[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Daping Hospital and the Research Institute of Surgery of the Third Military Medical University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":587},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,39,0,25,[9,48,71,100,122,147,163,182,198,219,241,267,291,317,342,368,392,414,440,457,479,499,517,542,565],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100627841","phase-1-ldrt-sequential-nips-immunochemotherapy-for-peritoneal-metastasis-of-gastric-and-colorectal-cancer-100627841",false,"NCT07453875","LDRT Sequential NIPS Immunochemotherapy for Peritoneal Metastasis of Gastric and Colorectal Cancer","A Prospective, Single-center, Single-arm Clinical Study on the Safety and Efficacy of LDRT Sequential NIPS Immunochemotherapy for Peritoneal Metastasis of Gastric and Colorectal Cancer","TRIUNITE06","Inclusion Criteria:\n\n1. Age between18 and 75 years old.\n2. Histologically confirmed gastric cancer\u002Fcolon cancer, and diagnosed as peritoneal metastasis of tumor through laparoscopy\u002Fpuncture (patients must have metastatic tumors located within the peritoneal cavity).\n3. An Eastern Cooperative Oncology Group (ECOG) performance status ≤2.\n4. According to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, patients must have measurable disease within the irradiated area.\n5. Expected survival period≥3 months\n6. Adequate cardiac function (Left Ventricular Ejection Fractions \\> 50%), hepatic function (total serum bilirubin ≤ 1.5 ×upper limit of normal, alanine aminotransferase or aspartate aminotransferase ≤ 2.5 × upper limit of normal), renal function (serum creatinine ≤ 1.5 × ULN or glomerular filtration rate \\> 60 ml\u002Fmin, based on Cockcroft-Gault), and hematopoietic function (white blood cells ≥ 4.0 × 109 cells per L, neutrophils ≥ 1.5 × 109 cells per L, hemoglobin ≥ 90 g\u002FL, platelets ≥ 100 × 109 cells per L).\n7. Sign the informed consent and have good compliance.\n\nExclusion Criteria:\n\n1. Presence of distant metastasis other than peritoneal metastasis (ovarian metastasis is allowed);\n2. Presence of uncontrolled clinical symptoms or diseases of the heart, including but not limited to: (1) NYHA class II or above heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias that have not been clinically intervened or remain uncontrolled after clinical intervention;\n3. Upper gastrointestinal obstruction or physiological dysfunction, or suffering from malabsorption syndrome, which may affect the absorption of oral drugs;\n4. Severe infection (CTCAE \\> grade 2) or other concomitant diseases within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, or infectious complications requiring hospitalization; baseline chest imaging shows active pulmonary inflammation, or symptoms and signs of infection within 14 days before the first use of the study drug, or requiring oral or intravenous antibiotic treatment, except for prophylactic use of antibiotics; active pulmonary tuberculosis infection is found through medical history or CT examination, or there is a history of active pulmonary tuberculosis within 1 year before enrollment, or there is a history of active pulmonary tuberculosis more than 1 year ago but without regular treatment;\n5. History of immunodeficiency (including positive HIV test, or suffering from other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation or allogeneic bone marrow transplantation);\n6. Moderate or severe renal impairment (creatinine clearance ≤ 50 ml\u002Fmin);\n7. Allergy to paclitaxel, oxaliplatin, monoclonal antibodies or any component of the study drug;\n8. Pregnant or lactating women;\n9. Presence of clinically detectable second primary malignancy, or a history of other malignancies within 5 years, excluding adequately treated non-melanoma skin cancer, cervical carcinoma in situ, and superficial bladder tumors (non-invasive tumors, or carcinoma in situ, or T1);\n10. Uncontrolled epilepsy, central nervous system disease or mental disorder, as judged by the investigator to be clinically significant enough to prevent signing the informed consent or affect the patient's compliance with drug treatment.","ALL","18 Years","75 Years",{"count":22,"type":23},9,"ESTIMATED","INTERVENTIONAL",[26],"PHASE1","There have been initial explorations on the treatment of peritoneal metastasis of gastric and colorectal cancer both at home and abroad. However, the comprehensive treatment plan of \"LDRT + NIPEC + immunotherapy + systemic therapy\" has not been reported either domestically or internationally. This study will explore the safety and efficacy of total abdominal low-dose radiotherapy followed by NIPEC and PD-1 treatment for peritoneal metastasis of gastric and colorectal cancer. 9-18 participants will be enrolled in this study. All will take part at Daping Hospital, Army Medical University.",[29,30],"Peritoneal Metastasis of Gastric and Colorectal Cancer","LDRT",[32,30,33,34],"Gastric and colorectal cancer","NIPS","Immunochemotherapy","NOT_YET_RECRUITING","2026-04-22",{"date":38,"type":39},"2026-04-27","ACTUAL",{"date":41,"type":23},"2026-05",{"date":43,"type":23},"2027-12-30",{"name":45,"class":46},"Daping Hospital and the Research Institute of Surgery of the Third Military Medical University","OTHER",2,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":24,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":47},"100581296","phase-1-ldrt-combined-with-immunochemotherapy-for-colorectal-cancer-with-liver-metastasis-100581296","NCT06848465","LDRT Combined With Immunochemotherapy for Colorectal Cancer With Liver Metastasis","A Phase Ib Trial on the Safety and Feasibility of Low Dose Radiotherapy (LDRT) Combined With Immunochemotherapy for Colorectal Cancer With Liver-limited Metastasis","Inclusion Criteria:\n\n1. Age between18 and 75 years old.\n2. Histopathological confirmed MSS\u002FpMMR adenocarcinoma of the colon or rectum.\n3. The clinical baseline stage of rectal cancer assessed by MRI\u002FCT\u002FTransrectal ultrasound was T3-4Nx or TXN1-2.\n4. Simultaneous liver metastasis confirmed by imaging examination.\n5. No previous antitumor treatment.\n6. An Eastern Cooperative Oncology Group (ECOG) performance status ≤1.\n7. Adequate cardiac function (Left Ventricular Ejection Fractions \\> 50%), hepatic function (total serum bilirubin ≤ 1.5 × upper limit of normal, alanine aminotransferase or aspartate aminotransferase ≤ 2.5 × upper limit of normal), renal function (serum creatinine ≤ 1.5 × ULN or glomerular filtration rate \\> 60 ml\u002Fmin, based on Cockcroft-Gault), and hematopoietic function (white blood cells ≥ 4.0 × 109 cells per L, neutrophils ≥ 1.5 × 109 cells per L, hemoglobin ≥ 90 g\u002FL, platelets ≥ 100 × 109 cells per L).\n8. Sign the informed consent and have good compliance.\n\nExclusion Criteria:\n\n1. Distant metastasis from other than the liver.\n2. BMI \\\u003C 18.5 kg\u002Fm² or weight loss ≥ 10% within the past 6 months (with consideration of the impact of large amounts of pleural and ascitic fluid on body weight).\n3. Received any of the following treatments: any investigational drug; enrolled in another clinical trial concurrently, unless it is an observational (non-interventional) clinical study; received anti-tumor vaccines or live vaccines.\n4. Active autoimmune diseases, or a history of autoimmune diseases. A history of liver disease including, but not limited to HBV infection or HBV DNA positive(≥1×10\\^4\u002Fml), HCV infection or HCV DNA positive(≥1×10\\^3\u002Fml) and liver cirrhosis.\n5. History of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow transplantation.\n6. A history of heart disease within 6 months (including congestive heart failure, acute myocardial infarction, severe\u002Funstable angina, coronary artery bypass grafting, cardiac insufficiency ≥ NYHA grade 2 and LVEF\\\u003C50%).\n7. The presence of a clinically detectable second primary malignancy, or history of other malignancies within 5 years excluding adequately treated non-melanoma skin cancer, carcinoma in situ of cervix and superficial bladder tumour (non-invasive tumour, or carcinoma in situ, or T1).\n8. Pregnant or lactating women.\n9. The investigator considers that the subject is not suitable to participate in this clinical study due to any clinical or laboratory abnormalities or compliance problems.","80 Years",{"count":22,"type":23},[26],"In recent years, growing evidences have demonstrated promising synergistic antitumor effects of radiotherapy combined with immunotherapy. More over, LDRT may enhance the antitumor effect of immunotherapy by altering the tumor immune microenvironment (TIME) and adjusting the immune response. In this study, we will explore the safety and feasibility of LDRT and immunochemotherapy in liver metastatic colorectal cancer. 9-18 participants will be enrolled in this study. All will take part at Daping Hospital, Army Medical University.",[60,61,30],"Colorectal Cancer","Liver Metastasis","RECRUITING","2026-04-02",{"date":65,"type":39},"2026-04-03",{"date":67,"type":39},"2025-02-28",{"date":69,"type":23},"2027-11-30",{"name":45,"class":46},{"id":72,"slug":73,"hasResults":12,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":55,"enrollmentInfo":79,"targetDuration":4,"studyType":24,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},"100628975","phase-2-tolecizumab-plus-chemoimmunotherapy-for-pmmrmss-locally-advanced-colon-adenocarcinoma-100628975","NCT07468630","Tolecizumab Plus Chemoimmunotherapy for pMMR\u002FMSS Locally Advanced Colon Adenocarcinoma","A Multicenter, Randomized, Open-Label, Blinded-Endpoint Phase II Study of Tolecizumab (a PCSK9 Inhibitor) Enhancing Chemoimmunotherapy as Neoadjuvant Treatment for Patients With pMMR\u002FMSS Locally Advanced Colon Adenocarcinoma (TRIUNITE-08)","TRIUNITE-08","Inclusion Criteria:\n\n* Signed the written informed consent form and voluntarily participate in the study.\n\nPathohistologically confirmed colon adenocarcinoma with cT3c stage or above. Aged 18 to 80 years, regardless of gender. The lower edge of the tumor is more than 10 cm from the anus. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Sufficient bone marrow, liver, kidney and coagulation functions assessed by laboratory tests (in accordance with the local laboratory reference range).\n\nNo previous anti-tumor treatment for the current colon cancer (including radiotherapy, chemotherapy, surgery, etc.).\n\nNo pregnancy or lactation for female patients; male patients agree to take effective contraceptive measures during the study.\n\nExclusion Criteria:\n\n* Previous anti-tumor treatment for the current colon cancer. Previous use of PCSK9 inhibitors or PD-1\u002FPD-L1 inhibitors. Active autoimmune diseases or a history of autoimmune diseases. Receiving immunosuppressant or systemic glucocorticoid therapy (except for local low-dose glucocorticoid use).\n\nActive infection requiring systemic anti-infective treatment. Severe cardiovascular diseases (e.g., severe hypertension, myocardial infarction, heart failure, etc.).\n\nComplicated primary tumor (e.g., tumor perforation, intestinal obstruction without relief after intervention).\n\nPregnant or lactating women. Other conditions that the investigator deems unfit for participation in the study (e.g., poor compliance, severe organ dysfunction, etc.).",{"count":80,"type":23},106,[82],"PHASE2","This multicenter, randomized, open-label, blinded-endpoint Phase II trial assesses the efficacy and safety of tolecizumab (PCSK9 inhibitor) plus sintilimab\u002FCapeOX chemoimmunotherapy as neoadjuvant treatment for pMMR\u002FMSS locally advanced colon adenocarcinoma (cT3c+). 106 patients are 1:1 randomized to the combination or chemoimmunotherapy alone, with pCR as the primary endpoint.",[85],"Colon Adenocarcinoma",[87,88,89,90],"pMMR\u002FMSS","neoadjuvant immunochemotherapy","PCSK9 inhibitor","Tolecizumab","2026-03-09",{"date":93,"type":39},"2026-03-12",{"date":95,"type":23},"2026-04-10",{"date":97,"type":23},"2028-12-31",{"name":45,"class":46},1,{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":55,"enrollmentInfo":108,"targetDuration":4,"studyType":24,"phases":110,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":116,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":4},"100628895","phase-2-combination-of-high-and-low-dose-radiotherapy-with-immune-therapy-and-tki-in-advanced-colorectal-cancer-a-phase-ii-study-100628895","NCT07467590","Combination of High and Low-Dose Radiotherapy With Immune Therapy and TKI in Advanced Colorectal Cancer: A Phase II Study","Efficacy of Combined High and Low-Dose Radiotherapy With Immune Therapy and Tyrosine Kinase Inhibitors (TKI) as a Second-Line or Later Treatment Strategy for Advanced Colorectal Cancer: A Single-Arm, Open-Label Phase II Study","TRIUNITE-07","Inclusion Criteria:\n\n1. Ability to understand and willingness to sign a written informed consent form.\n2. Age 18-80 years, male or female.\n3. Histologically confirmed microsatellite stable (MSS) \u002F proficient mismatch repair (pMMR) colorectal adenocarcinoma.\n4. Clinical stage IV disease confirmed by systemic imaging. At least two measurable metastatic lesions per RECIST 1.1, including:\n\n   At least one lesion ≥2 cm in diameter and at least one lesion \\\u003C2 cm in diameter;\n\n   For lesions within the same organ, at least one lesion ≥2 cm and one lesion \\\u003C2 cm must be located within independent, non-overlapping radiation fields;\n\n   For lesions in different organs, high-dose and low-dose radiotherapy should preferably be delivered to lesions in different organs.\n\n   Second-line or later treatment setting, defined as disease progression after prior platinum- and irinotecan-based chemotherapy, including:\n5. Failure after first-line triplet chemotherapy containing platinum and irinotecan; Or failure after first-line platinum-based chemotherapy followed by second-line irinotecan-based chemotherapy.\n6. Ability to swallow oral medication.\n7. ECOG performance status 0-1.\n8. Adequate organ function as defined by laboratory criteria.\n\nExclusion Criteria:\n\nDiffuse miliary liver or lung metastases, or bulky metastatic lesions ≥10 cm in diameter.\n\nPresence of brain metastases.\n\n1. History of severe hypersensitivity to monoclonal antibodies or anti-angiogenic agents.\n2. Prior exposure to immune checkpoint inhibitors (including anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies), immune checkpoint agonists (e.g., targeting ICOS, CD40, CD137, GITR, OX40), or any prior cancer immunotherapy.\n3. Active autoimmune disease or history of autoimmune disease, including but not limited to interstitial pneumonitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism (patients on stable hormone replacement therapy may be eligible). Patients with psoriasis or childhood asthma\u002Fallergy that has completely resolved and requires no adult intervention may be eligible; patients requiring bronchodilator therapy are excluded.\n4. History of immunodeficiency, including positive HIV test, congenital or acquired immunodeficiency, prior organ transplantation, or allogeneic bone marrow transplantation.\n5. Uncontrolled cardiovascular disease, including:\n\n   NYHA class II or higher heart failure;\n6. Unstable angina;\n7. Myocardial infarction within 1 year;\n8. Clinically significant uncontrolled supraventricular or ventricular arrhythmias.\n9. Severe infection (CTCAE grade \\>2) within 4 weeks prior to first study treatment, including severe pneumonia, bacteremia, or infection requiring hospitalization. Active pulmonary inflammation on baseline imaging, signs or symptoms of infection within 14 days before treatment requiring systemic antibiotics (except prophylactic antibiotics), or active tuberculosis (current or within 1 year without adequate treatment).\n10. Active hepatitis B (HBV DNA ≥2000 IU\u002FmL) or active hepatitis C (positive HCV antibody with detectable HCV RNA above the lower limit of detection).\n11. Diagnosis of another malignancy within 5 years prior to first study treatment, except for malignancies with low risk of metastasis or death (5-year survival rate \\>90%), such as adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.\n12. Pregnant or breastfeeding women.",{"count":109,"type":23},33,[82],"The goal of this clinical trial is to learn whether a high- and low-dose radiotherapy regimen followed by anti-angiogenic TKI and anti-PD-1 antibody therapy works to treat advanced metastatic colorectal cancer. It will also evaluate long-term survival outcomes and explore potential biomarkers associated with tumor response and immune modulation.\n\nThe main questions it aims to answer are:\n\nDoes the high- and low-dose radiotherapy regimen followed by sequential anti-angiogenic TKI and anti-PD-1 therapy improve the objective response rate (ORR) in patients with advanced metastatic colorectal cancer?\n\nWhat are the disease control rate (DCR) and survival outcomes following this treatment strategy?\n\nAre tumor response and long-term survival associated with specific biomarkers related to systemic immune modulation induced by radiotherapy to different metastatic organs?\n\nHow does this radiotherapy pattern affect tumor immune infiltration in metastatic lesions?\n\nThis is a single-arm, single-center, prospective Phase II clinical study designed to evaluate the efficacy of a high- and low-dose radiotherapy regimen targeting metastatic lesions followed by sequential anti-angiogenic TKI and anti-PD-1 antibody therapy in patients with advanced metastatic colorectal cancer.\n\nParticipants will:\n\nReceive high- and low-dose radiotherapy to metastatic lesions. Subsequently receive anti-angiogenic TKI combined with anti-PD-1 antibody therapy.\n\nUndergo regular clinical assessments and imaging evaluations to determine tumor response.\n\nProvide blood and tumor samples for biomarker and immune infiltration analysis. Be followed for survival outcomes and disease progression.",[113,114,115],"Refractory Colorectal Cancer","Radiotherapy-Induced Immune Priming","Immune Response",{"date":93,"type":39},{"date":118,"type":23},"2026-04-01",{"date":120,"type":23},"2029-04-01",{"name":45,"class":46},{"id":123,"slug":124,"hasResults":12,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":131,"phases":4,"briefSummary":132,"conditions":133,"keywords":135,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":144,"leadSponsor":146,"locationsCount":99},"100628249","clinical-study-on-the-application-of-pet-probes-targeting-ddr2-in-the-diagnosis-of-interstitial-lung-disease-with-cognitive-impairment-100628249","NCT07459179","Clinical Study on the Application of PET Probes Targeting DDR2 in the Diagnosis of Interstitial Lung Disease With Cognitive Impairment","Clinical Study on the Application of Positron Emission Tomography (PET) Probes Targeting DDR2 in the Diagnosis of Interstitial Lung Disease and Interstitial Lung Disease With Cognitive Impairment","Inclusion Criteria:\n\n* No gender restriction, age ≥18 years (inclusive);\n* Patients with interstitial lung disease who meet one of the following diagnoses: connective tissue disease-associated interstitial lung disease (CTD-ILD), idiopathic nonspecific interstitial pneumonia (iNSIP), chronic allergic pneumonia, sarcoidosis, environmental\u002Foccupational lung disease, or unclassifiable idiopathic interstitial disease (IIP);\n* Screening subjects who were definitively diagnosed with interstitial lung disease (ILD) by high-resolution computed tomography (HRCT) within the preceding 6 months;\n* In the first 3 months prior to screening, the carbon monoxide diffusion capacity (DLCO) (Hb-corrected) was within 30% to 80% (inclusive) of the predicted value; the forced vital capacity (FVC) was within 40% to 70% (inclusive) of the predicted value;\n* The chief complaint is memory decline or other symptoms of cognitive impairment, with a disease course of ≥3 months;\n* meets the diagnostic criteria for cognitive impairment caused by Alzheimer's disease (AD), mild cognitive impairment (MCI), or other related neurodegenerative diseases;\n* The scores on the cognitive function screening scale meet the criteria for cognitive impairment (e.g., Mini-Mental State Examination (MMSE) \\\u003C24 points, or Montreal Cognitive Assessment (MoCA) \\\u003C26 points);\n* Exclusion of cognitive dysfunction caused by severe depression, brain trauma, brain tumors, cerebrovascular accidents, etc.\n\nExclusion Criteria:\n\n* patients in critical condition requiring emergency care;\n* Individuals with drug and\u002For alcohol abuse, or those with allergic predisposition;\n* women of childbearing potential, pregnant and lactating women;\n* bacterial, viral or fungal infections that require systemic treatment;\n* The study excluded participants deemed unsuitable by the investigators.",{"count":130,"type":23},50,"OBSERVATIONAL","According to statistics, 45% of human disease-related deaths are associated with organ fibrosis, among which pulmonary fibrosis poses a severe threat to patients' lives. In recent years, the application of novel therapeutic approaches (such as tumor immunotherapy and organ transplantation) and COVID-19 infections have further expanded the clinical demand for the diagnosis and treatment of pulmonary fibrosis. Currently, the two small-molecule drugs approved for idiopathic pulmonary fibrosis (IPF) (pirotinib and nintedanib) can only slow the decline in lung function and fail to improve patient mortality . Therefore, early diagnosis and early treatment of pulmonary fibrosis have become a clinical consensus , urgently requiring the emergence of innovative technologies and methods.\n\nRecent studies have demonstrated that collagen is not only a product of fibrosis but also a driving factor in its sustained progression . Therefore, identifying key molecular targets that promote collagen-driven fibrotic progression represents a critical direction for anti-fibrotic therapeutic research. Human collagen receptors identified include the discoidin domain receptor (DDR) family (including DDR1 and DDR2) and the integrin family (including α1β1, α2β1, α10β1, and α11β1). Extensive literature and preliminary research by various groups have established that DDR2 is the collagen receptor with the most significantly elevated expression level in the lung tissue of IPF patients. Unlike the \"fast-on, fast-off\" activation pattern of cytokine receptor tyrosine kinases (RTKs), the tyrosine phosphorylation of DDR1 and DDR2 requires the binding of large ligand molecules such as collagen for several hours before induction and can persist for dozens of hours, exhibiting a unique \"slow-on, slow-off\" pattern. This activation characteristic suggests that such molecular mechanisms may underlie the enduring biological effects mediated by DDRs in the progression of chronic fibrotic diseases.",[134],"Interstitial Lung Disease",[136,137,138,139],"PET","Interstitial lung disease","cognitive disorder","68Ga-1A12","2026-03-08",{"date":142,"type":39},"2026-03-11",{"date":118,"type":23},{"date":145,"type":23},"2027-12-31",{"name":45,"class":46},{"id":148,"slug":149,"hasResults":12,"nctId":150,"briefTitle":151,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":131,"phases":4,"briefSummary":154,"conditions":155,"keywords":157,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":158,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":162,"locationsCount":99},"100628251","clinical-application-of-68ga-1a12-pet-in-fibrosis-related-diseases-100628251","NCT07459205","Clinical Application of 68Ga-1A12 PET in Fibrosis-related Diseases","Inclusion Criteria:\n\n* No gender restriction, age ≥18 years (inclusive);\n* patients suspected or confirmed to have fibrosis-related disease;\n* patients eligible for 68Ga-1A12 PET scan\n* Patients who can provide informed consent (signed by the participant, parent or legal representative) and consent forms in accordance with the guidelines of the clinical research ethics committee.\n\nExclusion Criteria:\n\n* patients in critical condition requiring emergency care;\n* Individuals with druand\u002For alcohol abuse, or those with allergic predisposition;\n* women of childbearing potential, pregnant and lactating women;\n* bacterial, viral or fungal infections that require systemic treatment;\n* The study excluded participants deemed unsuitable by the investigators.",{"count":130,"type":23},"Organ fibrosis is a common end-stage pathological change in various chronic diseases, characterized by excessive deposition of extracellular matrix (ECM) and disruption of tissue architecture, which can involve multiple organs such as the heart, liver, lungs, kidneys, and intestines. Although the pathogenic triggers vary, the core molecular mechanisms are highly conserved, involving sustained activation of signaling pathways such as transforming growth factor-β (TGF-β), transdifferentiation of fibroblasts into myofibroblasts, and processes like epithelial-mesenchymal transition (EMT) . Currently, histopathological biopsy remains the gold standard for the diagnosis and staging of fibrosis, but its inherent invasiveness, sampling errors, and procedural risks limit its repeated application and dynamic monitoring .\n\nIn clinical practice, functional imaging modalities such as high-resolution computed tomography (CT) and ultrasonic elastography have been employed to assess fibrosis in specific organs (e.g., lungs, liver). However, these methods predominantly rely on secondary morphological or physical property alterations, exhibiting limited capacity for identifying early-stage, active molecular-level pathological processes. Additionally, they are challenging to perform for systemic, multi-target quantitative evaluation.",[156],"Pulmonary Fibrosis",[136,139,156],{"date":142,"type":39},{"date":160,"type":23},"2026-03-01",{"date":145,"type":23},{"name":45,"class":46},{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":131,"phases":4,"briefSummary":170,"conditions":171,"keywords":173,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":179,"completionDateStruct":180,"leadSponsor":181,"locationsCount":99},"100628250","clinical-study-of-68ga-dota-blp-pet-imaging-in-noninvasive-diagnosis-of-malignant-tumors-100628250","NCT07459192","Clinical Study of 68Ga-DOTA-BLP PET Imaging in Noninvasive Diagnosis of Malignant Tumors","Inclusion Criteria:\n\n* Age over 18 years, gender not restricted;\n* patients with malignant tumors confirmed by biopsy or surgical pathology;\n* Imaging findings of suspicious lymph nodes or distant metastases;\n* informed consent signed in writing by the subject or his\u002Fher legal guardian.\n\nExclusion Criteria:\n\n* patients who have received antitumor therapy prior to PET\u002FCT or PET\u002FMR scanning;\n* Patients with severe medical conditions who cannot tolerate PET\u002FCT or PET\u002FMR scans;\n* The alternative subjects have contraindications to PET\u002FCT or PET\u002FMR scans;\n* exposure to radiation of more than 50 mSv in the past year;\n* The alternative subjects underwent major surgery within the past 3 months; received experimental drug or device therapy (with unclear efficacy or safety) within the past 1 month;\n* The alternative subjects had any clinical conditions that the principal investigator of this study considered to be potentially harmful or associated with the formulation.",{"count":130,"type":23},"Immune checkpoint blockade (ICB) therapy has become a milestone breakthrough in oncology by activating the host immune system to recognize and eliminate tumor cells . Among these, programmed death protein 1 (PD-1) and its ligand (PD-L1) are currently the most widely used targets in clinical practice . However, clinical data indicate that only a subset of patients benefit from anti-PD-1\u002FPD-L1 therapy. Due to the heterogeneity of the tumor microenvironment and the spatiotemporal dynamic changes in PD-L1 expression, traditional tissue biopsy-based detection methods often fail to comprehensively assess disease status, leading to limited treatment response rates . Therefore, there is an urgent need to develop precise strategies for non-invasive, real-time, and dynamic evaluation of PD-L1 expression and treatment response.\n\nNuclear medicine molecular imaging techniques, particularly positron emission tomography (PET), provide a critical means for non-invasive in vivo visualization of tumor biomarkers . Given the pivotal role of PD-L1 in tumor immune evasion, real-time monitoring of its expression levels is of significant importance for the precise guidance of immunotherapy. In recent years, radiotracer agents based on peptides and small molecules have garnered considerable attention due to their advantages in tissue penetration, rapid blood clearance, and high signal-to-noise ratio imaging. Various PD-L1 probes (e.g., \\[¹⁸F\\]BMS-986229, \\[¹⁸F\\]AlF-NOTA-IMB) have demonstrated promising application potential in preclinical or clinical studies . Meanwhile, although PD-1\u002FPD-L1 monoclonal antibodies such as nivolumab and atezolizumab have significantly improved treatment outcomes for multiple tumors , they still exhibit inherent limitations in tissue penetration, in vivo clearance rate, imaging background, immunogenicity, and cost. Additionally, PD-L1-targeted therapies alone show limited efficacy in some patients, prompting researchers to further explore novel mechanisms such as protein degradation targeting (PROTAC) to achieve more comprehensive regulation of PD-L1.",[172],"Canser",[174,136,175,176],"canser","DOTA-BLP","PD-L1","2026-03-04",{"date":91,"type":39},{"date":118,"type":23},{"date":145,"type":23},{"name":45,"class":46},{"id":183,"slug":184,"hasResults":12,"nctId":185,"briefTitle":186,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":188,"enrollmentInfo":189,"targetDuration":4,"studyType":131,"phases":4,"briefSummary":190,"conditions":191,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":195,"completionDateStruct":196,"leadSponsor":197,"locationsCount":99},"100627423","clinical-study-of-trap-fapi3-pet-imaging-in-the-diagnosis-of-pulmonary-nodules-100627423","NCT07448441","Clinical Study of Trap-(FAPI)3 PET Imaging in the Diagnosis of Pulmonary Nodules","Inclusion Criteria:\n\n* 1\\) Patients aged over 18 years with no gender restriction;\n* 2\\) Patients with radiographic findings of pulmonary nodules;\n* 3\\) Patients eligible for Trap-(FAPI)3 PET examination;\n* 4\\) Written informed consent signed by the subject or their legal guardian.\n\nExclusion Criteria:\n\n* 1\\) Patients who have received antitumor therapy prior to PET\u002FCT scanning;\n* 2\\) Patients with severe diseases that cannot tolerate PET\u002FCT scanning;\n* 3\\) Alternative subjects with contraindications to PET\u002FCT scanning;\n* 4\\) Radiation exposure exceeding 50 mSv dose in the past year;\n* 5\\) Alternative subjects who underwent major surgery within the past 3 months; those who received experimental drugs or devices (with unclear efficacy or safety) within the past 1 month;\n* 6\\) Alternative subjects with any clinical conditions that the principal investigator of this study considers may cause or pose potential hazards from the investigational product.","65 Years",{"count":130,"type":23},"The excellent tumor-targeting efficacy of FAP has been confirmed by multiple clinical studies. The results unequivocally establish FAPI as a tumor-targeting ligand with significant potential, demonstrating important application prospects in translational oncology. However, its therapeutic effects remain under investigation. An ideal radiopharmaceutical for cancer treatment should possess outstanding targeting specificity and relatively prolonged tumor retention time. Previous studies have shown that radiolabeled FAPI variants (FAPI-04 and FAPI-46) rapidly and satisfactorily accumulate in tumors, while exhibiting low physiological uptake in normal tissues. However, prior FAP-related tracers demonstrated relatively short retention times in small pulmonary lesions. Our aim is to design a FAPI trimer, Trap-(FAPI)3, to optimize pharmacokinetics and evaluate whether this novel drug offers superior advantages over its monomer analogs in the imaging diagnosis and staging of pulmonary tumors.",[192],"Lung Nodules","2026-03-02",{"date":177,"type":39},{"date":160,"type":23},{"date":145,"type":23},{"name":45,"class":46},{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":131,"phases":4,"briefSummary":205,"conditions":206,"keywords":208,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":218,"locationsCount":99},"100626790","clinical-study-on-noninvasive-evaluation-of-ivonescimab-antibody-distribution-and-expression-in-esophageal-cancer-patients-by-89zr-ak112-pet-imaging-100626790","NCT07440212","Clinical Study on Noninvasive Evaluation of Ivonescimab Antibody Distribution and Expression in Esophageal Cancer Patients by 89Zr-AK112 PET Imaging","Inclusion Criteria:\n\n* 1\\) Patients aged over 18 years with no gender restriction;\n* 2\\) Patients diagnosed with esophageal cancer;\n* 3\\) Patients eligible for 89Zr-AK112 PET examination;\n* 4\\) Written informed consent signed by the subject or their legal guardian.\n\nExclusion Criteria:\n\n* 1\\) Patients who have received antitumor therapy prior to PET\u002FCT scanning;\n* 2\\) Patients with severe diseases that cannot tolerate PET\u002FCT scanning;\n* 3\\) Alternative subjects with contraindications to PET\u002FCT scanning;\n* 4\\) Radiation exposure exceeding 50 mSv dose in the past year;\n* 5\\) Alternative subjects who underwent major surgery within the past 3 months; those who received experimental drugs or devices (with unclear efficacy or safety) within the past 1 month;\n* 6\\) Alternative subjects with any clinical conditions that the principal investigator of this study considers may cause or pose potential hazards from the investigational product.",{"count":130,"type":23},"As a humanized bispecific antibody targeting PD-1 and VEGF-A, everolizumab exhibits high specificity for binding PD-1 and VEGF-A in vivo. This critical property was systematically validated in a recent molecular imaging study based on positron emission tomography (PET). The study utilized radiolabeled everolizumab to construct an everolizumab PET probe, enabling non-invasive and dynamic monitoring of drug distribution and targeting behavior in living organisms. The results demonstrated that the PET probe exhibited excellent target tissue enrichment in the HCT-116 colorectal cancer xenograft model. In vivo PET imaging revealed a sustained increase in tumor uptake over time, peaking at 48 hours post-administration at 13.73 ± 0.95% ID\u002Fg, indicating strong tumor retention. Blocking experiments (pre-injection of excess everolizumab) significantly reduced tumor uptake to 5.20 ± 0.10% ID\u002Fg (P=0.00011), strongly supporting that its in vivo targeting is mediated by PD-1\u002FVEGF-A-specific interactions rather than nonspecific accumulation. At 48 hours, the tumor-to-muscle signal-to-noise ratio (T\u002FM ratio) reached 15.62, with an outstanding target-to-background ratio explaining the superior efficacy and safety of everolizumab. Furthermore, in vitro distribution studies confirmed that the retention levels of this antibody in non-target organs such as the liver and blood were significantly lower than those in tumor tissues, suggesting favorable pharmacokinetic properties that may reduce associated potential toxicity risks. Histopathological analysis (H\\&E staining) demonstrated no signs of inflammation, necrosis, or other pathological damage in major organs (including the heart, liver, spleen, and kidneys), indicating that evolocimab exhibits good biocompatibility and tolerable safety characteristics.",[207],"Esophagus Cancer",[209,136,210,211],"esophagus cancer","Ivonescimab","PD-1","2026-02-23",{"date":214,"type":39},"2026-02-27",{"date":216,"type":23},"2026-02-01",{"date":145,"type":23},{"name":45,"class":46},{"id":220,"slug":221,"hasResults":12,"nctId":222,"briefTitle":223,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":131,"phases":4,"briefSummary":227,"conditions":228,"keywords":230,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":99},"100624110","construction-and-application-of-an-idh-mutation-targeted-petmri-imaging-framework-for-precision-diagnosis-of-gliomas-100624110","NCT07405372","Construction and Application of an IDH Mutation-Targeted PET\u002FMRI Imaging Framework for Precision Diagnosis of Gliomas","Inclusion Criteria:\n\n* Patient ≥ 18 years of age at the time of consent;\n* Patients with suspected, newly diagnosed, or previously treated gliomas;\n* Provided written informed consent authorisation before participating in the study.\n\nExclusion Criteria:\n\n* Pregnancy or lactation;\n* MRI contraindications, not limited to cardiac implantable electronic devices and claustrophobia;\n* Participants with radiation exposure exceeding 50 mSv in the past year.",{"count":226,"type":23},10,"Glioma is the most common primary intracranial tumor in adults, with high-grade gliomas accounting for more than 50% of all gliomas and having the highest mortality rate. The molecular characteristics of gliomas are closely associated with the selection of treatment regimens, therapeutic efficacy, and patient prognosis. Mutations in isocitrate dehydrogenase (IDH) are an important diagnostic marker for diffuse gliomas and a key component in distinguishing and defining glioma subtypes. Furthermore, the advent of IDH-targeting inhibitors has brought hope to patients with IDH-mutant gliomas. Therefore, accurately assessing the IDH mutation status of gliomas is a prerequisite and key to precision diagnosis, targeted therapy, and prognostic evaluation. This study explores the application value of targeted IDH PET\u002FMRI imaging in glioma subtype diagnosis, tumor grading, and prognostic evaluation. It aims to establish a non-invasive in vivo tracing technology platform and evaluation system for accurately assessing glioma IDH mutation status, subtype diagnosis, and prognostic evaluation. This will provide a basis for the precise diagnosis of gliomas, the selection of targeted treatment regimens, and prognostic assessment, and promote future research and development of therapeutic drugs using labeled therapeutic radionuclides.",[229],"Glioma",[229,231,232],"IDH","PET\u002FMRI","2026-02-22",{"date":235,"type":39},"2026-02-24",{"date":237,"type":39},"2025-12-01",{"date":239,"type":23},"2027-12-01",{"name":45,"class":46},{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":55,"enrollmentInfo":248,"targetDuration":4,"studyType":24,"phases":250,"briefSummary":251,"conditions":252,"keywords":255,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":99},"100621919","phase-2-indocyanine-green-guided-omental-shield-anastomosis-for-cervical-esophagogastric-anastomosis-in-minimally-invasive-mckeown-esophagectomy-100621919","NCT07376876","Indocyanine Green-guided Omental Shield Anastomosis for Cervical Esophagogastric Anastomosis in Minimally Invasive McKeown Esophagectomy","Indocyanine Green-guided Omental Shield Anastomosis (ICG-OSA) for Cervical Esophagogastric Anastomosis in Minimally Invasive McKeown Esophagectomy: a Single-center, Single-arm, Open-label Clinical Study","Inclusion Criteria:\n\n1. Age 18 to 80 years, of both sexes;\n2. Pathological diagnosis: Histologically confirmed esophageal squamous cell carcinoma (ESCC) by biopsy;\n3. Clinical staging: Preoperative clinical stage cT1-4aN0-3M0 (according to the 8th edition AJCC staging criteria), evaluated by the thoracic surgery team as eligible for radical McKeown esophagectomy;\n4. Performance status ECOG 0-1；\n5. Major organ function (cardiovascular, respiratory, digestive, hematological systems) assessed as having no contraindications for chemotherapy or immunotherapy, and no surgical contraindications;\n6. Able to understand and comply with study protocol requirements, and willing to accept and undergo standardized postoperative follow-up;\n7. Able to understand and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Allergy history: History of allergy to indocyanine green (ICG), iodide, or iodinated contrast agents (ICG contains iodine, and allergy may cause severe anaphylactic reactions);\n2. Severe hepatic or renal dysfunction: Severe hepatic insufficiency (Child-Pugh Class C) or severe renal insufficiency (eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m²), affecting ICG metabolism and excretion;\n3. Unfavorable tumor location: Tumor located in the cervical or upper thoracic esophagus (\\\u003C25 cm from the incisors), making it difficult to ensure negative proximal resection margin;\n4. Previous surgery history: Prior history of esophageal, gastric, or mediastinal surgery resulting in altered anatomy or severe adhesions;\n5. Multiple primary cancers: Concurrent active malignant tumors in other sites (except cured basal cell carcinoma of the skin or cervical carcinoma in situ);\n6. Special physiological status: Pregnant or lactating women, or those with planned pregnancy during the study period who are unwilling to use effective contraception;\n7. Cognitive and behavioral issues: Presence of severe psychiatric illness, cognitive impairment, or history of substance abuse that would preclude compliance with study procedures;\n8. Participation in other studies: Currently enrolled in other interventional clinical trials that may interfere with the results of this study;\n9. Investigator judgment: Investigator considers the patient unsuitable for this clinical study (e.g., intraoperative exploration reveals severe tumor invasion of major structures such as the aorta or trachea, making R0 resection unachievable).",{"count":249,"type":23},73,[82],"Brief Summary Study title: Indocyanine green (ICG)-guided omental shield anastomosis (ICG-OSA) technique for cervical esophagogastric anastomosis in esophageal cancer surgery Purpose: To evaluate whether a novel surgical technique can reduce the risk of anastomotic leakage after minimally invasive esophageal cancer surgery.\n\nEligible participants: Adults aged 18-80 years with histologically confirmed esophageal squamous cell carcinoma (ESCC) in the middle or lower thoracic esophagus who are scheduled for esophagectomy.\n\nThe technique: All participants will undergo the ICG-OSA procedure, which uses indocyanine green fluorescence imaging to assess gastric perfusion, creates a T-shaped esophagogastric anastomosis, and wraps the anastomosis with a pedicled omental flap.\n\nOutcome assessments: The primary outcome is anastomotic leakage rate within 30 days after surgery. Secondary assessments include surgical site infection, anastomotic stricture, and hospitalization costs.\n\nStudy site: Daping Hospital, Army Medical Center, Chongqing, China Study duration: December 2025 to March 2027 Contact: For more information, please contact the research team at Daping hospital.",[253,254],"Esophageal Squamous Cell Carcinoma (ESCC)","Esophageal Cancer",[256,257,258,253],"Indocyanine Green Fluorescence Navigation","Anastomotic Leakage","Omental Shield","2026-01-26",{"date":261,"type":39},"2026-01-29",{"date":263,"type":23},"2026-01-01",{"date":265,"type":23},"2026-12-31",{"name":45,"class":46},{"id":268,"slug":269,"hasResults":12,"nctId":270,"briefTitle":271,"officialTitle":271,"acronym":272,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":188,"enrollmentInfo":274,"targetDuration":4,"studyType":24,"phases":276,"briefSummary":278,"conditions":279,"keywords":281,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":288,"leadSponsor":290,"locationsCount":99},"100620213","phase-4-application-of-mitoxantrone-hydrochloride-injection-in-transoral-robotic-thyroid-cancer-surgery-100620213","NCT07354698","Application of Mitoxantrone Hydrochloride Injection in Transoral Robotic Thyroid Cancer Surgery","MHI","Inclusion Criteria:\n\n* Age 18-65 years old, both male and female;\n* Preoperative neck ultrasound and\u002For puncture pathology suggested thyroid cancer, and postoperative pathology diagnosed thyroid cancer (tumor diameter \\\u003C4cm);\n* There are no obvious contraindications to surgery during routine preoperative examination;\n* Meet the indications for thyroid lobe\u002Ftotal resection + unilateral\u002Fbilateral central lymph node dissection;\n* Subjects voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up. 4.2 Exclusion Criteria\n\nExclusion Criteria:\n\n* Those who have a history of severe drug allergy or are allergic to the drugs in this study;\n* Those with serious primary diseases such as cardiovascular and cerebrovascular, liver, kidney, and hematological system;\n* Combined with parathyroid disease or other calcium and phosphorus metabolism-related diseases;\n* Benign thyroid lesions;\n* Received mitoxantrone treatment within 4 weeks;\n* Enrolled in other clinical studies at the same time;\n* Known history of psychotropic drug abuse, alcohol abuse or drug abuse;\n* Pregnant or lactating women;\n* According to the investigator's judgment, the subject has other factors that may cause him to be forced to terminate the study midway, such as suffering from other serious diseases (including mental illness) requiring combined treatment, serious abnormal laboratory examination values, family or social factors, which may affect the safety of the subject or the collection of trial data.",{"count":275,"type":23},114,[277],"PHASE4","Dear Patient, You are invited to participate in a clinical study investigating the Application of Mitoxantrone Hydrochloride Injection for Lymphatic Tracing in Transoral Robotic Thyroid Cancer Surgery. This protocol (Protocol No.: \\[To be filled\\]) has been reviewed and approved by the Ethics Committee of the Army Center of Specialized Medicine.\n\nI. Background and Objectives 1.1 Disease Burden and Current Treatments 1.1.1 Thyroid Cancer Surgery Thyroid cancer, the most common head and neck malignancy, exhibits rising global incidence. Central compartment lymph nodes are frequent sites of metastasis in papillary thyroid carcinoma (PTC). Transoral endoscopic thyroid surgery offers superior cosmesis versus open surgery. The da Vinci® robotic system enhances visualization and instrument maneuverability, overcoming technical limitations of narrow endoscopic operating channels.\n\n1.1.2 Lymphatic Tracers in Thyroid Surgery\n\nMitoxantrone Hydrochloride Injection for Lymphatic Tracing is China's only approved tracer for thyroid lymphatic mapping. Its high lymphotropic specificity enables:\n\nLymph node mapping: Forms nanocrystals that permeate lymphatics, staining nodes blue.\n\nParathyroid negative imaging: Spares parathyroid glands, aiding their identification and reducing postoperative hypocalcemia.\n\n1.2 Study Objectives\n\nPrimary: Compare lymph node dissection efficacy and parathyroid protection between:\n\nIntervention: Transoral robotic thyroid lobectomy\u002Ftotal thyroidectomy + central neck dissection (CND) with lymphatic tracing.\n\nControl: Identical surgery without tracing.\n\nSecondary:\n\n1. Compare postoperative parathyroid function between groups.\n2. Evaluate tracer sensitivity for metastatic lymph nodes.\n\n1.3 Participating Site and Sample Size Site: Army Center of Specialized Medicine Sample: 114 treatment-naïve PTC patients scheduled for transoral robotic surgery (Jan-Dec 2024).\n\nIntervention group (n=57): Mitoxantrone Hydrochloride tracing Control group (n=57): No tracer II. Study Procedures Pre-study: Medical history review, preoperative assessments, and documentation of concomitant medications (30 days postsurgery).\n\nIntervention:\n\nThyroid exposure → Intervention group: Multisite intraglandular tracer injection (0.1 mL\u002Fsite, depth ≈0.3 cm; total dose thyroid-dependent).\n\nBoth groups: Thyroid lobectomy\u002Ftotal thyroidectomy ± unilateral\u002Fbilateral CND. Intraoperative recording: Thyroid characteristics, tracer dose\u002Finjection sites, lymphadenectomy duration.\n\nPathology:\n\nTotal lymph node yield and blue-staining rate. Intraoperative frozen section + final histopathology for metastatic nodes.\n\nFollow-up (Postoperative Day 7±3):\n\nPhysical exam, vital signs, lab tests (CBC, biochemistry, thyroid\u002Fparathyroid hormones, electrolytes).\n\n12-lead ECG. Safety monitoring: Adverse events (AEs) tracked until Postoperative Day 14. III. Potential Benefits Improved lymphatic mapping → Reduced parathyroid injury, enhanced lymph node clearance, lower AE rates.\n\nTracer provided at no cost by the sponsor. Note: Efficacy is not guaranteed. Alternative treatments exist. IV. Risks and Inconveniences Potential AEs: Per product labeling and surgical risks. Procedural burdens: Multiple hospital visits and tests. AE management: Immediate medical intervention provided. Compensation per GCP regulations if injury is trial-related.\n\nV. Costs Tracer: NMPA-approved and insurance-covered. Routine care\u002Fmedications: Patient\u002Finsurance responsibility. AE compensation: Sponsor-covered if causally related (per Chinese GCP). VI. Confidentiality\n\nMedical records accessible only to:\n\nResearch team Ethics Committee Regulatory authorities No personally identifiable data will be published. VII. Contact Information Ethics Committee: 68757140 Principal Investigator: Dr. Yan Xu \u002F TEL: 68729250 VIII. Voluntary Participation Right to withdraw anytime without penalty. Investigator may discontinue your participation for safety\u002Fadministrative reasons.\n\nExit assessments may be required. IX. Decision Process Discuss with your physician\u002Ffamily. Retain this document.\n\nParticipant Signature: \\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_ Date: \\_\\_\\_\\_\\_\\_\\_\\_\\_\n\nInvestigator Signature: \\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_ Date: \\_\\_\\_\\_\\_\\_\\_\\_\\_",[280],"Papillary Thyroid Cancer",[282,283],"Mitoxantrone Hydrochloride Injection","Transoral Robotic Surgery","2026-01-12",{"date":286,"type":39},"2026-01-21",{"date":216,"type":23},{"date":289,"type":23},"2028-02-01",{"name":45,"class":46},{"id":292,"slug":293,"hasResults":12,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":298,"targetDuration":4,"studyType":24,"phases":300,"briefSummary":302,"conditions":303,"keywords":305,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":99},"100611172","single-port-robotic-radical-gastrectomy-for-gastric-cancer-100611172","NCT07237126","Single-port Robotic Radical Gastrectomy for Gastric Cancer","Efficacy and Safety Assessment of Single-port Robotic Radical Gastrectomy for Gastric Cancer: a Phase 2a Trial Based on the IDEAL Framework","Inclusion Criteria:\n\n* (1) Age: 18-75 years; (2) Histologically confirmed gastric adenocarcinoma by endoscopic biopsy; (3) Preoperatively staged as either endoscopically unresectable T1, or cT2-4a with or without nodal involvement (N-\u002F+), and no distant metastasis (M0), according to the 7th edition of the AJCC Cancer Staging Manual; (4) Eligible for potentially curative surgical resection; (5) Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; (6) American Society of Anesthesiologists (ASA) physical status classification of I-III; (7) Provision of written informed consent.\n\nExclusion Criteria:\n\n* (1) Pregnant or lactating women; (2) Severe psychiatric disorder; (3) History of prior upper abdominal surgery; (4) Previous gastrectomy, endoscopic submucosal dissection (ESD), or endoscopic mucosal resection (EMR); (5) Preoperative imaging showing regional lymphadenopathy with lymph node(s) larger than 3 cm in diameter; (6) History of another primary malignancy within the past 5 years; (7) Prior neoadjuvant chemotherapy or radiotherapy; (8) History of cerebrovascular or cardiovascular event (e.g., stroke or myocardial infarction) within the past 6 months; (9) Systemic corticosteroid use for more than one month within the past month; (10) Requirement for concomitant surgery for other conditions; (11) Need for emergency surgery due to gastric cancer-related complications (e.g., bleeding, obstruction, or perforation); (12) Participation in another interventional clinical trial previously; (13) Active severe infectious disease; (14) Severe systemic disease.",{"count":299,"type":23},20,[301],"NA","This study is a single-center, phase 2a exploratory clinical study based on IDEAL framework. The intraoperative and postoperative complications were analyzed to evaluate the safety, feasibility and clinical efficacy of single-port robot-assisted gastric tumor resection.",[304],"Gastric Cancer Patients Undergoing Gastrectomy",[306,307,308],"Single-port robotic","Gastric cancer","Radical Gastrectomy","2025-11-16",{"date":311,"type":39},"2025-11-19",{"date":313,"type":23},"2025-11-20",{"date":315,"type":23},"2027-11-20",{"name":45,"class":46},{"id":318,"slug":319,"hasResults":12,"nctId":320,"briefTitle":321,"officialTitle":321,"acronym":322,"eligibilityCriteria":323,"healthyVolunteers":12,"sex":18,"minAge":324,"maxAge":325,"enrollmentInfo":326,"targetDuration":4,"studyType":24,"phases":328,"briefSummary":329,"conditions":330,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":341,"locationsCount":99},"100342291","high-frequency-oscillation-ventilation-versus-conventional-mechanical-ventilation-in-very-preterm-infants-with-perinatal-acute-respiratory-distress-syndrome-multicenters-randomized-controlled-superiority-trial-100342291","NCT03736707","High-Frequency Oscillation Ventilation Versus Conventional Mechanical Ventilation in Very Preterm Infants With Perinatal Acute Respiratory Distress Syndrome: Multicenters Randomized Controlled, Superiority Trial","HFOV for ARDS","Inclusion criteria\n\n1. GA was between 24+0 and 31+6 weeks.\n2. Preterm neonates were admitted to NICU within 1 hours after birth, diagnosed with perinatal ARDS using Montreux guidelines and stable supported by CMV.\n3. Stabilization for 2 hours before randomization: FiO2 0.40, mean airway pressure (MAP) 10-14 cmH2O, ≤ 40 bpm of respiratory rate, 90%-94% of SpO2, pH \\> 7.20, PaCO2 60 mmHg, tidal volume of 5 ml\u002Fkg and \\> 35% of hematocrit (these may be evaluated by arterial blood gas analysis).\n\nExclusion criteria\n\nNeonates were not included if any of the following criteria were met:\n\n1. Parents or guardians' decision not to participate.\n2. Major congenital anomalies or chromosomal abnormalities\n3. Need for surgery or more than grade 2nd of IVH before randomization.","1 Minute","1 Hour",{"count":327,"type":23},400,[301],"Bronchopulmonary dysplasia (BPD) is a complex disorder and remains the most common complication in very preterm infants. Its incidence is increased with gestational age from 95.5% among infants born at 22 weeks' gestation to 22.2% among those born at 29 weeks' gestation. BPD is associated with the increased risks of delayed neurodevelopment and pulmonary impairment. High incidences of BPD and morbidities indicate inadequacy of current management guidelines of BPD.3 Caffeine reduces the development of BPD by lowering the duration of intubation.4 How to further reduce the risk of BPD and the duration of invasive ventilation remain the key focus for neonatologists.",[331,332,333,334],"Acute Respiratory Distress Syndrome","High Frequency Oscillatory Ventilation","Preterm","Conventional Mechanical Ventilation","2025-09-30",{"date":337,"type":39},"2025-10-06",{"date":339,"type":23},"2025-10-01",{"date":97,"type":23},{"name":45,"class":46},{"id":343,"slug":344,"hasResults":12,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":348,"eligibilityCriteria":349,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":55,"enrollmentInfo":350,"targetDuration":352,"studyType":131,"phases":4,"briefSummary":353,"conditions":354,"keywords":357,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":365,"leadSponsor":367,"locationsCount":4},"100607994","expansion-floating-craniotomy-for-the-treatment-of-malignant-cerebral-edema-caused-by-acute-ischemic-stroke-100607994","NCT07195786","Expansion-floating Craniotomy for the Treatment of Malignant Cerebral Edema Caused by Acute Ischemic Stroke","Expansion-floating Craniotomy for the Treatment of Malignant Cerebral Edema Caused by Acute Ischemic Stroke--A Prospective, Multicenter, Non-inferiority,Cohort Study（ECAIS）","ECAIS","Inclusion Criteria:\n\n* Age requirement: Adults aged \\>18 but \\\u003C80 years\n* Acute cerebral infarction diagnosis: Patients with internal carotid artery or middle cerebral artery occlusion within 48 hours, meeting all three criteria:\n\nNIHSS score ≥16 with item 1a (level of consciousness) ≥1 CT demonstrating \\>50% MCA territory infarction or hypoperfused area \\>2\u002F3, OR DWI hyperintensity volume \\>82 ml within 6 hours of onset, OR DWI infarct volume \\>145 ml within 14 hours\n\n* Imaging evidence: Midline shift ≥5 mm to the contralateral side on CT, OR significant ipsilateral ventricular compression with effacement of cerebral sulci\u002Fcisterns.\n\nExclusion Criteria:\n\n* Pre-stroke mRS score ≥1\n* Significant contralateral cerebral infarction\n* Symptomatic intracranial hemorrhage\n* Any known coagulopathy\n* Life expectancy \\\u003C3 years\n* Any severe comorbidities potentially interfering with treatment evaluation",{"count":351,"type":23},356,"3 Months","This clinical study investigates Expansion-floating Craniotomy (EC), a novel surgical technique for treating life-threatening malignant cerebral edema following large hemispheric infarction (commonly known as massive stroke). Malignant edema causes rapid increases in intracranial pressure, compressing vital brain structures and risking fatal brain herniation, requiring urgent intervention.\n\nThe current international standard treatment is traditional decompressive craniectomy (DC). DC involves removing a section of the skull to allow brain swelling, effectively reducing pressure and mortality risk. It is strongly recommended (Class I, Level A evidence) in major guidelines. However, DC typically requires a second major surgery (cranioplasty) approximately 3 months later to replace the removed bone flap, involving additional costs and risks like progressive intracranial hemorrhage or subdural hygroma.\n\nEC is a newer approach designed to potentially eliminate the need for a second surgery. During EC, surgeons use medical titanium plates to temporarily elevate the bone flap, creating immediate space for brain swelling while keeping the bone flap attached. Once brain swelling subsides (usually within weeks), a minor procedure flattens the titanium plates, allowing the patient's own bone to naturally reposition without requiring cranioplasty. EC may be performed based on surgeon assessment of brain swelling, guideline considerations, or experience. If EC is deemed unsuitable during surgery, DC will be performed instead.\n\nWhile early research suggests EC achieves decompression similar to DC while preserving the bone flap, its safety and effectiveness compared to the established DC procedure are not yet fully proven. DC is a well-understood, mature technique with known risks and benefits, including the certainty of needing cranioplasty. Conservative management is reserved for patients unfit for surgery but may not prevent neurological deterioration.This study aims to conduct a preliminary assessment of the outcomes of EC versus DC.",[355,356],"Ischemic Stroke, Acute","Malignant Cerebral Edema",[358,356,359,360],"Expansion-floating Craniotomy","decompressive craniectomy","Acute Ischemic Stroke","2025-09-24",{"date":363,"type":39},"2025-09-29",{"date":339,"type":23},{"date":366,"type":23},"2027-05-30",{"name":45,"class":46},{"id":369,"slug":370,"hasResults":12,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":4,"eligibilityCriteria":374,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":375,"targetDuration":4,"studyType":24,"phases":377,"briefSummary":378,"conditions":379,"keywords":381,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":391,"locationsCount":99},"100607188","postbiotics-ameliorate-cachexia-in-patients-with-non-small-cell-lung-cancer-100607188","NCT07185308","Postbiotics Ameliorate Cachexia in Patients With Non-small-cell Lung Cancer","Postbiotics Ameliorate Cancer Cachexia in Patients With Non-small-cell Lung Cancer: a Multicentre, Double-blind, Randomised Controlled Trial","Inclusion Criteria:\n\n1. Age ≥ 18 years, regardless of gender.\n\n   \\-\n2. Patients with histologically or cytologically confirmed non-small-cell lung cancer (NSCLC) classified as stage III-IV according to the 9th TNM edition of IASLC, who are either currently receiving or have completed chemotherapy combined with immunotherapy.\n\n   \\-\n3. Cachexia was diagnosed according to the international consensus criteria: involuntary weight loss \\>5 % within 6 months preceding screening, or BMI \\\u003C20 kg\u002Fm² combined with \\>2 % involuntary weight loss within the same period.\n\n   \\-\n4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3 and an estimated life expectancy of ≥ 4 months.\n\n   \\-\n5. Prior to the first dose of study treatment, adequate organ function must be documented (no blood products, granulocyte-colony-stimulating factors, or thrombopoietic agents within 14 days before randomisation): 1) Absolute neutrophil count ≥ 1.5 × 10\\^9\u002FL;2)Platelet count ≥ 100 × 10\\^9\u002FL; 3) Haemoglobin \\> 90 g\u002FL; 4) Serum creatinine \\\u003C 1.5 × upper limit of normal (ULN) or creatinine clearance (Cockcroft-Gault) \\> 50 mL\u002Fmin; 5) Total bilirubin \\\u003C 1.5 × ULN (\\\u003C 3 × ULN in Gilbert's syndrome) ;6) AST and ALT \\\u003C 2.5 × ULN (≤ 5 × ULN if hepatic metastases present); 7) INR and aPTT ≤ 1.5 × ULN unless the participant is on therapeutic anticoagulation; 8) Left-ventricular ejection fraction (LVEF) \\> 50 %\n\n   \\-\n6. Participants must be capable of providing written informed consent and comprehending the potential risks associated with the intervention.\n\n   \\-\n7. Participants must demonstrate high adherence to the study protocol.\n\n   \\-\n8. Gastrointestinal function score of \\\u003C 5.\n\nExclusion Criteria:\n\n1. Current presence of reversible causes of reduced food intake (e.g., oral mucositis or mechanical obstruction).\n\n   \\-\n2. Participants who are receiving tube feeding or parenteral nutrition at the time of screening or randomization.\n\n   \\-\n3. Cachexia attributable to other etiologies (e.g., chronic obstructive pulmonary disease, heart failure, or HIV\u002FAIDS).\n\n   \\-\n4. Major surgery within 4 weeks prior to randomization or major surgery planned during the study period.\n\n   \\-\n5. Initiation of systemic corticosteroid therapy within 4 weeks prior to randomization.\n\n   \\-\n6. Use of any appetite- or weight-enhancing agent within 30 days before randomisation, including anamorelin, megestrol acetate, cannabinoids, olanzapine, or mirtazapine.\n\n   \\-\n7. Use of antibiotics or probiotic-containing medications\u002Ffoods within 2 weeks prior to randomization.\n\n   \\-\n8. Use of glucagon-like peptide-1 (GLP-1) receptor agonists for weight reduction within 30 days prior to randomization.\n\n   \\-\n9. Pregnant or lactating women.\n\n   \\-\n10. Participants who are unable to understand the study objectives or who do not agree to comply with the study requirements.\n\n    \\-\n11. Individuals who lack full legal capacity or whose legal capacity is restricted.\n\n    \\-\n12. Any medical condition that could interfere with the interpretation of study results or increase the participant's risk in the opinion of the investigators.\n\n    \\-\n13. Participation in any other clinical trial.\n\n    \\-\n14. Gastrointestinal function score of ≥ 5.",{"count":376,"type":23},150,[301],"This study aims to evaluate the efficacy of the oral postbiotic preparation JK-5G in improving body weight among patients with non-small-cell lung cancer (NSCLC)-related cachexia. By means of a randomized controlled trial, we will compare the between-group difference in body-weight changes between the JK-5G and placebo arms to clarify its nutritional therapeutic benefit.",[380],"Cachexia; Cancer",[382,383,384],"Non-small-cell lung cancer","Cachexixa","Postbiotics","2025-09-22",{"date":387,"type":39},"2025-09-25",{"date":389,"type":23},"2025-11-01",{"date":265,"type":23},{"name":45,"class":46},{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":4,"eligibilityCriteria":398,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":399,"targetDuration":4,"studyType":24,"phases":401,"briefSummary":402,"conditions":403,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":407,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":413,"locationsCount":99},"100579468","single-port-versus-multi-port-robotic-surgery-for-rectal-cancer-100579468","NCT06824688","Single-port Versus Multi-port Robotic Surgery for Rectal Cancer","Efficacy and Safety Assessment of Single-port Versus Multi-port Robotic Surgery for Rectal Cancer: a Phase 2a Non-randomized Controlled Study Based on the IDEAL Framework","Inclusion criteria comprised: (1) MRI-confirmed distal tumor margin \\\u003C15 cm from the anal verge, (2) biopsy-proven adenocarcinoma, (3) clinical stage I-III (AJCC 8th edition) with potential downstaging post-neoadjuvant therapy, (4) intent-to-treat with sphincter preservation and primary anastomosis, (5) documented informed consent, and (6) adult patients (≥18 years).",{"count":400,"type":23},40,[301],"Single-port versus multi-port robotic surgery for rectal cancer",[404,405],"Rectal Cancer Patients","Robotic Surgical Procedures","2025-09-15",{"date":408,"type":39},"2025-09-19",{"date":410,"type":39},"2024-10-23",{"date":412,"type":23},"2025-12-31",{"name":45,"class":46},{"id":415,"slug":416,"hasResults":12,"nctId":417,"briefTitle":418,"officialTitle":418,"acronym":4,"eligibilityCriteria":419,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":420,"targetDuration":4,"studyType":24,"phases":421,"briefSummary":422,"conditions":423,"keywords":429,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":99},"100605694","phase-2-neoadjuvant-radiotherapy-plus-tegafur-oxaliplatin-and-iparomlimab-and-tuvonralimab-in-resectable-gastric-and-ge-junction-cancer--a-randomized-two-arm-prospective-trial-triunite-05-100605694","NCT07165847","Neoadjuvant Radiotherapy Plus Tegafur, Oxaliplatin and Iparomlimab and Tuvonralimab in Resectable Gastric and GE-junction Cancer : A Randomized, Two-arm, Prospective Trial (TRIUNITE-05)","Inclusion Criteria:\n\n* The patients are able to understand and voluntarily sign the written informed consent, which must be signed prior to the implementation of the designated research procedures required by the study.\n* The age at the time of signing the informed consent form (ICF) is ≥ 18 years old, both male and female.\n* Histologically confirmed to have HER2-negative gastric or gastroesophageal junction adenocarcinoma (Siewert type II or Siewert type III with ≤2 cm of esophageal involvement) with AJCC 8th edition staging of Stage IIA- Stage III, i.e., T1- 2N+, and T3-4 and or N+, and resectable;.\n* The patients are willing to provide fresh blood, feces, and tumor tissue for biomarker analysis, and the tissue samples provided are of sufficient quality to evaluate the status of biomarkers. If sufficient tissue is not provided, repeated sampling may be required.\n* The patient has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.\n* The expected survival time was ≥ 3 months.\\\\\n* No previous anti-tumor therapy (including chemotherapy, radiotherapy, targeted therapy, immunotherapy, interventional therapy, and traditional Chinese medicine with clear anti-tumor effects, excluding abdominal exploration for diagnostic staging);\n* The patient has adequate organs function\n\n  1. The patient has adequate hematologic function, as evidenced by an absolute neutrophil count (ANC) ≥1.5\\*10\\^9\u002FL, hemoglobin ≥90g\u002FL (5.58 mmol\u002FL), and platelets ≥100\\*10\\^9\u002FL.\n  2. The patient has adequate renal function as defined by a serum creatinine ≤1.5 times the ULN, or creatinine clearance (measured via 24-hour urine collection) ≥50 mL\u002Fminute (that is, if serum creatinine is \\>1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed).\n  3. The patient has adequate hepatic function as defined by a total bilirubin ≤1.5 mg\u002FdL (25.65 μmol\u002FL), and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 times the upper limit of normal (ULN; or 5.0 times the ULN in the setting of liver metastases).\n  4. The patient must have adequate coagulation function as defined by international normalized ratio (INR) ≤1.5\n* Within 7 days before the first administration, women of childbearing age must confirm that the serum pregnancy test is negative and agree to use effective contraceptives during the study period and within 180 days after the last administration. In this program, women of childbearing age are defined as sexually mature women:\n\n  1. No hysterectomy or bilateral ovariectomy\n  2. Natural menopause does not last for 24 months (amenorrhea after cancer treatment does not rule out fertility) (that is, menstruation occurs at any time in the previous 24 months).\n\nFor male patients whose sexual partners are women of childbearing age, they must agree to use effective contraception during the study drug use and within 180 days after the last administration.\n\nExclusion Criteria:\n\n* Palliative local treatment was given to non-target lesions within 2 weeks before the first administration, and systemic non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, etc.) was received within 2 weeks before the first administration. Chinese herbal medicine or proprietary Chinese medicine with anti-tumor indications was received within 2 weeks before the first administration.\n* The patient has previously received immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.), immune checkpoint agonists (such as antibodies against ICOS, CD40, CD137, GITR, OX40 targets, etc.), immune cell therapy, etc. any treatment aimed at the immune mechanism of tumor.\n* There was a history of gastrointestinal perforation and gastrointestinal fistula within 6 months before the first administration. If the perforation or fistula has been removed or repaired, and the disease has been judged by the researchers to recover or remission, it may be allowed to join the group.\n* Active or previously recorded inflammatory bowel disease (such as Crohn's disease or ulcerative colitis). Unable to swallow, malabsorption syndrome, or uncontrollable nausea, vomiting, diarrhea or other gastrointestinal diseases that seriously affect drug use and absorption.\n* There were active malignant tumors in the past 3 years, except for tumors that participated in the study and local tumors that had been cured. such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, breast cancer in situ, localized prostate cancer and so on.\n* Active or untreated brain metastases, meningeal metastases, spinal cord compression or leptomeningeal diseases are known.\n\nHowever, the patients who met the following requirements and had measurable lesions outside the central nervous system were allowed to enter the group: asymptomatic after treatment, imaging was stable for at least 4 weeks before the start of treatment (such as no new or enlarged brain metastases). And systemic corticosteroids and anticonvulsant drugs have been stopped for at least 2 weeks.\n\n* There are pleural effusion with clinical symptoms, pericardial effusion or ascites requiring frequent drainage (≥ 1 \u002F month).\n* Study active autoimmune diseases that require systematic treatment within 2 years before the start of treatment, or researchers determine the existence of autoimmune diseases that may recur or plan treatment. Except for the following:\n\n  1. Skin diseases that do not require systematic treatment (e.g. vitiligo, hair loss, psoriasis or eczema)\n  2. Hypothyroidism caused by autoimmune thyroiditis requires only a stable dose of hormone replacement therapy.\n  3. Type I diabetes mellitus requiring only a stable dose of insulin replacement therapy\n  4. Asthma has been completely relieved in childhood and no intervention is needed in adults.\n  5. The researchers determined that the disease would not recur without external triggers.\n* There are any of the following cardio-cerebrovascular diseases or cardio-cerebrovascular risk factors:\n\n  1. Within 6 months before the first administration, there were myocardial infarction, unstable angina pectoris, cerebrovascular accident, transient ischemic attack, acute or persistent myocardial ischemia, symptomatic heart failure (according to New York Heart Association functional grade 2 or above), symptomatic or poorly controlled arrhythmia, or any arterial thromboembolic event.\n  2. There was a history of deep venous thrombosis, pulmonary embolism or other severe thromboembolism within 3 months before the first administration.\n  3. There are major vascular diseases, such as aortic aneurysm, aortic dissecting aneurysm, internal carotid artery stenosis, which may be life-threatening or require surgery within 6 months.\n  4. Previous history of myocarditis and cardiomyopathy.\n  5. Left ventricular ejection fraction (LVEF) \\\u003C 50%.\n* Toxicity that has not been alleviated by previous antineoplastic therapy is defined as undiminished to Grade 0 or 1 of the National Cancer Institute (NCI) General terminology Standard for adverse events (CTCAE) (NCICTCAEv5.0), or to the level specified in the selection \u002F exclusion criteria, with the exception of alopecia \u002F pigmentation. The patients who develop irreversible toxicity and are not expected to increase after drug administration (such as hearing loss) may be included in the study after consultation with researchers. Long-term toxicity caused by radiotherapy may be included in the study after consultation with the researchers who are determined by the researchers to be unable to recover.\n* Grade 2 peripheral nerve disease was defined according to NCI CTCAE v5.0 standard.\n* Interstitial lung disease or non-infectious pneumonia is known to be symptomatic or requires systemic glucocorticoid treatment in the past, and researchers have determined that it may affect toxicity assessment or management associated with research treatment.\n* Active tuberculosis is known to exist. The patients suspected of having active pulmonary tuberculosis should be examined for chest X-ray, sputum and excluded by clinical symptoms and signs.\n* Received systemic anti-infective therapy (excluding antiviral therapy for hepatitis B or C) within 2 weeks before the first administration.\n* The history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation are known.\n* There are clinical active hemoptysis, active diverticulitis, abdominal abscess and gastrointestinal obstruction.\n* There were significant clinical bleeding symptoms or definite bleeding tendency within 1 month before the first administration, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or vasculitis.\n* It is known that endoscopy shows signs of active bleeding.\n* There were other major operations in addition to the diagnosis of gastric cancer within 28 days before the first administration.\n* Untreated active hepatitis B patients (HBsAg positive and HBV-DNA more than 1000 copies \u002F ml \\[200IU\u002Fml\\] or higher than the detection lower limit), patients with hepatitis B were required to receive anti-HBV treatment during the study treatment; active hepatitis C patients (HCV antibody positive and HCV-RNA levels higher than the detection lower limit).\n* Those who are known to have a history of immunodeficiency or are HIV positive.\n* Known active syphilis infection.\n* Is participating in another clinical study, unless it is a follow-up period for observational, non-interventional clinical studies or interventional studies.\n* The patients who needed systemic treatment with glucocorticoids (\\> 10mg\u002F prednisone or equivalent dose) or other immunosuppressive drugs within 14 days before the first administration. Except for the following:\n\n  1. If there is no active autoimmune disease, inhaled, ophthalmic or topical glucocorticoids or doses of ≤ 10mg\u002F prednisone or equivalent doses of other glucocorticoids are allowed.\n  2. Physiological dose of systemic glucocorticoid ≤ 10mg\u002F prednisone or equivalent dose of other glucocorticoids.\n  3. Glucocorticoids are used as pretreatment of infusion-related reactions or allergic reactions (such as medication before CT examination).\n* The live vaccine was given within 30 days of the first administration, or is planned during the study period.\n* A history of severe hypersensitivity to other monoclonal antibodies is known.\n* It is known to be unable to meet the requirements of the trial because of mental illness or substance abuse disorder.\n* The patients who are known to have a history of allergy or hypersensitivity to drugs or any of its components in the combined immunotherapy regimen.\n* The patient is pregnant or breastfeeding.\n* The researchers believe that there may be a risk of receiving the study drug treatment, or any condition that will interfere with the evaluation of the study drug or the safety of the patients or the interpretation of the research results.",{"count":400,"type":23},[82],"Neoadjuvant radiotherapy plus Tegafur, Oxaliplatin and Iparomlimab and Tuvonralimab in Resectable Gastric and GE-junction Cancer : A Randomized, Two-arm, Prospective Trial (TRIUNITE-05)",[424,425,426,427,428],"Immunotherapy","Gastric Cancer (GC)","Radiotherapy","Neoadjuvant Therapy","Neoadjuvant Chemoimmunotherapy",[424,430,426,431,428],"Gastric Cancer","Neoadjuvant therapy","2025-09-03",{"date":434,"type":39},"2025-09-10",{"date":436,"type":39},"2025-07-23",{"date":438,"type":23},"2030-12-31",{"name":45,"class":46},{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":188,"enrollmentInfo":446,"targetDuration":4,"studyType":131,"phases":4,"briefSummary":447,"conditions":448,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":456,"locationsCount":99},"100602804","clinical-study-of-trap-fapi-3-pet-imaging-in-noninvasive-diagnosis-of-malignant-tumors-100602804","NCT07128277","Clinical Study of Trap (FAPI) 3 PET Imaging in Noninvasive Diagnosis of Malignant Tumors","Inclusion Criteria:\n\n* Age between 18 and 65 years old, gender is not limited\n* Patients with malignant tumors confirmed by biopsy or surgical pathology\n* Suspected lymph node or distant metastasis found by imaging\n* Written informed consent signed by the subject or his\u002Fher legal guardian\n\nExclusion Criteria:\n\n* Patients receiving anti-tumor therapy prior to PET\u002FCT or PET\u002FMR scans\n* Patients with severe medical conditions unable to tolerate PET\u002FCT or PET\u002FMR scans\n* Eligible participants with contraindications for PET\u002FCT or PET\u002FMR scans\n* Participants with radiation exposure exceeding 50 mSv in the past year\n* Participants who underwent major surgery within the last three months or received experimental drugs\u002Finstruments (with unclear efficacy\u002Fsafety) within one month\n* Participants with clinical conditions that the study sponsor considers potentially hazardous or harmful to this investigational agent.",{"count":226,"type":23},"Positron Emission Tomography (PET) is a functional imaging technology for diagnosing and monitoring tumors. In clinical applications for malignant tumors, PET includes staging, response assessment, and prognosis prediction, providing attractive semi-quantitative biomarkers for both clinical and research platforms. Understanding the fundamentals of imaging science and evaluating the strengths and limitations of imaging modalities is crucial for optimizing research assessments. With the widespread use of functional techniques and the development of novel PET biomarkers, PET-based research evaluations will be further enhanced. The field of oncology has undergone a revolution through molecular imaging, which evaluates tumor biology, while traditional radiological imaging focuses on morphological anatomy . Molecular imaging employs non-invasive visualization at cellular or subcellular levels to observe physiological or pathological processes, whereas PET\u002FCT serves as a hybrid imaging tool that provides complementary information on both function and structure . \\[18F\\] Fluorodeoxyglucose (FDG), first developed in the late 1970s as a tracer for brain region metabolism, remains the most widely used PET tracer with diverse applications in both oncology and non-oncology fields . Despite its undeniable clinical utility, FDG uptake serves as an alternative indicator for glucose transport\u002Fmetabolism rather than being specific to malignant tumors. Continuous exploration of cellular targets has led to the discovery of fibroblast activation protein (FAP). Cancer-associated fibroblasts are present in many tumors, particularly those with strong fibrotic-promoting responses such as breast cancer, colorectal cancer, pancreatic cancer, prostate cancer, and lung cancer. Consequently, FAP expression has been observed in over 90% of epithelial tumors. To date, FAP expression has been associated with poor tumor prognosis in colorectal cancer, pancreatic cancer, hepatocellular carcinoma, and ovarian cancer . Although more research is needed, this advantage makes cancer-associated fibroblasts an ideal target for anti-tumor therapy. In practical applications, low FAP expression in fibroblasts or healthy tissues facilitates imaging of subtle pathological changes. Cancer-associated fibroblasts (CAFs), a key component of the tumor microenvironment, account for over half the mass in various tumor types. Previous studies indicate that CAFs play significant roles in tumor growth, immune suppression, and cancer invasion . Therefore, CAFs may become emerging targets for tumor diagnosis and treatment. Fibroblast activation protein (FAP) is overexpressed in CAFs of multiple epithelial cancers but shows weak expression in healthy tissues, making it a promising target in cancer research. Recent years have seen expanded molecular imaging studies targeting FAP in tumor diagnosis . The excellent tumor-targeting efficacy of FAP has been confirmed through multiple clinical trials . The results clearly establish FAPI as a highly promising tumor-targeting ligand with significant potential applications in translational oncology. However, its therapeutic efficacy remains under investigation. An ideal radiopharmaceutical for cancer treatment should demonstrate excellent targeting specificity and relatively long tumor retention time. Previous studies have shown that radiolabeled FAPI variants (FAPI-04 and FAPI-46) accumulate rapidly and satisfactorily in tumors while showing low physiological uptake in normal tissues. However, previous FAP-related tracers exhibited relatively short tumor retention times . Our aim is to design a FAPI trimer, Trap-(FAPI)3, to optimize pharmacokinetics and evaluate whether this novel drug demonstrates superior advantages over its monomeric analogs in tumor imaging diagnosis and staging.",[449],"Cancer","2025-08-18",{"date":452,"type":39},"2025-08-22",{"date":454,"type":23},"2025-08-13",{"date":389,"type":23},{"name":45,"class":46},{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":461,"acronym":4,"eligibilityCriteria":462,"healthyVolunteers":12,"sex":18,"minAge":463,"maxAge":464,"enrollmentInfo":465,"targetDuration":4,"studyType":131,"phases":4,"briefSummary":467,"conditions":468,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":99},"100597836","artificial-intelligence-model-assisted-accurate-diagnosis-of-early-stage-breast-cancer-100597836","NCT07063667","Artificial Intelligence Model-Assisted Accurate Diagnosis of Early-Stage Breast Cancer","Inclusion Criteria:\n\n* Patients pathologically diagnosed with breast cancer or excluded from breast cancer\n* Available pathological results of breast masses\n* Involving diagnostic population onl\n\nExclusion Criteria:\n\n* Suffering from mental disorders\n* Presence of non-breast diseases during examination\n* Presence of breast implants\n* Undergoing non-breast surgery or having received radiotherapy\u002Fchemotherapy\n* Lactating or pregnant women\n* Missing data","19 Years","85 Years",{"count":466,"type":23},900,"Retrospectively collect the clinical data, breast MRI images, breast ultrasound images and reports, laboratory indicators (such as CA199, CA153, CA125, CEA\u002FAFP), pathological diagnosis results, HE staining images, and existing immunohistochemical results (including CD8A, KPT5, GFRA1, PFKP, ER\u002FPR percentage, Her-2 expression, Ki-67 index, etc.) of patients pathologically confirmed with or excluded from breast cancer in our center between January 2019 and December 2024. For biopsy specimens from patients diagnosed with breast cancer and immunohistochemically confirmed as HR+\u002FHer-2+ during the same period, additional immunohistochemical staining for CD8A, KPT5, GFRA1, and PFKP should be performed, with images and results collected.\n\nThe collected basic clinical information, imaging data, pathological findings, and laboratory metrics of patients will serve as candidate inputs. Units of measurement will be standardized, and missing data will be imputed using the multiple imputation by chained equations algorithm. Data harmonization will employ the Box-Cox algorithm, while min-max scaling will be used for standardization. The adaptive synthetic sampling method with a balance ratio of 0.5 will address data imbalance. For the collected patient data, deep learning will be applied to screen features from the images, combined with clinical significance to identify malignant risk factors. A neural network classifier will be trained on the training set data, with independent variables including breast MRI\u002Fultrasound images, CA199, CA153, CA125, AFP\u002FCEA, etc., and dependent variables including breast cancer status and subtype. Pathological biopsy results will be set as the validation standard.\n\nModel tuning will be conducted on the validation set to construct a breast cancer prediction model. It should be noted that as a single-center study, the results have limited generalizability. The further optimization and evaluation plan for the model involves using breast disease screening data from external centers for validation and refinement, evaluating the model's practical impact on clinical decision-making, and continuously tracking and optimizing its performance.",[469,470],"Breast Cancer, Metastatic","Artifical Intelligence","2025-07-02",{"date":473,"type":39},"2025-07-14",{"date":475,"type":23},"2025-08-01",{"date":477,"type":23},"2026-10-31",{"name":45,"class":46},{"id":480,"slug":481,"hasResults":12,"nctId":482,"briefTitle":483,"officialTitle":483,"acronym":4,"eligibilityCriteria":484,"healthyVolunteers":485,"sex":18,"minAge":19,"maxAge":55,"enrollmentInfo":486,"targetDuration":488,"studyType":131,"phases":4,"briefSummary":489,"conditions":490,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":498,"locationsCount":4},"100596880","deep-learning-based-confocal-laser-microendoscopy-feature-atlas-construction-and-its-application-in-intelligent-diagnosis-of-irritable-bowel-syndrome-100596880","NCT07051226","Deep Learning-Based Confocal Laser Microendoscopy Feature Atlas Construction and Its Application in Intelligent Diagnosis of Irritable Bowel Syndrome","Inclusion Criteria:\n\n* ①Healthy control group and test group of IBS with clear clinical diagnosis (Rome IV diagnostic criteria). Healthy controls are free of gastrointestinal symptoms, test results (blood count, CRP, ESR, etc.) and colonoscopy abnormalities.Patients with IBS have recurrent abdominal pain (≥1 day per week on average in the past 3 months), with onset ≥6 months before diagnosis, and the abdominal pain is accompanied by at least two of the following three symptoms: pain related to defecation, change in stool frequency, and change in the shape (appearance) of the feces, and other organic or metabolic disorders are excluded.② Age: between 18 and 80 years old.③ Probe-based confocal Laser Endomicroscopy (pCLE) is required, and patients have good compliance. ④ Normal coagulation function, and biopsies can be obtained for pathological examination.⑤ Voluntary signing of informed consent.\n\nExclusion Criteria:\n\n* Fluorescein sodium allergy. ②Contraindications to colonoscopy (pregnant or breastfeeding patients, uncooperative psychiatric patients with severe mental disorders, colonic obstruction) or inadequate bowel preparation (Boston Bowel Preparedness Scale score of \\\u003C2 for any colonic segment).③ Comorbidities with major organ dysfunction (with severe cardiopulmonary disease) or impaired renal function (blood creatinine \\>450umol\u002FL). ④ Other conditions that, in the judgment of the investigator, make it unsuitable for participation in the study (inflammatory bowel disease, infected IBS, having taken nonsteroidal anti inflammatory drugs, corticosteroids or antibiotics within the last year, etc.).",true,{"count":487,"type":23},90,"1 Day","In this study, the healthy control group and IBS patients are taken as the research subjects, and CLE is applied to image and analyze the enrolled persons respectively, to derive and compare the characteristic microstructural images of the healthy control group with those of the IBS patients, to establish a diagnostic model of IBS by using deep learning and to evaluate the diagnostic efficacy of the model for IBS.Participants will undergo colonoscopy and confocal laser microendoscopy, and IBS patients will undergo targeted biopsy in CLE to observe suspicious lesions and lesion margins, and specimens will undergo HE staining and immunohistochemistry testing.\n\nTranslated with DeepL.com (free version)",[491],"Irritable Bowel Syndrome (IBS)","2025-06-26",{"date":494,"type":39},"2025-07-04",{"date":496,"type":23},"2025-07-01",{"date":145,"type":23},{"name":45,"class":46},{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":503,"acronym":4,"eligibilityCriteria":504,"healthyVolunteers":12,"sex":18,"minAge":324,"maxAge":505,"enrollmentInfo":506,"targetDuration":4,"studyType":131,"phases":4,"briefSummary":507,"conditions":508,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":512,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":516,"locationsCount":99},"100422202","surfactant-for-neonatal-respiratory-distress-syndromenrds-and-neonatal-acute-respiratory-distress-syndromenards-100422202","NCT04777760","Surfactant for Neonatal Respiratory Distress Syndrome(NRDS) and Neonatal Acute Respiratory Distress Syndrome(NARDS)","Inclusion Criteria:\n\nEligibility requirements for neonates were as follows:\n\n* The gestational age is less than 37 weeks and admitted to neonatal intensive care unit(NICU) in 24 h after birth\n* The neonates will be diagnosed with NRDS or NARDS\n* The neonates will be at least administrated one dose of surfactant\n\nExclusion Criteria:\n\none of the following criteria will be needed\n\n* major congenital anomalies\n* chromosomal abnormalities\n* upper respiratory tract abnormalities","24 Hours",{"count":327,"type":23},"In preterm infants with neonatal respiratory distress syndrome (NRDS), exogenous pulmonary surfactant(PS) replacement therapy is one of the most important therapeutic breakthrough to reduce neonatal mortality. Nowadays, PS is commonly used in newborn infants with respiratory distress, but the incidences of bronchopulmonary dysplasia(BPD) and\u002For death are inconsistent. The result indicates that not all preterm infants with respiratory distress can be beneficial from PS.\n\nIn 2017, the international neonatal ARDS (NARDS) collaborative group provides the first consensus definition for NARDS. And whether or not PS being beneficial for preterm infants with NARDS remains unknown.",[509,510,331,511],"Respiratory Distress Syndrome","Preterm Birth","Surfactant Dysfunction",{"date":496,"type":39},{"date":514,"type":39},"2021-01-01",{"date":265,"type":23},{"name":45,"class":46},{"id":518,"slug":519,"hasResults":12,"nctId":520,"briefTitle":521,"officialTitle":521,"acronym":522,"eligibilityCriteria":523,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":524,"targetDuration":4,"studyType":131,"phases":4,"briefSummary":526,"conditions":527,"keywords":531,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":541,"locationsCount":99},"100588757","evaluation-of-intestinal-lesions-and-disease-activity-in-inflammatory-bowel-disease-based-on-18f-fapi-pet-imaging-100588757","NCT06945549","Evaluation of Intestinal Lesions and Disease Activity in Inflammatory Bowel Disease Based on 18F-FAPI PET Imaging","IBD，18F-FAPI","Inclusion Criteria:\n\n* Patients diagnosed with IBD according to clinical, imaging, endoscopic, and histopathological criteria;\n* Patients ≥18 years old;\n* 18F-FAPI PET\u002FCT intestinal imaging, conventional endoscopic and enhanced CT were performed within 1 week;\n* Intestinal segment matching was evaluated by endoscopy and imaging;\n* Patients voluntarily participate and sign informed consent.\n\nExclusion Criteria:\n\n* Pregnant or lactating patients;\n* Imaging images are of poor quality and cannot be used for diagnosis and evaluation;\n* Patients with contraindications for endoscopic or CT examination.",{"count":525,"type":23},30,"The goal of this observational study is to evaluate the role and effect of 18F-FAPI PET imaging in the identification of intestinal lesions and the assessment of disease activity in inflammatory bowel disease. The main question it aims to answer is:\n\nCan 18F-FAPI PET imaging effectively identify intestinal lesions in inflammatory bowel disease and accurately assess disease activity? Colonoscopy, enhanced abdominal CT, and 18F-FAPI intestinal imaging were completed within 1 week, and major adverse outcomes (MAO) were followed up 12 months after enrollment.\n\nLast updated on March 25, 2025",[528,529,530],"Inflammatory Bowel Disease (IBD)","Disease Activity","FAPI",[532,533,534],"Inflammatory bowel disease","18F-FAPI PET","disease activity","2025-06-25",{"date":537,"type":39},"2025-06-29",{"date":539,"type":39},"2025-04-25",{"date":145,"type":23},{"name":45,"class":46},{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":4,"eligibilityCriteria":548,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":549,"targetDuration":4,"studyType":24,"phases":551,"briefSummary":552,"conditions":553,"keywords":556,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":564,"locationsCount":99},"100595668","enteral-nutrition-with-l-carnitine-for-cachexia-in-non-small-cell-lung-cancer-100595668","NCT07035444","Enteral Nutrition With L-Carnitine for Cachexia in Non-Small Cell Lung Cancer","Enteral Nutrition Supplemented With L-Carnitine for Cachexia in Non-Small Cell Lung Cancer: A Randomized Controlled Trial","Inclusion Criteria:\n\n* 1\\. Primary lung tumor confirmed by cytology or histology; 2.Meeting the diagnostic criteria for cachexia (with one of the following criteria):\n\n  1. Weight loss \\>5% in the past 6 months (without active weight loss);\n  2. Body mass index (BMI) \\\u003C20 and weight loss \\>2%;\n  3. Decreased total skeletal muscle index (detected by bioelectrical impedance analysis: \\\u003C7.26 kg\u002Fm² for males; \\\u003C5.45 kg\u002Fm² for females) and weight loss \\>2%; 3.Age ≥18 years; 4.Patients scheduled to receive or currently undergoing chemotherapy; 5.Patients with an expected survival period ≥3 months; 6.Signed written informed consent and able to comply with the study visit schedule and relevant procedures; 7.Sufficient organ function before the first study treatment (no use of any blood components, leukocyte-elevating drugs, or platelet-elevating drugs within 14 days prior to randomization):\n\n  \u003C!-- -->\n\n  1. Absolute neutrophil count ≥1.5×10⁹\u002FL;\n  2. Platelet count ≥100×10⁹\u002FL;\n  3. Hemoglobin \\>90 g\u002FL;\n  4. Serum creatinine \\\u003C1.5×upper limit of normal (ULN) or creatinine clearance (CLcr) calculated by the Cockcroft-Gault formula \\>50 mL\u002Fmin;\n  5. Total bilirubin \\\u003C1.5×ULN (for Gilbert syndrome patients, \\\u003C3×ULN is acceptable);\n  6. AST and ALT \\\u003C2.5×ULN (for patients with liver metastases, ≤5×ULN);\n  7. International normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤1.5×ULN, unless the subject is receiving anticoagulant therapy\n\nExclusion Criteria:\n\n* 1.Patients scheduled for lung cancer surgery within the next 3 months; 2.Patients with uncontrolled hyperglycemia after adequate treatment; 3.Patients allergic to levocarnitine; 4.Patients with contraindications to enteral nutrition, including but not limited to active gastrointestinal bleeding, complete intestinal obstruction, etc.; 5.Patients with diseases severely affecting digestion and absorption, including but not limited to subtotal gastrectomy, history of intestinal surgery, etc.; 6.Patients with clinically significant cardiovascular and cerebrovascular diseases, including but not limited to:\n\n  1. Myocardial infarction or unstable angina within 6 months before the first drug administration;\n  2. Stroke or transient ischemic attack within 6 months before the first drug administration;\n  3. Hypertension that cannot be controlled after optimal antihypertensive treatment (systolic blood pressure \\>160 mmHg and\u002For diastolic blood pressure ≥100 mmHg);\n  4. Patients with clinically significant arrhythmia who have been stable for \\>14 days before the first drug administration may be enrolled;\n  5. Congestive heart failure (New York Heart Association \\[NYHA\\] functional classification \\> Class 3; see Appendix VI for details);\n  6. Myocarditis; 7.Patients currently participating in interventional clinical research treatment, or who have received other investigational drugs or devices within 4 weeks prior to randomization; 8.Active tuberculosis or tuberculosis requiring medical intervention at the current stage, including but not limited to pulmonary tuberculosis; 9.Patients with known mental illnesses or substance abuse that may affect compliance with trial requirements, or a history of alcohol abuse; 10.Patients with medical history, diseases, treatments, or laboratory abnormalities that may interfere with trial results or prevent the subject from participating in the study throughout the process, or where the investigator deems participation not in the subject's best interest; 11.Local or systemic diseases caused by non-malignant tumors, or secondary reactions to cancer, which may lead to higher medical risks and\u002For uncertainty in survival evaluation.",{"count":550,"type":23},126,[301],"This is a multicenter, double-blind randomized controlled clinical study designed to evaluate the efficacy and safety of oral nutritional supplements (ONS) containing levocarnitine for cachexia in lung cancer patients scheduled for or undergoing chemotherapy.\n\nStudy Design:\n\nRecruitment: Approximately 126 pathologically confirmed patients meeting the inclusion criteria will be enrolled across four hospitals (Army Characteristic Medical Center, Chongqing Fifth People's Hospital, Chongqing Thirteenth People's Hospital, and Chongqing Qianjiang District Central Hospital). The planned enrollment is 60 patients at Army Characteristic Medical Center, 22 at Chongqing Fifth People's Hospital, 22 at Chongqing Thirteenth People's Hospital, and 22 at Chongqing Qianjiang District Central Hospital.\n\nRandomization: Patients will be randomly assigned in a 1:1 ratio to the control group (63 patients) or the intervention group (63 patients).\n\nInterventions:\n\nControl Group: Receive 500 mL of enteral nutrition solution daily for 12 weeks (84 days).\n\nIntervention Group: Receive 500 mL of enteral nutrition solution containing 4 g of levocarnitine daily for 12 weeks (84 days).\n\nEvaluations:\n\nEfficacy Assessments: Body composition analysis and other evaluations will be conducted at baseline and after ONS treatment with levocarnitine to assess the effectiveness of the intervention.\n\nSafety Assessments: Safety events during the levocarnitine-containing ONS treatment period and within 28 days after neoadjuvant therapy will be collected to evaluate treatment safety.\n\nFollow-up: After chemotherapy, the investigator will determine the optimal adjuvant treatment and follow-up protocols to assess recurrence and survival outcomes.",[554,555],"Non-Small Cell Lung Cancer","Cachexia",[557,558],"L-carnitine","Enteral nutrition","2025-06-15",{"date":535,"type":39},{"date":562,"type":23},"2025-06-30",{"date":265,"type":23},{"name":45,"class":46},{"id":566,"slug":567,"hasResults":12,"nctId":568,"briefTitle":569,"officialTitle":570,"acronym":4,"eligibilityCriteria":571,"healthyVolunteers":12,"sex":18,"minAge":572,"maxAge":188,"enrollmentInfo":573,"targetDuration":4,"studyType":24,"phases":575,"briefSummary":577,"conditions":578,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":581,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":586,"locationsCount":99},"100583936","early-phase-1-human-umbilical-cord-mesenchymal-stem-cells-treatment-in-sepsis-100583936","NCT06882811","Human Umbilical Cord Mesenchymal Stem Cells Treatment in Sepsis","Clinical Study on Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Sepsis","Inclusion Criteria:\n\n* Age: 0-65 years old, diagnosed with sepsis\n* Clinical diagnosis of sepsis (based on Sepsis 3.0 International Guidelines)\n* Confirmed or suspected infection\n\nExclusion Criteria:\n\n* Violation of medical ethics\n* Significant confounding factors likely to bias study outcomes\n* Poor adherence to the study protocol\n* Concurrent participation in other clinical trials\n* Specific medical conditions:\n\n  1. History of chronic enteritis, neuropsychiatric disorders, or transplantation (bone marrow, lung, liver, pancreas, or small intestine)\n  2. Severe primary diseases affecting survival (e.g., life-limiting hepatic, renal, or endocrine disorders) or psychiatric disorders\n  3. History of hypersensitivity or severe adverse reactions to biological products\n  4. Imminent terminal status (e.g., septic shock, life expectancy \\\u003C7 days)\n  5. Foreseeable risk of medical errors or disputes during hospitalization\n  6. Active drug-resistant infections\n  7. History of malignancy at screening\n  8. Pregnancy, lactation, or plans for pregnancy within the next year","0 Years",{"count":574,"type":23},180,[576],"EARLY_PHASE1","The primary objective: To evaluate the efficacy of intravenous infusion of universal UC-MSCs and CD83+MSCs subpopulation injection in the treatment of sepsis by using the 28-day survival rate of the subjects as the primary efficacy criterion.The secondary objectives: 1. To systematically evaluate the safety of universal UC-MSCs and CD83+MSCs subpopulation in the treatment of sepsis; 2. To provide theoretical basis and clinical research data for establishing a safe, effective and feasible clinical treatment plan for sepsis using stem cells.",[579],"Sepsis","2025-05-23",{"date":582,"type":39},"2025-05-25",{"date":584,"type":39},"2025-05-22",{"date":145,"type":23},{"name":45,"class":46},""]