[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Cancer Hospital, China\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":86},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,63],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100585396","phase-2-a-study-of-the-safety-and-efficacy-of-pemetrexed-combined-with-nivolumab-via-intraventricular-injection-for-the-treatment-of-refractory-non-squamous-non-small-cell-lung-cancer-with-leptomeningeal-metastases-100585396",false,"NCT06901817","A Study of the Safety and Efficacy of Pemetrexed Combined with Nivolumab Via Intraventricular Injection for the Treatment of Refractory Non-squamous Non-small Cell Lung Cancer with Leptomeningeal Metastases","A Multicenter, Prospective, Phase II Study on Intraventricular Injection of Pemetrexed Combined with Nivolumab Via an Ommaya Reservoir for the Treatment of Refractory Non-squamous Non-small Cell Lung Cancer (NSCLC) with Leptomeningeal Metastases in Previously Treated Patients","Inclusion Criteria:\n\n* Patients who sign the informed consent form and are willing to complete the study according to the protocol;\n* Patients must have radiographic and\u002For cerebrospinal fluid cytology evidence of leptomeningeal disease (LMD). The diagnosis of non-small cell lung cancer must be confirmed, based on histological and\u002For cytological diagnosis.\n* Patients must have an ECOG performance status score of ≤ 2.\n* Patients may use steroids to control symptoms related to the central nervous system, but the dose must be ≤ 4 mg of dexamethasone (or equivalent dose) within 24 hours. The patient's neurological symptoms should remain stable for at least 7 days, or they are reducing the dose of steroids. Physiological replacement doses for adrenal insufficiency are allowed.\n* Patients who have received brain and\u002For spinal radiotherapy, including whole-brain radiation, stereotactic radiosurgery, or SBRT, can be enrolled, but must have completed radiation therapy at least 7 days before starting treatment.\n* Patients who have received approved systemic treatments may continue the systemic treatment chosen by the researcher. Concurrent use of other drugs for intrathecal treatment is not allowed. For patients who have received other systemic treatments, the minimum washout periods are as follows:\n\n  1. Patients who have received intrathecal treatment must have had their last treatment at least 7 days before starting the study treatment.\n  2. Patients who have received systemic chemotherapy must have had their last treatment at least 14 days before starting the study treatment.\n  3. Patients who have received approved systemic immunotherapy (such as anti-PD-1, anti-CTLA4) must have had their last treatment at least 2 weeks before starting the study treatment.\n  4. Patients who have received any other investigational drugs must have had their last treatment at least 14 days before starting the study treatment.\n* Age ≥ 18 years.\n* Able to provide written informed consent, including compliance with the requirements and restrictions listed in the consent form.\n* Patients must have the organ and bone marrow function defined in Table 1 below.\n* No contraindications to the installation of an Ommaya reservoir.\n* Criteria for refractory leptomeningeal metastasis:\n\n  1. Failed first- or second-generation TKI treatment, T790M mutation-negative;\n  2. Failed third-generation TKI treatment;\n  3. EGFR gene mutation-negative, failed first-line treatment.\n\nExclusion Criteria:\n\n* Patients who require a VP shunt due to increased intracranial pressure.\n* Patients must not have active autoimmune diseases requiring systemic treatment in the past two years (i.e., using disease-modifying agents, corticosteroids, or immunosuppressive drugs). Alternative therapies (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) are not considered forms of systemic treatment.\n* Subjects who need systemic treatment within 14 days prior to administration of the study drug, including the use of corticosteroids (\\>4 mg daily dexamethasone equivalent dose) or other immunosuppressive drugs. Inhaled or topical steroids and adrenal replacement therapy at a daily replacement dose \\>10 mg prednisone equivalent are allowed in the absence of active autoimmune diseases.\n* Patients who have previously received PD-1 and\u002For anti-CTLA-4 therapy are eligible, unless they are experiencing \\> grade 2 side effects from such treatments. Ongoing physiological replacement doses for adrenal and thyroid insufficiency are allowed in the protocol.\n* Patients currently receiving experimental anti-cancer drugs (co-treatment with approved targeted therapies is permitted).\n* Patients with a history of other malignancies are eligible if they have appropriately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other cancers with no evidence of disease for more than 5 years.\n* Participation in another clinical trial within 30 days prior to randomization, receiving investigational drugs and any concomitant treatments containing investigational drugs.\n* Immunodeficiency, HIV infection;\n* Severe dysfunction of the heart, lungs, liver, or kidneys;\n* Uncontrolled infection or active infection;\n* Pregnant or breastfeeding women.","ALL","18 Years",{"count":19,"type":20},97,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The goal of this clinical trial is to learn if the intraventricular injection of Pemetrexed and Nivolumab works to treat refractory non-squamous non-small cell lung cancer with leptomeningeal metastases. The main questions to answer are:\n\n* Is the combination of Pemetrexed and Nivolumab safe to inject?\n* How effective is the combination in disease control?\n\nParticipants will：\n\n* Intrathecal injection of 30 mg pemetrexed via Ommaya reservoir, once every 4 weeks until disease progression;\n* Intrathecal injection of 40 mg nivolumab via Ommaya reservoir, once every 4 weeks until disease progression;\n* Before each intrathecal administration, a preliminary intrathecal injection of dexamethasone, 5 mg\u002F2 mL, is given.",[26],"Leptomeningeal Metastasis","RECRUITING","2025-03-24",{"date":30,"type":31},"2025-03-30","ACTUAL",{"date":33,"type":31},"2025-03-01",{"date":35,"type":20},"2027-12",{"name":37,"class":38},"Shanghai Cancer Hospital, China","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":39},"100500743","phase-3-armatinib-alone-or-in-combination-with-srt-for-brain-metastases-egfr-mutated-non-small-cell-lung-cancer-100500743","NCT05800223","Armatinib Alone or in Combination With SRT for Brain Metastases EGFR-mutated Non-small Cell Lung Cancer","Prospective, Multicenter, Randomized Controlled, Phase III Clinical Study of Armatinib Alone or in Combination With Stereotactic Body Radiotherapy (SRT) for First-line Treatment of Brain Metastases From EGFR-mutated Non-small Cell Lung Cancer","Inclusion Criteria:\n\n1. aged 18 years or older (including 18 years) and up to 75 years (including 75 years)\n2. histologically confirmed NSCLC (by AJCC 8th edition lung cancer staging criteria)\n3. asymptomatic or minimally symptomatic brain metastases (i.e., headache, nausea, or seizures responding to dexamethasone\u002Fanalgesic\u002Fantiepileptic agents at a stable drug dose for at least 3 days);\n4. brain metastases must meet the following criteria on diagnostic MRI: at least one lesion that can be classified as measurable disease according to RANO-BM, ≤ 10 brain or brainstem metastases\n5. epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutation (alone or in combination with other EGFR mutations);\n6. no prior systemic therapy other than neoadjuvant therapy, adjuvant therapy, or concurrent chemotherapy for more than 3 months prior to study entry\n7. Eastern Cooperative Oncology Organization Group (ECOG) physical status score of 0 or 1 and no worsening in the previous 2 weeks, with a minimum expected survival of 12 weeks.\n8. good hematopoietic function, defined as absolute neutrophil count ≥ 1.5 × 109 \u002FL, platelet count ≥ 100 × 109 \u002FL, and hemoglobin ≥ 90 g\u002FL \\[no transfusion or erythropoietin (EPO-dependent) within 7 days\n9. good coagulation, defined as an international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; if the subject is on anticoagulation therapy, as long as the PT is within the proposed range of anticoagulant medication\n10. good liver function, defined as a total bilirubin level ≤ 1.5 times the upper limit of normal (ULN); glutathione transaminase (AST) and glutamate transaminase (ALT) levels ≤ 2.5 times the ULN for patients without liver metastases; and AST and ALT levels ≤ 5 times the ULN for patients with documented liver metastases\n11. good renal function, defined as serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance ≥ 60 ml\u002Fmin; urine protein less than 2+ on routine urine examination, or 24-hour urine protein quantification \\\u003C 1 g\n12. Women of childbearing potential should have a negative urine or serum pregnancy test within 3 days prior to receiving the first dose of study drug (Week 1, Day 1).\n13. male patients should be using barrier contraception (i.e., condoms) from screening until 6 months after discontinuation of study treatment\n14. Subjects will voluntarily participate and sign an informed consent in writing.\n\nExclusion Criteria:\n\n1. Received any of the following treatments:\n\n   1. Currently participating in an interventional clinical study treatment or received another study drug within 4 weeks prior to the first dose\n   2. Received palliative intracranial radiation therapy prior to the first dose\n   3. Patient has undergone major surgery (including biopsy) or major trauma within 4 weeks prior to the first dose of study drug; patients who are expected to require major surgery during the study period\n   4. Patients previously treated with EGFR-TKI.\n2. patients with NSCLC EGFR driver gene negative or known severe allergic reactions (≥ grade 3) to TKIs drugs;\n3. patients who are unable to undergo MR examination\n4. brain metastases requiring surgical decompression;\n5. the presence of a previous solid organ or hematologic transplant; clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction; the presence of clinically uncontrollable pleural effusion\u002Fperitoneal effusion\n6. malignancy other than non-small cell lung cancer within 5 years prior to enrollment, excluding adequately treated carcinoma in situ of the cervix, basal cell or squamous epithelial cell skin cancer of the skin, localized prostate cancer after radical surgery, and ductal carcinoma in situ of the breast;\n7. having unremitting residual toxicity of prior therapy greater than CTCAE grade 1 at the time of initiation of study treatment, with the exception of alopecia and grade 2 neurotoxicity from prior chemotherapy;\n8. have any serious or poorly controlled systemic disease, such as active bleeding-prone body or active infection, as judged by the investigator. Chronic illnesses that do not require exclusion;\n9. the known presence of a psychiatric illness or substance abuse condition that may have an impact on compliance with trial requirements\n10. any serious or uncontrolled ocular pathology that, in the judgment of the physician, may increase the safety risk to the patient\n11. a known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1\u002F2 antibody positive)\n12. patients who, in the judgment of the investigator, are likely to be poorly compliant with the procedures and requirements of the study.","75 Years",{"count":49,"type":20},300,[51],"PHASE3","Objective:Patients with asymptomatic or minimally symptomatic Stage IV EGFR-positive NSCLC with baseline intracranial metastases.\n\nAim: To investigate the timing, efficacy and safety of radiotherapy in patients with EGFR positive brain metastases treated with armatinib alone or combined with stereotactic radiotherapy.\n\nMethod: Almonertinib: specification 55mg\u002Ftablet; The dosage is 110 mg \u002F day (2 tablets \u002F day) orally once a day; SBRT: 3-5 doses of 27-40 Gy",[54],"Non-small Cell Lung Cancer Metastatic","2023-03-23",{"date":57,"type":31},"2023-04-05",{"date":59,"type":31},"2023-01-01",{"date":61,"type":20},"2028-12",{"name":37,"class":38},{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":72,"phases":4,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":39},"100402624","influence-of-radiotherapy-and-chemotherapy-in-the-value-of-peripheral-blood-lymphocyte-subsets-among-thoracic-cancer-100402624","NCT04522687","Influence of Radiotherapy and Chemotherapy in the Value of Peripheral Blood Lymphocyte Subsets Among Thoracic Cancer","Observation of the Impact of Radiotherapy With or Without Chemotherapy in the Value of Peripheral Blood Lymphocyte Subsets for Patients With Thoracic Cancer","Inclusion Criteria:\n\nAge at least 18 years. ECOG PS 0-1. Pathologically confirmed NSCLC, esophageal squamous cell carcinoma or thymic epithelial tumor.\n\nLife expectancy of more than 3 months. Patients with no indications for palliative radiotherapy in the opinion of the investigator.\n\nPatients with a prior history of surgery are eligible if they have recovered adequately from the toxicity and\u002For complications of surgery.\n\nSigned informed consent for the use of fresh tumor biopsies before and during the treatment.\n\nWomen of childbearing age and men must agree to use effective contraception during the trial.\n\nAdequate organ function within 1 week prior to the enrollment：\n\n1. Adequate bone marrow function: hemoglobin ≥80g\u002FL, white blood cell (WBC) count ≥ 4.0 \\* 10 \\^ 9\u002FL or neutrophil count ≥ 1.5 \\* 10 \\^ 9\u002FL, and platelet count ≥ 100 \\* 10 \\^ 9\u002FL;\n2. Adequate hepatic function: total bilirubin \\\u003C 1.5 x upper limit of normal (ULN). Note: If total bilirubin is \\> 1.5 x ULN, direct bilirubin must ≤ ULN, Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.5 ULN;\n3. Adequate renal function: serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL\u002Fmin;\n\nExclusion Criteria:\n\nPregnant or lactating women. History of any other malignancy. Patients in whom palliative radiotherapy is indicated in the opinion of the investigator.\n\nActive infection, congestive heart failure, myocardial infarction within the 6 months prior to enrollment, unstable angina pectoris or cardiac arrhythmia.\n\nPatients who have received tumor vaccine; or administration of live, attenuated vaccine within 4 weeks before the start of treatment.\n\nMental disorders, drug abuse, and social condition that may negatively impact compliance in the opinion of the investigator.",{"count":71,"type":20},500,"OBSERVATIONAL","This study is an observation, single center study to evaluate the alternations and prognostic value of peripheral blood lymphocyte (PBL) in patients diagnosed with thoracic cancers, including lung cancer, esophageal squamous cell carcinoma and thymic epithelial carcinoma underwent radiotherapy with or without chemotherapy.",[75,76,77],"NSCLC","Esophageal Squamous Cell Carcinoma","Thymic Epithelial Tumor","2020-08-19",{"date":80,"type":31},"2020-08-21",{"date":82,"type":31},"2012-01-01",{"date":84,"type":20},"2026-12",{"name":37,"class":38},""]