Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2025-12-27 @ 9:43 PM
Study NCT ID:
NCT06779461
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-16
First Post:
2024-12-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial Assessing the Safety and Efficacy of Biodegradable Magnesium Embolic Microspheres for Primary Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 228}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-10', 'studyFirstSubmitDate': '2024-12-25', 'studyFirstSubmitQcDate': '2025-01-10', 'lastUpdatePostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ORR', 'timeFrame': '30 days after the last TACE treatment.', 'description': 'The objective response rate of the target lesion'}], 'secondaryOutcomes': [{'measure': 'Success rate of embolization technique for the target lesion', 'timeFrame': 'on the day of the surgery', 'description': 'Success rate of embolization technique for the target lesion'}, {'measure': 'DCR', 'timeFrame': '30 days after the first TACE treatment', 'description': 'Disease control rate of the target lesion'}, {'measure': 'CR', 'timeFrame': '30 days after the first TACE treatment', 'description': 'Complete Response of the target lesion'}, {'measure': 'ORR', 'timeFrame': '90 days after the last TACE treatment', 'description': 'Objective Response Rate of the target lesion'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma Non-Resectable']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to determine if the addition of biodegradable magnesium metal microspheres to traditional TACE (Transarterial Chemoembolization) is effective in treating hepatocellular carcinoma, and to assess the safety of these microspheres.\n\nThe main questions it aims to answer are:\n\n* Is the treatment more effective than traditional TACE alone?\n* What additional medical issues arise when using the microspheres?\n\nResearchers will compare TACE with magnesium microspheres to traditional TACE without microspheres to see if the addition of the microspheres improves treatment outcomes.\n\nParticipants will:\n\n* Receive up to 3 treatments of TACE with or without microspheres\n* Undergo checkups and tests every 30 days\n* Keep records of tumor size and other safety issues'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age range: 18 to 80 years inclusive, regardless of gender;\n2. Patients with primary hepatocellular carcinoma (HCC) at CNLC stage Ib to IIIa who require transarterial chemoembolization (TACE) treatment and are unsuitable for or refuse surgical resection, liver transplantation, and ablation therapy;\n3. ECOG score ≤ 2, and Child-Pugh classification of A or B;\n4. Presence of at least one untreated, measurable tumor lesion with a diameter ≥ 3.0 cm according to mRECIST criteria (the maximum diameter of the target lesion ≤ 10.0 cm);\n5. Patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) infection who are willing to receive antiviral treatment throughout the study period;\n6. Voluntary participation in this clinical trial and signing of the informed consent form by the subject.\n\nExclusion Criteria:\n\n1. Patients with prior embolization or other local treatments within 28 days before enrollment, or needing combined local treatment with TACE;\n2. Received other antitumor systemic treatment within 28 days before enrollment;\n3. Unsuitable for TACE due to lesion characteristics or vascular issues;\n4. Vp3/Vp4 portal vein tumor thrombus;\n5. Tumor occupying ≥70% of liver volume;\n6. Decompensated cirrhosis or recent ascites drainage/TIPS;\n7. Severe allergies to contrast agents or embolization materials;\n8. Received blood products or certain corrective treatments within 7 days before enrollment;\n9. Abnormal blood counts (WBC, platelets, neutrophils, hemoglobin);\n10. Abnormal liver function tests (bilirubin, enzymes, albumin);\n11. Renal impairment (creatinine, creatinine clearance);\n12. Prolonged PT;\n13. Unsuitable feeding artery for TACE or embolization risks;\n14. Expected survival \\<6 months;\n15. Pregnant, lactating, or planning pregnancy;\n16. Factors affecting study results or necessitating study termination (alcoholism, drug abuse, severe diseases);\n17. Severe infections unsuitable for TACE;\n18. Participation in other clinical trials within 28 days before enrollment;\n19. Other reasons deemed unsuitable by the investigator.'}, 'identificationModule': {'nctId': 'NCT06779461', 'briefTitle': 'A Clinical Trial Assessing the Safety and Efficacy of Biodegradable Magnesium Embolic Microspheres for Primary Hepatocellular Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'InnoBM Pharmaceuticals Co., Ltd.'}, 'officialTitle': 'A Prospective, Multicenter, Randomized, Open-Label, Parallel-Controlled Clinical Trial Assessing the Safety and Efficacy of Biodegradable Magnesium Embolic Microspheres for Primary Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'BM601-Q001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'cTACE', 'interventionNames': ['Procedure: cTACE']}, {'type': 'EXPERIMENTAL', 'label': 'cTACE with magnesium microspheres', 'interventionNames': ['Device: Magnesium Microspheres', 'Procedure: cTACE']}], 'interventions': [{'name': 'Magnesium Microspheres', 'type': 'DEVICE', 'description': 'Biodegradable Magnesium Embolic Microspheres', 'armGroupLabels': ['cTACE with magnesium microspheres']}, {'name': 'cTACE', 'type': 'PROCEDURE', 'description': 'cTACE', 'armGroupLabels': ['cTACE', 'cTACE with magnesium microspheres']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bengbu', 'state': 'Anhui', 'country': 'China', 'facility': 'The First Affiliated Hospital of Bengbu Medical University', 'geoPoint': {'lat': 32.94083, 'lon': 117.36083}}, {'city': 'Anyang', 'state': 'Henan', 'country': 'China', 'facility': 'Anyang Tumor Hospital', 'geoPoint': {'lat': 36.096, 'lon': 114.38278}}, {'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Zhongda Hospital Southeast University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Lishui', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Lishui Central Hospital', 'geoPoint': {'lat': 28.46042, 'lon': 119.91029}}, {'city': 'Guangzhou', 'country': 'China', 'facility': 'The Third Affiliated Hospital,Sun Yat-Sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Lanzhou', 'country': 'China', 'facility': 'The First Hospital of Lanzhou University', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'city': 'Luoyang', 'country': 'China', 'facility': 'The First Affiliated Hospital of Henan University of Science & Technology', 'geoPoint': {'lat': 34.67345, 'lon': 112.43684}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Tianjin', 'country': 'China', 'facility': 'Tianjin Medical University Cancer Institute & Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Chuntao G PM', 'role': 'CONTACT', 'email': 'ctgong@innobm.cn', 'phone': '86+0512 6938 6599'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InnoBM Pharmaceuticals Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'CHONGQING BAIMAITENGSHI PHARMACEUTICAL TECHNOLOGY CO., LTD', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}