Combination of Erlotonib plus Sorafenib in Patients with unresectable Hepatocellular Carcinoma; a randomized placebo controlled Phase II pilot trial. - Erlosora-1
- Conditions
- nresectable Hepatocellular Carcinoma
- Registration Number
- EUCTR2008-001401-42-AT
- Lead Sponsor
- Medizinische Universität Wien, Univ. KlM III, Klinische Abt. f. Gastroenterologie/Hepatologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 90
1) Patients with the clinical stage C according to the Barcelona Clinic Liver Cancer Staging System
2 Patients with the clinical stage B according to the Barcelona Clinic Liver Cancer Staging System who have a contraindication for transarterial chemoembolisation (TACE) or who are non-responders to TACE
3) Age > 18 years.
4) ECOG Performance Status of 0-2
5) Life expectancy of at least 12 weeks.
6) Subjects with at least one uni-dimensional (for RECIST) measurable lesion. Lesions must be measured by CT-scan or MRI
7) Child Pugh A or B (max. 9 points)
8) Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior start of therapy:
Hemoglobin > 8.5 g/dl
Absolute neutrophil count (ANC) >1,500/mm3
Platelet count ? 60,000/µl
Total bilirubin < 5 mg/dl
ALT and AST < 5 x upper limit of normal
Normotest >40% [Patients who are being therapeutically anticoagulated with an agent such as coumarin-derivative or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.]
Serum creatinine < 1.5 x upper limit of normal.
9) Signed and dated informed consent at the beginning of the study.
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
1) Patients with the clinical stage A or D according to the Barcelona Clinic Liver Cancer Staging System
2) Patients with the clinical stage B according to the Barcelona Clinic Liver Cancer Staging System, who have no contraindication for TACE or who do respond to TACE therapy.
3) History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrythmias requiering anti-arrythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension.
4) Large oesophageal varices (>5 mm diameter) without prophylactic band ligation
5) History of HIV infection
6) Symptomatic metastatic brain or meningeal tumors (unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry)
7) Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
8) History of organ allograft. The organ allograft may be allowed as protocol specific.
9) Patients undergoing renal dialysis
10) Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry.
11) Patients unable to swallow oral medication
12) Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - Time to progression;Secondary Objective: - Safety<br>- Radiological response as measured by Choi criteria<br>- Overall survival<br>- Progression free survival<br>- Overall disease control rate<br>- Overall response rate<br>- Quality of Life<br>- Number of hepatic decompensations<br>;Primary end point(s): Time to progression
- Secondary Outcome Measures
Name Time Method