Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-03-05 @ 4:54 PM
Study NCT ID:
NCT01903694
Status:
COMPLETED
Last Update Posted:
2014-05-13
First Post:
2013-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Trial Sorafenib-Pravastatin Versus Sorafenib Alone for the Palliative Treatment of Child-Pugh A Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077157', 'term': 'Sorafenib'}, {'id': 'D017035', 'term': 'Pravastatin'}], 'ancestors': [{'id': 'D010671', 'term': 'Phenylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009536', 'term': 'Niacinamide'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 474}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'lastUpdateSubmitDate': '2014-05-12', 'studyFirstSubmitDate': '2013-07-17', 'studyFirstSubmitQcDate': '2013-07-17', 'lastUpdatePostDateStruct': {'date': '2014-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'determination of the tumor according to the evaluation criteria of Response Evaluation Criteria in Solid Tumors', 'timeFrame': 'To be done within the month preceding baseline'}]}, 'conditionsModule': {'conditions': ['Child-Pugh A Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': '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.\n\nSecondary 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)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hepatocellular carcinoma diagnosed by:\n* either a histological examination\n* 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\n* 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\n\nExclusion Criteria:\n\n* 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.\n\nAny 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.'}, 'identificationModule': {'nctId': 'NCT01903694', 'briefTitle': 'Randomized Trial Sorafenib-Pravastatin Versus Sorafenib Alone for the Palliative Treatment of Child-Pugh A Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'orgStudyIdInfo': {'id': 'JOUVE PHRC K 2009'}}, 'armsInterventionsModule': {'armGroups': [{'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']}], 'interventions': [{'name': 'Sorafenib + Pravastatin', 'type': 'DRUG', 'otherNames': ['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.'], 'armGroupLabels': ['sorafenib-pravastatin']}, {'name': 'Sorafenib', 'type': 'DRUG', 'otherNames': ['800 mg of sorafenib twice daily orally.'], 'armGroupLabels': ['sorafenib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'CHU de Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}