Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-02-19 @ 10:55 PM
Study NCT ID:
NCT06844357
Status:
RECRUITING
Last Update Posted:
2025-04-06
First Post:
2025-02-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II/III Trial Comparing Transarterial Tirapazamine Embolization (TATE) With cTACE for Intermediate-stage Liver Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077704', 'term': 'Tirapazamine'}], 'ancestors': [{'id': 'D014227', 'term': 'Triazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2029-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2025-02-19', 'studyFirstSubmitQcDate': '2025-02-19', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival (PFS)', 'timeFrame': '36 months', 'description': 'Progression-free survival (PFS) assessed by the Independent Radiology Committee (IRC) using mRECIST criteria.'}], 'secondaryOutcomes': [{'measure': 'Complete Response (CR) rate', 'timeFrame': '36 months', 'description': 'Complete response rate (CR) assessed by IRC using mRECIST criteria'}, {'measure': 'objective response rate (ORR)', 'timeFrame': '36 months'}, {'measure': 'duration of complete response (DOCR)', 'timeFrame': '36 months'}, {'measure': 'overall survival (OS)', 'timeFrame': '36 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HCC']}, 'descriptionModule': {'briefSummary': 'This phase I/II clinical trial aims to determine the efficacy and safety of TATE compared to TACE in patients with intermediate-stage HCC. The results will provide valuable insights into the potential benefits of TATE as a novel treatment option for HCC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with primary hepatocellular carcinoma according to AASLD criteria.\n* No evidence of extrahepatic metastasis, regional lymph node involvement, or vascular tumor thrombus.\n* Patients must be eligible for TAE or TACE treatment.\n* ECOG ≤ 1.\n* Child-Pugh score ≤ 7.\n* Adequate bone marrow, liver, and kidney function is required.\n\nExclusion Criteria:\n\n* History of liver transplantation.\n* Previous radioemblization or radiotherapy for liver tumors.\n* severe cardiovascular or renal diseases, active systemic infections.\n* Clinically significant hypoxia (oxygen saturation \\< 92% without oxygen supplementation)'}, 'identificationModule': {'nctId': 'NCT06844357', 'briefTitle': 'A Phase II/III Trial Comparing Transarterial Tirapazamine Embolization (TATE) With cTACE for Intermediate-stage Liver Cancer.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zhejiang Raygene Pharmaceuticals Co., Ltd'}, 'officialTitle': 'A Multi-center, Randomized, Controlled, Open-label Phase II/III Clinical Trial to Investigate Whether Transarterial Tirapazamine Injection Followed by Transarterial Embolization (TATE) is Superior to Traditional Transarterial Chemoembolization (TACE) in Patients With Intermediate-Stage Hepatocellular Carcinoma (HCC)', 'orgStudyIdInfo': {'id': 'RG001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TATE', 'description': 'Patients will receive a fixed dose of 35 mg tirapazamine via hepatic arterial injection, followed by embolization with iodized oil, gelatin sponge and contrast agent suspension.', 'interventionNames': ['Drug: tirapazamine', 'Procedure: Transarterial Embolization (TAE)']}, {'type': 'EXPERIMENTAL', 'label': 'TACE', 'description': 'Patients will receive cTACE with a mixture of iodized oil （10mL）and epirubicin (50 mg ), followed by embolization with gelatin sponge and contrast agent suspension.', 'interventionNames': ['Procedure: TACE']}], 'interventions': [{'name': 'tirapazamine', 'type': 'DRUG', 'description': 'Intra-arterial injection into the tumor feeding artery', 'armGroupLabels': ['TATE']}, {'name': 'Transarterial Embolization (TAE)', 'type': 'PROCEDURE', 'description': 'Lipiodol and Gelfoam used to embolize tumor vessels and induce tumor hypoxia', 'armGroupLabels': ['TATE']}, {'name': 'TACE', 'type': 'PROCEDURE', 'description': 'TACE with epirubicin', 'armGroupLabels': ['TACE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Gaojun Teng, M.D.', 'role': 'CONTACT', 'email': 'gjteng@vip.sina.com', 'phone': '13805171500'}], 'facility': 'Zhongda Hospital, Affiliated to Southeast University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '323000', 'city': 'Lishui', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiansong Ji, M.D.', 'role': 'CONTACT', 'email': 'jjstcty@sina.com', 'phone': '13857088508'}], 'facility': 'Lishui Central Hospital', 'geoPoint': {'lat': 28.46042, 'lon': 119.91029}}], 'centralContacts': [{'name': 'Bill Shen, Ph.D.', 'role': 'CONTACT', 'email': 'bill.shen@raygene.cn', 'phone': '057185131875'}], 'overallOfficials': [{'name': 'Gaojun Teng, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhongda Hospital'}, {'name': 'Jiansong Ji, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Central Hospital of Lishui City'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Privacy Protection for Participants'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang Raygene Pharmaceuticals Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}