patients with advanced inoperable hepatocellular carcinoma Child A or B MedDRA version: 9.1 Level: LLT Classification code 10019695 Term: Hepatic neoplasm
Conditions
Interventions
Product Name: 5-FLUOROURACILE
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: 5-FLUOROURACILE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Sponsors
AZIENDA OSPEDALIERA PISANA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with measurable, histologically or cytological documented hepatocellular carcinoma, which is inoperable or have refused surgery. Patients must have previously untreated disease. No prior anti-cancer treatment for HCC is permitted except for local therapy, including chemoembolization, which is permitted . Patients will not be permitted to re-enter the study after leaving it Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Previous malignancy except for cervical carcinoma in situ, adequately treated basal cell carcinoma, or superficial bladder tumors Ta, Tis T1 or other malignancies curatively treated 3 years prior to entry . Patients with clinically significant gastrointestinal bleeding within the past month prior to study entry are ineligible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: N of non progressive disease stable disease, partial and minor responses ;Primary end point(s): N of non progressive disease stable disease, partial and minor responses after 6 cycles treatment;Secondary Objective: Objective response rate Recist Criteria Duration of responses, time to progression and overall survival. Pharmacokinetics and pharmacodynamics of Sorafenib plus 5-FU Baseline pERK concentration, phospho VEGF-R2 concentration, plasma levels of adrenomedullin a surrogate marker of angiogenesis , plasma proteomics and gene expression profiling on blood cells and tumor biopsy | — |
Countries
Italy
Outcome results
None listed