[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Yang Hong\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"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":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100616772","phase-2-neoadjuvant-sbrt-followed-by-sintilimab-plus-chemotherapy-for-n3-positive-nsclc-100616772",false,"NCT07309952","Neoadjuvant SBRT Followed by Sintilimab Plus Chemotherapy for N3-Positive NSCLC","Neoadjuvant Stereotactic Body Radiotherapy Followed by Sintilimab Plus Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer With Contralateral Mediastinal (N3) Lymph Node Metastasis: A Prospective Phase II Clinical Trial","SACTION 2501","Inclusion Criteria:\n\n1. Voluntary Participation: The patient volunteers to participate and signs a written informed consent form.\n2. Pathology and Staging: Cytologically or histologically confirmed, previously untreated non-small cell lung cancer (NSCLC) with contralateral mediastinal lymph node involvement (N3), classified as stage IIIB or IIIC according to the 9th edition of the International Association for the Study of Lung Cancer (IASLC) staging manual. Baseline staging must be performed with either PET\u002FCT or a combination of contrast-enhanced CT of chest\u002Fabdomen + bone scan + brain MRI.\n3. Surgical Feasibility: The lung lesion is considered \\*\\*potentially resectable as evaluated by a multidisciplinary team that includes a thoracic surgeon.\n4. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n5. Adequate Organ Function:\n\n(1) Absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL (2) Platelet count ≥ 100 x 10\\^9\u002FL (3) Hemoglobin \\> 9.0 g\u002FdL (4) Serum creatinine ≤ 1.5 x upper limit of normal (ULN) OR creatinine clearance (CrCl) ≥ 40 mL\u002Fmin (5) Aspartate aminotransferase (AST)\u002FAlanine aminotransferase (ALT) ≤ 3 x ULN (6) Total bilirubin ≤ 1.5 x ULN (7) Forced expiratory volume in 1 second (FEV1) ≥ 1.2 L or \\> 40% of predicted value (8) International normalized ratio (INR) and activated partial thromboplastin time (aPTT) within normal limits.\n\n6\\. Age: Between 18 and 75 years old.\n\nExclusion Criteria\n\n1. Autoimmune Disease: Active or suspected autoimmune disease. Exception: Patients with vitiligo, type I diabetes mellitus, or hypothyroidism requiring only hormone replacement therapy (e.g., Hashimoto's thyroiditis) with no signs of active disease may be enrolled.\n2. Immunosuppressive Therapy: Requires systemic corticosteroid therapy (\\>10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days prior to enrollment.\n3. Prior Chest Radiotherapy: History of prior radiotherapy to the chest.\n4. Active Bleeding: Presence of clinically significant active bleeding prior to treatment.\n5. Severe Organ Dysfunction: Severe cardiac, pulmonary, hepatic, or renal dysfunction, hematopoietic system disease, or cachexia, as judged by the investigator to be intolerable to chemo-radiotherapy.\n6. Poorly Controlled Diabetes: History of diabetes mellitus for \\>10 years with unsatisfactory glycemic control.\n7. Interstitial Lung Disease: History of interstitial lung disease or non-infectious pneumonitis.\n8. Driver Gene Mutations: NSCLC with known activating EGFR mutations or ALK fusion gene positivity.\n9. Other Malignancies:\n\n   Excluded: History of other active malignancies within the past 2 years, except for adequately treated non-melanoma skin cancer or carcinoma in situ (e.g., bladder, gastric, colorectal, endometrial, cervical, melanoma, or breast).\n\n   Exception: Patients with other malignancies who have achieved complete remission for ≥2 years and do not require additional anti-tumor therapy during this study may be enrolled.\n10. Compliance\u002FUnderstanding: Medical, psychological, or physiological conditions that, in the investigator's judgment, prevent the patient from completing the study or understanding the study information.\n11. Prior Immune Therapy: Previous treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other drug targeting T-cell co-stimulation or checkpoint pathways.\n12. Active Viral Infection:\n\n(1) Active Hepatitis B (HBsAg positive AND HBV DNA ≥ 2000 IU\u002FmL or 10\\^4 copies\u002FmL).\n\n(2) Active Hepatitis C (HCV antibody positive AND HCV RNA above the lower limit of detection).\n\n13\\. HIV\u002FAIDS: Known positive test for human immunodeficiency virus (HIV) or diagnosed acquired immunodeficiency syndrome (AIDS).\n\n14\\. Allergy: Known history of hypersensitivity to sintilimab, any of the chemotherapy agents used, or any of their excipients.\n\n15\\. Pregnancy\u002FLactation: Pregnant or breastfeeding women. 16. Metastatic Disease: Presence of supraclavicular lymph node metastasis or distant metastasis.","ALL","18 Years","75 Years",{"count":21,"type":22},28,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This is a Phase II clinical trial evaluating the efficacy and safety of a new treatment approach for patients with locally advanced non-small cell lung cancer (NSCLC) that has spread to lymph nodes on the opposite side of the chest (known as N3 lymph node involvement).\n\nThe study will enroll 28 patients aged 18 to 75 years with previously untreated, potentially resectable NSCLC classified as stage IIIB-IIIC. Participants will receive a combination of stereotactic body radiation therapy (SBRT) to the primary lung tumor, followed by two cycles of sintilimab (an immunotherapy drug) plus platinum-based chemotherapy before surgery.\n\nThe main goals of the study are to see whether this treatment can shrink or eliminate cancer in the contralateral mediastinal lymph node (lymph node downstaging) and allow more patients to undergo curative surgery. Secondary goals include assessing pathological response rates, surgical outcomes, survival, and safety.\n\nPatients will be closely monitored during and after treatment, with follow-up visits planned for up to 5 years after surgery.",[28,29,30],"Locally Advanced Non-Small Cell Lung Cancer","Stage IIIb Non-small Cell Lung Cancer","Stage IIIC Non-Small Cell Lung Cancer","RECRUITING","2026-04-24",{"date":34,"type":35},"2026-04-30","ACTUAL",{"date":37,"type":35},"2025-12-31",{"date":39,"type":22},"2032-10-31",{"name":41,"class":42},"Yang Hong","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":43},"100562081","phase-3-stereotactic-body-radiotherapy-followed-by-tislelizumab-plus-platinum-based-chemotherapy-versus-tislelizumab-plus-platinum-based-chemotherapy-as-neoadjuvant-therapy-in-patients-with-resectable-stage---non-small-cell-lung-cancer-a-phase--randomized-multicenter-prospective-study-100562081","NCT06598527","Stereotactic Body Radiotherapy Followed by Tislelizumab Plus Platinum-based Chemotherapy Versus Tislelizumab Plus Platinum-based Chemotherapy as Neoadjuvant Therapy in Patients With Resectable Stage Ⅱ-Ⅲ Non-small Cell Lung Cancer: A Phase Ⅲ, Randomized, Multicenter, Prospective Study","SACTION2401","Inclusion Criteria:\n\n* 1\\. Patients voluntarily agree to participate and sign the informed consent; 2. Patients with cytologically\u002Fhistologically diagnosed (by means of percutaneous lung aspiration biopsy, bronchoscopy, mediastinoscopy, etc.), untreated stage IIa-IIIa (according to the AJCC 8th edition of thoracic tumor staging) non-small cell lung cancer. In addition, patients with potentially resectable stage IIIb (T3-4N2) NSCLC will also be enrolled. All patients are required to receive PET\u002FCT (or chest + upper abdominal CT + brain MRI) at baseline for clinical staging; 3. Pulmonary lesions will be assessed as resectable\u002Fpotentially resectable by a multiple disciplinary team including thoracic surgeon; 4. Eastern Cooperative Oncology Group Performance Status 0 to 1 5. Requirements for hematology: i, neutrophils ≥ 1500 x 109\u002FL; ii, platelets ≥ 100 x 109\u002FL; iii, hemoglobin \\> 9.0 g\u002FdL; iv, serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL\u002Fmin; v, aspartate transaminase (AST)\u002Falanine transaminase (ALT) ≤ 3 x ULN; vi, total bilirubin ≤ 1.5 x ULN; vii. forced expiratory volume in the first second (FEV1) ≥ 1.2 L or \\> 40% predicted; viii. International Normalized Ratio\u002Factivated partial thromboplastin time (INR\u002FAPTT) within the normal range; 6. Age 18-75\n\nExclusion Criteria:\n\n* 1\\. Patients with or suspected with autoimmune diseases. Note: patients with vitiligo, type 1 diabetes, hypothyroidism managed with hormone replacement therapy only (Hashimoto's thyroiditis) can be enrolled in the study when there is no clear evidence of recurrence; 2. Patients required systemic corticosteroids treatment (dose \\> 10 mg daily prednisolone \\[or equivalent\\]) or other immunosuppressive drugs within 14 days of enrollment. Note: inhaled or topical corticosteroids, or adrenal replacement therapy (dose \\> 10 mg daily prednisolone \\[or equivalent\\]) are acceptable for patients without apparent autoimmune disease; 3. Historical radiotherapy of chest 4. Active bleeding before treatment 5. Patents with sever heart, lung, liver, or kidney insufficiency 6. Diabetes more than 10-year; unsatisfactory blood glucose control 7. Patients with interstitial lung disease or non-infectious pneumonia 8. EGFR-mutations and ALK-fusion positive NSCLC 9. Patients with other prior malignancies (except skin malignancies other than non-melanoma, and carcinoma in situ at the following sites \\[bladder, stomach, colorectal, endometrium, cervix, melanoma, or breast\\]) are not eligible for enrollment in this study. However, if the prior malignancies remain in complete response (CR) for ≥ 2 years and no additional anti-cancer therapy is required during the study, such patients are permitted to be enrolled; 10. The patient is medically, psychologically, or physiologically unable to complete the study or to understand the Patient Information Sheet, in the opinion of the investigator; 11. Received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA any other drugs specifically targeting T-cell co-stimulation or immunoregulation pathways; 12. Present active hepatitis B or hepatitis C 13. Patients with positive HIV test results or diagnosed with acquired immunodeficiency disease (AIDS); 14. Hypersensitivity to the investigational product; 15. Pregnant or lactating women.",{"count":52,"type":22},360,[54],"PHASE3","The goal of this clinical trial is to compare the efficacy and safety of neoadjuvant Stereotactic Body Radiotherapy (SBRT) combined with immunochemotherapy versus neoadjuvant immunochemotherapy. The main questions it aims to answer are:\n\nDose SBRT combined with immunochemotherapy improve event-free survival? Is SBRT combined with immunochemotherapy safe enough?\n\nParticipants will:\n\nReceive neoadjuvant SBRT combined with immunochemotherapy or neoadjuvant immunochemotherapy.\n\nTumor assessment will be performed prior to surgery. Surgery will be performed within 4 to 6 weeks (+ 7 days) after completion of the last cycle of immunochemotherapy.",[57],"Lung Cancer (NSCLC)",[59,60,61],"NSCLC","SBRT","immunochemotherapy","2025-05-22",{"date":64,"type":35},"2025-05-29",{"date":66,"type":35},"2024-10-15",{"date":68,"type":22},"2030-01-30",{"name":41,"class":42},""]