At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Trial of Sorafenib Plus Hepatic Arterial Infusion with Oxaliplatin and Fluorouracil Versus Sorafenib for Hepatocellular Carcinoma with Major Portal Vein Tumor Thrombosis
In Brief
A Phase 2 clinical trial evaluating HAIC and Sorafenib for HepatoCellular Carcinoma and Portal Vein Thrombosis. Completed, enrolled 64 participants across 1 site.
Detailed Summary
According to the Barcelona clinic liver cancer (BCLC) staging treatment guideline, sorafenib is recommended for Hepatocellular Carcinoma (HCC) with Portal Vein Tumor Thrombosis (PVTT), but HCC with major PVTT (in the main trunk or 1st-order branches of the portal vein) did not benefit much from sorafenib in previous studies. There is no established standard treatment for HCC patients with major PVTT, the investigators conducted a randomized, phase 2 study to investigate the survival benefit of sorafenib plus Hepatic arterial infusion chemotherapy (HAIC) with Oxaliplatin and Fluorouracil versus sorafenib for Hepatocellular Carcinoma with Major Portal Vein Tumor Thrombosis.
Study Details
Timeline
Interventions
Intra-arterial chemotherapy consisted of infusions of oxaliplatin (35 mg/m2 for 2 hours), followed by 5-fluorouracil (600 mg/m2 for 22 hours) on day1-3 every 4 weeks. For each cycle, leucovorin calcium 200 mg/m2 was intravenously administered for 2 hours from beginning of 5-fluorouracil infusion.
400 mg of sorafenib (consisting of two 200-mg tablets) twice daily.