NCT02447679

Oral Thalidomide and Tegafur-uracil to Decrease Hepatocellular Carcinoma Recurrence

Oral Thalidomide and Tegafur-uracil to Decrease Hepatocellular Carcinoma Recurrent After Hepatectomy in High Risk Patients -A Phase II Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This single-centered phase II clinical study is to obtain preliminary information on 1-year recurrence-free survival rate, recurrence-free survival and safety profile of thalidomide in combination with tegafur-uracil in hepatocellular carcinoma after hepatectomy and explore biomarkers(VEGF/bFGF) for thalidomide response.

Detailed description

After liver resection to remove the hepatocellular carcinioma completely, the patients with high risk of tumor recurrence will be enrolled into this study. The high risk of tumor recurrence depends on tumor characteristics. The risk factors of tumor characteristics included tumor size \>5 cm in diameter, abscence of encapsulation, vascular invasion and presence of daughter nodules. The patients with high risk of tumor recurrence will have 1 to 3 risk factors. When the patients are enrolled into the study, oral thalidomide in combination with tegafur-uracil will be applied to prevent tumor recurrence. The patients will be fillowed uo erevy 3 mnoths.

Conditions

• Adult Hepatocellular Carcinoma
• Recurrent Hepatocellular Carcinoma
• Adverse Reaction to Drug
• Vascular Endothelial Growth Factor Overexpression

Interventions

Type	Name	Description
DRUG	thalidomine	thalidomine (400mg/day) for 1 year to prevent HCC recurrence
DRUG	tegafur-uracil	tegafur-uracil (2 tablelet twice a day) for 1 year to prevent HCC recurrence

Timeline

• Start date: 2010-08-01
• Primary completion: 2017-01-31
• Completion: 2017-02-02
• First posted: 2015-05-19
• Last updated: 2017-02-07

Locations

1 site across 1 country: Taiwan