Nctid:
NCT06221423
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D015179", "term"=>"Colorectal Neoplasms"}], "ancestors"=>[{"id"=>"D007414", "term"=>"Intestinal Neoplasms"}, {"id"=>"D005770", "term"=>"Gastrointestinal Neoplasms"}, {"id"=>"D004067", "term"=>"Digestive System Neoplasms"}, {"id"=>"D009371", "term"=>"Neoplasms by Site"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D004066", "term"=>"Digestive System Diseases"}, {"id"=>"D005767", "term"=>"Gastrointestinal Diseases"}, {"id"=>"D003108", "term"=>"Colonic Diseases"}, {"id"=>"D007410", "term"=>"Intestinal Diseases"}, {"id"=>"D012002", "term"=>"Rectal Diseases"}], "browseLeaves"=>[{"id"=>"M5534", "name"=>"Carcinoma", "relevance"=>"LOW"}, {"id"=>"M17890", "name"=>"Colorectal Neoplasms", "asFound"=>"Colorectal Cancer", "relevance"=>"HIGH"}, {"id"=>"M10448", "name"=>"Intestinal 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"=>"M6336", "name"=>"Colonic Diseases", "relevance"=>"LOW"}, {"id"=>"M10444", "name"=>"Intestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M14844", "name"=>"Rectal Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>20}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2020-01-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-05-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-13", "studyFirstSubmitDate"=>"2023-12-27", "studyFirstSubmitQcDate"=>"2024-01-13", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-05-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Progression-free Survival (PFS)", "timeFrame"=>"3 years", "description"=>"PFS was calculated from the date of fruquintinib administration to the first observation of disease progression or death."}, {"measure"=>"Overall Survival (OS)", "timeFrame"=>"3 years", "description"=>"OS was defined as the time from fruquintinib administration to death."}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Colorectal Cancer", "Metastatic Colorectal Cancer", "Refractory Colorectal Carcinoma"]}, "descriptionModule"=>{"briefSummary"=>"Fruquintinib, as a standard treatment for refractory metastatic colorectal cancer (mCRC), has attracted increasing research efforts to explore its innovative strategies in combination with immunotherapy and chemotherapy because of its multi-target mechanism which enhances the sensitivity of the immune system and chemotherapy, aiming to further improve the survival benefits for mCRC patients. Trifluridine/tipiracil (TAS-102) is also a standard treatment for mCRC. This study aims to investigate the safety and effectiveness of the combined use of these two drugs in mCRC."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"75 years", "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patients with refractory metastatic colorectal cancer who have undergone third-line or later treatment with a combination of fruquintinib and TAS-102.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Histology-confirmed metastatic CRC (mCRC)\n* Disease progression on standard therapy with at least two lines of chemotherapy, including fluorouracil, oxaliplatin, and irinotecan with or without biologics such as bevacizumab and cetuximab\n* Fruquintinib administered as salvage treatment\n* Age: 18-75 years old\n* Informed consent\n\nExclusion Criteria:\n\n* Liver or kidney dysfunction, or other conditions unsuitable for chemotherapy\n* Fruquintinib and/or TAS-102 administration as second-line treatment\n* Drug administration stopped after less than two cycles"}, "identificationModule"=>{"nctId"=>"NCT06221423", "briefTitle"=>"Fruquintinib Combined With TAS-102 in Refractory Metastatic Colorectal Cancer", "organization"=>{"class"=>"OTHER", "fullName"=>"Fudan University"}, "officialTitle"=>"A Single-center, Prospective Cohort Study of Fruquintinib Combined With TAS-102 in Refractory Metastatic Colorectal Cancer", "orgStudyIdInfo"=>{"id"=>"Fru plus TAS-102 in mCRC"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Fru plus TAS-102", "description"=>"mCRC patients receiveing Fruquintinib combined with TAS-102 in third- or late- line", "interventionNames"=>["Drug: Fruquintinib Combined With TAS-102"]}], "interventions"=>[{"name"=>"Fruquintinib Combined With TAS-102", "type"=>"DRUG", "description"=>"Fruquintinib Combined With TAS-102", "armGroupLabels"=>["Fru plus TAS-102"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"200032", "city"=>"Shanghai", "state"=>"Shanghai", "status"=>"RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Donghao Xu", "role"=>"CONTACT", "email"=>"xdh1225@yeah.net", "phone"=>"17621317456"}, {"name"=>"Jianmin Xu", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Zhongshan Hospital, Fudan University", "geoPoint"=>{"lat"=>31.22222, "lon"=>121.45806}}], "centralContacts"=>[{"name"=>"Donghao Xu", "role"=>"CONTACT", "email"=>"xdh1225@yeah.net", "phone"=>"17621317456"}], "overallOfficials"=>[{"name"=>"Jianmin Xu", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Department of Colorectal Surgery, Zhongshan Hospital, Fudan University"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Fudan University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Director of Colorectal Surgery", "investigatorFullName"=>"Xu jianmin", "investigatorAffiliation"=>"Fudan University"}}}}
