[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ji Yongling\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":92},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,67],{"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":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100622595","phase-2-neoadjuvant-chemoimmunotherapy-or-chemoradiotherapy-in-escc-100622595",false,"NCT07385664","Neoadjuvant Chemoimmunotherapy or Chemoradiotherapy in ESCC","A Phase II Study of Neoadjuvant Chemoimmunotherapy or Concurrent Chemoradiotherapy Guided by Post-Chemoimmunotherapy FAPI-PET\u002FCT","FAIR","Inclusion Criteria:\n\n* Be able to understand and voluntarily provide written informed consent before any procedures required for the study are performed.\n* Age between 18 and 75 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status score 0-1.\n* Histologically confirmed esophageal squamous cell carcinoma.\n* T1N1-3M0 or T2-4aNanyM0 as determined by endoscopic ultrasound (EUS) or magnetic resonance imaging (MRI) and PET\u002FCT. All lesions, including tumor and lymph nodes, were required to be resectable.\n* Tumors with strong FAPI uptake on baseline PET\u002FCT scan should have a maximum standardized uptake value (SUVmax) ≥5.0.\n* Subjects were required to provide preoperative paraffin blocks or white slides of tumor tissue, or freshly collected samples, including at least 3 unstained FFPE pathological slides.\n* Female subjects of childbearing potential must have a urine or serum pregnancy test with a negative result within 3 days before the first dose. If urine testing could not confirm the negative result, serum testing was required. Participants who had sex with an unsterilized male partner were required to use an effective contraceptive method from the time of screening and to agree to continue using a contraceptive method for 120 days after the last dose. Discontinuation of contraception after 120 days was discussed with the investigator.\n* Unsterilized male subjects who have sex with a female partner of childbearing potential are required to use effective contraception from the time of screening until 120 days after the last dose; Discontinuation of contraception after 120 days is also discussed with the investigator.\n* Laboratory tests must meet the following criteria:\n\nAbsolute neutrophil count (ANC) ≥ 1500 \u002FµL Platelet count ≥ 100,000\u002FµL Total bilirubin ≤ 2.5 times the upper limit of normal Creatinine clearance (calculated by the following formula) ≥ 60 mL\u002F minute AST\u002FALT ≤ 1.5 times the upper limit of normal The modified Cockcroft-Gault equation was used to estimate creatinine clearance (Clcr) : \\*\\*\n\nFor serum creatinine concentration (Sr Cr) expressed in mg\u002FdL:\n\nClcr (mL\u002Fmin) = (140-age) × actual weight (kg)\u002F(72 × Sr Cr(mg\u002FdL)) Results for women were calculated using 85% of the Clcr values for men.\n\nExclusion Criteria:\n\n* A history of malignant tumors within the past five years prior to registration (excluding basal cell carcinoma, squamous cell skin cancer, carcinoma in situ of the bladder, or cervical cancer). Patients who have undergone surgical treatment and have remained disease-free for over five years are still eligible for inclusion.\n* Known contraindications include severe allergic reactions to taxanes, platinum-based drugs, 5-FU medications, etc.\n* Patients with a documented history of severe allergic reactions to sintilimab.\n* Patients who are unwilling or unable to adhere to visit schedules, treatment plans, laboratory tests, and other study requirements.\n* Previous radiotherapy administered to the chest or abdomen.\n* Patients who have received treatments involving platinum agents, taxanes, 5-FU drugs or PD-1 inhibitors.\n* T4 stage tumors exhibiting definite invasion into the spine, heart, major blood vessels or tracheobronchial tree.\n* Patients with confirmed cervical or supraclavicular lymph node metastasis or other metastatic lymph nodes that cannot be included in the radiotherapy field nor removed during esophagectomy.\n* Patients diagnosed with distant metastases through PET\u002FCT scans or other examinations indicating liver, lung or bone metastases.\n* Individuals suffering from significant uncontrolled cardiovascular diseases (such as heart failure), severe coronary artery disease or recent myocardial infarction; also includes those with serious conditions affecting liver or kidney function (e.g., renal insufficiency or liver cirrhosis).\n* History of severe central nervous system disorders or mental health issues that may impact treatment compliance and study monitoring.\n* Individuals presenting severe surgical contraindications that render them unable to tolerate surgery.","ALL","18 Years","75 Years",{"count":21,"type":22},66,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This study was a single-arm, two-cohort, phase II trial aimed at evaluating the efficacy and safety of FAPI-PET\u002FCT response for guiding the selection of neoadjuvant treatment modes after chemotherapy combined with immunotherapy.",[28],"Resectable Esophageal Cancer",[30,28,31],"FAPI-PET\u002FCT","Neoadjuvant Therapy","NOT_YET_RECRUITING","2026-01-26",{"date":35,"type":36},"2026-02-04","ACTUAL",{"date":38,"type":22},"2026-01-28",{"date":40,"type":22},"2028-02-01",{"name":42,"class":43},"Ji Yongling","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":44},"100545222","phase-2-radiation-therapy-followed-by-tislelizumab-and-anlotinib-aeoadjuvantadjuvant-therapy-for-stage-ii-iiia-nsclc-100545222","NCT06379087","Radiation Therapy Followed by Tislelizumab and Anlotinib Aeoadjuvant\u002FAdjuvant Therapy for Stage II-IIIA NSCLC","Prospective Phase II Study of Hypofractionated Radiotherapy Sequential Tislelizumab and Anlotinib in the Neoadjuvant and Adjuvant Therapy for Stage II-IIIA Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* (1) Aged 18-75 years old;\n* (2) Early stage II-IIIA NSCLC (AJCC 8th edition), NSCLC, confirmed in tissue (AJCC eighth edition);\n* (3) All lesions are assessed to be eligible for surgical resection;\n* (4) The primary tumor can be treated with hypofractionated radiotherapy after evaluation;\n* (5) Epidermal growth factor receptor\u002Fanaplastic lymphoma kinase\u002FROS1 gene fusions mutation was negative in primary tumor or lymph node metastasis;\n* (6) ECOG PS score: 0\\~1;\n* (7) Expected survival more than 1 year;\n* (8) At least one measurable lesion (RECIST 1.1);\n* (9) Females of childbearing potential should agree to use contraceptive measures (such as intrauterine device, contraceptives or condoms) during the study and within 3 months after the end of the study; have a negative serum or urine pregnancy test within 7 days before study enrollment and must be non-lactating subjects; and males should agree to use contraceptive measures during the study and within 3 months after the end of the study period;\n* (10) Subjects voluntarily participate in this study, sign the informed consent form and had good compliance;\n* (11) Subjects are suitable after MDT discussion.\n\nExclusion Criteria:\n\nParticipants with any of the following criteria were excluded from the trial:\n\n* (1) The location of the primary tumor was assessed by the radiologist and considered unsuitable for hypofractionated therapy;\n* (2) The pathological type is small cell lung cancer, or mixed tumor with small cell components;\n* (3) A history of or concurrent with other malignancies;\n* (4) Received any anti-tumor treatment before this study, including chemotherapy, radiotherapy, targeted therapy (including but not limited to monoclonal antibodies, small molecule tyrosine kinase inhibitors, etc.) and immunotherapy;\n* (5) The Imaging (CT\u002FMR\u002FPET-CT) showed tumor invasion of great vessels or blurred boundary with blood vessels, or the presence of any pulmonary cavity or necrotic lesions;\n* (6) Hemoptysis, active bleeding, ulcer, intestinal perforation, intestinal obstruction within 3 months before enrollment;\n* (7) Previous interstitial lung disease, drug-induced interstitial disease or any clinical evidence of active interstitial lung disease; baseline CT scan found idiopathic pulmonary fibrosis;\n* (8) According to the investigator's judgment, there are serious or uncontrollable systemic diseases (such as unstable or uncompensated respiratory, cardiac, hepatic or renal diseases) or any unstable systemic diseases (including active infection, grade III hypertension, unstable angina, congestive heart failure, liver and kidney or metabolic diseases);\n* (9) Previous treatment with anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs acting on another co-inhibitory T cell receptor (e.g., CTLA-4, OX-40, CD137);\n* (10) The presence of uncontrollable third space effusion, such as a large number of pleural effusion or ascites or pericardial effusion;\n* (11) Urine routine showed urine protein ≥ + +, or 24h urine protein ≥ 1g or severe liver and kidney dysfunction;\n* (12) Uncontrollable hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg);\n* (13) Subjects requiring systemic treatment with corticosteroids (\\> 10 mg\u002Fday prednisone or equivalent) or other immunosuppressive agents within 14 days before the first dose;\n* (14) Hyperactive\u002Fvenous thrombotic events occurred within 6 months, such as cerebrovascular accident (including cerebral hemorrhage, cerebral infarction, temporary ischemic attack, etc.);\n* (15) Excessive surgery or significant trauma within 28 days before enrollment;\n* (16) Pregnant or lactating women;\n* (17) Subjects who are considered to be unsuitable for enrollment for other reasons according to the judgment of the investigators..",{"count":53,"type":22},20,[25],"This study is a single-center, prospective, single-arm exploratory clinical study of hypofractionated radiotherapy followed by tislelizumab and anlotinib neoadjuvant and adjuvant therapy. It is designed for patients with stage II-IIIA non-small cell lung cancer. The efficacy and safety of hypofractionated radiotherapy sequential tislelizumab and anlotinib in the neoadjuvant and adjuvant treatment of stage II-IIIA non-small cell lung cancer are observed. Finally, it provides new evidence-based medical evidence for the perioperative treatment of non-small cell lung cancer.",[57],"Non-Small Cell Lung Cancer","RECRUITING","2025-07-06",{"date":61,"type":36},"2025-07-10",{"date":63,"type":36},"2024-05-01",{"date":65,"type":22},"2026-12-31",{"name":42,"class":43},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":74,"targetDuration":4,"studyType":76,"phases":4,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":44},"100595700","efficacy-and-safety-of-chemoimmunotherapy-and-carbon-ion-radiotherapy-in-unresectable-locally-advanced-non-small-cell-lung-cancer-100595700","NCT07035860","Efficacy and Safety of Chemoimmunotherapy and Carbon Ion Radiotherapy in Unresectable Locally Advanced Non-small Cell Lung Cancer","Efficacy and Safety of Induction Chemoimmunotherapy Followed by Carbon Ion Radiotherapy and Consolidation Immunotherapy in Unresectable Locally Advanced Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* Unresectable, locally advanced non-small cell lung cancer (according to the 8th edition of the AJCC staging system).\n* No prior anti-cancer treatment.\n* No significant internal medical conditions or major organ dysfunction.\n\nExclusion Criteria:\n\n* Histological evidence of small cell lung cancer or other primary malignancies\n* EGFR, ALK, or ROS-1 gene mutations.\n* Active or prior autoimmune\u002Finflammatory disorders.\n* Inability to comply with study protocol as judged by the investigator.",{"count":75,"type":22},34,"OBSERVATIONAL","This is the first prospective clinical study to evaluate the efficacy and safety of induction chemoimmunotherapy followed by carbon ion radiotherapy and consolidation immunotherapy in patients with unresectable locally advanced non-small cell lung cancer (NSCLC). Based on this prospective study, tumor tissue, blood, urine, and stool samples from participants will be collected and analyzed to identify predictive markers of treatment response.",[79],"Carbon Ion Radiotheray",[81,82,83],"non-small cell lung cancer","carbon ion radiotherapy","immunotherapy","2025-06-17",{"date":86,"type":36},"2025-06-25",{"date":88,"type":22},"2025-06-16",{"date":90,"type":22},"2028-06-15",{"name":42,"class":43},""]