Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2026-02-28 @ 5:31 AM
Study NCT ID:
NCT06707233
Status:
RECRUITING
Last Update Posted:
2025-01-28
First Post:
2024-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Y-90 SIRT for Unresectable HCC Larger Than 7cm
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': 'D037761', 'term': 'Sirtuins'}], 'ancestors': [{'id': 'D056545', 'term': 'Group III Histone Deacetylases'}, {'id': 'D006655', 'term': 'Histone Deacetylases'}, {'id': 'D000581', 'term': 'Amidohydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D036002', 'term': 'ADP Ribose Transferases'}, {'id': 'D010430', 'term': 'Pentosyltransferases'}, {'id': 'D016695', 'term': 'Glycosyltransferases'}, {'id': 'D014166', 'term': 'Transferases'}, {'id': 'D047908', 'term': 'Intracellular Signaling Peptides and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 33}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-26', 'studyFirstSubmitDate': '2024-11-24', 'studyFirstSubmitQcDate': '2024-11-24', 'lastUpdatePostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate (ORR) per mRECIST', 'timeFrame': '3 years', 'description': 'The proportion of patients with the best response of complete response (CR) or partial response (PR) according to mRECIST'}], 'secondaryOutcomes': [{'measure': 'Objective response rate (ORR) per RECIST 1.1', 'timeFrame': '3 years', 'description': 'The proportion of patients with the best response of complete response (CR) or partial response (PR) according to RECIST 1.1'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': '3 years', 'description': 'The proportion of patients with the best response of CR, PR, or stable disease (SD) according to mRECIST and RECIST 1.1'}, {'measure': 'Progression free survival (PFS)', 'timeFrame': '3 years', 'description': 'The time from date of treatment initiation until the first occurrence of disease progression (according to mRECIST and RECIST 1.1) or death due to any cause, whichever occurs first.'}, {'measure': 'time to response (TTR)', 'timeFrame': '3 years', 'description': 'The time from treatment initiation to first tumour remission (mRECIST and RECIST 1.1)'}, {'measure': 'Duration of response (DOR)', 'timeFrame': '3 years', 'description': 'Time from first tumor response to first disease progression (mRECIST and RECIST 1.1 assessment) or death from any cause (whichever occurs first)'}, {'measure': 'Overall survival (OS)', 'timeFrame': '4 years', 'description': 'The time from date of treatment initiation to death due to any cause'}, {'measure': 'Adverse Events (AEs)', 'timeFrame': '3 years', 'description': 'Number of patients with AEs assessed by Common Terminology Criteria for Adverse Events v5.0'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatocellular Carcinoma', 'yttrium-90', 'selective internal radiation therapy'], 'conditions': ['Hepatocellular Carcinoma Non-Resectable']}, 'descriptionModule': {'briefSummary': 'This is a phase II clinical study to evaluate the efficacy and safety of SIRT in patients with HCC greater than 7 cm. After enrollment, patients received yttrium-90 selective internal radiation therapy. The primary endpoint of the study is objective reponse rate (ORR) as assessed by mRECIST. Secondary endpoints were: objective response rate (ORR) as assessed by RECIST 1.1, disease control rate (DCR), progression-free survival (PFS), time to response (TTR), duration of response (DOR), overall survival (OS), and safety (incidence and severity of adverse events).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically confirmed or clinically diagnosed HCC\n* Unresectable HCC as assessed by a team of surgeons\n* The largest tumor size \\> 7 cm\n* Tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment\n* At least one measurable intrahepatic target lesion\n* Appropriate for SIRT treatment after evaluation (including SPECT/CT evaluation after arterial perfusion with 99Tc-MAA)\n* Child-Pugh score ≤ 7\n* ECOG PS ≤ 1\n* Adequate organ and hematologic function with platelet count ≥75×10\\^9/L, leukocyte \\>3.0×10\\^9/L, Neutrophil count ≥1.5×10\\^9/L, haemoglobin ≥85 g/L, ALT and AST≤5×ULN, creatinine≤1.5×ULN, and prolongation of prothrombin time ≤4 seconds\n* life expectancy of at least 6 months\n\nExclusion Criteria:\n\n* Macrovascular invasion or extrahepatic metastasis\n* Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy\n* Organ (heart and kidneys) dysfunction\n* History of other malignancies\n* Uncontrollable infection\n* History of organ or cells transplantation\n* History of HIV\n* Pregnant or lactating patients'}, 'identificationModule': {'nctId': 'NCT06707233', 'briefTitle': 'Y-90 SIRT for Unresectable HCC Larger Than 7cm', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital of Guangzhou Medical University'}, 'officialTitle': 'Y-90 Selective Internal Radiation Therapy for Unresectable Hepatocellular Carcinoma Larger Than 7cm: a Prospective, Single Arm Trial', 'orgStudyIdInfo': {'id': 'MIIR-17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SIRT', 'description': 'Patients will receive SIRT treatment', 'interventionNames': ['Procedure: SIRT']}], 'interventions': [{'name': 'SIRT', 'type': 'PROCEDURE', 'description': 'The patients will receive 1-2 sessions of SIRT.', 'armGroupLabels': ['SIRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510260', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Kangshun Zhu, Dr.', 'role': 'CONTACT', 'email': 'zhksh010@126.com', 'phone': '+86-20-34156205'}, {'name': 'Kangshun Zhu, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Second Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510260', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Mingyue Cai, Dr.', 'role': 'CONTACT', 'email': 'cai020@yeah.net', 'phone': '+86-20-34156205'}, {'name': 'Kangshun Zhu, Dr.', 'role': 'CONTACT', 'email': 'zhksh010@163.com', 'phone': '+86-20-34156205'}, {'name': 'Kangshun Zhu, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Second Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Mingyue Cai, Dr.', 'role': 'CONTACT', 'email': 'cai020@yeah.net', 'phone': '+86-20-34156205'}, {'name': 'Kangshun Zhu, Dr.', 'role': 'CONTACT', 'email': 'zhksh010@163.com', 'phone': '+86-20-34156205'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital of Guangzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}