Randomized Trial Sorafenib-Pravastatin Versus Sorafenib Alone for the Palliative Treatment of Child-Pugh A Hepatocellular Carcinoma

NCT01903694 | Completed Phase 3

• 1 other identifier: JOUVE PHRC K 2009
• Study Type: interventional
• Target: 474
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Child-Pugh A Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• determination of the tumor according to the evaluation criteria of Response Evaluation Criteria in Solid Tumors

  To be done within the month preceding baseline

Study Arms (2)

sorafenib

ACTIVE COMPARATOR

800 mg of sorafenib twice daily orally.

Drug: Sorafenib

sorafenib-pravastatin

EXPERIMENTAL

800 mg of sorafenib twice daily oral doses associated with 40 mg of pravastatin in a taken per os. Pravastatin will be taken during dinner.

Drug: Sorafenib + Pravastatin

Interventions

Sorafenib + Pravastatin DRUG

Also known as: 800 mg of sorafenib twice daily oral doses associated with, 40 mg of pravastatin in a taken per os. Pravastatin will be taken during dinner.

sorafenib-pravastatin

Sorafenib DRUG

Also known as: 800 mg of sorafenib twice daily orally.

sorafenib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU de Dijon

Dijon, 21079, France

Location

Related Publications (1)

• Jouve JL, Lecomte T, Bouche O, Barbier E, Khemissa Akouz F, Riachi G, Nguyen Khac E, Ollivier-Hourmand I, Debette-Gratien M, Faroux R, Villing AL, Vergniol J, Ramee JF, Bronowicki JP, Seitz JF, Legoux JL, Denis J, Manfredi S, Phelip JM; PRODIGE-11 investigators/collaborators. Pravastatin combination with sorafenib does not improve survival in advanced hepatocellular carcinoma. J Hepatol. 2019 Sep;71(3):516-522. doi: 10.1016/j.jhep.2019.04.021. Epub 2019 May 22.

  PMID: 31125576 RESULT

MeSH Terms

Interventions

Sorafenib; Pravastatin

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2013
• First Posted: July 19, 2013
• Study Start: March 1, 2010
• Primary Completion: November 1, 2013
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

FR (1)