[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642356":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":22,"centralContacts":31,"locations":22,"responsibleParty":37,"collaborators":22,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":22,"eligibilityCriteria":46,"healthyVolunteers":43,"sex":47,"minAge":48,"maxAge":22,"enrollmentInfo":49,"targetDuration":22,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":22,"overallStatus":58,"whyStopped":22,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":22},{"fullName":5,"class":6},"Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Toripalimab, Anlotinib Hydrochloride Combined with Standard Chemotherapy","EXPERIMENTAL","All enrolled patients will receive study intervention starting on Day 1 of each 3-week cycle until disease progression, intolerable toxicity, or study withdrawal: Toripalimab 240 mg (fixed dose) administered intravenously once every 3 weeks (Q3W); Anlotinib 10 mg administered orally once daily on Days 1-14 of each 3-week cycle; and standard chemotherapy based on anthracycline or gemcitabine once every 3 weeks (Q3W).",[13,14,15],"Drug: Toripalimab","Drug: Anlotinib","Drug: Standard Chemotherapy",[17,23,27],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Toripalimab","All enrolled patients will receive study intervention starting on Day 1 of each 3-week cycle until disease progression, intolerable toxicity, or study withdrawal: Toripalimab 240 mg (fixed dose) administered intravenously once every 3 weeks (Q3W).",[9],null,{"type":18,"name":24,"description":25,"armGroupLabels":26,"otherNames":22},"Anlotinib","All enrolled patients will receive study intervention starting on Day 1 of each 3-week cycle until disease progression, intolerable toxicity, or study withdrawal: Anlotinib 10 mg administered orally once daily on Days 1-14 of each 3-week cycle.",[9],{"type":18,"name":28,"description":29,"armGroupLabels":30,"otherNames":22},"Standard Chemotherapy","All enrolled patients will receive study intervention starting on Day 1 of each 3-week cycle until disease progression, intolerable toxicity, or study withdrawal: standard chemotherapy based on anthracycline or gemcitabine once every 3 weeks (Q3W).",[9],[32],{"name":33,"role":34,"phone":35,"phoneExt":22,"email":36},"Haihua Yuan","CONTACT","+86-021-56691101-7261","ayuan790415@shsmu.edu.cn",{"type":38,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"SPONSOR_INVESTIGATOR","Yanjie Zhang, MD","Principal Investigator, Clinical Professor, Department Director, Chief Physician, Department of Oncology, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University","100642356","phase-2-exploratory-study-on-toripalimab-and-anlotinib-combined-with-standard-chemotherapy-for-refractory-dermatofibrosarcoma-protuberans-100642356",false,"NCT07646080","Exploratory Study on Toripalimab and Anlotinib Combined With Standard Chemotherapy for Refractory Dermatofibrosarcoma Protuberans","Inclusion Criteria\n\n1. Male or female patients aged ≥18 years.\n2. Locally advanced, unresectable or metastatic dermatofibrosarcoma protuberans (DFSP) with histologically confirmed specific subtypes; disease progression following standard imatinib therapy, or no satisfactory alternative treatment options. Specific subtypes include: fibrosarcomatous DFSP (FS-DFSP) or DFSP with transformation to high-grade sarcoma, such as undifferentiated pleomorphic sarcoma, leiomyosarcoma, rhabdomyosarcoma, etc.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. At least one measurable lesion at baseline according to RECIST 1.1 criteria.\n5. Adequate organ and bone marrow function within 14 days prior to enrollment:\n\n   * Hemoglobin ≥9 g\u002FdL\n   * Platelet count ≥75,000\u002Fmm³\n   * Absolute neutrophil count ≥1500\u002Fmm³\n   * Serum albumin ≥2.5 g\u002FdL\n   * PT, aPTT, and INR ≤1.5 × ULN\n   * AST and ALT ≤3 × ULN, or \\\u003C5 × ULN in patients with liver metastases\n   * Total bilirubin ≤1.5 × ULN (without liver metastasis), or \\\u003C3 × ULN (with Gilbert syndrome or liver metastasis at baseline)\n   * Creatinine clearance ≥30 mL\u002Fmin calculated by the Cockcroft-Gault formula\n6. Left ventricular ejection fraction (LVEF) ≥50% as assessed by ECHO or MUGA scan within 28 days prior to enrollment.\n\nExclusion Criteria\n\nPatients with any of the following will be excluded:\n\n1. Spinal cord compression, leptomeningeal disease, or clinically active central nervous system (CNS) metastases.\n2. Active primary immunodeficiency, known HIV infection, active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n3. History of non-infectious interstitial lung disease (ILD)\u002Fnon-infectious pneumonitis requiring corticosteroid therapy, current ILD\u002Fnon-infectious pneumonitis, or suspected ILD\u002Fnon-infectious pneumonitis that cannot be ruled out by imaging at screening.\n4. Myocardial infarction within 6 months prior to enrollment, symptomatic congestive heart failure (CHF, NYHA class II-IV), unstable angina, or recent cardiovascular event (including stroke) within \\\u003C6 months.\n5. Pulmonary criteria:\n\n   1. Clinically significant pulmonary comorbidities including but not limited to underlying pulmonary disease (e.g., pulmonary embolism, severe asthma, severe COPD, restrictive lung disease, pleural effusion within 3 months before enrollment);\n   2. Documented autoimmune, connective tissue, or inflammatory disease (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.) or suspected pulmonary involvement at screening; full disease details must be documented in the eCRF;\n   3. Prior pneumonectomy.\n6. Poor compliance unable to cooperate with study treatment and procedures.","ALL","18 Years",{"count":50,"type":51},20,"ESTIMATED","INTERVENTIONAL",[54],"PHASE2","This study aims to evaluate the efficacy and safety of toripalimab and anlotinib hydrochloride combined with standard chemotherapy in patients with refractory dermatofibrosarcoma protuberans (DFSP) resistant to imatinib therapy, and to provide evidence for the exploration of DFSP treatment.",[57],"Dermatofibrosarcoma Protuberans (DFSP)","NOT_YET_RECRUITING","2026-06-12",{"date":61,"type":62},"2026-06-16","ACTUAL",{"date":64,"type":51},"2026-06-15",{"date":66,"type":51},"2029-12-31",{"name":39,"class":6}]