UFUR Plus Thalidomide for Advanced Hepatocellular Carcinoma

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Treatments: Tegafur; Thalidomide

Criteria

Inclusion Criteria:

• Histologically confirmed HCC or HBC/HCV carrier with hepatic tumor of α-FP>400 Stage IV dis. By AJCC KPS>70% Age>18 Liver function reserves:Child-Pugh Class A, ALT<5xUNL, Bil-T<1.5xUNL WBC>4000 or ANC>1500, PLT>75K, Cr<1.5xUNL Previous local therapy completed 6wks

Exclusion Criteria:

• Concurrent corticosteroids Previous exposure to C/T, Thalidomide CNS metastasis Concomitant illness: active infection, >NCIG2 neuropathy, Hx of seizures Organ transplantation