Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 3:09 AM
Study NCT ID:
NCT07321067
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-06
First Post:
2025-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Immune Checkpoint Inhibitors in Patients With Advanced Hepatocellular Carcinoma : Efficacy and Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-21', 'studyFirstSubmitDate': '2025-12-21', 'studyFirstSubmitQcDate': '2025-12-21', 'lastUpdatePostDateStruct': {'date': '2026-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ICI-Specific Survival (OS-ICI).', 'timeFrame': '12 months', 'description': 'Time from ICI initiation to death or last follow-up.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['advanced hepatocellular carcinoma', 'immune checkpoint inhibitors'], 'conditions': ['Advanced Hepatocellular Carcinoma (HCC)']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '10. Cheng, A. L., Rimassa, L., Ducreux, M., et al. (2022). J Hepatol, 76, 862-873.'}, {'type': 'BACKGROUND', 'citation': '9. Yau, T., Cheng, A. L., Rimassa, L., et al. (2025). Lancet, 405, 1851-1864.'}, {'type': 'BACKGROUND', 'citation': '8. Llovet, J. M., Yau, T., Cheng, A. L., et al. (2008). N Engl J Med, 359, 378-390.'}, {'type': 'BACKGROUND', 'citation': '7. Reig, M., Llovet, J. M., Yau, T., et al. (2021). J Hepatol, 76, 681-693.'}, {'type': 'BACKGROUND', 'citation': '6. Singal, A. G., Reig, M., Llovet, J. M., et al. (2023). Hepatology, 78, 1922-1965.'}, {'pmid': '15508094', 'type': 'BACKGROUND', 'citation': 'El-Serag HB. Hepatocellular carcinoma: recent trends in the United States. Gastroenterology. 2004 Nov;127(5 Suppl 1):S27-34. doi: 10.1053/j.gastro.2004.09.013.'}, {'pmid': '39182603', 'type': 'BACKGROUND', 'citation': 'Kalligeros M, Henry L, Younossi ZM. Metabolic dysfunction-associated steatotic liver disease and its link to cancer. Metabolism. 2024 Nov;160:156004. doi: 10.1016/j.metabol.2024.156004. Epub 2024 Aug 23.'}, {'type': 'BACKGROUND', 'citation': '3. Liu, Y., Kalligeros, M., El-Serag, H. B., et al. (2022). Cancer Med, 11, 1310-1323.'}, {'type': 'BACKGROUND', 'citation': '2. McGlynn, K. A., Liu, Y., Kalligeros, M., et al. (2021). Hepatology, 73, 4-13.'}, {'type': 'BACKGROUND', 'citation': '1. Siegel, R. L., McGlynn, K. A., Liu, Y., et al. (2024). CA Cancer J Clin, 74, 12-49.'}]}, 'descriptionModule': {'briefSummary': 'the Objectives of this study are:\n\n• Primary Objective: To prospectively evaluate overall survival (OS), ICI-specific survival (OS-ICI), and progression-free survival (PFS) in patients with advanced HCC treated with immune checkpoint inhibitors.\n\nthe main question it aims to answer is: What are the clinical outcomes (overall survival, progression-free survival, and OS-ICIs) of immune checkpoint inhibitor therapy in patients with advanced hepatocellular carcinoma? Participants already taking immune checkpoint inhibitors as part of their regular medical care.', 'detailedDescription': 'Objectives • Primary Objective: To prospectively evaluate overall survival (OS), ICI-specific survival (OS-ICI), and progression-free survival (PFS) in patients with advanced HCC treated with immune checkpoint inhibitors.\n\n• Secondary Objectives: To assess the incidence, type, and severity of irAEs. To identify clinical predictors of survival outcomes, including ALBI grade, prior LRT, SBRT or resection.\n\nTo guide personalized therapy for Tailoring immunotherapy to individual patients, reducing unnecessary toxicity and cost.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients diagnosed with advanced hepatocellular carcinoma either denovoor after prior line of treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (≥18 years) with radiologically or histologically confirmed advanced HCC\n* Candidates for systemic immune checkpoint inhibitors (e.g., atezolizumab-bevacizumab, durvalumab-tremelimumab).\n* Patients with preserved liver function. ( up to G2 using ALBI score or up to B (7 ) using Child-Pugh socring system) .\n\nExclusion Criteria:\n\n* Child-Pugh C liver function.\n* Prior liver transplantation.\n* patients with concurrent malignancies other than HCC.\n* Active autoimmune disease requiring systemic immunosuppression.'}, 'identificationModule': {'nctId': 'NCT07321067', 'acronym': 'ICIs', 'briefTitle': 'Use of Immune Checkpoint Inhibitors in Patients With Advanced Hepatocellular Carcinoma : Efficacy and Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Use of Immune Checkpoint Inhibitors in Patients With Advanced Hepatocellular Carcinoma : Efficacy and Outcomes', 'orgStudyIdInfo': {'id': 'Soh-Med--25-12-8MD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'all patients diagnosed with advanced hepatocellular carcinoma eligible for ICIs'}]}, 'contactsLocationsModule': {'locations': [{'zip': '82511', 'city': 'Sohag', 'state': 'Sohag Governorate', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed Karam, MSc', 'role': 'CONTACT', 'email': 'ahmed011028@med.sohag.edu.eg', 'phone': '2+01090784895'}], 'facility': 'Sohag university hospitals', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}, {'zip': '82511', 'city': 'Sohag', 'state': 'Sohag Governorate', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed Karam Helmy, MSc', 'role': 'CONTACT', 'email': 'ahmed011028@med.sohag.edu.eg', 'phone': '2+01090784895'}, {'name': 'Ahmed Karam Helmy, MSc', 'role': 'CONTACT', 'email': 'ahmed011028@med.sohag.edu.eg'}], 'facility': 'sSohag oncology centre', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Ahmed Karam Helmy, MSc', 'role': 'CONTACT', 'email': 'ahmed011028@med.sohag.edu.eg', 'phone': '2+01090784895'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ahmed Karam Helmy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Use of immune checkpoint inhibitors in patients with advanced hepatocellular carcinoma : efficacy and outcomes', 'investigatorFullName': 'Ahmed Karam Helmy', 'investigatorAffiliation': 'Sohag University'}}}}