NCT03009461

Sorafenib Plus Hepatic Arterial Infusion Versus Sorafenib for HCC with Major Portal Vein Tumor Thrombosis

Randomized Trial of Sorafenib Plus Hepatic Arterial Infusion with Oxaliplatin and Fluorouracil Versus Sorafenib for Hepatocellular Carcinoma with Major Portal Vein Tumor Thrombosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HepatoCellular Carcinoma
• Portal Vein Thrombosis

Interventions

Type	Name	Description
PROCEDURE	HAIC	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.
DRUG	Sorafenib	400 mg of sorafenib (consisting of two 200-mg tablets) twice daily.

Timeline

• Start date: 2017-06-01
• Primary completion: 2020-06-15
• Completion: 2020-12-28
• First posted: 2017-01-04
• Last updated: 2024-12-04

Locations

1 site across 1 country: China