Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-30 @ 12:08 PM
Study NCT ID:
NCT06379256
Status:
RECRUITING
Last Update Posted:
2025-05-14
First Post:
2024-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Immune Responses and Outcomes in Patients With Hepatocellular Carcinoma Undergoing Radiotherapy
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': 'D017785', 'term': 'Photons'}], 'ancestors': [{'id': 'D004601', 'term': 'Elementary Particles'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D008027', 'term': 'Light'}, {'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055620', 'term': 'Optical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2032-03-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-11', 'studyFirstSubmitDate': '2024-04-18', 'studyFirstSubmitQcDate': '2024-04-18', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-03-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival (PFS)', 'timeFrame': '12 months', 'description': 'PFS is defined as the time from signing the informed consent to the first occurrence of disease progression or death from any cause (whichever occurs first) according to RECIST1.1.'}], 'secondaryOutcomes': [{'measure': 'Local control (LC)', 'timeFrame': '12 months', 'description': 'LC is defined as the time from signing the informed consent to the first occurrence of disease progression in the irradiated field according to RECIST1.1.'}, {'measure': 'Time to progression (TTP)', 'timeFrame': '12 months', 'description': 'TTP is defined as the time from signing the informed consent to the first occurrence of disease progression according to RECIST1.1.'}, {'measure': 'Overall Response Rate (ORR)', 'timeFrame': '12 months', 'description': 'ORR is defined as a complete or partial response according to RECIST1.1.'}, {'measure': 'Overall survival (OS)', 'timeFrame': '12 months', 'description': 'OS is defined as the time from signing the informed consent to death from any cause.'}, {'measure': 'Incidence and severity of adverse events', 'timeFrame': '12 months', 'description': 'Adverse events will be graded using CTCAE v5'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Photon Radiotherapy', 'Proton Radiotherapy', 'HCC'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'Radiation therapy is a highly effective modality for managing localized solid tumors and has become a fundamental component of treating unresectable hepatocellular carcinoma. Our previous preclinical investigation revealed that radiotherapy can initiate immunogenic cell death and facilitate the cross-presentation of tumor antigens by antigen-presenting cells, thereby augmenting systemic anti-tumor T cell responses in murine tumor models. However, this immune response subsequent to irradiation has not been comprehensively evaluated in clinical trials involving hepatocellular carcinoma patients. Given that radiotherapy represents a standard therapeutic approach for unresectable hepatocellular carcinoma, our ongoing phase II non-randomized trial aims to prospectively assess immunological responses and dose-volumetric parameters, while identifying predictors of clinical outcomes in patients undergoing definitive radiotherapy for hepatocellular carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing routine radiotherapy using photons or protons for HCC', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participants must have diagnosis of HCC. Participants may have multiple lesions. Diagnosis should be confirmed by at least 1 criteria listed below:\n\n * Histologically or cytologically proven diagnosis of HCC.\n * Typical arterial enhancement and delayed washout on multiphasic CT or MRI.\n2. Age ≥18 years at the time of signing informed consent document.\n3. ECOG performance status 0-2.\n4. Child-Pugh score 5-9 liver function within 28 days of study registration.\n5. Documented virology status of hepatitis B virus (HBV), as confirmed by screening HBV serology test.\n6. Documented virology status of hepatitis C virus (HCV), as confirmed by screening HCV serology test.\n7. Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n1. Presence of distant metastases that cannot be encompassed by radiotherapy\n2. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception\n3. Inability to treat all sites of disease by radiotherapy\n4. Known HIV infection.'}, 'identificationModule': {'nctId': 'NCT06379256', 'briefTitle': 'Evaluation of Immune Responses and Outcomes in Patients With Hepatocellular Carcinoma Undergoing Radiotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Prospective Evaluation of Immune Responses and Outcomes in Patients With Hepatocellular Carcinoma Undergoing Radiotherapy', 'orgStudyIdInfo': {'id': '202400364B0'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Radiotherapy', 'description': 'Definitive photon or proton radiotherapy', 'interventionNames': ['Radiation: Photon or proton radiotherapy']}], 'interventions': [{'name': 'Photon or proton radiotherapy', 'type': 'RADIATION', 'description': '* 39.6-72.6 Gy (or Cobalt Gray Equivalent, CGE) in 22 fractions for tumors ≤1 cm from hepatic hilum, bowel, and heart.\n* 30-66 Gy (or CGE) in 10 fractions for tumors \\>1 cm from hepatic hilum, bowel, and heart.\n* 27.5-60 Gy (or CGE) in 5 fractions using stereotactic body radiation therapy (SBRT) techniques', 'armGroupLabels': ['Radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '333', 'city': 'Taoyuan', 'state': 'Taiwan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Rodney Cheng-En Hsieh, MD, PhD', 'role': 'CONTACT', 'email': 'rodney445@gmail.com', 'phone': '+88633281200', 'phoneExt': '7000'}], 'facility': 'Chang Gung Memorial Hospital at Linkou', 'geoPoint': {'lat': 24.99368, 'lon': 121.29696}}], 'centralContacts': [{'name': 'Rodney Cheng-En Hsieh, MD, PhD', 'role': 'CONTACT', 'email': 'chsieh@cgmh.org.tw', 'phone': '+886-3-3281200', 'phoneExt': '7000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Sharing individual participant data (IPD) with other researchers requires IRB review and approval. Presently, we do not have a plan to provide IPD to other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}