Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-01-11 @ 11:00 AM
Study NCT ID:
NCT06518434
Status:
RECRUITING
Last Update Posted:
2024-07-24
First Post:
2021-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study on the Effect of Cannabis Oil in Untreatable Liver Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D002189', 'term': 'Marijuana Abuse'}], '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'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064086', 'term': 'Medical Marijuana'}, {'id': 'D013759', 'term': 'Dronabinol'}, {'id': 'D002185', 'term': 'Cannabidiol'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D002186', 'term': 'Cannabinoids'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2027-04-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-23', 'studyFirstSubmitDate': '2021-09-28', 'studyFirstSubmitQcDate': '2024-07-23', 'lastUpdatePostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor size', 'timeFrame': '9 months', 'description': 'Tumor size based on RECIST and mRECIST criteria'}], 'secondaryOutcomes': [{'measure': 'Tumor size', 'timeFrame': '3 months', 'description': 'Tumor size based on RECIST and mRECIST criteria'}, {'measure': 'Tumor size', 'timeFrame': '6 months', 'description': 'Tumor size based on RECIST and mRECIST criteria'}, {'measure': 'Tumor markers', 'timeFrame': '3 months', 'description': 'Alfa-foetoprotein (AFP) and des-gamma-carboxy-protrombine (DGCPT)'}, {'measure': 'Tumor markers', 'timeFrame': '6 months', 'description': 'Alfa-foetoprotein (AFP) and des-gamma-carboxy-protrombine (DGCPT)'}, {'measure': 'Tumor markers', 'timeFrame': '9 months', 'description': 'Alfa-foetoprotein (AFP) and des-gamma-carboxy-protrombine (DGCPT)'}, {'measure': 'Quality of Life questionnaires', 'timeFrame': '3 months', 'description': 'EORTC-QLQ30 and -HCC18'}, {'measure': 'Quality of Life questionnaires', 'timeFrame': '6 months', 'description': 'EORTC-QLQ30 and -HCC18'}, {'measure': 'Quality of Life questionnaires', 'timeFrame': '9 months', 'description': 'EORTC-QLQ30 and -HCC18'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma', 'Cannabis']}, 'descriptionModule': {'briefSummary': 'to study the anti-tumor effect of cannabis oil (THC10% / CBD5%) in untreatable HCC patients based on mRECIST and RECIST criteria'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age =\\>18 yrs\n* Histologically proven hepatocellular carcinoma\n* Non-cirrhosis or Child Pugh A cirrhosis\n* Hepatic encephalopathy grade 0 or 1\n* Multidisciplinary treatment (MDT)-advised best supportive care for untreatable advanced HCC or patients unable to undergo or declining treatment for advanced HCC.\n* Minimal life expectancy of 3 months\n* Willing and able to attend follow-up examinations\n* Willing to stop active traffic participation or controlling machinery during the study period if applicable\n* Signed informed consent\n* Language: Dutch or English\n\nExclusion Criteria:\n\n* Child Pugh B or C cirrhosis\n* Hepatic encephalopathy grade 2 or more\n* Previous systemic treatment for HCC\n* Mental conditions rendering the subject incapable to understand the nature, scope and consequences of the trial\n* Use of medicinal cannabis for other purposes\n* Contra-indications for medicinal cannabis oil:\n\n * Patients who have experienced a myocardial infarction or clinically significant cardiac dysfunction within the last 12 months or have had a cardiac disorder that, in the opinion of the investigator would have put the participant at risk of a clinically significant arrhythmia or myocardial infarction.\n * Patients with known psychotic disorders\n * Female patients who are pregnant or lactating\n * Patients (men or women) intending to start a family\n * Hypersensitivity to cannabinoids or any of the excipients of the cannabis oil'}, 'identificationModule': {'nctId': 'NCT06518434', 'acronym': 'CanHep', 'briefTitle': 'A Pilot Study on the Effect of Cannabis Oil in Untreatable Liver Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'A Phase 2a Study on the Anti-tumoral Effect of Cannabis Oil (THC 10% / CBD 5%) in Patients With Advanced Untreatable Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': '201800881'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cannabis oil', 'description': 'Treatment with cannabis oil', 'interventionNames': ['Drug: Medical Cannabis']}], 'interventions': [{'name': 'Medical Cannabis', 'type': 'DRUG', 'otherNames': ['Cannabis oil containing 10% delta-9-tetrahydrocannabinol (THC) and 5% cannabidiol (CBD)'], 'description': 'Medical cannabis oil three times daily', 'armGroupLabels': ['Cannabis oil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9713 GZ', 'city': 'Groningen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Maarten W Nijkamp, MD PhD', 'role': 'CONTACT', 'email': 'm.w.nijkamp@umcg.nl', 'phone': '+31625649985'}], 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'centralContacts': [{'name': 'M W Nijkamp, MD PhD', 'role': 'CONTACT', 'email': 'm.w.nijkamp@umcg.nl', 'phone': '+31625649985'}, {'name': 'DJ A de Groot, MD PhD', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'M W Nijkamp, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Groningen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Maarten Nijkamp', 'investigatorAffiliation': 'University Medical Center Groningen'}}}}