Clinical trial · Interventional
Randomized Trial Sorafenib-Pravastatin Versus Sorafenib Alone for the Palliative Treatment of Child-Pugh A Hepatocellular Carcinoma
NCT01903694CI-TRIAL-00102795completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Child-Pugh A Hepatocellular Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sorafenib | Drug | Sorafenib | ALIAS |
| Sorafenib + Pravastatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- sorafenib
- description
- 800 mg of sorafenib twice daily orally.
- interventionNames
- Drug: Sorafenib
- type
- EXPERIMENTAL
- label
- sorafenib-pravastatin
- description
- 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.
- interventionNames
- Drug: Sorafenib + Pravastatin
Primary outcomes (1)
- measure
- determination of the tumor according to the evaluation criteria of Response Evaluation Criteria in Solid Tumors
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTJouve 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