Nctid:
NCT06611137
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000002294", "term"=>"Carcinoma, Squamous Cell"}, {"id"=>"D000077195", "term"=>"Squamous Cell Carcinoma of Head and Neck"}, {"id"=>"D000007822", "term"=>"Laryngeal Neoplasms"}], "ancestors"=>[{"id"=>"D000002277", "term"=>"Carcinoma"}, {"id"=>"D000009375", "term"=>"Neoplasms, Glandular and Epithelial"}, {"id"=>"D000009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000018307", "term"=>"Neoplasms, Squamous Cell"}, {"id"=>"D000007818", "term"=>"Laryngeal Diseases"}, {"id"=>"D000012140", "term"=>"Respiratory Tract Diseases"}, {"id"=>"D000010038", "term"=>"Otorhinolaryngologic Diseases"}, {"id"=>"D000006258", "term"=>"Head and Neck Neoplasms"}, {"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000010039", "term"=>"Otorhinolaryngologic Neoplasms"}, {"id"=>"D000012142", "term"=>"Respiratory Tract Neoplasms"}], "browseLeaves"=>[{"id"=>"M5534", "name"=>"Carcinoma", "relevance"=>"LOW"}, {"id"=>"M5550", "name"=>"Carcinoma, Squamous Cell", "asFound"=>"Squamous Cell Carcinoma", "relevance"=>"HIGH"}, {"id"=>"M10835", "name"=>"Laryngeal Diseases", "relevance"=>"LOW"}, {"id"=>"M1689", "name"=>"Squamous Cell Carcinoma of Head and Neck", "asFound"=>"Squamous cell carcinoma of the larynx", "relevance"=>"HIGH"}, {"id"=>"M10839", "name"=>"Laryngeal Neoplasms", "asFound"=>"Laryngeal Cancer", "relevance"=>"HIGH"}, {"id"=>"M12320", "name"=>"Neoplasms, Glandular and Epithelial", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M20451", "name"=>"Neoplasms, Squamous Cell", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}, {"id"=>"M12961", "name"=>"Otorhinolaryngologic Diseases", "relevance"=>"LOW"}, {"id"=>"M9348", "name"=>"Head and Neck Neoplasms", "relevance"=>"LOW"}, {"id"=>"M12962", "name"=>"Otorhinolaryngologic Neoplasms", "relevance"=>"LOW"}, {"id"=>"M14979", "name"=>"Respiratory Tract Neoplasms", "relevance"=>"LOW"}, {"id"=>"T3311", "name"=>"Laryngeal Cancer", "asFound"=>"Laryngeal Cancer", "relevance"=>"HIGH"}, {"id"=>"T2952", "name"=>"Hypopharyngeal Cancer", "asFound"=>"Hypopharynx Cancer", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"Ear, Nose, and Throat Diseases", "abbrev"=>"BC09"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000077143", "term"=>"Docetaxel"}], "ancestors"=>[{"id"=>"D000000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D000050257", "term"=>"Tubulin Modulators"}, {"id"=>"D000050256", "term"=>"Antimitotic Agents"}, {"id"=>"D000050258", "term"=>"Mitosis Modulators"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}], "browseLeaves"=>[{"id"=>"M2853", "name"=>"Immunomodulating Agents", "relevance"=>"LOW"}, {"id"=>"M1668", "name"=>"Docetaxel", "asFound"=>"Breast", "relevance"=>"HIGH"}, {"id"=>"M6182", "name"=>"Cisplatin", "relevance"=>"LOW"}, {"id"=>"M26197", "name"=>"Tubulin Modulators", "relevance"=>"LOW"}, {"id"=>"M26196", "name"=>"Antimitotic Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>35}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-09-11", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2027-09-11", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-09-23", "studyFirstSubmitQcDate"=>"2024-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-24", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-09-11", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"objective response rate", "timeFrame"=>"two weeks after the last course of neoadjuvant chemotherapy", "description"=>"complete and partial response rate"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["SBRT", "immunotherapy", "larynx preservation", "laryngeal cancer", "hypopharynx cancer"], "conditions"=>["Laryngeal Cancer", "Hypopharynx Cancer"]}, "descriptionModule"=>{"briefSummary"=>"This trial aims to evaluate the safety and efficiency of SBRT followed by Chemoimmunotherapy of Toripalimab Plus Docetaxel and Cisplatin for Patients with Locally Regionally Advanced Squamous Cell Carcinoma of the Larynx and Hypopharynx"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"70 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Laryngeal (T3-4N0-3M0 ) and hypopharyngeal ( T2-4N0-3M0) cancers staged by AJCC8th\n* age 18-70\n* PS score 0-1\n* normal functions to tolerate chemotherapy, immunotherapy and radiotherapy\n\nExclusion Criteria:\n\n* Patients with a combination of other malignant tumours\n* Individuals with contraindications to immunotherapy"}, "identificationModule"=>{"nctId"=>"NCT06611137", "briefTitle"=>"SBRT Followed by Chemoimmunotherapy of Toripalimab Plus Docetaxel and Cisplatin for Larynx Preservation in Patients with Locally Regionally Advanced Squamous Cell Carcinoma of the Larynx and Hypopharynx", "organization"=>{"class"=>"OTHER", "fullName"=>"Sun Yat-sen University"}, "officialTitle"=>"SBRT Followed by Chemoimmunotherapy of Toripalimab Plus Docetaxel and Cisplatin for Larynx Preservation in Patients with Locally Regionally Advanced Squamous Cell Carcinoma of the Larynx and Hypopharynx", "orgStudyIdInfo"=>{"id"=>"B2024-373-01"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"SBRT+Toripalimab Plus Docetaxel and Cisplatin", "description"=>"SBRT for gross tumor and metastatic lymph nodes, followed by neoadjuvant chemoimmunotherapy of Toripalimab Plus Docetaxel and Cisplatin", "interventionNames"=>["Combination Product: SBRT+Toripalimab Plus Docetaxel and Cisplatin"]}], "interventions"=>[{"name"=>"SBRT+Toripalimab Plus Docetaxel and Cisplatin", "type"=>"COMBINATION_PRODUCT", "description"=>"All participants will receive SBRT (18Gy/3 fractions, QOD ) to gross tumor and metastatic lymph nodes, followed by neoadjuvant chemoimmunotherapy of Toripalimab (240mg) Plus Docetaxel (75mg/m2, q3w) and Cisplatin (75mg/m2, q3w) for 3 cycles. If tumor has complete or partial response at 2 weeks after the last course of neoadjuvant chemotherapy, participants will then receive intensity modulated radiotherapy (54Gy/27 fractions). If tumor is stable or progressive, participants will receive radical resection with or without postoperative intensity modulated radiotherapy when necessary.", "armGroupLabels"=>["SBRT+Toripalimab Plus Docetaxel and Cisplatin"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"510060", "city"=>"Guangzhou", "state"=>"Guangdong", "status"=>"RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Fang-Yun Xie", "role"=>"CONTACT", "email"=>"xiefy@sysucc.org.cn", "phone"=>"+8613902205880"}, {"name"=>"Dian OuYang", "role"=>"CONTACT", "email"=>"ouyd@sysucc.org.cn"}, {"name"=>"Fang-Yun Xie", "role"=>"CONTACT"}, {"name"=>"Dian OuYang", "role"=>"CONTACT"}], "facility"=>"Sun Yat-sen University Cancer Center", "geoPoint"=>{"lat"=>23.11667, "lon"=>113.25}}], "centralContacts"=>[{"name"=>"Fang-Yun Xie", "role"=>"CONTACT", "email"=>"xiefy@sysucc.org.cn", "phone"=>"+8613902205880"}, {"name"=>"Dian OuYang", "role"=>"CONTACT", "email"=>"ouyd@sysucc.org.cn"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Sun Yat-sen University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"professor", "investigatorFullName"=>"Fang-Yun Xie", "investigatorAffiliation"=>"Sun Yat-sen University"}}}}
