drugset / Trial / NCT00519688

UFUR Plus Thalidomide for Advanced Hepatocellular Carcinoma

NCT00519688 ↗

Phase 2 Completed 44 enrolled National Taiwan University Hospital
NaSingle-groupOpen-labelTreatment

Summary

We hypothesize that combination of tegafur/uracil(UFUR) and thalidomide, both of which have been shown to be active in some HCC patients,may be a highly useful regimen for the treatment of advanced HCC. There are several rationales underlying this combination. First, anti-angiogenesis therapy may improve the efficacy of chemotherapy by normalizing the abnormal vasculature in tumors, and thus improving the delivery of chemotherapeutic agents to the tumor cells. Second, chemotherapeutic drugs given in a low-dose, un interrupted, and protracted way can induce anti-tumor effect through the anti-angiogenesis activity (so-called"metronomic chemotherapy"). The efficacy of metronomic chemotherapy can be suppressed by VEGF/VEGFR signaling pathways and thus can bo further potentiated by agents blocking those survival signals of endothelial cell. In this regard, tegafur/uracil appears to be a good candidate for metronomic chemotherapy because tegafur/uracil and its metabolites bave already been shown to inhibit angiogenesis in several pre-clinical models.

Timeline

Start
2006-07
Primary completion
2010-08
Completion
2010-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Tegafur/Uracil Unknown 125 mg/m2 Oral
Subject Thalidomide Other / unclassified 100 mg Oral