Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-01-05 @ 5:45 PM
Study NCT ID:
NCT04996459
Status:
UNKNOWN
Last Update Posted:
2021-08-09
First Post:
2021-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tislelizumab in the Systematic Treatment of 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': 'C000707970', 'term': 'tislelizumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-05', 'studyFirstSubmitDate': '2021-08-04', 'studyFirstSubmitQcDate': '2021-08-05', 'lastUpdatePostDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall response rate', 'timeFrame': '6 weeks', 'description': 'overall response rate'}], 'secondaryOutcomes': [{'measure': 'disease control rate', 'timeFrame': '6 weeks', 'description': 'disease control rate'}, {'measure': 'progress free survival', 'timeFrame': '6 weeks', 'description': 'progress free survival'}, {'measure': 'overall survival', 'timeFrame': '6 weeks', 'description': 'overall survival'}, {'measure': 'Safety (the incidence of adverse events and serious adverse events)', 'timeFrame': '3 weeks', 'description': 'the incidence of adverse events and serious adverse events'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'Study purpose: To evaluate the efficacy and safety of Tislelizumab in combination with advanced hepatocellular carcinoma in the real world; Study design: Non-intervention, single center, case registration, real-world study; Number of registrations: 40;\n\nSource of data: This project is a non-interventionary real world case follow-up registration. All registration data are from real clinical practice cases. The collected data include the following requirements:\n\n1. Age ≥18 years old;\n2. Unresectable hepatocellular carcinoma confirmed by histological examination or clinical diagnosis;\n3. Plan or have received systemic therapy combined with Tiralizumab;\n4. No participation in other clinical studies;\n5. Access to Tislelizumab treatment and other clinical records; Primary endpoint: Overall response rate; Secondary endpoint: Disease control rate, progress free survival, overall survival, safety; Exploratory endpoint: To explore the predictive value of multiple Biomarker combinations, such as PD-L1, TMB, MSI, DDR, POLE/POLD, in HCC immunotherapy response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients registrated and treated with Tislelizumab at least once were included in the efficacy analysis population as well as the safety analysis population.', 'healthyVolunteers': False, 'eligibilityCriteria': 'This project is a non-interventionary real world case follow-up registration. All registration data are from real clinical practice cases. The collected data include the following requirements:\n\n1. Age ≥18 years old;\n2. Unresectable hepatocellular carcinoma confirmed by histological examination or clinical diagnosis;\n3. Plan or have received systemic therapy combined with Tislelizumab;\n4. No participation in other clinical studies;\n5. Access to Tislelizumab treatment and other clinical records.'}, 'identificationModule': {'nctId': 'NCT04996459', 'briefTitle': 'Tislelizumab in the Systematic Treatment of Advanced Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Real-world Study of Tislelizumab in the Systematic Treatment of Advanced Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'GWK-2020-06'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tislelizumab group', 'interventionNames': ['Drug: Tislelizumab']}], 'interventions': [{'name': 'Tislelizumab', 'type': 'DRUG', 'description': 'Tislelizumab 200mg iv q3w', 'armGroupLabels': ['Tislelizumab group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'country': 'China', 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Lu Wang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'FUSCC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of liver surgery department', 'investigatorFullName': 'Lu Wang, MD, PhD', 'investigatorAffiliation': 'Fudan University'}}}}