* Unlike the Asian and western regions, The vast majority of the Egyptian/Arabic Hepatocellular Carcinoma (HCC) patients are hepatitis C virus (HCV) associated. * According to the SHARP study subgroup analysis, it seems that HCV associated HCC patients derive the max benefit of Sorafenib, the absolute gain between the Sorafenib arm \& the placebo in m OS = 7 months, HR=0.58 (95% CI: 0.37-0.91). * In spite of improvement in terms of overall survival (OS) and time to progression (TTP), in all studies where Sorafenib was compared to placebo, the Sorafenib arm was not accompanied by a significant volumetric reduction, and this may explains the lack of any symptomatic improvement (time to symptomatic progression (TTSP) almost identical) * Reviewing the chemotherapy outcome, although there is no convincing evidence in survival benefit to patients with advanced HCC, however true shrinkage (reduction in tumor size), has been consistently reported although the magnitude of response is lacking consistency. This indicates the need for coupling Sorafenib to a chemotherapeutic agent but: * For patients with Hepatocellular Carcinoma, the toxicity profile of any chemotherapeutic agent of choice to be added to Sorafenib should be take in consideration * The agent to be added to Sorafenib should be effective in terms of Tumor Shrinkage \& with minimal toxicity regarding: * Cardio-toxicity * HFSR * Diarrhea * Hepato-toxicity * Bone marrow suppression (although not relevant to the toxicity profile of Sorafenib, yet the HCC patients may have HCV related thrombocytopenia and variable degree of hypersplenism related pancytopenia) Circulatory Overload (Hypertension) Why Tegafur-uracil (UFT)? * Efficacy: For UFT, although the efficacy data in HCC are not as extensive as Doxorubicin, however in one phase II study UFT could improve survival when compared with conservative management. * UFT Toxicity Profile: In a phase III trial to asses the compare Efficacy \& Safety of UFT with that of 5 FU in treatment of m CRC, Hematological toxicities were minimal (0% Grade ¾ leukopenia, neutropenia, febrile neutropenia, thrombocytopenia \& was 3% for anemia), while the most commonly seen SE was grade I \& II Diarrhea •Accordingly UFT may be considered as a potential partner to Sorafenib in patients with advanced HCC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
77
Sorafenib 400 mg p.o. twice daily until progression or intolerable toxicity alone.
Sorafenib 400 mg p.o. twice daily until progression or intolerable toxicity and TEGAFUR-URACIL 125mg/m2 PO BID For 4 weeks and to be repeated on day 36 till progression or intolerance
Ain shams university
Cairo, Egypt
Cairo University Hospitals
Cairo, Egypt
National cancer institute
Cairo, Egypt
NHTMRI
Cairo, Egypt
National Liver Institute
Monofeiya, Egypt
time to progression (TTP):recist criteria
Time frame: one year
progression free survival (PFS):recist criteria
Time frame: one year
Time to symptomatic improvement:FHSI-8 questionnaire
Time frame: one year
Quality of Life Using EQ-5D questionnaire.
Time frame: one year
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