UFUR Plus Thalidomide for Advanced Hepatocellular Carcinoma
NCT00519688 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44
Last updated 2011-10-17
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.
Conditions
Interventions
- DRUG
-
Thalidomide
100 mg, BID
- DRUG
-
Tegafur/Uracil
125 mg/m2, based on tegafur, BID
Sponsors & Collaborators
-
National Taiwan University Hospital
lead OTHER
Principal Investigators
-
Chih-Hung Hsu, M.D. Ph.D. · Department of Oncology, National Taiwan University hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-07-31
- Primary Completion
- 2010-08-31
- Completion
- 2010-08-31
Countries
- Taiwan
Study Locations
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