression, the development of unacceptable toxicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
190
Sorafenib will be administered orally at a dose of 400 mg bid for 28 days in a cycle. Cisplatin at the dose of 20 mg/m2 will be administered at day 1 and day8, and fluorouracil at the dose of 330 mg/m2 will be administered continuously at day 1-day 5, and day8-day12 via the implanted catheter system. A cycle is defined as 28 days.
Sorafenib will be administered orally at a dose of 400 mg bid for 28 days in each cycle.A cycle is defined as 28 days.
Overall survival
Time frame: Overall survival is defined as the time from randomization to death due to any cause
Time to progression
Time frame: TTP is defined as the time from randomization to radiological progression.
Progression Free Survival
Time frame: PFS is defined as the time from randomization to radiological progression or death due to any cause
Change of tumor marker
Time frame: Every 4-6 weeks
Biomarker predicting the efficacy
Time frame: Pre and after treatment
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