[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628567":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":40,"responsibleParty":55,"collaborators":26,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":26,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":26,"studyType":71,"phases":72,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":84,"whyStopped":26,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"6-Cycle Neoadjuvant Chemotherapy","EXPERIMENTAL","Participants receive 6 cycles of neoadjuvant chemotherapy prior to surgery. For WHO type B thymoma: cyclophosphamide 500 mg\u002Fm2 IV + doxorubicin 50 mg\u002Fm2 IV + cisplatin 50 mg\u002Fm2 IV (CAP regimen), every 3 weeks. For thymic carcinoma: nab-paclitaxel 260 mg\u002Fm2 IV + carboplatin AUC 5 IV, every 3 weeks.",[13,14],"Drug: Cyclophosphamide, Doxorubicin, and Cisplatin (CAP)","Drug: nab-Paclitaxel and Carboplatin",{"label":16,"type":17,"description":18,"interventionNames":19},"3-Cycle Neoadjuvant Chemotherapy","ACTIVE_COMPARATOR","Participants receive 3 cycles of neoadjuvant chemotherapy prior to surgery. For WHO type B thymoma: cyclophosphamide 500 mg\u002Fm2 IV + doxorubicin 50 mg\u002Fm2 IV + cisplatin 50 mg\u002Fm2 IV (CAP regimen), every 3 weeks. For thymic carcinoma: nab-paclitaxel 260 mg\u002Fm2 IV + carboplatin AUC 5 IV, every 3 weeks.",[13,14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Cyclophosphamide, Doxorubicin, and Cisplatin (CAP)","Chemotherapy regimen for WHO type B thymoma. Cyclophosphamide 500 mg\u002Fm2 IV + Doxorubicin 50 mg\u002Fm2 IV + Cisplatin 50 mg\u002Fm2 IV, administered every 3 weeks. Experimental arm receives 6 cycles; Control arm receives 3 cycles prior to surgery.",[16,9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"nab-Paclitaxel and Carboplatin","Chemotherapy regimen for thymic carcinoma. nab-Paclitaxel 260 mg\u002Fm2 IV + Carboplatin AUC 5 IV, administered every 3 weeks. Experimental arm receives 6 cycles; Control arm receives 3 cycles prior to surgery.",[16,9],[32],{"name":33,"affiliation":5,"role":34},"Fan Jiang, MD, PhD","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","86-21-63240090","fan_jiang@sjtu.edu.cn",[41],{"facility":5,"status":26,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Shanghai","Shanghai Municipality","200080","China","CN",{"type":48,"coordinates":49},"Point",[50,51],121.45806,31.22222,{"lat":51,"lon":50},[54],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},{"type":34,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Jiang Fan","Chief of Thoracic Surgery","100628567","phase-2-6-vs-3-cycles-of-neoadjuvant-chemotherapy-for-potentially-resectable-locally-advanced-thymic-epithelial-tumors-100628567",false,"NCT07463313","6 vs 3 Cycles of Neoadjuvant Chemotherapy for Potentially Resectable Locally Advanced Thymic Epithelial Tumors","A Randomized Controlled Trial of 6 Versus 3 Cycles of Neoadjuvant Chemotherapy on Event-Free Survival in Patients With Potentially Resectable Locally Advanced Thymic Epithelial Tumors","Inclusion Criteria:\n\n* Histologically or cytologically confirmed thymic epithelial tumor (thymoma or thymic carcinoma)\n* Locally advanced, potentially resectable disease (Masaoka-Koga stage III or IVA), as evaluated by a multidisciplinary team (MDT) including thoracic surgery and thoracic oncology\n* Age 18 to 65 years\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Adequate bone marrow function: absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL, platelet count ≥100×10⁹\u002FL, hemoglobin ≥90 g\u002FL\n* Adequate liver function: total bilirubin ≤1.5× upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN\n* Adequate renal function: creatinine clearance ≥50 mL\u002Fmin (Cockcroft-Gault formula)\n* No prior systemic anticancer therapy for thymic epithelial tumor\n* At least one measurable lesion per RECIST v1.1\n* Willing to accept randomization and able to comply with study procedures\n* Written informed consent obtained prior to any study-related procedures\n\nExclusion Criteria:\n\n* Prior chemotherapy, targeted therapy, or immunotherapy for thymic epithelial tumor\n* Prior thoracic radiation therapy\n* Active autoimmune disease requiring systemic treatment within the past 2 years\n* Known hypersensitivity or contraindication to study drugs (cisplatin, epirubicin, etoposide, ifosfamide, or any component of these formulations)\n* Severe cardiac dysfunction: New York Heart Association (NYHA) class III or IV heart failure, or left ventricular ejection fraction (LVEF) \\\u003C50%\n* Active hepatitis B (HBsAg positive with HBV DNA ≥2000 IU\u002FmL), active hepatitis C, or known HIV infection\n* Pregnancy or lactation; women of childbearing potential unwilling to use adequate contraception\n* Other malignancy within 5 years prior to enrollment, except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix\n* Uncontrolled active infection requiring systemic therapy\n* Any condition that, in the investigator's judgment, would preclude safe participation in the study","ALL","18 Years","65 Years",{"count":69,"type":70},116,"ESTIMATED","INTERVENTIONAL",[73,74],"PHASE2","PHASE3","This randomized controlled trial compares 6 versus 3 cycles of neoadjuvant chemotherapy in patients with potentially resectable locally advanced thymic epithelial tumors (TETs, WHO type AB\u002FB\u002FC, AJCC TNM stage IIIA-IVA). Patients are randomized 1:1 to receive either 6 or 3 cycles of chemotherapy (cisplatin + doxorubicin + cyclophosphamide for type B; nab-paclitaxel + carboplatin for type C thymoma\u002Fthymic carcinoma) every 3 weeks, followed by surgical resection when feasible. The primary endpoint is event-free survival (EFS). The study aims to determine whether extended neoadjuvant chemotherapy improves surgical outcomes and long-term survival in this rare malignancy.",[77],"Thymoma and Thymic Carcinoma",[79,80,81,82,83],"Neoadjuvant Chemotherapy","Thymic Epithelial Tumor","Thymic Carcinoma","Event-Free Survival","Mediastinal Tumor","NOT_YET_RECRUITING","2026-03-06",{"date":87,"type":88},"2026-03-11","ACTUAL",{"date":90,"type":70},"2026-03",{"date":92,"type":70},"2032-03",{"name":5,"class":6},1]