Child-Pugh A Hepatocellular Carcinoma Clinical Trial
| NCT number | NCT01903694 |
| Other study ID # | JOUVE PHRC K 2009 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | July 17, 2013 |
| Last updated | May 12, 2014 |
| Start date | March 2010 |
Principal objective: to evaluate the effect of the combination pravastatin - sorafenib
versus sorafenib alone on overall survival in patients with hepatocellular carcinoma
developing on Child-Pugh A cirrhosis who are unsuitable for curative treatment.
Secondary objectives: evaluate the effect of this treatment on progression-free survival,
the time to progression, the time to treatment failure and quality of life (QLQ-C30 et FACT
HEP)
| Status | Completed |
| Enrollment | 474 |
| Est. completion date | |
| Est. primary completion date | November 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Hepatocellular carcinoma diagnosed by: - either a histological examination - or if histological evidence cannot be obtained (ascites, coagulation disorders) the diagnosis can be made in cases of cirrhosis according to EASL/AASLD 2005 criteria, by revealing a hepatic focal lesion of more than 10 mm - on two dynamic imaging techniques (helical CT-scan, MRI, contrast-enhanced ultrasound) for tumours measuring less than 2 cm. The lesion must be characterised by hyperdensity during the arterial phase and wash-out during the delayed portal phase Patients who are not suitable for treatment with a curative intent (transplantation, resection, percutaneous destruction) or by chemo-embolisation or with progressive hepatocellular carcinoma after the failure of specific treatment Prognostic CLIP score 0 to 4 Child-Pugh Class A Transaminases = 5 N and Creatininemia = 1.5 N WHO: 0, 1 or 2 Age more than 18 years Foreseeable survival > 12 weeks Possibility of regular follow-up Written informed consent Exclusion Criteria: - Extra-hepatic disease that could be life-threatening in the short or medium term Another progressive cancer with the exception of in situ cervical cancer, a superficial bladder tumour and treated basocellular carcinoma. Any other cancer treated with a curative intent in the previous 3 years can be included in the study Heart failure (=New York Heart Association class 2), uncontrolled AHT or arrhythmia, myocardial infarction in the previous 6 months Digestive haemorrhage in the previous month Patients who are receiving or have already received treatment with statins or sorafenib Pregnancy and breast-feeding. Women of child-bearing age must use an effective method of contraception throughout the trial and for 3 months after the end of the treatment. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | CHU de Dijon | Dijon |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire Dijon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | determination of the tumor according to the evaluation criteria of Response Evaluation Criteria in Solid Tumors | To be done within the month preceding baseline | No |