PHASE II STUDY OF BAY 43-9006 AND INFUSIONAL 5-FLUOROURACIL IN ADVANCED HEPATOCELLULAR CARCINOMA - ND

Conditions: patients with advanced inoperable hepatocellular carcinoma Child A or B
MedDRA version: 9.1Level: LLTClassification code 10019695Term: Hepatic neoplasm

Registration Number: EUCTR2007-000747-10-IT

Lead Sponsor: AZIENDA OSPEDALIERA PISANA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures