A Phase 2 interventional study of sorafenib and Pravastatin in Hepatocellular Carcinoma and CHILD B, sponsored by University Hospital, Bordeaux. Completed at 35 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-01.
Sponsored by University Hospital, Bordeaux · Phase 2, Interventional, and Treatment
The incidence of Hepatocellular Carcinoma (HCC) is currently increasing in Europe and in France and about 2 / 3 of patients, are not eligible for curative treatment at the time of diagnosis. The palliative management of patients with advanced and symptomatic disease is complex and requires treatment combining anti-tumor activity and safety in patients with impaired liver functions. Sorafenib is the standard of care in a palliative setting, but the benefit of sorafenib in patient with altered liver function is uncertain. The aim of this trial is to study the interest of sorafenib in patients with HCC and impaired liver function compared to pravastatin (a drug with anti-tumoral activity in HCC) or to the combination sorafenib/pravastatin or to best supportive care (usually used in these patients).
The incidence of Hepatocellular Carcinoma (HCC) is currently increasing in Europe and in France. It almost always occurs on liver disease and in 80 to 90% of cases, at least in France, on liver with cirrhosis. If curative treatment may be proposed for some "small" HCC (transplantation, resection, percutaneous destruction), about 2 / 3 of patients, which represents nearly 4,000 new cases per year in France, are not eligible for such treatment. The palliative management of patients with advanced and symptomatic disease is complex and requires treatment combining anti-tumor activity and safety in patients with impaired liver functions. Indeed, in most cases the palliative treatment of HCC is applied to patients with altered liver function (stage B of the Child-Pugh classification).
To date, the proposed treatment in France for such patients is based on best supportive care.
The objective of this study is to assess the interest in this situation of 2 molecules - taken alone or in combination:
In this French multicenter open randomized study, 160 patients will be included in 4 arms (40/arms): sorafenib, pravastatin, pravastatin + sorafenib, and supportive care.
The aim of this phase II multicenter study is to select the two best arms for further Phase III study in order to identify a reference treatment in this palliative situation.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 160 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
Counted across the registry records on this site, refreshed daily.
(ii)Hepatic lesion with a diameter > 2 cm : CT-scan or MRI +alpha fetoprotein : HCC diagnosed with contrast uptake in the arterial phase and a rapid wash out in the venous /late phase or a alpha fetoprotein > 200µg/L
Exclusion Criteria:
patients receiving sorafenib 400 mg - twice a day
Drug: sorafenib
patients receiving pravastatin 40 mg - once a day
Drug: Pravastatin
patients receiving sorafenib 400 mg (twice a day) and pravastatin 40 mg (once a day)
Drug: Sorafenib + Pravastatin
patients receiving best supportive care
Other: patients receiving best supportive care
patients receiving sorafenib 400 mg - twice a day
patients receiving pravastatin 40 mg - once a day
patients receiving sorafenib 400 mg (twice a day) and pravastatin 40 mg (once a day)
palliative management
Time to radiologic progression
Time frame: Every 4 weeks (CT-scan or MRI) until progression of HCC or date of last news (for patients alive or dead without progression)
Overall survival
Time frame: End of the study (estimated date August 2012)
Survival without progression
Time frame: Every 4 weeks (CT-scan or MRI) until progression of HCC or date of last news (for patients alive or dead without progression)
Time to treatment failure
Time frame: every 4 weeks (CT-scan or MRI) until clinical or radiological progression of HCC or date of last news (for patients alive or dead without progression)
Objective response rate at four months
Time frame: Radiological evaluation at 4 months
Number and description of AE for toxicity and SAE
Time frame: Clinical evaluation every month
Quality of life
Time frame: Clinical evaluation every month
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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University Hospital, Bordeaux