[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593742":3},{"organization":4,"armGroups":7,"interventions":49,"overallOfficials":55,"centralContacts":100,"locations":110,"responsibleParty":130,"collaborators":55,"id":133,"slug":134,"hasResults":135,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":55,"eligibilityCriteria":139,"healthyVolunteers":135,"sex":140,"minAge":141,"maxAge":142,"enrollmentInfo":143,"targetDuration":55,"studyType":146,"phases":147,"briefSummary":149,"conditions":150,"keywords":152,"overallStatus":164,"whyStopped":55,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},{"fullName":5,"class":6},"Fujian Medical University","OTHER",[8,19,25,29,34,41,45],{"label":9,"type":10,"description":11,"interventionNames":12},"BRAF V600E Mutation","EXPERIMENTAL","Dabrafenib 150 mg PO BID + trametinib 2 mg PO QD given in 28-day cycles (Day 1-28). After Cycle 4 (Day 112 ± 7) patients undergo imaging review; if previously unresectable disease becomes operable, conversion surgery is scheduled within 3 weeks. Those still unresectable continue treatment until progression\u002Ftoxicity.",[13,14,15,16,17,18],"Drug: Dabrafenib","Drug: Trametinib","Drug: Lenvatinib","Drug: Anlotinib","Drug: Cabozantinib","Procedure: Conversion Surgery",{"label":20,"type":10,"description":21,"interventionNames":22},"RET Fusion PTC","Selpercatinib 160 mg PO BID, continuous 28-day cycles. Surgery conversion assessment at Day 112 (end of Cycle 4). Resectable cases proceed to thyroidectomy ± neck dissection; others maintain therapy per label.",[23,24,15,16,17,18],"Drug: Selpercatinib","Drug: Pralsetinib",{"label":26,"type":10,"description":27,"interventionNames":28},"RET Point-Mutation MTC","Prospective cohort: selpercatinib 160 mg PO BID, 28-day cycles; Retrospective sub-cohort: historical pralsetinib 400 mg PO QD (also 28-day cycles). Cycle 4 reassessment (Day 112) for potential curative resection of residual neck disease or distant oligometastases.",[23,15,16,17,18],{"label":30,"type":10,"description":31,"interventionNames":32},"NTRK Fusion","Larotrectinib 100 mg PO BID in continuous 28-day cycles with multidisciplinary resectability evaluation after 4 cycles (Day 112). Eligible patients undergo surgery; non-eligible continue TRK inhibitor.",[15,33,16,17,18],"Drug: Larotrectinib",{"label":35,"type":10,"description":36,"interventionNames":37},"TERT-Only (MKI)","Investigator-selected MKI: lenvatinib 24 mg PO QD (28-day cycle), anlotinib 12 mg PO d1-14 q21d (21-day cycle; Cycle 4 ends Day 84), or cabozantinib 60 mg PO QD (28-day cycle). Conversion-surgery review: Day 112 for 28-day regimens or Day 84 for anlotinib.",[15,16,38,39,17,40,18],"Drug: Pembrolizumab","Drug: Sintilimab","Drug: Bemosuzumab",{"label":42,"type":10,"description":43,"interventionNames":44},"Triple-Negative (driver-negative) - MKI","Same MKI options\u002Fcycle lengths as Arm 5. Cycle 4 resectability check (Day 112 or Day 84 depending on drug). Successful conversions proceed to definitive surgery; others remain on systemic therapy.",[14,15,16,38,39,17,40,18],{"label":46,"type":10,"description":47,"interventionNames":48},"PD-L1 ≥ 1 % \u002F MKI-Refractory - Immunotherapy ± MKI","Checkpoint agents: pembrolizumab 200 mg IV q3w (21-day cycles), sintilimab 200 mg IV q3w (21 d), or domestic PD-L1 Ab bemosuzumab 900 mg IV q2w (14-day cycles). Combination option: lenvatinib 20 mg PO QD (28-day cycles) added at investigator discretion. Conversion assessment occurs after 4 cycles of the longest component being used (e.g., Day 84 for pembrolizumab; Day 112 if combined with 28-day MKI). Resectable patients undergo surgery; others continue or switch therapy.",[15,16,38,39,17,40,18],[50,56,60,64,68,72,76,80,84,87,91,95],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"DRUG","Dabrafenib","150 mg orally twice daily; ≤4 × 28-day cycles",[9],null,{"type":51,"name":57,"description":58,"armGroupLabels":59,"otherNames":55},"Trametinib","2 mg orally once daily; same duration",[9,42],{"type":51,"name":61,"description":62,"armGroupLabels":63,"otherNames":55},"Selpercatinib","160 mg orally twice daily; ≤4 cycles",[20,26],{"type":51,"name":65,"description":66,"armGroupLabels":67,"otherNames":55},"Pralsetinib","retrospective, 400 mg orally once daily; ≤4 cycles",[20],{"type":51,"name":69,"description":70,"armGroupLabels":71,"otherNames":55},"Lenvatinib","24 mg orally once daily; ≤4 cycles",[9,30,46,20,26,35,42],{"type":51,"name":73,"description":74,"armGroupLabels":75,"otherNames":55},"Larotrectinib","Larotrectinib 100 mg orally twice daily, continuous 28-day cycles.",[30],{"type":51,"name":77,"description":78,"armGroupLabels":79,"otherNames":55},"Anlotinib","12 mg orally once daily; 2 weeks on \u002F 1 week off, ≤4 cycles (alternative)",[9,30,46,20,26,35,42],{"type":51,"name":81,"description":82,"armGroupLabels":83,"otherNames":55},"Pembrolizumab","200 mg IV infusion every 3 weeks; ≤4 cycles",[46,35,42],{"type":51,"name":85,"description":82,"armGroupLabels":86,"otherNames":55},"Sintilimab",[46,35,42],{"type":51,"name":88,"description":89,"armGroupLabels":90,"otherNames":55},"Cabozantinib","Cabozantinib 60 mg orally once daily, continuous 28-day cycles.",[9,30,46,20,26,35,42],{"type":51,"name":92,"description":93,"armGroupLabels":94,"otherNames":55},"Bemosuzumab","China PD-L1 antibody bemosuzumab 900 mg IV every 2 weeks (14-day cycle).",[46,35,42],{"type":96,"name":97,"description":98,"armGroupLabels":99,"otherNames":55},"PROCEDURE","Conversion Surgery","Conversion Surgery if resectable",[9,30,46,20,26,35,42],[101,106],{"name":102,"role":103,"phone":104,"phoneExt":55,"email":105},"Bo Wang Professor, MD","CONTACT","+13959123550","wangbo@fjmu.edu.cn",{"name":107,"role":103,"phone":108,"phoneExt":55,"email":109},"Si-si Wang, MD","+8618650064852","WangSiSi@fjmu.edu.cn",[111],{"facility":112,"status":55,"city":113,"state":114,"zip":115,"country":116,"countryCode":117,"cosmosGeoPoint":118,"geoPoint":123,"contacts":124},"Fujian Medical University Union Hospital","Fuzhou","Fujian","350001","China","CN",{"type":119,"coordinates":120},"Point",[121,122],119.30611,26.06139,{"lat":122,"lon":121},[125,127],{"name":126,"role":103,"phone":55,"phoneExt":55,"email":105},"Bo Wang Porfessor, MD",{"name":128,"role":129,"phone":55,"phoneExt":55,"email":55},"Bo Wang MD, Principal Investigator","PRINCIPAL_INVESTIGATOR",{"type":129,"investigatorFullName":131,"investigatorTitle":132,"investigatorAffiliation":112,"oldNameTitle":55,"oldOrganization":55},"Bo Wang,MD","Director, Head of Thyroid Surgery, Principal Investigator, Clinical Professor","100593742","phase-4-genotype-driven-neoadjuvant-therapy-for-locally-advanced-thyroid-cancer-a-real-world-cohort-study-100593742",false,"NCT07010393","Genotype-Driven Neoadjuvant Therapy for Locally Advanced Thyroid Cancer: A Real-World Cohort Study","A Multicenter Prospective-Retrospective Real-World Study Evaluating Conversion-to-Surgery and Survival After Genotype-Matched Neoadjuvant Systemic Therapy in Locally Advanced Thyroid Carcinoma","Inclusion Criteria:\n\n1. Age ≥ 18 years at enrollment.\n2. Histologically or cytologically confirmed thyroid carcinoma that meets ≥ 1 of the following:\n\n   * Radioactive-iodine-refractory differentiated thyroid carcinoma (DTC)\n   * Medullary thyroid carcinoma (MTC)\n   * Anaplastic or poorly differentiated thyroid carcinoma (ATC\u002FPDTC)\n   * Other locally advanced \u002F metastatic thyroid malignancy deemed incurable by surgery alone.\n3. Disease judged unresectable or entailing prohibitively high-morbidity surgery at baseline by a multidisciplinary thyroid-oncology board.\n4. Documented molecular or immunophenotype qualifying for ≥ 1 study arm:\n\n   * BRAF V600E mutation\n   * RET gene fusion\n   * RET activating point mutation (e.g., M918T)\n   * NTRK1\u002F2\u002F3 fusion\n   * Isolated TERT-promoter mutation with no BRAF\u002FRET\u002FNTRK alterations\n   * Driver-negative \u002F VEGFR-wild type (\"triple-negative\")\n   * PD-L1 expression ≥ 1 % OR progression after prior multi-kinase inhibitor (MKI).\n5. ECOG Performance Status 0-2.\n6. At least one measurable lesion per RECIST v1.1 \u002F iRECIST (MTC with calcitonin\u002FCEA evaluable disease accepted).\n7. Written informed consent obtained.\n\nExclusion Criteria:\n\n1. Untreated or symptomatic CNS metastases; patients with treated, stable lesions ≥ 4 weeks and off corticosteroids are eligible.\n2. Pregnant or breastfeeding. Women and men of child-bearing potential must agree to effective contraception during study and for ≥ 120 days after last dose (≥ 180 days for men after dabrafenib\u002Ftrametinib).","ALL","18 Years","80 Years",{"count":144,"type":145},335,"ESTIMATED","INTERVENTIONAL",[148],"PHASE4","This multicenter registry tests whether genomically matched neoadjuvant therapy (1-4 cycles tailored to BRAF V600E, RET fusion\u002Fmutation, isolated TERT mutation, triple-negative BRAF\u002FRET\u002FTERT, or ICI ± TKI) can render locally advanced, initially unresectable-or high-morbidity-thyroid cancers operable. The primary endpoint is conversion-to-surgery; key secondaries are R0\u002F1 margin rate and 12-month event-free survival, with propensity-score weighting correcting cohort imbalances. Findings aim to define a precision-guided neoadjuvant standard for down-staging advanced thyroid tumors.",[151],"Thyroid Neoplasms",[153,154,155,156,157,158,159,97,160,161,162,163],"Locally Advanced","Neoadjuvant Therapy","Real-World Study","BRAF V600E","RET Fusion","VEGF-TKI","Immunotherapy","R0 Resection","Precision Oncology","Real-World Evidence","Conversion Therapy","NOT_YET_RECRUITING","2025-06-01",{"date":167,"type":168},"2025-06-08","ACTUAL",{"date":170,"type":145},"2025-07-01",{"date":172,"type":145},"2028-12-31",{"name":5,"class":6},1]