TRIAL WITH SORAFENIB & PRAVASTATIN VERSUS SORAFENIB ALONE FOR THE PALLIATIVE TREATMENT OF PATIENTS SUFFERING FROM CHILD-PUGH A HEPATOCELLULAR CARCINOMA

Phase 1

• Conditions: Hepatocellular carcinoma (HCC) non available for curative intent treatment; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2009-015785-64-BE
• Lead Sponsor: CHU de DIJON - Délégation à la recherche clinique et à l’innovation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-13
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Hepatocellular carcinoma diagnosed:
-either histologically
-or, in cases where histological proof cannot be obtained (ascitis, coagulation disorders), the diagnosis may be done in cases of cirrhosis according to the 2005 EASL/AASLD criteria by demonstration of a focal hepatic lesion larger than 10 mm:
•by two dynamic imaging techniques (helicoïdal scan, MRI, ultrasound with contrast medium) for tumors smaller than 2 cm. The lesion must be characterized by hypervascularisation in the arterial time and a wash in the late portal time.
•by one dynamic imaging technique (helicoïdal scan, MRI, ultrasound with contrast medium) for tumors larger than 2 cm with hypervascularisation in the arterial time and a wash in the late portal time
•Patient not eligible for curative treatment (transplant, resection, percutaneous destruction) or chemo-embolisation or with HCC which is still progressing following the failure of specific treatment
•CLIP prognosis score 0 to 4
•Child-Pugh score A
•Transaminases activity = 5 ULN and serum creatinine = 1.5 ULN
•WHO performance status: 0, 1 or 2
•Over the age of 18 years
•Expected survival > 12 weeks
•Possibility for regular follow-up
•Written informed consent prior randomization
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 427
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 47

Exclusion Criteria

•Extra-hepatic disease threatening the short- or medium-term vital prognosis
•Other cancerous pathology in progression, not including in situ cervical cancer, superficial bladder tumours and treated basal cell carcinoma. Any other cancer treated curatively more than 3 years previously can be included in the study
•Cardiac insufficiency (= NYHA class 2), uncontrolled arterial hypertension or arrhythmia, myocardial infarction less than 6 months previously
•Digestive haemorrhage less than 1 month
•Patients receiving or having previously received treatment with statins or sorafenib
•Pregnancy or lactation. Women at the age of procreation must use an acceptable method of contraception during the study and until 3 months after the end of the treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified