Nctid:
NCT06233994
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000002277", "term"=>"Carcinoma"}, {"id"=>"D000006528", "term"=>"Carcinoma, Hepatocellular"}], "ancestors"=>[{"id"=>"D000009375", "term"=>"Neoplasms, Glandular and Epithelial"}, {"id"=>"D000009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000000230", "term"=>"Adenocarcinoma"}, {"id"=>"D000008113", "term"=>"Liver Neoplasms"}, {"id"=>"D000004067", "term"=>"Digestive System Neoplasms"}, {"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000004066", "term"=>"Digestive System Diseases"}, {"id"=>"D000008107", "term"=>"Liver Diseases"}], "browseLeaves"=>[{"id"=>"M5534", "name"=>"Carcinoma", "asFound"=>"Carcinoma", "relevance"=>"HIGH"}, {"id"=>"M9613", "name"=>"Carcinoma, Hepatocellular", "asFound"=>"Hepatocellular Carcinoma", "relevance"=>"HIGH"}, {"id"=>"M12320", "name"=>"Neoplasms, Glandular and Epithelial", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M3585", "name"=>"Adenocarcinoma", "relevance"=>"LOW"}, {"id"=>"M11113", "name"=>"Liver Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8886", "name"=>"Gastrointestinal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M7256", "name"=>"Digestive System Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"M11107", "name"=>"Liver Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000068258", "term"=>"Bevacizumab"}], "ancestors"=>[{"id"=>"D000074322", "term"=>"Antineoplastic Agents, Immunological"}, {"id"=>"D000000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D000020533", "term"=>"Angiogenesis Inhibitors"}, {"id"=>"D000043924", "term"=>"Angiogenesis Modulating Agents"}, {"id"=>"D000006133", "term"=>"Growth Substances"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000006131", "term"=>"Growth Inhibitors"}], "browseLeaves"=>[{"id"=>"M246", "name"=>"Bevacizumab", "asFound"=>"Non-", "relevance"=>"HIGH"}, {"id"=>"M1346", "name"=>"Antineoplastic Agents, Immunological", "relevance"=>"LOW"}, {"id"=>"M22318", "name"=>"Angiogenesis Inhibitors", "relevance"=>"LOW"}, {"id"=>"M9231", "name"=>"Growth Inhibitors", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "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"}}}}
