Neoplasms Clinical Trial
Official title:
Randomized Controlled Trial Comparing Efficacy of Sorafenib Versus Sorafenib In Combination With Low Dose Cisplatin /Fluorouracil Hepatic Arterial InfUSion Chemotherapy in Patients With Advanced Hepatocellular Carcinoma
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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