[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Yanjie Zhang, MD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":89},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,69],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100650744","phase-2-anti-pd-1-therapy-in-recurrent-and-metastatic-head-and-neck-squamous-cell-carcinoma-100650744",false,"NCT07751289","Anti-PD-1 Therapy in Recurrent and Metastatic Head and Neck Squamous Cell Carcinoma","Anti-PD-1 Therapy in Locoregionally Recurrent and Metastatic Head and Neck Squamous Cell Carcinoma: A Multicenter, Randomized Controlled Clinical Trial","neo-Recur","Inclusion Criteria:\n\n1. Age: 18 to 80 years old (inclusive).\n2. Primary Tumor: Histologically or cytologically confirmed head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma). Patients must have previously received surgery and\u002For radiotherapy.\n3. Diagnosis: Locally recurrent or metastatic disease confirmed by pathology and\u002For imaging.\n4. Clinical Stage: T1-4a, N0-2, M0 (AJCC TNM Staging System, 8th Edition), with no evidence of distant metastasis, and the recurrent lesion is assessed as surgically resectable.\n5. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Life Expectancy: Expected survival ≥ 6 months.\n7. Immunotherapy: No significant contraindications to immunotherapy.\n8. Consent to Surgery: Willing to undergo surgical treatment.\n9. Adequate Organ Function:\n\n   Hematology (without transfusion or hematopoietic growth factor support within 14 days): WBC ≥ 4.0 × 10⁹\u002FL, ANC ≥ 1.5 × 10⁹\u002FL, Platelets ≥ 100 × 10⁹\u002FL, Hemoglobin ≥ 90 g\u002FL.\n\n   Biochemistry: Serum albumin ≥ 3.0 g\u002FdL (30 g\u002FL), Total bilirubin (TBIL) ≤ 1.5 × ULN, ALT and AST ≤ 2.5 × ULN, BUN and Creatinine ≤ 1.5 × ULN, or calculated creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft-Gault formula).\n\n   Coagulation: Adequate coagulation function defined as International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN. For participants receiving anticoagulant therapy, PT must be within the intended therapeutic range of the anticoagulant.\n10. Contraception: Female participants of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment and must agree to use effective contraception during the study and for 6 months after the last dose of the anti-PD-1 antibody. Male participants with female partners of childbearing potential must agree to use effective contraception during the study and for 6 months after the last dose of the anti-PD-1 antibody.\n11. Informed Consent: The participant must voluntarily join the study, sign the informed consent form, be compliant, and be willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Prior treatment with anti-PD-1\u002FPD-L1 antibodies, anti-PD-L2 antibodies, anti-CD137 antibodies, CTLA-4 antibodies, or other drugs\u002Fantibodies targeting T-cell co-stimulation or checkpoint pathways.\n2. Presence of active severe autoimmune disease. Participants with conditions that are stable and do not require systemic immunosuppressive therapy are eligible, such as: Type I diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, and skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, and alopecia).\n3. Has a congenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B (HBV-DNA ≥ 10⁴ copies\u002FmL), or active hepatitis C (positive hepatitis C antibody and HCV-RNA above the lower limit of detection of the assay).\n4. Known allergy to the study drug or any of its excipients; or a history of severe allergic reactions to other monoclonal antibodies.\n5. Occurrence of any of the following within 6 months prior to randomization: myocardial infarction, severe\u002Funstable angina pectoris, cardiac insufficiency of NYHA Class 2 or higher, clinically significant supraventricular or ventricular arrhythmias, or symptomatic congestive heart failure.\n6. Vaccination with a live vaccine within 4 weeks prior to the first dose of the study drug. Inactivated virus vaccines for seasonal influenza administered via injection are permitted; however, intranasal live attenuated influenza vaccines are not permitted.\n7. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n8. Known history of psychoactive substance abuse or drug addiction.\n9. Pregnant or breastfeeding women.\n10. Diagnosis of any other malignancy within 5 years prior to study entry, with the exception of locally treated and cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, ductal carcinoma in situ of the breast, and papillary thyroid cancer.\n11. Presence of any other severe physical or mental illness or laboratory abnormality that may increase the risk of participating in the study, interfere with the study results, or render the participant unsuitable for participation in the study, as judged by the investigator.","ALL","18 Years","80 Years",{"count":21,"type":22},217,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The goal of this clinical trial is to determine whether a perioperative PD-1 antibody-based treatment strategy, consisting of neoadjuvant PD-1 antibody plus chemotherapy followed by adjuvant PD-1 antibody after surgery, improves outcomes compared with the current standard treatment in patients with resectable locally recurrent head and neck squamous cell carcinoma (HNSCC). The study will also evaluate the safety of this perioperative treatment approach.\n\nThe main questions it aims to answer are:\n\nDoes perioperative PD-1 antibody-based therapy improve event-free survival compared with the current standard treatment? What adverse events occur during treatment with neoadjuvant PD-1 antibody plus chemotherapy and adjuvant PD-1 antibody?\n\nResearchers will compare a perioperative PD-1 antibody-based treatment strategy with the current standard treatment to determine which approach provides better clinical outcomes.\n\nParticipants will:\n\nBe randomly assigned to one of two study groups. Receive either neoadjuvant PD-1 antibody plus chemotherapy followed by surgery and adjuvant PD-1 antibody, or undergo upfront surgery followed by standard postoperative treatment as indicated.\n\nVisit the clinic regularly for physical examinations, blood tests, imaging assessments, and other study procedures.\n\nBe followed after treatment to monitor disease status, treatment response, survival outcomes, and adverse events.",[28],"Recurrent Head and Neck Squamous Cell Carcinoma",[30,31,32,33,34],"PD-1 inhibitor","Randomized Controlled Trial","Neoadjuvant Chemoimmunotherapy","Head and Neck Squamous Cell Carcinoma","Locally Recurrent Disease","NOT_YET_RECRUITING","2026-08-06",{"date":38,"type":39},"2026-08-07","ACTUAL",{"date":41,"type":22},"2026-08-01",{"date":43,"type":22},"2032-12-31",{"name":45,"class":46},"Yanjie Zhang, MD","OTHER",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":67,"leadSponsor":68,"locationsCount":4},"100650731","phase-2-perioperative-finotonlimab-plus-chemotherapy-in-untreated-stage-ii-hnscc-100650731","NCT07751276","Perioperative Finotonlimab Plus Chemotherapy in Untreated Stage II HNSCC","A Multicenter, Randomized Controlled Clinical Trial of Finotonlimab Combined With Chemotherapy as Perioperative Therapy for Untreated Stage II Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Age 18-75 years\n2. Pathologically confirmed primary head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma)\n3. Clinical stage II (8th edition TNM staging), no distant metastasis, primary tumor resectable\n4. ECOG sccore 0-1\n5. No prior radiotherapy, chemotherapy, immunotherapy, or biological therapy for the current head and neck tumor\n6. Willing to undergo surgical treatment\n7. No significant contraindications to immunotherapy, radiotherapy, or chemotherapy\n8. Major organ function meets the following criteria: a) Hematologic: WBC ≥ 4.0 × 10⁹\u002FL, ANC ≥ 1.5 × 10⁹\u002FL, PLT ≥ 100 × 10⁹\u002FL, Hb ≥ 90 g\u002FL (no blood transfusion or blood products, no G-CSF or other hematopoietic growth factors within 14 days); b) Biochemistry: serum albumin ≥ 3.0 g\u002FdL (30 g\u002FL), TBIL ≤ 1.5 × ULN, ALT and AST ≤ 2.5 × ULN, BUN and CRE ≤ 1.5 × ULN or endogenous creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft-Gault formula); c) Adequate coagulation: defined as INR or PT ≤ 1.5 × ULN; if the subject is receiving anticoagulation therapy, PT within the intended therapeutic range of the anticoagulant is acceptable\n9. Both male and female subjects are eligible; women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and must agree to use effective contraception during the study and for 2 months after the last dose of anti-PD-1 antibody. Male subjects with female partners of childbearing potential must agree to use effective contraception during the study and for 2 months after the last dose of anti-PD-1 antibody\n10. The subject voluntarily enrolls in this study, signs the informed consent form, demonstrates good compliance, and cooperates with follow-up\n\nExclusion Criteria:\n\n1. Prior treatment with anti-PD-1\u002FPD-L1 antibodies, anti-PD-L2 antibodies, anti-CD137 antibodies, CTLA-4 antibodies, or other drugs\u002Fantibodies targeting T-cell co-stimulation or checkpoint pathways\n2. Active severe autoimmune disease. Subjects in stable condition not requiring systemic immunosuppressive therapy are eligible, such as type 1 diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, and skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia)\n3. Congenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B (HBV-DNA ≥ 10⁴ copies\u002FmL), or hepatitis C (HCV antibody positive and HCV-RNA above the lower limit of detection)\n4. Known hypersensitivity to the study drug or any of its excipients, or history of severe allergic reaction to other monoclonal antibodies\n5. Within 6 months prior to randomization: myocardial infarction, severe\u002Funstable angina, NYHA class ≥ 2 cardiac dysfunction, clinically significant supraventricular or ventricular arrhythmias, or symptomatic congestive heart failure\n6. Receipt of a live vaccine within 4 weeks prior to the first dose of study drug; inactivated influenza vaccine administered by injection is permitted, while intranasal live attenuated influenza vaccine is not permitted\n7. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation\n8. Known history of psychotropic substance abuse or drug addiction\n9. Pregnant or lactating women\n10. Diagnosis of any other malignancy within 5 years prior to study entry, except for curatively treated localized cancers including basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma\n11. Any other severe physical or psychiatric illness or laboratory abnormality that may increase the risk of study participation, interfere with study results, or render the patient unsuitable for study participation in the opinion of the investigator","75 Years",{"count":56,"type":22},142,[25],"This multicenter, randomized, open-label, parallel-controlled clinical trial aims to evaluate the efficacy and safety of surgery combined with postoperative chemoradiotherapy versus finotonlimab plus induction chemotherapy followed by postoperative finotonlimab maintenance therapy in patients with locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN).",[60],"Head and Neck Squamous Cell Carcinoma HNSCC",[62,32,63,64],"Stage II Head and Neck Squamous Cell Carcinoma","Anti-PD-1 Therapy","Finotonlimab",{"date":38,"type":39},{"date":41,"type":22},{"date":43,"type":22},{"name":45,"class":46},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":23,"phases":77,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":4},"100642356","phase-2-exploratory-study-on-toripalimab-and-anlotinib-combined-with-standard-chemotherapy-for-refractory-dermatofibrosarcoma-protuberans-100642356","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.",{"count":76,"type":22},20,[25],"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.",[80],"Dermatofibrosarcoma Protuberans (DFSP)","2026-06-12",{"date":83,"type":39},"2026-06-16",{"date":85,"type":22},"2026-06-15",{"date":87,"type":22},"2029-12-31",{"name":45,"class":46},""]