Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-28 @ 10:48 PM
Study NCT ID:
NCT06233994
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-31
First Post:
2024-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Evaluating the Efficacy and Safety of ZG005 in Combination With Donafenib or Bevacizumab in Patients With Advanced Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007267', 'term': 'Injections'}, {'id': 'C000710249', 'term': 'donafenib'}, {'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-23', 'studyFirstSubmitDate': '2024-01-23', 'studyFirstSubmitQcDate': '2024-01-23', 'lastUpdatePostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'up to approximately 2 years', 'description': 'The sum of the proportions of subjects who achieved CR or PR in imaging evaluation as assessed by the investigator based on RECIST1.1 criteria.'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'up to approximately 2 years', 'description': 'Time from first dose of the investigational drug to PD or death from any cause.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'This is a randomized, open-label study to evaluate the safety and efficacy of ZG005 in combination with Donafenib or Bevacizumab in patients with advanced hepatocellular carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female ≥18 years of age.\n* Fully understand the study and voluntarily sign the informed consent form.\n* Histologically or cytologically confirmed diagnosis of metastatic or unresectable hepatocellular carcinoma (HCC).\n* Life expectancy \\>= 3 months.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n\nExclusion Criteria:\n\n* Fibrolamellar or sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.\n* Patients were deemed unsuitable for participating in the studyl by the investigator for any reasons.'}, 'identificationModule': {'nctId': 'NCT06233994', 'briefTitle': 'A Study Evaluating the Efficacy and Safety of ZG005 in Combination With Donafenib or Bevacizumab in Patients With Advanced Hepatocellular Carcinoma', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Changsha Taihe Hospital'}, 'officialTitle': 'A Study Evaluating the Efficacy and Safety of ZG005 in Combination With Donafenib Tosilate Tablets or Bevacizumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'ZG005-IIT-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ZG005+Donafenib', 'description': 'Participants will receive ZG005 plus Donafenib until unacceptable toxicity or loss of clinical benefit.', 'interventionNames': ['Biological: ZG005 Powder for Injection', 'Drug: Donafenib Tosilate Tablets']}, {'type': 'EXPERIMENTAL', 'label': 'ZG005+Bevacizumab', 'description': 'Participants will receive ZG005 plus bevacizumab until unacceptable toxicity or loss of clinical benefit.', 'interventionNames': ['Biological: ZG005 Powder for Injection', 'Biological: Bevacizumab']}], 'interventions': [{'name': 'ZG005 Powder for Injection', 'type': 'BIOLOGICAL', 'otherNames': ['ZG005'], 'description': 'ZG005 will be administered at a dose of 10 mg/kg by intravenous (IV) infusion, once every 3 weeks (Q3W).', 'armGroupLabels': ['ZG005+Bevacizumab', 'ZG005+Donafenib']}, {'name': 'Donafenib Tosilate Tablets', 'type': 'DRUG', 'otherNames': ['Donafenib'], 'description': 'Donafenib will be administered at a dose of 0.2 g by orally, Bis in die(Bid).', 'armGroupLabels': ['ZG005+Donafenib']}, {'name': 'Bevacizumab', 'type': 'BIOLOGICAL', 'description': 'Bevacizumab will be administered at a dose of 15 mg/kg by IV infusion, once every 3 weeks (Q3W).', 'armGroupLabels': ['ZG005+Bevacizumab']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'contacts': [{'name': 'Xiaoli Chai', 'role': 'CONTACT'}], 'facility': 'Changsha Taihe Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Yongsheng Chu', 'role': 'CONTACT', 'email': 'chuys@zelgen.com', 'phone': '+8651257309965'}], 'overallOfficials': [{'name': 'Xiaoli Chai', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changsha Taihe Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changsha Taihe Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}