Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT00241020
Status:
COMPLETED
Last Update Posted:
2016-04-12
First Post:
2005-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy of Long-acting Release Octreotide in Patients With Advanced Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015282', 'term': 'Octreotide'}], 'ancestors': [{'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 270}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2005-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-11', 'studyFirstSubmitDate': '2005-10-14', 'studyFirstSubmitQcDate': '2005-10-16', 'lastUpdatePostDateStruct': {'date': '2016-04-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival'}], 'secondaryOutcomes': [{'measure': 'Objective response'}, {'measure': 'Survival without progression'}, {'measure': 'Digestive bleeding'}, {'measure': 'Renal insufficiency'}, {'measure': 'Quality of life'}, {'measure': '· Safety'}]}, 'conditionsModule': {'keywords': ['hepatocellular carcinoma', 'Octreotide'], 'conditions': ['Advanced Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'Hepatocellular carcinoma (HCC) is one of the most common malignant disease worldwide with an increasing incidence in industrialized countries. For patients with advanced HCC no efficient treatment is currently available. The objective of this study is to assess the efficacy and safety of octreotide in patients with advanced hepatocellular carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 18 years\n* HCC diagnosis :\n* histologically or cytologically proven HCC\n* or association of the three following criteria:\n* cirrhosis\n* typical measurable mass (\\> 3cm, by 2 methods)\n* serum alpha-foetoprotein (AFP) ≥500 µg/L\n* Cancer Liver Italian Program (CLIP) score : 0 to 3\n* Not eligible for specific treatment (surgery, percutaneous ablation or chemo-embolization)\n\nExclusion Criteria:\n\n* Glycemia \\> 2.5 g/L or hypoglycemia\n* Extra hepatic life-threatening disease\n* Serum creatinin\\> 120 µmol/L\n* Prothrombin time \\< 50 %\n* Platelet count \\< 50.000 /µL\n* Symptomatic cholelithiasis\n* Non-measurable tumor'}, 'identificationModule': {'nctId': 'NCT00241020', 'briefTitle': 'Evaluation of the Efficacy of Long-acting Release Octreotide in Patients With Advanced Hepatocellular Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Evaluation of the Efficacy of Long-acting Release Octreotide in Patients With Advanced Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'CSMS995BFR04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Octreotide', 'interventionNames': ['Drug: Octreotide']}], 'interventions': [{'name': 'Octreotide', 'type': 'DRUG', 'armGroupLabels': ['Octreotide']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}