[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":612},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,190,0,25,[9,49,76,99,125,154,177,201,226,249,286,310,329,354,377,401,417,443,467,485,506,527,547,567,591],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100652728","phase-2-iparomlimab-and-tuvonralimab-with-lenvatinib-radiotherapy-and-haic-for-hepatocellular-carcinoma-with-portal-vein-tumor-thrombus-100652728",false,"NCT07776080","Iparomlimab and Tuvonralimab With Lenvatinib, Radiotherapy, and HAIC for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus","A Clinical Study of Iparomlimab and Tuvonralimab Combined With Lenvatinib, Radiotherapy, and Hepatic Arterial Infusion Chemotherapy as First-Line Treatment for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus","Inclusion Criteria:\n\n1. Age ≥18 and ≤75 years at the time of signing informed consent.\n2. Histologically or clinically confirmed hepatocellular carcinoma (HCC) according to the 2024 Chinese Guidelines for the Diagnosis and Treatment of Primary Liver Cancer.\n3. Radiologically confirmed portal vein tumor thrombus (PVTT), classified as Cheng type I-IV.\n4. No prior systemic or local treatment directed at PVTT, including targeted therapy, immunotherapy, or systemic chemotherapy.\n5. Child-Pugh class A or B with a Child-Pugh score ≤7.\n6. Considered unsuitable for curative surgery or liver transplantation after multidisciplinary evaluation, but suitable for radiotherapy.\n7. Adequate organ function, including: WBC ≥3.0 × 10⁹\u002FL; PLT ≥50 × 10⁹\u002FL; hemoglobin ≥80 g\u002FL; ALT ≤5 × ULN; AST ≤5 × ULN; total bilirubin ≤3 × ULN; albumin ≥28 g\u002FL; and creatinine clearance ≥80 mL\u002Fmin.\n8. At least one measurable lesion according to mRECIST.\n9. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n10. Life expectancy \\>3 months.\n11. No history of abdominal radiotherapy.\n12. Women of childbearing potential must use effective contraception beginning at least 1 month before screening and throughout the study until the protocol-specified period after study completion.\n13. Willing and able to comply with study follow-up until death, study completion, or study termination.\n\nExclusion Criteria:\n\n1. ECOG performance status ≥2.\n2. Child-Pugh score ≥8.\n3. Severe dysfunction of major organs, including the heart, liver, or kidneys.\n4. Prior targeted therapy, immunotherapy, radiotherapy, systemic chemotherapy, or other anticancer treatment.\n5. Known hypersensitivity or allergic reaction to any component of the study treatment.\n6. History of organ transplantation or autologous\u002Fallogeneic stem cell transplantation.\n7. Currently receiving chronic systemic immunotherapy or hormonal therapy other than physiologic replacement therapy.\n8. Any unstable systemic disease, including active infection; uncontrolled severe hypertension; unstable angina; new-onset angina within the previous 3 months; congestive heart failure of NYHA class II or higher; myocardial infarction within the previous 6 months; severe cardiac arrhythmia requiring medication; gastrointestinal bleeding within the previous 1 month; or active bleeding tendency.\n9. Concurrent other malignancy that has not been cured, except carcinoma in situ at another site.\n10. Any disease, metabolic disorder, physical examination finding, or laboratory abnormality that, in the investigator's judgment, suggests a contraindication to the study treatment or a high risk of treatment-related complications.\n11. Evidence of acute or active hepatitis B or hepatitis C infection, including HBV-DNA \\>2,000 IU\u002FmL or HCV-RNA \\>1,000 copies\u002FmL.\n12. Pregnancy or breastfeeding.\n13. Any other unfavorable medical or psychiatric condition that, in the investigator's judgment, may affect protocol compliance or evaluation of study endpoints and makes the participant unsuitable for the study.\n14. Lack of legal capacity or limited legal capacity.\n15. Other contraindications to radiotherapy or targeted\u002Fimmunotherapy.\n16. Any participant considered unsuitable for enrollment by the investigator.","ALL","18 Years","75 Years",{"count":21,"type":22},35,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The purpose of this study is to learn how well a combination of iparomlimab and tuvonralimab (QL1706), lenvatinib, radiotherapy, and hepatic arterial infusion chemotherapy (HAIC) works and how safe it is for people with hepatocellular carcinoma (HCC) that has grown into the portal vein, forming a portal vein tumor thrombus (PVTT).\n\nParticipants will receive iparomlimab and tuvonralimab together with lenvatinib, radiotherapy directed at the portal vein tumor thrombus, and HAIC, which delivers chemotherapy directly through the hepatic artery. Researchers will evaluate how long the cancer remains controlled without getting worse, how much the tumors shrink, how long participants survive, and whether the treatment makes surgery possible for some participants. Treatment-related side effects will also be assessed.\n\nThe study will also explore whether features in tumor tissue and blood are associated with treatment response and may help identify patients who are more likely to benefit from this treatment strategy.",[28],"HCC - Hepatocellular Carcinoma",[30,31,32,33,34,35],"Hepatocellular Carcinoma","Portal Vein Tumor Thrombus","Lenvatinib","Iparomlimab and Tuvonralimab","Radiotherapy","Hepatic Arterial Infusion Chemotherapy","NOT_YET_RECRUITING","2026-08-17",{"date":39,"type":40},"2026-08-20","ACTUAL",{"date":42,"type":22},"2026-10-01",{"date":44,"type":22},"2028-10-01",{"name":46,"class":47},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",1,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":48},"100652597","ct-imaging-and-clinical-features-to-predict-outcomes-in-patients-with-gastric-cancer-100652597","NCT07776067","CT Imaging and Clinical Features to Predict Outcomes in Patients With Gastric Cancer","Prospective Validation of a CT Radiomics-Based Model Combined With Clinical Features for Prognosis Prediction in Gastric Cancer Patients","Inclusion Criteria:\n\nHistologically or pathologically confirmed gastric cancer and receiving treatment at the study center.\n\nAge ≥18 years. Complete pretreatment CT imaging data available from the study center.\n\nExclusion Criteria:\n\nPretreatment CT images of insufficient quality for analysis. Incomplete clinical data. Presence of another malignant tumor in addition to gastric cancer.",{"count":57,"type":22},600,"OBSERVATIONAL","The goal of this prospective observational study is to evaluate how well a previously developed prediction model can estimate outcomes in adults with gastric cancer. The model combines information from computed tomography (CT) images obtained before treatment with routine clinical information. The main questions are how well the model predicts how long participants live after treatment begins and whether their cancer progresses.\n\nParticipants will receive their usual medical care. Researchers will collect pretreatment CT images, basic clinical and tumor information, laboratory and tumor marker results, treatment information, and follow-up outcomes obtained during routine care. These data will be entered into the predefined prediction model, and the model's predictions will be compared with what actually happens during follow-up.\n\nThe study will not change the participants' usual treatment. Model predictions will be used for research purposes only and will not be used to make treatment decisions.",[61],"Gastric Cancer",[63,64,65,66,67,68],"Computed Tomography","Radiomics","Prognostic Model","Overall Survival","Progression-Free Survival","Prospective Validation","RECRUITING",{"date":39,"type":40},{"date":72,"type":40},"2026-04-01",{"date":74,"type":22},"2027-04-01",{"name":46,"class":47},{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":17,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":23,"phases":87,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":4},"100652478","a-clinical-exploratory-study-of-yolt-204-in-the-treatment-of-hemoglobinopathies-100652478","NCT07774351","A Clinical Exploratory Study of YOLT-204 in the Treatment of Hemoglobinopathies","A Clinical Exploratory Study on the Safety and Efficacy of YOLT-204 in the Treatment of Hemoglobinopathies (Sickle Cell Disease and Transfusion-Dependent Thalassemia)","Common inclusion criteria:\n\n1. Male or female subjects aged 14 to 35 years (inclusive).\n2. The subject and\u002For their legal guardian has been fully informed about the study and has voluntarily signed a written ICF.\n3. KPS score ≥ 70 for subjects aged 16 years or older; LPS score ≥ 70 for subjects under 16 years of age.\n4. Detailed medical records regarding red blood cell transfusions within the 2-year period prior to signing the ICF are available, including the volume or number of units transfused, as well as pre- and post-transfusion red blood cell and hemoglobin levels.\n5. No severe hematopoietic abnormalities; cardiac, pulmonary, hepatic, and renal function are generally normal.\n6. Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) both ≤ 1.5 × ULN (upper limit of normal).\n7. Renal function: Creatinine ≤ 1.5 × ULN, or if creatinine \\> 1.5 × ULN, calculated endogenous creatinine clearance \\> 50 mL\u002Fmin (according to the Cockcroft-Gault formula).\n8. Hepatic function: Alanine aminotransferase (ALT) ≤ 3 × ULN and aspartate aminotransferase (AST) ≤ 3 × ULN.\n9. Cardiac function: Left ventricle ejection fraction (LVEF) ≥ 50%.\n10. Good compliance and willingness to adhere to visit schedules, study plans, laboratory tests, and other study procedures.\n11. Subjects agree to use at least one effective method of contraception from the time of signing the ICF through the end of the main study (W52 visit).\n12. Willingness to participate in the long-term follow-up study.\n\n    Additional criteria for SCD cohort only:\n13. Genotyping performed during the screening period confirms HbSS, HbSβ0, or HbSβ+ phenotype; previous test reports are acceptable upon assessment by the investigator.\n14. For subjects using L-glutamine, the regimen must have been stable for at least 3 months prior to study drug administration. For subjects using hydroxyurea, it must be discontinued for 8 weeks or more prior to study drug administration. For subjects using luspatercept, it must be discontinued for 3 months or more prior to study drug administration.\n15. Meets criteria for severe SCD: At least 2 occurrences of one or more of the following events within 1 year prior to screening, despite standard supportive care (including but not limited to analgesic therapy, hydroxyurea):\n\nSevere episodic acute pain requiring medical intervention; Acute chest syndrome, defined as new pulmonary infiltrate on chest imaging accompanied by pneumonia-like symptoms, pain, or pyrexia; Splenic sequestration crisis, characterized by splenomegaly, left upper quadrant pain, and an acute decrease in hemoglobin level \\> 20 g\u002FL.\n\nCommon exclusion criteria:\n\n1. History of multiple drug allergies or allergic reaction history to oligonucleotides or LNP;\n2. Presence of clinically significant active bacterial, viral, fungal, or parasitic infection as judged by the investigator at screening;\n3. White blood cell (WBC) count \\\u003C 3 × 109\u002FL and\u002For platelet count \\\u003C 100 × 109\u002FL at screening (using pre-lymphodepletion results if lymphodepletion is considered);\n4. Uncorrected hemorrhagic disorders;\n5. Severe splenomegaly at screening, defined as the spleen extending beyond the level of the umbilicus (or \\>4 cm below the costal margin), and deemed unsuitable for enrollment by the investigator;\n6. Serum ferritin ≥ 5000 ng\u002FmL, or evidence of severe cardiac or hepatic iron overload as indicated by magnetic resonance imaging (MRI)-T2\\*;\n7. Positive for one or more of the following: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody, anti-human immunodeficiency virus antibody, or anti-Treponema pallidum specific antibody;\n8. Prior hematopoietic stem cell (HSC) transplantation, gene therapy, or genome editing therapy; or eligible for allogeneic HSC transplantation with an identified HLA-matched related donor;\n9. Participation in another clinical trial with administration of an investigational product within 3 months prior to study drug administration;\n10. History or current diagnosis of malignancy, myeloproliferative disorder, or immunodeficiency disease;\n11. Presence of severe psychiatric illness that precludes compliance with treatment; significant pulmonary hypertension requiring medical intervention; recent history of malaria; family history (first-degree relative) of hematologic malignancy;\n12. Female subjects with a positive pregnancy test at screening, or who are pregnant or breastfeeding;\n13. Any prior or current disease, treatment, or laboratory abnormality that may interfere with study results or affect the patient's full participation in the study, or any condition that, in the investigator's judgment, makes the patient unsuitable for participation in this clinical study.\n\n    Additional criteria for TDT cohort only:\n14. Receipt of any of the following treatments within 3 months prior to study drug administration: erythropoiesis-stimulating agents (e.g., erythropoietin \\[EPO\\]), thalidomide, hydroxyurea, or luspatercept.\n\n    Additional criteria for SCD cohort only:\n15. Abnormal transcranial Doppler (TCD), defined as flow velocity ≥ 200 cm\u002Fs in the middle cerebral artery or internal carotid artery.\n16. History of moyamoya disease, or evidence of moyamoya at screening with an increased risk of hemorrhage as assessed by the investigator.","14 Years","35 Years",{"count":86,"type":22},30,[88],"NA","This is a single-arm, open-label, dose-escalation study designed to enroll approximately 5-30 patients with TDT or SCD. The objectives are to evaluate the safety and tolerability in patients following intravenous administration of YOLT-204 and to preliminarily assess its effect on fetal hemoglobin levels in plasma.\n\nIn this study, the maximum screening period of the main study is 60 days, the treatment day is Day 0 (D0), and the safety follow-up period is up to Week 52 after administration.",[91],"Hemoglobinopathies",{"date":93,"type":40},"2026-08-19",{"date":95,"type":22},"2026-09-30",{"date":97,"type":22},"2028-04-01",{"name":46,"class":47},{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":106,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},"100329789","biomarkers-for-predicting-neoadjuvant-chemoradio-resistance-for-middle-low-advanced-rectal-cancer-100329789","NCT03573791","Biomarkers for Predicting Neoadjuvant Chemoradio-resistance for Middle-low Advanced Rectal Cancer","Identification of Tissue Biomarkers for Predicting Neoadjuvant Chemoradio-resistance in Patients With Middle-low Local Advanced Rectal Cancer.","Inclusion Criteria:\n\n* Histopathology proved to be adenocarcinoma of the rectum.\n* The edge of tumor is within 12cm of anus margin.\n* According to the eighth edition of AJCC TNM staging standard ,that staging for Ⅱ-Ⅲ period, as T3-T4, N0 or any T, N1-2.\n* There is no history of chemotherapy, radiotherapy or immunotherapy before neoadjuvant therapy.\n* Understand and agree to sign the informed consent for the study.\n\nExclusion Criteria:\n\n* With intestinal obstruction or impending obstruction, or perforation.\n* With other malignancies occurred within 5 years.",{"count":107,"type":22},152,"Neoadjuvant therapy has been widely applied to locally advanced rectal cancer. However, about 50% of patients receiving this therapy do not respond well as evidenced by the fact that their T or N stages are not effectively decreased judged by postoperative pathological examination. The purpose of this trail is to identify the biomarkers (from within patients' tumor mass before neoadjuvant therapy) to predict resistance to neoadjuvant therapy. These biomarkers can help stratify neoadjuvant-resistant patients towards surgery while avoiding unnecessary chemoradio-based neoadjuvant therapy.",[110,111,112,113,114,115,116],"Rectal Cancer","Cancer of Rectum","Cancer of the Rectum","Neoplasms, Rectal","Rectal Tumors","Rectum Cancer","Rectum Neoplasms",{"date":118,"type":40},"2026-08-18",{"date":120,"type":40},"2018-05-21",{"date":122,"type":22},"2028-05-21",{"name":46,"class":47},2,{"id":126,"slug":127,"hasResults":12,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":133,"enrollmentInfo":134,"targetDuration":4,"studyType":23,"phases":136,"briefSummary":137,"conditions":138,"keywords":142,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":48},"100579575","phase-2-safety-and-efficacy-study-of-sorbitol-with-neoadjuvant-chemotherapy-combined-with-tirellizumab-pd-1-inhibitor-in-patients-with-locally-advanced-gastric-cancer-100579575","NCT06826079","Safety and Efficacy Study of Sorbitol With Neoadjuvant Chemotherapy Combined With Tirellizumab (PD-1 Inhibitor) in Patients With Locally Advanced Gastric Cancer","Safety and Efficacy Study of Oral Sorbitol to Enhance the Therapeutic Effect of Neoadjuvant Chemotherapy Combined With Tirellizumab (PD-1 Inhibitor) in Patients With Locally Advanced Gastric Cancer","SNCCTGC","Inclusion Criteria\n\n* Age: 18 years ≤ age ≤ 70 years, gender not restricted.\n* Written informed consent obtained from the patient.\n* Histologically confirmed, untreated HER2-negative gastric cancer or gastroesophageal junction (GEJ) cancer, with clinical stage cT3-4N+M0, and histological examination confirming mainly adenocarcinoma. Only Siewert type III GEJ cancer and Siewert type II GEJ cancer patients who do not require combined thoracotomy are eligible for inclusion.\n* ECOG PS score of 0-1.\n* Normal major organ function, meeting the following criteria:\n* Blood routine examination criteria (no blood or blood product transfusion within 14 days, no use of G-CSF or other hematopoietic stimulating factors for correction):\n* HB ≥ 90 g\u002FL;\n* ANC ≥ 1.5×109\u002FL;\n* PLT ≥ 125×109\u002FL;\n* Biochemical examination criteria:\n* TBIL \\\u003C 1.5ULN;\n* ALT and AST \\\u003C 2.5ULN, and for patients with liver metastasis, \\\u003C 5ULN; serum Cr ≤ 1.25ULN or endogenous creatinine clearance rate \\> 50ml\u002Fmin (Cockcroft-Gault formula);\n* Fertile women must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days before enrollment, with a negative result, and be willing to use appropriate contraceptive methods during the trial and for 8 weeks after the last administration of the investigational drug. For men, they must agree to use appropriate contraceptive methods during the trial and for 8 weeks after the last administration of the investigational drug or have undergone surgical sterilization.\n\nExclusion Criteria\n\n* Presence of distant organ metastasis and peritoneal disseminated metastasis.\n* Active or previously recorded autoimmune or inflammatory diseases (including inflammatory bowel disease \\[such as colitis or Crohn's disease\\], diverticulitis \\[excluding diverticular disease\\], systemic lupus erythematosus, sarcoidosis syndrome, or Wegener's syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\\]), except for patients with vitiligo or alopecia, provided that they have celiac disease that can be controlled through diet after consultation with the study doctor.\n* Other active malignant tumors within 5 years or concurrently. Patients with cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc., can be included.\n* Patients preparing for or having previously undergone organ or bone marrow transplantation.\n* Uncontrolled concurrent diseases, including but not limited to: persistent or active infections (tuberculosis, HBV\u002FHCV, pneumonia, etc.), symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled arrhythmia, active ILD, severe chronic gastrointestinal diseases with diarrhea, or conditions that may limit compliance with study requirements, significantly increase the risk of adverse events (AEs), or affect the ability of the subject to provide written informed consent.\n* Patients currently using immunosuppressants, systemic or absorbable local hormones for immunosuppressive purposes (dose \\> 10mg\u002Fday prednisone or other equivalent efficacy hormones), and still using them within 2 weeks before enrollment.\n* Patients who have previously received platinum-based, fluorouracil-based chemotherapy or targeted therapy, patients whose target lesions have undergone radiotherapy during combination therapy, or patients who have previously received other PD-1 antibody treatment or other PD-1\u002FPD-L1 immune therapy.\n* Have multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction, etc.);\n* Have experienced significant clinically significant bleeding symptoms or have a clear bleeding tendency within the last three months, such as a history of black stool or hematemesis, or are at high risk of bleeding due to conditions such as intestinal perforation, gastric perforation, or extensive ulcers, or have active gastric ulcers and a positive fecal occult blood test (++) ;\n* Have hypertension that cannot be well controlled with a single antihypertensive drug (systolic blood pressure \\> 140 mmHg, diastolic blood pressure \\> 90 mmHg); have a history of unstable angina pectoris; have been newly diagnosed with angina pectoris within the last three months or have had a myocardial infarction within the last six months; have arrhythmia (including QTcF: male ≥ 450 ms, female ≥ 470 ms) and need long-term use of antiarrhythmic drugs or have New York Heart Association functional class ≥ II heart failure; Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) \\\u003C 50%;\n* Urinalysis indicates proteinuria ≥ ++ and confirmed 24-hour urine protein quantification \\> 1.0 g;\n* Have long-term non-healing wounds or incompletely healed fractures;\n* Have abnormal coagulation function and a bleeding tendency (INR must be within the normal range without anticoagulants 14 days before enrollment); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; low-dose warfarin (1 mg orally, once daily) or low-dose aspirin (daily dose not exceeding 100 mg) for prophylactic purposes is allowed if the international normalized ratio (INR) of prothrombin time is ≤ 1.5;\n* Have experienced arterial or venous thrombotic events within the last year, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis (except for venous thrombosis caused by previous chemotherapy catheterization and judged by the investigator to have healed), and pulmonary embolism, etc.;\n* Have a history of abuse of psychotropic drugs and are unable to quit or have mental disorders;\n* Have serious concomitant diseases that, in the judgment of the investigator, pose a significant risk to the patient's safety or affect the patient's ability to complete the study;\n* Pregnant or lactating women.","70 Years",{"count":135,"type":22},86,[25],"The goal of this clinical trial is to learn if sorbitol works to enhance the therapeutic effect of neoadjuvant chemotherapy combined with Tirellizumab (PD-1 inhibitor) in patients with locally advanced gastric cancer. It will also learn about the safety of sorbitol. The main questions it aims to answer are:\n\nDoes sorbitol enhance the therapeutic effect of immunotherapy and increase the major response rate in patients with locally advanced gastric cancer? Does sorbitol with neoadjuvant chemotherapy combined with Tirellizumab (PD-1 inhibitor) can improve the prognosis of patients with locally advanced gastric cancer?\n\nResearchers will compare sorbitol to a standard-of-care treatment (aPD-1 + SOX chemotherapy) to see if sorbitol works to enhance the therapeutic effect (Add-on Effect) of neoadjuvant chemotherapy combined with Tirellizumab (PD-1 inhibitor) in patients with locally advanced gastric cancer.\n\nParticipants will:\n\nTake sorbitol every day for 3 months in 3 treatment cycles Visit the clinic once every 4 weeks for checkups and tests Keep a diary of their symptoms and the number of times they use a rescue inhaler Participants will follow up as planned until PD occurs, informed consent is withdrawn, or follow-up is lost (whichever occurs first). After the end of treatment and safety follow-up, all subjects will be followed up for survival (OS data collected every 3 months ±14 days).",[139,61,140,141],"Gastric Junction Adenocarcinoma","Immunotherapy","Neoadjuvant Therapies",[143,144,145,146],"sorbitol","tislelizumab","SOX","gastric cancer","2026-08-16",{"date":118,"type":40},{"date":150,"type":40},"2024-11-01",{"date":152,"type":22},"2029-08-01",{"name":46,"class":47},{"id":155,"slug":156,"hasResults":12,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":161,"targetDuration":4,"studyType":23,"phases":162,"briefSummary":163,"conditions":164,"keywords":168,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":48},"100553289","phase-1-fruquintinib-and-pirfenidone-in-combination-with-anti-pd-1-antibody-in-advanced-or-metastatic-pmmrmss-colorectal-carcinoma-100553289","NCT06484153","Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Advanced or Metastatic pMMR\u002FMSS Colorectal Carcinoma","A Randomized Phase 2 Clinical Trial Evaluating Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Patients With Standard Treatment Failure of Advanced or Metastatic pMMR\u002FMSS Colorectal Carcinoma","Inclusion Criteria:\n\n1. Histologically confirmed diagnosis of unresectable locally advanced, recurrent or metastatic colorectal adenocarcinoma.\n2. Tumor tissues were identified as mismatch repair-proficient (pMMR) by immunohistochemistry (IHC) method or microsatellite stability (MSS) by polymerase chain reaction (PCR).\n3. Subjects must have failed at least two lines of prior treatment.\n4. Subjects must have one measurable lesion according to RECIST v1.1 at least.\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 6. 18-75 years old.\n\n7\\. Life expectancy of at least 12 weeks. 8. Adequate bone marrow, liver, renal and coagulation function as assessed by the laboratory required by protocol\n\nExclusion Criteria:\n\n1. Previously received anti-programmed death-1 (PD-1) or its ligand (PD-L1) antibody or Pirfenidone.\n2. Received last dose of anti-tumor therapy (chemotherapy, targeted therapy, tumor immunotherapy or arterial embolization) within 3 weeks of the first dose of study medication.\n3. Received radiotherapy with 4 weeks of the first dose of study medication.\n4. Underwent major operation within 4 weeks of the first dose of study medication or open wound, ulcer or fracture.\n5. Known symptomatic central nervous system (CNS) metastasis and\u002For carcinomatous meningitis. Subjects received prior treatment and have stable disease more than 4 weeks from first dose of study medication are permitted to enroll.\n6. Active, known or suspected autoimmune disease or has a history of the disease within the last 2 years.\n7. Interstitial lung disease requiring corticosteroids.\n8. Active or poorly controlled serious infections.\n9. Significant malnutrition.\n10. Symptomatic congestive heart failure (NYHA Class II-IV) or symptomatic or poorly controlled arrhythmia.\n11. Uncontrolled hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg) despite standard treatment.\n12. Within 6 months prior to the enrollment, history of gastrointestinal perforation and\u002For fistula, gastrointestinal ulcer, bowel obstruction, extensive bowel resection, Crohn\\'s disease, or ulcerative colitis, intra-abdominal abscesses, or long-term chronic diarrhea.\n13. History or evidence of inherited bleeding diathesis or coagulopathy or thrombus\n14. Any life-threatening bleeding within 3 months prior to the enrollment.\n15. High risk of bleeding.",{"count":7,"type":22},[25],"The purpose of this study is to evaluate the efficacy and safety of fruquintinib and pirfenidone in combination with anti-PD-1 antibody in patients with standard treatment failure of advanced or metastatic pMMR\u002FMSS colorectal adenocarcinoma.",[165,166,167],"To Evaluate the Efficacy of Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Colorectal Carcinoma","To Evaluate Whether Pirfenidone Can Reshape the Tumor Microenvironment in Colorectal Cancer","Combination of Fruquintinib and Anti-PD-1 Antibody Was Reported to Improve Patient Prognosis in Colorectal Cancer",[169],"Pirfenidone,tumor microenvironment, PD-1 antibody","2026-08-14",{"date":118,"type":40},{"date":173,"type":40},"2024-07-22",{"date":175,"type":22},"2026-12-30",{"name":46,"class":47},{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":133,"enrollmentInfo":184,"targetDuration":4,"studyType":23,"phases":186,"briefSummary":188,"conditions":189,"keywords":191,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":4},"100650639","early-phase-1-a-clinical-study-of-acg102-injection-in-patients-with-refractory-active-systemic-lupus-erythematosus-100650639","NCT07749430","A Clinical Study of ACG102 Injection in Patients With Refractory Active Systemic Lupus Erythematosus","A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamic Characteristics, and Preliminary Efficacy of ACG102 Injection in Patients With Refractory Active Systemic Lupus Erythematosus","Key Inclusion Criteria:\n\n1. ≥18 years of age at time of informed consent.\n2. Diagnosis of systemic lupus erythematosus (SLE) fulfilling the 2019 EULAR\u002FACR classification criteria.\n3. Refractory active disease defined as inadequate response to, or relapse following, standard of care (SoC) therapy.\n4. Patients on a stable dose of SoC for at least 4 weeks prior to enrollment.\n5. Sufficient organ function as defined by the protocol.\n\nKey Exclusion Criteria:\n\n1. Active severe infection, including tuberculosis.\n2. Severe hypogammaglobulinemia or IgA deficiency.\n3. Active hepatitis or history of severe liver disease.\n4. Severe cardiovascular diseases.\n5. History of cancer within the past 5 years (with exceptions per protocol).\n6. Receipt of B-cell-targeted therapies or other biologic therapies within the defined washout window prior to enrollment.\n7. History of organ transplantation, bone marrow transplantation, or hematopoietic stem cell transplantation.\n8. Known allergy to any active or inactive component of the study drug.",{"count":185,"type":22},13,[187],"EARLY_PHASE1","The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy of ACG102 administered via intravenous injection in patients with refractory active systemic lupus erythematosus (SLE)",[190],"Refractory Active Systemic Lupus Erythematosus",[192],"ACG102-001","2026-08-03",{"date":195,"type":40},"2026-08-06",{"date":197,"type":22},"2026-09-15",{"date":199,"type":22},"2028-01-30",{"name":46,"class":47},{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":207,"sex":17,"minAge":18,"maxAge":208,"enrollmentInfo":209,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":211,"conditions":212,"keywords":215,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":225,"locationsCount":48},"100506542","correlation-of-memory-cd8-t-cells-with-sepsis-severity-and-mortality-a-single-center-unblinded-prospective-non-interventional-observational-study-100506542","NCT05875740","Correlation of Memory CD8+ T Cells With Sepsis Severity and Mortality: a Single-center, Unblinded, Prospective, Non-interventional, Observational Study","Inclusion Criteria:\n\nPatients aged 18-60 years old without restriction of gender, race, religion, creed or nationality; No sedative drugs with elimination half-life were used before inclusion in the study; Patients and\u002For their family members know and agree to participate in the trial.\n\nExclusion Criteria:\n\nHistory of solid organ or bone marrow transplantation; Diseases that may affect immune-related indicators, such as autoimmune diseases such as rheumatoid arthritis and SLE, or hematological malignancies such as leukemia and lymphoma; Have received radiotherapy or chemotherapy within the past 30 days, or have received immunosuppressive drugs (tripterygium, mycophenolate, cyclophosphamide, FK506, etc); Pregnancy or lactation; Chronic nephrosis; Severe chronic liver disease (child-Pugh: Grade C); alcohol or opioid dependence, mental illness, or severe cognitive impairment; Patients and\u002For their family members refuse to participate in the trial.",true,"60 Years",{"count":210,"type":22},80,"Sepsis is defined as a life-threatening organ dysfunction that is caused by a dysregulated host response to infection. Severe sepsis is the most common cause of death among critically ill patients in non-coronary intensive care units (ICU). Sustained excessive inflammation and immune dysfunction have been confirmed to play a key role in organ damage and early death of sepsis patients. Therefore, it is important to reduce excessive inflammatory response mediated by immune cells and pro-inflammatory cytokines in the acute phase of sepsis.\n\nSingle-cell RNA sequencing performed on both septic patients and mice suggest that changes in Tcm (CD3+ CD8+ CD44+ CD127+ CD62L+) and Tem (CD3+ CD8+ CD44+ CD127+ CD62L -) in the acute phase of sepsis may play an important role in sepsis. In addition, animal researches showed that Tcm and Tem decreased decreased continuously at 24, 48 and 72h after cecal ligation and perforation (CLP) in mice, and the adoptive transfer of Tcm , sorting from spleen of mice 24h after CLP , but not Tem improved 7-day survival rate of sepsis mice.\n\nThis observational study is aimed to investigate the quantity and proliferation of Tcm and Tem in the acute phase of sepsis and their correlation with severity level and mortality of septic patients in ICU.",[213,214],"Sepsis","Inflammatory Response",[216,217,218,219],"sepsis","CD8+ T cell","central memory CD8+ T cell","inflammatory response",{"date":221,"type":40},"2026-08-04",{"date":223,"type":40},"2023-09-06",{"date":95,"type":22},{"name":46,"class":47},{"id":227,"slug":228,"hasResults":12,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":133,"enrollmentInfo":234,"targetDuration":4,"studyType":23,"phases":236,"briefSummary":237,"conditions":238,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":48},"100590657","fmt-for-lung-and-associated-organ-rescue-efficacy-in-mdro-infected-ventilated-patients-100590657","NCT06970262","FMT for Lung and Associated-organ Rescue Efficacy in MDRO-infected Ventilated Patients","FMT for Lung and Associated-organ Rescue Efficacy in Multidrug-resistant Organism (MDRO)-Infected Ventilated Patients: a Single-center, Open-Label, Randomized Controlled Trial","FLARE-MV","Inclusion Criteria:\n\n1. Age 18-70 years, inclusive, irrespective of sex or ethnic background;\n2. Admission to the intensive care unit (ICU) within 24-48 hours;\n3. Anticipated ICU length of stay of ≥7 days, as determined by the attending intensivist prior to enrollment;\n4. Mechanically ventilated patients with MDRO infection;\n5. Provision of written informed consent by the participant or legally authorized representative.\n\nExclusion Criteria:\n\n1. Severe systemic infection during early resuscitation, accompanied by hemodynamic instability, profound tissue hypoperfusion, or life-threatening electrolyte and acid-base disturbances;\n2. Clinician-assessed high risk of mortality within 5 days, or presence of formal treatment-limiting directives (e.g., do-not-intubate or do-not-resuscitate orders);\n3. Active gastrointestinal bleeding or perforation consistent with severe intestinal barrier dysfunction;\n4. Inability to tolerate enteral nutrition providing ≥50% of estimated caloric requirements due to structural intestinal pathology-including fibrotic bowel stenosis or high-output enterocutaneous fistula;\n5. Planned abdominal surgery or history of abdominal surgery within 14 days prior to enrollment;\n6. Confirmed diagnosis of fulminant colitis or toxic megacolon;\n7. Neutropenia defined as absolute neutrophil count \\\u003C 1.5 × 10⁹\u002FL;\n8. Recent exposure to high-risk immunosuppressive or cytotoxic agents within the preceding 3 months, including but not limited to: rituximab (within 6 months), anthracyclines (e.g., doxorubicin), or systemic corticosteroids at ≥20 mg\u002Fday prednisone-equivalent dose for ≥4 consecutive weeks;\n9. Pregnancy or lactation;\n10. Participation in another interventional clinical trial within 3 months prior to enrollment or ongoing at the time of study entry.",{"count":235,"type":22},60,[88],"Multidrug-resistant organism (MDRO)-infection represents a substantial global health burden. In the intensive care unit (ICU), the concurrent administration of antibiotics, opioids, proton pump inhibitors (PPIs), vasoconstrictors, and parenteral nutrition-compounded by the intrinsic severity of critical illness-induces profound gut microbiota dysbiosis. Accumulating preclinical and clinical evidence indicates that such intestinal dysregulation may trigger distal immunomodulatory and microbial shifts in the lung via the gut-lung axis, thereby contributing to pulmonary microecological imbalance and impairing recovery trajectories. Although pulmonary microecology has garnered increasing scientific attention, the causal and temporal relationship between gut dysbiosis and the establishment or exacerbation of pulmonary microbial dysbiosis in MDRO-infecction remains inadequately characterized. As a result, it is currently unclear whether gut dysbiosis serves as a primary pathogenic driver, a disease-amplifying factor, or a secondary epiphenomenon in the context of MDRO-infecction-associated lung injury.\n\nFecal microbiota transplantation (FMT) is a targeted microbiome-modulating intervention that involves the transfer of functionally diverse, minimally processed microbial communities from comprehensively screened healthy donors to restore ecological stability and functional redundancy in the recipient gut. Robust clinical data demonstrate that FMT effectively decolonizes the gastrointestinal tract of MDROs and reduces the incidence of secondary infections in immunocompetent, non-critically ill populations. Over the past decade, FMT has demonstrated reproducible efficacy in recurrent Clostridioides difficile infection and emerging promise in select extra-intestinal inflammatory conditions-highlighting its capacity as a mechanism-informed strategy for systemic host-microbe recalibration. Given the established role of the gut as a reservoir for enteric pathogens implicated in sepsis, hospital-acquired bloodstream infections, and ventilator-associated pneumonia (VAP), we propose a prospective, single-center, open-Label, randomized controlled trial (RCT) enrolling mechanically ventilated adults with MDRO-infeccted ventilated patients. The primary objective is to evaluate whether adjunctive FMT-delivered via nasojejunal tube-decrease 28-day mortality.",[239,240,241],"Lung Infection","Microbial Colonization","Food Intolerance Syndromes","2026-07-31",{"date":193,"type":40},{"date":245,"type":40},"2026-03-20",{"date":247,"type":22},"2027-12-31",{"name":46,"class":47},{"id":250,"slug":251,"hasResults":12,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":4,"eligibilityCriteria":255,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":256,"targetDuration":4,"studyType":23,"phases":258,"briefSummary":260,"conditions":261,"keywords":263,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":48},"100640348","phase-1-a-study-of-in026-in-participants-with-refractory-gout-100640348","NCT07587684","A Study of IN026 in Participants With Refractory Gout","A Clinical Study on the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of IN026 in the Treatment of Refractory Gout","Inclusion Criteria:\n\n1. Can voluntarily sign the informed consent form (ICF) and comply with ICF and study protocol requirements.\n2. Male or female, 18-75 years old (inclusive) at screening.\n3. Meet 2015 ACR\u002FEULAR gout classification criteria, in the intercritical phase of gout or acute flare resolved ≥2 weeks at screening.\n4. Serum uric acid ≥420 μmol\u002FL (7 mg\u002Fdl) at screening.\n5. Meet the definition of refractory gout (poor uric acid control accompanied by severe gout symptoms)\n\nExclusion Criteria:\n\n1. Gout secondary to radiotherapy\u002Fchemotherapy, lead poisoning, organ transplantation, tumor, etc. at screening\u002Fbaseline.\n2. Rheumatoid arthritis, infectious\u002Fseptic arthritis, or other acute inflammatory arthritis at screening\u002Fbaseline.\n3. Glucose-6-phosphate dehydrogenase (G6PD) deficiency history, or G6PD level below normal lower limit.\n4. Positive HBsAg; HCV antibody positive is excluded except those with sustained HCV-RNA negativity after standard treatment; HIV antibody positive; active syphilis.\n5. Presence of chronic liver diseases including active hepatitis, cirrhosis and alcoholic liver disease.\n6. Participants with a history of any of the following: serious cardiovascular diseases within 6 months prior to screening; or serious diseases of the digestive, respiratory, urinary, musculoskeletal, neuropsychiatric, hematological, or immune systems within 3 months prior to screening.\n7. Prolonged QTcF at screening.\n8. Uncontrolled or untreated hypertension at screening.\n9. Participants who have received medications that may affect endpoint assessment, such as other urate-lowering therapies, mRNA-LNP vaccine, PEGylated drugs and uricase agents.\n10. History of severe allergy, or known allergy to IN026 or its components.\n11. Participation in other clinical trials within 30 days prior to screening.\n12. Participants with poor compliance, or those deemed otherwise unsuitable for this study by the investigator.",{"count":257,"type":22},16,[259],"PHASE1","The goal of this clinical study is to learn if IN026 Injection is safe and works to lower uric acid levels in adults with refractory gout (gout that does not respond well to standard treatments). The main questions it aims to answer are:\n\n* What medical problems do participants have when taking IN026, such as changes in vital signs, blood tests, or heart rhythm?\n* How does the body absorb, process, and respond to IN026, and does it trigger an immune reaction?\n* Does IN026 lower uric acid levels in the blood and reduce tophi?\n\nInvestigator will start with lower doses of IN026 and slowly increase the dose to find the well-tolerated dose.\n\nParticipants will:\n\n* Receive IN026 through an intravenous (IV) drip into a vein at a set dose.\n* Complete a screening period of up to 4 weeks, followed by treatment and check-ups for up to 20 weeks.\n* Have blood and urine samples taken at set times to check safety and how the body responds to IN026.",[262],"Refractory Gout",[264,265,266,267,268,269,262,270,271,272,273,274,275,276,277,278],"Uricase","Gout","Uric acid","IN026","hyperuricemia","Metabolic Diseases","Safety","Pharmacokinetics","Pharmacodynamics","Efficacy","mRNA-LNP medicine","Rheumatic Diseases","Messenger RNA","Urate oxidase","immunogenicity","2026-07-30",{"date":242,"type":40},{"date":282,"type":40},"2026-06-12",{"date":284,"type":22},"2028-05",{"name":46,"class":47},{"id":287,"slug":288,"hasResults":12,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":23,"phases":296,"briefSummary":297,"conditions":298,"keywords":300,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":48},"100645795","endovascular-treatment-for-posterior-circulation-ischemic-stroke-post-1-day-24-hours-100645795","NCT07699029","Endovascular Treatment for Posterior Circulation Ischemic Stroke Post 1 Day （24 Hours）","Endovascular Treatment for Posterior Circulation Ischemic Stroke Post 1 Day （24 Hours） A Randomized Controlled Clinical Trial On Efficacy","ETP1-PC","Inclusion Criteria:\n\n1. Age ≥ 18 years old\n2. Baseline NIHSS score of 4 or higher, maintained prior to randomization\n3. Stroke onset or more than 24 hours since the last known good state, but within 14 days\n4. CTA\u002FMRA\u002FDSA confirmed occlusion of the responsible vessel in basilar artery or intracranial segments of both vertebral arteries (V4)\n5. Modified Rankin Scale (mRS) score of 0 or 1 pre-stroke\n6. The subject or their legally authorized representative has signed the informed consent form for the study\n\nExclusion Criteria:\n\n1. Hemorrhage on CT or MRI\n2. Based on the judgment of the treating physician, the patient is considered unlikely to benefit from the trial (e.g., advanced dementia, severe pre-stroke disability (mRS ≥ 2), or high risk of early mortality)\n3. Major comorbidities that may interfere with outcome assessment and follow-up (e.g., severe heart failure, renal failure, etc.).\n4. Evidence of vascular recanalization prior to randomization\n5. Uncontrolled seizures at the time of stroke onset, if they interfere with obtaining an accurate baseline NIHSS\n6. Posterior circulation Acute Stroke Prognosis Early CT score (pc-ASPECTS) \\\u003C 6 on non-contrast CT or CT angiography source images or MR with diffusion-weighted imaging\n7. Complete cerebellar infarct with significant mass effect and compression of the fourth ventricle,or bilateral thalamic infarction on CT or MRI\n8. Baseline platelet count \\\u003C50,000\u002FuL\n9. Severe, persistent hypertension (systolic blood pressure \\> 220 mmHg or diastolic blood pressure \\> 120 mmHg)\n10. Known hereditary or acquired bleeding disorders, coagulation factor deficiencies, or recent oral anticoagulant therapy with an International Normalized Ratio (INR) \\> 3\n11. Suspected purulent embolism, with a suspicion of bacterial endocarditis\n12. Known allergies to iodine, heparin, anesthetics, or other explicit contraindications to the endovascular treatment procedure\n13. Pregnancy\n14. Other serious, progressive, or end-stage diseases (as determined by the investigator) or a life expectancy of less than 6 months\n15. Attempted use of a neurothrombectomy device to remove the clot prior to randomization\n16. Currently participating in a study involving other investigational drugs or devices\n17. Evidence of intracranial tumor on CT or MRI (excluding meningioma)\n18. CTA\u002FMRA showing excessive tortuosity of the cervical vessels, which may interfere with endovascular treatment\n19. Suspicion of aortic dissection based on medical history and CTA\u002FMRA findings\n20. Any other conditions that the investigator believes may interfere with the endovascular procedure or pose significant risk to the subject during the procedure",{"count":295,"type":22},244,[88],"To evaluate the efficacy and safety of endovascular therapy for posterior circulation ischemic stroke presenting more than 24 hours after symptom onset.",[299],"Posterior Circulation Ischemic Stroke",[301,302],"stroke","Posterior Circulation","2026-07-28",{"date":279,"type":40},{"date":306,"type":22},"2026-07-16",{"date":308,"type":22},"2030-08-01",{"name":46,"class":47},{"id":311,"slug":312,"hasResults":12,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":317,"targetDuration":4,"studyType":23,"phases":318,"briefSummary":319,"conditions":320,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":326,"leadSponsor":328,"locationsCount":48},"100648857","phase-2-efficacy-and-safety-of-retlirafusp-alfa-plus-bevacizumab-and-chemotherapy-with-or-without-short-course-radiotherapy-in-patients-with-crclm-100648857","NCT07728019","Efficacy and Safety of Retlirafusp Alfa Plus Bevacizumab and Chemotherapy With or Without Short-Course Radiotherapy in Patients With CRCLM","Efficacy and Safety of Retlirafusp Alfa Plus Bevacizumab and Chemotherapy With or Without Short-Course Radiotherapy in Patients With Colorectal Cancer Liver Metastases: a Randomized Phase II Study","Inclusion Criteria:\n\n1. Provide signed written informed consent and voluntarily agree to participate in this study.\n2. Age ≥ 18 years and ≤ 75 years.\n3. Histologically confirmed colorectal adenocarcinoma.\n4. Liver metastasis confirmed by imaging or pathology.\n5. Have not received any prior anti-cancer therapy.\n6. At least one measurable lesion according to RECIST v1.1.\n7. pMMR\u002FMSS status confirmed by a local testing center, or unknown status.\n8. Be able to swallow tablets.\n9. ECOG PS 0-1\n10. Have no contraindications for surgery.\n11. Have adequate major organ function.\n\nExclusion Criteria:\n\n1. Have a history of allergy to monoclonal antibodies, any component of retlirafusp alfa, bevacizumab, capecitabine, oxaliplatin, or other platinum-based agents.\n2. Have previously received or are currently receiving any of the following treatments:\n\n   1. Any anti-tumor therapy including surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy.\n   2. Use of immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes within 2 weeks prior to the first dose of study drug (at a dose \\> 10 mg\u002Fday prednisone or equivalent). Inhaled or topical corticosteroids, and adrenal replacement therapy at doses \\> 10 mg\u002Fday prednisone or equivalent, are permitted in the absence of active autoimmune disease.\n   3. Receipt of live attenuated vaccine within 4 weeks prior to the first dose of study drug.\n   4. Major surgery or severe trauma within 4 weeks prior to the first dose of study drug.\n3. Have any active autoimmune disease or history of autoimmune disease, including but not limited to interstitial pneumonitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism (patients on hormone replacement therapy may be considered for inclusion). Patients with psoriasis or childhood asthma\u002Fallergy that has completely resolved and requires no intervention in adulthood may be considered for inclusion, but those requiring medical intervention with bronchodilators are not eligible.\n4. Have a history of immunodeficiency, including HIV-positive test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation.\n5. Have poorly controlled cardiac symptoms or diseases, including but not limited to: (1) heart failure of New York Heart Association (NYHA) class ≥ II; (2) unstable angina; (3) myocardial infarction within 1 year; (4) clinically significant supraventricular or ventricular arrhythmias that have not been clinically intervened or remain poorly controlled after intervention.\n6. Have experienced a severe infection (CTCAE grade \\> 2) within 4 weeks prior to the first dose of study drug, such as severe pneumonia requiring hospitalization, bacteremia, or infectious complications; or have evidence of active pulmonary inflammation on baseline chest imaging, or have signs\u002Fsymptoms of infection or require oral or intravenous antibiotic therapy within 14 days prior to the first dose of study drug (except for prophylactic antibiotic use).\n7. Have active pulmonary tuberculosis infection by history or CT examination, or a history of active pulmonary tuberculosis infection within 1 year prior to enrollment, or a history of active pulmonary tuberculosis infection \\> 1 year ago without adequate treatment.\n8. Have hepatitis B (HBV DNA ≥ 2000 IU\u002FmL or ≥ 10⁴ copies\u002FmL), or hepatitis C (positive anti-HCV antibody and HCV RNA above the lower limit of detection of the assay).\n9. Have been diagnosed with another malignancy within 5 years prior to the first dose of study drug, except for malignancies with a low risk of metastasis or death (5-year survival rate \\> 90%), such as adequately treated basal cell carcinoma or squamous cell skin cancer, or cervical carcinoma in situ, which may be considered for inclusion.\n10. Are pregnant or breastfeeding.",{"count":235,"type":22},[25],"Efficacy and safety of retlirafusp alfa combined with bevacizumab and chemotherapy with or without short-course radiotherapy in conversion therapy for advanced colorectal cancer liver metastases: an exploratory study.",[321],"CRC (Colorectal Cancer)","2026-07-22",{"date":324,"type":40},"2026-07-27",{"date":322,"type":22},{"date":327,"type":22},"2031-12-31",{"name":46,"class":47},{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":333,"acronym":4,"eligibilityCriteria":334,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":335,"targetDuration":4,"studyType":23,"phases":337,"briefSummary":338,"conditions":339,"keywords":341,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":48},"100625983","early-phase-1-a-clinical-study-to-evaluate-the-safety-and-preliminary-efficacy-of-qi-019a-in-patients-with-relapsedrefractory-multiple-myeloma-100625983","NCT07429721","A Clinical Study to Evaluate the Safety and Preliminary Efficacy of QI-019A in Patients With Relapsed\u002FRefractory Multiple Myeloma.","Inclusion Criteria:\n\n* 1\\. Age ≥ 18 years, any gender;\n* 2\\. Diagnosed with multiple myeloma (MM) according to IMWG diagnostic criteria;\n* 3\\. Have received at least 2 lines of anti-MM treatment, with at least one full treatment cycle per line, and experienced disease progression during the most recent anti-myeloma treatment or within 12 months after it, confirmed by available clinical evidence; or deemed by the investigator to be refractory to both immunomodulatory agents and proteasome inhibitors, with disease progression during the most recent anti-myeloma treatment or within 2 months after it (according to IMWG diagnostic criteria);\n* 4\\. Disease must be measurable at screening, meeting one or more of the following criteria:\n\n  * Serum M protein level ≥ 0.5 g\u002FdL;\n  * Or urine M protein level ≥ 200 mg\u002F24h;\n  * Or involved serum free light chain ≥ 10 mg\u002FdL with abnormal serum free light chain κ\u002Fλ ratio;\n* 5\\. ECOG performance status 0-2, with an expected survival of ≥ 3 months;\n* 6\\. Bone marrow function test results (from screening or within 2 months prior) meet the following requirements:\n\n  * Hemoglobin ≥ 6 g\u002FdL (no red blood cell transfusion within 1 week before screening), recombinant human erythropoietin allowed; for patients meeting the ≥ 6 g\u002FdL hemoglobin requirement at screening, red blood cell transfusions are allowed to maintain hemoglobin ≥ 6 g\u002FdL;\n  * Absolute neutrophil count (ANC) ≥ 600\u002FμL (no use of granulocyte colony-stimulating factor (G-CSF) within 1 week before screening or pegylated G-CSF within 2 weeks before screening);\n  * Platelet count ≥ 50,000\u002FμL;\n  * Lymphocyte count ≥ 500\u002FμL;\n* 7\\. Normal renal function: Creatinine clearance (CrCl) (Cockcroft-Gault formula) ≥45 mL\u002Fmin;\n* 8\\. Liver function must meet the following criteria:\n\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0× the upper limit of normal (ULN);\n  * Total bilirubin (TBIL) and alkaline phosphatase (AKP or ALP) ≤2.0× ULN (except for congenital hyperbilirubinemia, e.g., Gilbert's syndrome, direct bilirubin ≤1.5× ULN);\n  * Albumin ≥3 g\u002FdL;\n* 9\\. Cardiac function must meet the following criteria:\n\n  * Left ventricular ejection fraction ≥50% (by echocardiography or MUGA scan);\n  * No clinically significant pericardial effusion;\n  * No clinically significant electrocardiogram abnormalities;\n* 10\\. Pulmonary function must meet the following criteria:\n\n  • Blood oxygen saturation ≥90% without oxygen supplementation;\n* 11\\. Women of childbearing potential must have a negative pregnancy test at screening and before drug infusion and must not be breastfeeding.\n* 12\\. Men and women of childbearing potential must agree to use effective contraception from the time of signing the informed consent until 1 year after the use of the study drug;\n* 13\\. Men and women of childbearing potential must agree not to donate sperm or eggs (oocytes) or other reproductive cells from the time of signing the informed consent until 1 year after the use of the study drug;\n* 14\\. The subject or their legal guardian agrees to participate in this clinical trial and signs the informed consent form (ICF), indicating that they understand the purpose and procedures of this clinical trial and are willing to participate in the study.\n\nExclusion Criteria:\n\n* 1.During screening, participants who have received other anticancer treatments (based mainly on investigator judgment):\n\n  * Received targeted therapy, epigenetic therapy, other investigational drugs, or treatment using invasive research medical devices within 5 half-lives;\n  * Received immune\u002Fnon-immune-directed systemic therapy within 1 week;\n  * Received cytotoxic therapy within 2 weeks;\n  * Received proteasome inhibitors within 2 weeks;\n  * Received immunomodulatory therapy within 1 week.\n  * Received radiotherapy within 4 weeks (if the radiotherapy covered ≤5% of bone marrow reserve, the subject is eligible regardless of the radiotherapy end date);\n* 2\\. Received allogeneic hematopoietic stem cell transplantation within 6 months or autologous hematopoietic stem cell transplantation within 3 months before infusion;\n* 3\\. Had malignancies other than MM before screening, except for: malignancies treated with curative intent, with no known active disease ≥2 years prior to enrollment; or adequately treated non-melanoma skin cancer with no evidence of disease currently;\n* 4\\. Received any treatment using vesicular stomatitis virus G (VSVG) pseudotyped virus;\n* 5\\. Had severe, uncontrolled infection symptoms (bacterial, viral, fungal, etc.) during the screening period;\n* 6\\. Within 6 months before infusion, tested positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA levels above the normal range; tested positive for hepatitis C virus (HCV) antibody with peripheral blood HCV RNA levels above the normal range; tested positive for human immunodeficiency virus (HIV) antibody; or tested positive for syphilis;\n* 7\\. Had symptomatic heart failure or other serious cardiac diseases such as severe arrhythmias:\n\n  * New York Heart Association (NYHA) class III or IV congestive heart failure;\n  * Experienced myocardial infarction or underwent coronary artery bypass graft (CABG) or coronary stent implantation within 6 months prior to signing the ICF;\n  * Had clinically significant ventricular arrhythmias, or a history of unexplained syncope (excluding cases caused by vasovagal response or dehydration);\n  * Had a history of severe non-ischemic cardiomyopathy;\n* 8\\. Other clinically significant diseases, including:\n\n  * Primary immunodeficiency;\n  * Stroke or seizure within 6 months prior to screening;\n  * Clear clinical evidence of dementia or altered mental status;\n  * Parkinson's disease or Parkinsonian movement disorders or history thereof;\n* 9\\. Undergoing surgery within 2 weeks of administration or planned surgery within 2 weeks after administration, except for surgeries under local anesthesia;\n* 10\\. Administration of live attenuated vaccines within 1 month before dosing;\n* 11\\. Known severe allergic reaction to QI-019B or any of its formulation components;\n* 12\\. Known severe allergic reaction to tocilizumab;\n* 13\\. Unsuitable for establishing intravenous access;\n* 14\\. Other conditions deemed by the investigator to be unsuitable for participation in this study.",{"count":336,"type":22},24,[187],"This is a single-arm, open-label, single-center clinical trial to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of QI-019A in patients with relapsed\u002Frefractory multiple myeloma.",[340],"Multiple Myeloma (MM)",[342,343,344,345,346],"in vivo","multiple myeloma","BCMA","CD19","CAR-T","2026-07-20",{"date":322,"type":40},{"date":350,"type":40},"2026-03-03",{"date":352,"type":22},"2029-06-01",{"name":46,"class":47},{"id":355,"slug":356,"hasResults":12,"nctId":357,"briefTitle":358,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":360,"targetDuration":4,"studyType":23,"phases":362,"briefSummary":363,"conditions":364,"keywords":366,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":48},"100600762","early-phase-1-an-open-label-single-arm-clinical-study-to-evaluate-the-safety-and-preliminary-efficacy-of-oriv508-injection-in-treating-relapsedrefractory-hematological-malignancies-100600762","NCT07101705","An Open-label, Single-arm Clinical Study to Evaluate the Safety and Preliminary Efficacy of OriV508 Injection in Treating Relapsed\u002FRefractory Hematological Malignancies","Inclusion Criteria:\n\n1. Aged 18 - 75 years.\n2. ECOG scores 0-1.\n3. Expected survival time ≥ 12 weeks.\n4. Have a record of confirmed multiple myeloma (MM) according to IMWG criteria, or a record of histologically confirmed aggressive B-cell non-Hodgkin lymphoma (B-NHL). According to the definition of the 2022 World Health Organization (WHO) classification, the pathological types of aggressive B-NHL include: diffuse large B-cell lymphoma, not otherwise specified; diffuse large B-cell lymphoma\u002Fhigh-grade B-cell lymphoma with MYC and BCL2 rearrangements; high-grade B-cell lymphoma, not otherwise specified; primary mediastinal B-cell lymphoma; mantle cell lymphoma; grade 3b follicular lymphoma; large B-cell lymphoma transformed from indolent B-NHL.\n5. For MM subjects only: (1) Have received at least 2 lines of anti-tumor therapy, with each line of therapy undergoing at least one complete treatment cycle, and have experienced disease progression during or within 12 months after the last treatment; or be judged by the investigator as double-refractory to immunomodulators and proteasome inhibitors, and did not achieve a minimal response (MR) or better during the last treatment or experienced disease progression within 60 days after the end of treatment. (2) Have measurable lesions during the screening period, meeting any of the following criteria: (a) Serum M-protein ≥ 0.5 g\u002FdL; (b) Urine M-protein≥ 200 mg\u002F24h; (c) Involved free light chain (FLC) level ≥10 mg\u002FdL provided serum FLC ratio is abnormal; (d) Plasma cell percentage ≥30% detected by bone marrow aspirate\u002Fbiopsy; (e) Presence of at least one extramedullary lesion with a maximum diameter ≥ 2 cm.\n6. For aggressive B-NHL subjects only: (1) Have received at least 2 lines of anti-tumor therapy, and are refractory to the last line of therapy (at least 2 cycles) (best response is PD or SD) or have experienced disease progression after the end of treatment. Previous treatments must include standard treatment regimens with anti-CD20 monoclonal antibodies (except for subjects with CD20-negative tumors) and anthracyclines; (2) Have at least one measurable lesion during the screening period: lymph node lesions must have a longest diameter \\> 1.5 cm, and extranodal lesions must have a longest diameter \\> 1.0 cm.\n7. Hemogram meets the following requirements:\n\n   * Hemoglobin ≥ 6 g\u002FdL (no red blood cell transfusion within 1 week prior to screening, recombinant human erythropoietin is permitted);\n   * Absolute neutrophil count (ANC) ≥ 750 \u002FμL (no granulocyte colony-stimulating factor (G-CSF) used within 1 week prior to screening or no pegylated G-CSF used within 2 weeks prior to screening);\n   * Platelet count ≥ 50,000 \u002FμL;\n   * Lymphocyte count ≥ 500 \u002FμL.\n8. Renal function: Estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease (MDRD) equation) ≥ 40 mL\u002Fmin\u002F1.73m2 (If the eGFR of an MM subject is \\\u003C 40 mL\u002Fmin\u002F1.73m2, the Investigator may decide whether to enroll based on clinical indications).\n9. Liver function: Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 3.0 × upper limit of normal (ULN), total bilirubin ≤ 1.5 × ULN (for subjects with Gilbert's syndrome or liver invasion by tumor, ALT and AST ≤ 5.0 × ULN and total bilirubin ≤ 3 × ULN are permitted).\n10. Cardiac function: Left ventricular ejection fraction ≥ 45%.\n11. Pulmonary function: Pulse oxygen saturation ≥ 92% without oxygen inhalation.\n12. Women with childbearing potential must have a negative blood pregnancy test and not be in the lactation period.\n13. Men and women with childbearing potential must agree to use effective contraceptive measures from the time of signing the informed consent form (ICF) until 1 year after the investigational drug administration.\n14. Men and women with childbearing potential must agree not to donate reproductive cells such as sperm or eggs (oocytes) from the time of signing the ICF until 1 year after the investigational drug administration.\n15. The participant or their legally authorized representative agrees to participate in this clinical trial and signs the ICF, indicating that he\u002Fshe understands the objective and procedures of this clinical trial and is willing to participate in the study.\n\nExclusion Criteria:\n\n1. The subject has received the following therapy prior to signing the ICF:\n\n   * Small molecule targeted therapy, epigenetic therapy, or treatment with an investigational drug or used an invasive investigational medical device within 14 days or at least 5 half-lives, whichever is longer;\n   * Immunosuppressive agent therapy (such as tacrolimus, mycophenolate mofetil, etc.) within 28 days;\n   * Monoclonal antibody treatment within 21 days;\n   * Cytotoxic therapy within 14 days;\n   * Proteasome inhibitor therapy within 14 days;\n   * Immunomodulator agent therapy within 7 days;\n   * Therapeutic dose of corticosteroids (defined as prednisone ≥ 20 mg\u002Fday or equivalent dose of other corticosteroids) within 72 hours, but physiological replacement dose, topical and inhaled corticosteroids are permitted;\n   * Radiotherapy within 28 days (only for subjects whose radiation field covers \\> 5% of bone marrow reserve).\n2. Received autologous hematopoietic stem cell transplantation within 24 weeks prior to signing the ICF.\n3. Received organ transplantation or allogeneic hematopoietic stem cell transplantation.\n4. Have other malignant tumors prior to screening, except for the following cases: malignant tumors that have received radical treatment and have no known active disease within 2 years prior to screening; or adequately treated non-melanoma skin cancer with no evidence of active disease.\n5. Previously treated with any viral therapy using vesicular stomatitis virus G (VSVG)-pseudotyped virus.\n6. Known active central nervous system involvement or clinical signs of meningeal involvement.\n7. Complicated with severe uncontrolled active infections (bacterial, viral, fungal, etc.).\n8. Have active autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) or diseases requiring systemic application of immunosuppressive drugs.\n9. Have hereditary bleeding\u002Fcoagulation diseases, other diseases that may increase the risk of bleeding, etc.\n10. Have active deep vein thrombosis (cancer emboli or thrombus) or pulmonary embolism within 12 weeks prior to signing the ICF, but if the investigator judges that the thrombus has been clinically treated and has no risk of detachment, enrollment is permitted.\n11. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA titer exceeding the normal range; positive for hepatitis C virus (HCV) antibody with peripheral blood hepatitis C virus (HCV) RNA titer exceeding the normal range; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis test.\n12. Complicated with symptomatic heart failure or other severe cardiac diseases such as arrhythmia:\n\n    * New York Heart Association (NYHA) class III or IV congestive heart failure;\n    * Myocardial infarction, coronary artery bypass grafting (CABG) or coronary stent implantation within 24 weeks prior to signing the ICF;\n    * Clinically significant ventricular arrhythmia, or history of unexplained syncope (except those caused by vasovagal or dehydration);\n    * Significant non-ischemic cardiomyopathy history.\n13. Have other clinically significant diseases, including:\n\n    * Primary immunodeficiency;\n    * Stroke or epileptic seizure within 24 weeks prior to signing the ICF;\n    * Obvious clinical evidence of dementia or mental status changes;\n    * History of Parkinson's disease or Parkinson-like movement disorders.\n14. Underwent surgery within 2 weeks prior to signing the ICF or plan to undergo surgery within 2 weeks after drug administration, except for surgery under local anesthesia.\n15. Used attenuated\u002Finactivated vaccines within 28 days prior to signing the ICF.\n16. Known severe allergic reaction to OriV508 or its formulation components.\n17. Known severe allergic reaction to tocilizumab.\n18. Inability to establish venous access.\n19. Other situations deemed unsuitable for participating in the study by the investigator.",{"count":361,"type":22},40,[187],"This is a single center, single arm, open-label, dose escalation, phase 1 study to evaluate the safety, tolerability, preliminary efficacy and immunogenicity of OriV508 injection for patients with relapsed\u002Frefractory hematological malignancies.",[340,365],"Non-Hodgkin Lymphoma (NHL)",[367,343,368,369],"BCMA\u002FCD19","Non-Hodgkin lymphoma","In vivo CAR-T",{"date":371,"type":40},"2026-07-21",{"date":373,"type":40},"2025-09-08",{"date":375,"type":22},"2028-08-01",{"name":46,"class":47},{"id":378,"slug":379,"hasResults":12,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":207,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":23,"phases":386,"briefSummary":387,"conditions":388,"keywords":390,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":397,"completionDateStruct":398,"leadSponsor":400,"locationsCount":48},"100647452","early-phase-1-clinical-evaluation-of-68gaga-ffd-pet-imaging-in-healthy-volunteers-and-patients-with-solid-tumors-100647452","NCT07708103","Clinical Evaluation of [68Ga]Ga-FFD PET Imaging in Healthy Volunteers and Patients With Solid Tumors","A Single-Center, Prospective, Open-Label Clinical Study to Evaluate the Safety, Biodistribution, Radiation Dosimetry, and Diagnostic Performance of [68Ga]Ga-FFD PET Imaging in Healthy Volunteers and Adult Patients With Solid Tumors","Inclusion Criteria:\n\n* Written informed consent obtained before any study-specific procedures. Adults aged 18 years or older.\n* Healthy volunteers or patients with histologically, cytologically, or clinically confirmed malignant solid tumors.\n* ECOG performance status of 0-1 for patients.\n* Clinical indication for \\^18F-FDG PET\u002FCT imaging (patient cohort only).\n* Adequate organ function.\n* Willing and able to comply with all study procedures.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women.\n* Known hypersensitivity to gallium-containing radiopharmaceuticals or any component of the investigational product.\n* Clinically significant uncontrolled cardiovascular, hepatic, renal, hematologic, neurological, or psychiatric disease.\n* Active uncontrolled infection requiring systemic treatment.\n* Receipt of investigational drugs or participation in another interventional clinical study within 30 days before enrollment.\n* Previous anticancer therapy that does not satisfy the protocol-defined washout period (patient cohort only).\n* Inability to undergo PET\u002FCT imaging or comply with study procedures. Any condition that, in the investigator's judgment, would compromise participant safety or interfere with study assessments.",{"count":385,"type":22},12,[187],"This is a prospective, single-center, open-label clinical study designed to evaluate the safety, biodistribution, radiation dosimetry, and diagnostic performance of \\[68Ga\\]Ga-FFD PET imaging. The study consists of two cohorts: healthy volunteers and adult patients with histologically or clinically confirmed malignant solid tumors. Healthy volunteers will undergo serial PET imaging to evaluate tracer biodistribution, pharmacokinetics, and radiation dosimetry. Patients will undergo \\[68Ga\\]Ga-FFD PET imaging in addition to standard-of-care \\^18F-FDG PET imaging for assessment of lesion detection and diagnostic performance. Safety will be evaluated through adverse event monitoring, vital signs, laboratory tests, physical examinations, and electrocardiography. Diagnostic performance will be assessed using histopathology, conventional imaging, and clinical follow-up as the reference standard.",[389],"Solid Tumor Malignancies",[391,392,393,394],"pet","Solid Tumor","Biodistribution","Diagnostic Imaging","2026-07-12",{"date":306,"type":40},{"date":279,"type":22},{"date":399,"type":22},"2027-07-30",{"name":46,"class":47},{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":407,"targetDuration":4,"studyType":23,"phases":409,"briefSummary":410,"conditions":411,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":413,"startDateStruct":414,"completionDateStruct":415,"leadSponsor":416,"locationsCount":48},"100647347","early-phase-1-clinical-application-of-fap-targeted-radionuclide-imaging-in-the-diagnosis-and-staging-of-malignant-solid-tumors-100647347","NCT07707999","Clinical Application of FAP-Targeted Radionuclide Imaging in the Diagnosis and Staging of Malignant Solid Tumors","Inclusion Criteria:\n\n1. Voluntary participation and the patient or their legal representative is able to sign an informed consent form.\n2. Adult patients (aged 18 or above), regardless of gender.\n3. Patients with an ECOG performance status of 0 to 1 and able to tolerate PET and SPECT\u002FCT examinations.\n4. Patients with histopathologically or clinically confirmed malignant solid tumors who have measurable lesions according to RECIST 1.1 criteria.\n5. Patients with expected survival\\>6 months.\n6. Female patients of childbearing potential must have a negative pregnancy test, and all patients (including male patients) agree to use effective contraceptive measures during the study period and for at least three months after study drug administration.\n\nExclusion Criteria:\n\n1. Patients who are pregnant or breastfeeding, or plan to become pregnant during the study period or within three months after study drug administration (excluding those who have been postmenopausal for at least one year, or those who are surgically sterilized, such as bilateral tubal ligation without recanalization, bilateral oophorectomy, or hysterectomy); or patients who plan to donate sperm or eggs during the study period or within three months after study drug administration.\n2. Patients with known or suspected allergy to the investigational drug or any of its components, or patients with severe allergic constitution.\n3. Patients who have undergone procedures within 6 months prior to study entry that, in the investigator's judgment, may affect drug absorption, distribution, metabolism, or excretion.\n4. Patients with positive syphilis or HIV test results at screening.\n5. Patients with abnormal liver or kidney function: serum total bilirubin (TBIL) \\> 31.5 umol\u002FL; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 120 U\u002FL, or \\> 200 U\u002FL if the elevation is considered to be related to liver metastases from solid tumors; serum creatinine (Scr) \\> 150 umol\u002FL, or creatinine clearance \\\u003C 60 mL\u002Fmin (according to the Cockcroft-Gault formula).\n6. Patients with abnormal bone marrow parameters: absolute neutrophil count \\\u003C 1.5 x 10\\^9\u002FL, hemoglobin \\\u003C 10 g\u002FdL, serum albumin \\\u003C 2.8 g\u002FdL (normal range 3.5-5.5 g\u002FdL), platelets \\\u003C 100 x 10\\^9\u002FL (normal range 100-300 x 10\\^9\u002FL), international normalized ratio (INR) \\> 1.5 (normal range 0.8-1.3) in patients not taking warfarin, or prothrombin time (PT) \\> 2 x ULN (normal range 11-15 seconds).\n7. Patients with active infection (e.g., acute bacterial infection, tuberculosis, active hepatitis B\u002FC, active syphilis, etc.). Active hepatitis B is defined as: positive HBsAg or HBcAb, or results outside the normal reference range, accompanied by hepatitis B virus DNA titer \\> 2500 copies\u002FmL or \\> 500 IU\u002FmL. Active hepatitis C is defined as: positive hepatitis C antibody, or results outside the normal reference range, and positive HCV-RNA.\n8. Patients with dysuria or urinary incontinence due to any cause.\n9. Patients with claustrophobia or other conditions that preclude cooperation with PET\u002FMR and SPECT\u002FCT examinations.\n10. Patients with psychiatric disorders such as depressive symptoms, schizophrenia, delusions, hallucinations, or suicidal ideation.\n11. Patients with severe cardiovascular disease, including but not limited to New York Heart Association (NYHA) class II to IV congestive heart failure, or left ventricular ejection fraction (LVEF) \\\u003C 50% or below the lower limit of normal.\n12. Patients with other conditions that, in the investigator's opinion, make the patient unsuitable for participation in this study.",{"count":408,"type":22},20,[187],"This study is a single-center, open-label first-in-human clinical study. Patients with clinically suspected or confirmed malignant solid tumors will undergo \\[68Ga\\]Ga-FAP PET imaging or \\[177Lu\\]Lu-FAP SPECT imaging as well as \\[18F\\]FDG PET imaging to determine the presence or absence of lesions, and to assess lesion location, characteristics, and metastasis. Histopathological diagnosis or follow-up results will serve as the reference standard. The diagnostic efficacy of \\[68Ga\\]Ga-FAP PET imaging or \\[177Lu\\]Lu-FAP SPECT imaging for malignant tumors will be evaluated. Additionally, the study will analyze the biodistribution and dosimetry of \\[177Lu\\]Lu-FAP following a single administration, explore the correlation between tumor uptake values on imaging and immunohistochemical FAP expression levels, and evaluate the safety and tolerability of a single low-dose intravenous injection of \\[68Ga\\]Ga-FAP or \\[177Lu\\]Lu-FAP for diagnostic imaging.",[412],"Malignant Neoplasm",{"date":306,"type":40},{"date":279,"type":22},{"date":175,"type":22},{"name":46,"class":47},{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":424,"targetDuration":4,"studyType":23,"phases":426,"briefSummary":427,"conditions":428,"keywords":430,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":436,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":48},"100645694","early-phase-1-safety-and-preliminary-efficacy-of-177lulu-rtx-2358-combined-with-immune-checkpoint-inhibitors-in-patients-with-fap-positive-metastatic-non-small-cell-lung-cancer-100645694","NCT07689643","Safety and Preliminary Efficacy of [177Lu]Lu-RTX-2358 Combined With Immune Checkpoint Inhibitors in Patients With FAP-positive Metastatic Non-Small Cell Lung Cancer","A Single-Center, Prospective, Open-Label, Investigator-Initiated Study Evaluating the Safety, Biodistribution, Radiation Dosimetry, and Preliminary Efficacy of [177Lu]Lu-RTX-2358 Combined With Immune Checkpoint Inhibitors in Patients With FAP-positive Metastatic Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Written informed consent must be obtained prior to any study-related procedures.\n* Age ≥ 18 years old.\n* Histologically or cytologically confirmed metastatic non-small cell lung cancer (NSCLC).\n* FAP-positive lesions confirmed by FAPI PET imaging.\n* At least one measurable lesion per RECIST version 1.1 criteria.\n* ECOG performance status 0 or 1.\n* Estimated life expectancy ≥ 3 months.\n* Adequate bone marrow, hepatic, renal, and coagulation function.\n* Willing to comply with all radiation protection requirements throughout study participation.\n* Willing to use highly effective contraception during study treatment and post-treatment follow-up period.\n\nExclusion Criteria:\n\n* History of another active malignancy requiring treatment within 2 years before the first administration of \\[177Lu\\]Lu-RTX-2358, except adequately treated basal cell carcinoma of the skin or carcinoma in situ treated with curative intent.\n* Symptomatic brain metastases or central nervous system metastases requiring active treatment. Participants with previously treated brain metastases are eligible if the disease has remained clinically and radiographically stable for at least 24 weeks.\n* Symptomatic spinal cord compression or radiographic evidence of impending spinal cord compression.\n* Major surgery, open biopsy (excluding needle biopsy), or significant traumatic injury within 4 weeks before the first administration of \\[177Lu\\]Lu-RTX-2358.\n\nPrior treatment with any radioligand therapy or therapeutic radiopharmaceutical.\n\n* Receipt of systemic anticancer therapy, including chemotherapy, immunotherapy, targeted therapy, biologic therapy, investigational agents, or antitumor traditional Chinese medicine, within 21 days before the first administration of \\[177Lu\\]Lu-RTX-2358, unless the protocol-defined washout period has been satisfied.\n* Receipt of curative radiotherapy within 6 weeks before the first administration of \\[177Lu\\]Lu-RTX-2358. Palliative radiotherapy is permitted if completed at least 2 weeks before treatment, involves less than 10% of bone marrow, and does not include target lesions.\n* Unresolved toxicities from previous anticancer therapy greater than Grade 1 according to NCI CTCAE version 5.0, except stable chronic toxicities judged by the investigator not to pose a safety risk (e.g., alopecia, peripheral neuropathy, or fatigue).\n* Endocrine dysfunction involving the thyroid, adrenal, pituitary, or pancreas that would preclude treatment with immune checkpoint inhibitors.\n\nKnown interstitial lung disease, immune-related pneumonitis, pulmonary fibrosis, or active pulmonary fibrosis.\n\n* Severe urinary incontinence, hydronephrosis, bladder outlet obstruction, or other clinically significant urinary tract disorders that may interfere with radiopharmaceutical clearance.\n* Clinically significant cardiovascular disease, including myocarditis, pericarditis, myocardial infarction, unstable angina, New York Heart Association Class III or IV heart failure, uncontrolled arrhythmias, uncontrolled hypertension, or conditions associated with clinically significant QT interval prolongation within 6 months before enrollment.\n* Active uncontrolled infection, including human immunodeficiency virus (HIV) infection, active hepatitis B or hepatitis C infection, active syphilis, or any infection requiring systemic therapy that is not adequately controlled.\n\nSerious or non-healing wounds, active ulcers, or fractures requiring ongoing treatment.\n\n* Severe psychiatric illness or any medical condition that, in the investigator's judgment, would compromise participant safety, interfere with study participation, or affect protocol compliance.\n* Pregnant or breastfeeding women.\n* Known hypersensitivity to \\[177Lu\\]Lu-RTX-2358 or any of its components. History of significant occupational exposure to ionizing radiation exceeding applicable regulatory limits.\n* Participation in another interventional clinical trial within 4 weeks before screening.\n* Inability or unwillingness to undergo required study procedures, including PET\u002FCT, SPECT\u002FCT, CT\u002FMRI examinations, or inability to comply with protocol requirements.\n* Any other condition that, in the investigator's judgment, would make the participant unsuitable for participation in this study.",{"count":425,"type":22},36,[187],"This is a prospective, single-center, open-label investigator-initiated study designed to evaluate the safety, tolerability, radiation dosimetry, biodistribution, and preliminary antitumor activity of \\[177Lu\\]Lu-RTX-2358 in combination with immune checkpoint inhibitors (ICIs) in patients with fibroblast activation protein (FAP)-positive metastatic non-small cell lung cancer (NSCLC). Eligible participants will receive one or two cycles of \\[177Lu\\]Lu-RTX-2358 followed by standard PD-1 inhibitor therapy. Safety, tumor response, biodistribution, radiation dosimetry, and survival outcomes will be evaluated throughout treatment and follow-up.",[429],"Metastatic Non-small Cell Lung Cancer",[431,432,433,434,435],"Metastatic Non-Small Cell Lung Cancer","177Lu","FAP","Radioligand Therapy","PD-1",{"date":437,"type":40},"2026-07-14",{"date":439,"type":40},"2026-04-28",{"date":441,"type":22},"2027-12-30",{"name":46,"class":47},{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":4,"eligibilityCriteria":449,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":450,"targetDuration":4,"studyType":23,"phases":452,"briefSummary":453,"conditions":454,"keywords":456,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":461,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":4},"100645464","phase-2-sacituzumab-tirumotecan-in-previously-treated-trop2-positive-advanced-biliary-tract-cancer-100645464","NCT07701122","Sacituzumab Tirumotecan in Previously Treated TROP2-Positive Advanced Biliary Tract Cancer","A Single-Arm, Phase II, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan as Second-Line or Later Therapy in Patients With TROP2-Positive Advanced Biliary Tract Cancer","Inclusion Criteria:\n\nParticipants must meet all of the following criteria to be eligible for enrollment:\n\n1. Age ≥18 years, male or female.\n2. Histologically or cytologically confirmed locally advanced, recurrent, or metastatic biliary tract cancer, with disease progression after, or intolerance to, at least one prior line of systemic therapy.\n3. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).\n4. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.\n5. TROP2 expression by immunohistochemistry (IHC) ≥1+.\n6. Life expectancy of at least 3 months.\n7. Adequate organ and bone marrow function, without transfusion, recombinant human thrombopoietin, or colony-stimulating factor treatment within 2 weeks before the first dose of study treatment, defined as follows:\n\n   1. Hematology: absolute neutrophil count ≥1.5 × 10\\^9\u002FL; platelet count ≥80 × 10\\^9\u002FL; hemoglobin ≥90 g\u002FL.\n   2. Liver function: aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤2.5 × upper limit of normal (ULN); total bilirubin ≤1.5 × ULN; albumin ≥30 g\u002FL. For participants with liver metastases at baseline, ALT and AST must be ≤5 × ULN and total bilirubin must be ≤3 × ULN.\n   3. Renal function: serum creatinine ≤1.5 × ULN, or creatinine clearance ≥50 mL\u002Fmin as calculated using the standard Cockcroft-Gault formula.\n   4. Coagulation function: international normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) ≤1.5 × ULN.\n8. Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use effective medically accepted contraception from the time of signing the informed consent form until 6 months after the last dose of study treatment.\n9. Voluntarily agrees to participate in the study, provides written informed consent, has good compliance, and is willing to cooperate with study follow-up.\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria will be excluded:\n\n1. Prior treatment with any TROP2-directed therapy or any topoisomerase I inhibitor-containing therapy, including antibody-drug conjugate (ADC) therapy, whether administered in the adjuvant, neoadjuvant, or advanced disease setting.\n2. Ongoing or active infection.\n3. Participation in another clinical trial of an antitumor drug within 4 weeks before screening.\n4. History of another uncured malignancy within 5 years, except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix.\n5. Known hypersensitivity to the study drug or any of its components.\n6. Any of the following cardiovascular or cerebrovascular diseases or risk factors:\n\n   1. Myocardial infarction, unstable angina, acute or persistent myocardial ischemia, New York Heart Association (NYHA) class III or IV heart failure, symptomatic or poorly controlled severe arrhythmia, cerebrovascular accident, transient ischemic attack, or other severe cardiovascular or cerebrovascular disease within 6 months before the first dose of study treatment.\n   2. History of myocarditis, primary cardiomyopathy, specific cardiomyopathy, or other myocardial disease.\n   3. Deep vein thrombosis within 3 months before the first dose of study treatment, unless stable for ≥2 weeks after treatment with low-molecular-weight heparin or a drug with similar efficacy; peripheral arterial thromboembolic event, pulmonary embolism, or other severe thromboembolic event within 3 months before the first dose of study treatment.\n   4. Life-threatening major vascular disease, such as aortic aneurysm or aortic dissecting aneurysm, or major vascular disease requiring surgery within 6 months before the first dose of study treatment.\n7. Uncontrolled systemic disease as judged by the investigator, including:\n\n   1. Poorly controlled diabetes mellitus, defined as fasting blood glucose ≥10 mmol\u002FL on two consecutive tests.\n   2. Poorly controlled hypertension, defined as systolic blood pressure \\>160 mmHg and\u002For diastolic blood pressure \\>100 mmHg.\n   3. Symptomatic pleural effusion, pericardial effusion, or ascites requiring repeated drainage more than once per week.\n8. History of noninfectious interstitial pulmonary fibrosis or noninfectious pneumonitis requiring steroid treatment; current interstitial pulmonary fibrosis or noninfectious pneumonitis; or suspected interstitial pulmonary fibrosis or noninfectious pneumonitis that cannot be ruled out by imaging during screening.\n9. Documented severe dry eye syndrome, severe meibomian gland disease and\u002For blepharitis, or history of severe corneal disease that may impair or delay corneal healing.\n10. Clinically significant pulmonary impairment due to pulmonary comorbidities, including but not limited to severe asthma within 3 months before the first dose of study treatment, severe chronic obstructive pulmonary disease, restrictive lung disease, autoimmune, connective tissue, or inflammatory disease that may involve the lungs, such as rheumatoid arthritis, Sjögren syndrome, or sarcoidosis, or prior total pneumonectomy.\n11. Active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulcer, gastrointestinal perforation, intra-abdominal abscess, or acute gastrointestinal bleeding.\n12. Active gastrointestinal disease or other condition that may significantly affect the absorption, distribution, metabolism, or excretion of study treatment, such as refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow medication, or prior major bowel resection.\n13. Risk of esophagotracheal fistula or esophagopleural fistula, or tumor invasion or compression of surrounding vital organs or blood vessels, such as the heart, esophagus, or superior vena cava, accompanied by related symptoms, such as superior vena cava syndrome.\n14. Toxicities from prior antitumor therapy that have not recovered to Grade ≤1 according to NCI CTCAE version 5.0 or to the level specified in the eligibility criteria, except for toxicities considered by the investigator to pose low safety risk, such as alopecia or fatigue.\n15. Active autoimmune disease requiring systemic treatment within the past 2 years, including disease-modifying agents, immunosuppressive drugs, or systemic corticosteroids at a dose of \\>10 mg\u002Fday prednisone or equivalent. Hormone replacement therapy, such as thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency, is not considered systemic treatment. Participants who have received systemic corticosteroids at \\>10 mg\u002Fday prednisone or equivalent or other immunosuppressive drugs within 2 weeks before the first dose of study treatment will also be excluded.\n16. Severe infection within 4 weeks before the first dose of study treatment, including but not limited to infection with complications requiring hospitalization, sepsis, or severe pneumonia; or active infection requiring systemic anti-infective therapy within 2 weeks before the first dose of study treatment.\n17. Known active tuberculosis. Participants suspected of having active tuberculosis must undergo clinical evaluation to rule out active tuberculosis.\n18. Hepatitis B virus (HBV) infection with detectable HBV DNA, defined according to local laboratory requirements as ≥10 IU\u002FmL or above the lower limit of detection, unless antiviral therapy is initiated before treatment according to institutional practice to ensure adequate viral suppression and is maintained during the study and for 6 months after the last dose of study treatment. Participants who are anti-HBc positive but have undetectable HBV DNA do not require antiviral therapy unless HBV DNA becomes \\>10 IU\u002FmL or reaches the lower limit of detection according to local laboratory requirements during treatment.\n19. Positive human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.\n20. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n21. Major surgery within 4 weeks before the first dose of study treatment, or anticipated need for major surgery during the study.\n22. Known hypersensitivity to the study drug or any of its components, including polysorbate 20, or history of severe hypersensitivity reaction to other biologic agents.\n23. Receipt of nonspecific immunomodulatory therapy within 2 weeks before the first dose of study treatment, including but not limited to interferon or interleukin-2, or Chinese patent medicines approved for antitumor indications.\n24. Receipt of strong cytochrome P450 3A4 (CYP3A4) inhibitors or strong CYP3A4 inducers within 7 days before the first dose of study treatment, or need to continue such medications during the study.\n25. Receipt of a live vaccine within 30 days before the first dose of study treatment, or planned receipt of a live vaccine during the study.\n26. Rapid disease deterioration during screening before study drug administration, such as a significant change in performance status.\n27. Pregnant or breastfeeding women.\n28. Any condition that, in the investigator's judgment, may interfere with evaluation of the study drug, compromise participant safety, affect interpretation of study results, or otherwise make the participant unsuitable for participation in this study.",{"count":451,"type":22},33,[25],"This is a single-arm, Phase II, multicenter clinical trial evaluating sacituzumab tirumotecan in patients with TROP2-positive advanced biliary tract cancer who have experienced disease progression after, or intolerance to, at least one prior line of systemic therapy.\n\nEligible participants will receive sacituzumab tirumotecan monotherapy. The primary objective is to evaluate objective response rate as assessed by the investigator according to RECIST version 1.1. Secondary objectives include evaluation of progression-free survival, overall survival, and safety. Exploratory analyses will assess the association between TROP2 protein expression and clinical efficacy, as well as potential mechanisms of resistance.",[455],"Advanced Biliary Tract Cancer(BTC)",[457,458,459,460],"Biliary Tract Cancer","TROP2","Sacituzumab Tirumotecan","Antibody-Drug Conjugate",{"date":437,"type":40},{"date":463,"type":22},"2026-07-01",{"date":465,"type":22},"2028-07-01",{"name":46,"class":47},{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":4,"eligibilityCriteria":473,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":474,"targetDuration":4,"studyType":23,"phases":475,"briefSummary":476,"conditions":477,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":479,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":48},"100496706","phase-1-a-single-arm-open-label-clinical-trial-of-surufatinibserplulimabplatinumetoposide-in-neuroendocrine-carcinoma-100496706","NCT05747729","A Single-arm, Open-label, Clinical Trial of Surufatinib\u002FSerplulimab\u002FPlatinum\u002FEtoposide in Neuroendocrine Carcinoma.","A Single-arm, Open-label, Single-center Clinical Trial of Surufatinib and Serplulimab Combined With Standard Chemotherapy (Platinum\u002FEtoposide) in Neuroendocrine Carcinoma.","Inclusion Criteria:\n\n1. Written informed consent;\n2. With histologically or cytologically confirmed extra-pulmonary neuroendocrine carcinoma (including mixed neuroendocrine or non-neuroendocrine tumors \\[at least 30% neuroendocrine carcinoma component\\]);\n3. Previously untreated with systemic therapy;\n4. age ≥18 years;\n5. Have at least one measurable lesion according to RECIST v1.1;\n6. ECOG performance status: 0-1;\n7. Expected survival time \\> 3 months;\n8. For evidence of sufficient organ functions, the subjects shall meet the following laboratory parameters: 1) Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL without use of granulocyte colony stimulating factor in recent 14 days; 2) Platelet count ≥ 100 × 109\u002FL without blood transfusion in recent 14 days; 3) Hemoglobin \\> 9 g\u002FdL without blood transfusion or erythropoietin use in recent 14 days; 4) Total bilirubin ≤ 1.5 × upper limit of normal (ULN); or total bilirubin \\> ULN, direct bilirubin ≤ ULN; 5) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (ALT or AST ≤ 5 × ULN for patients with liver metastasis); 6) Blood creatinine ≤ 1.5 × ULN and creatinine clearance (calculated by Cockcroft- Gault formula) ≥ 50 mL\u002Fmin;\n9. Women of childbearing potential need to use at least one medically approved contraceptive measure (such as intrauterine device, contraceptive pill or condom) during the study treatment and within 180 days after the end of the study treatment; Before the first dose, serum HCG examination must be negative; and women must be non-lactating.\n\nExclusion Criteria:\n\n1. Neuroendocrine carcinoma of the lung;\n2. With known allergic reactions to the drugs in this study;\n3. Unable or unwilling to swallow Surufatinib or suffering from significant digestive system diseases that may interfere with absorption, metabolism, or excretion;\n4. With clinically significant or uncontrolled heart diseases, including unstable angina, acute myocardial infarction within 6 months before the first dose, grade III\u002FIV congestive heart failure (New York Heart Association), and uncontrolled arrhythmia (subjects with pacemakers or with atrial fibrillation but well controlled heart rate are allowed); With ECG changes or medical history considered clinically significant by the investigator; QTc interval \\> 450 ms for male or \\> 470 ms for female at screening;\n5. With active ulcers, intestinal perforation, and intestinal obstruction;\n6. With active bleeding or bleeding tendency;\n7. With uncontrolled hypertension (systolic pressure \\> 150 mmHg or diastolic pressure \\> 100 mmHg) after the optimal medical treatment;\n8. Urine protein ≥ ++ and the amount of urine protein in 24 hours \\>1.0g;\n9. Any active autoimmune disease requiring systemic treatment or with a history of autoimmune disease within 2 years, including but not limited to interstitial pneumonia, uveitis, inflammatory bowel disease, hepatitis, hypophysitis, vasculitis, systemic lupus erythematosus, etc. (Vitiligo, psoriasis, alopecia or Grave's disease without systemic treatment within the past 2 years, and type I diabetic patients who only need insulin replacement therapy can be included); with a history of primary immunodeficiency; patients only with positive autoimmune antibody need to confirm according to the investigator;\n10. Received systemic immunostimulant therapy within 4 weeks before the first dose;\n11. Received any live vaccines or live attenuated vaccines within 4 weeks prior to the first dose or planned to be administered live vaccines or live attenuated vaccines during the study;\n12. Pleural effusion, ascites, or pericardial effusion with obvious clinical symptoms that require drainage;\n13. Diagnosed with malignant tumors within 5 years before the first dose, excluding radically cured cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, and\u002For radically resected carcinoma in situ;\n14. Presence of severe infection in the active phase or with poor clinical control;\n\n    1. With known history of human immunodeficiency virus (HIV) infection or confirmed with positive immune test results;\n    2. Acute or chronic active hepatitis B or C infection; hepatitis B virus (HBV) DNA \\> 2000 IU\u002FmL or 104 copies\u002FmL; hepatitis C virus (HCV) RNA \\> 103 copies\u002FmL; or other hepatitis, liver cirrhosis.\n15. Symptomatic brain metastases (confirmed or suspected)\n16. The investigator confirms that the patients has any clinical or laboratory abnormalities who are not suitable for participating in this clinical study.",{"count":235,"type":22},[259,25],"This study is a prospective open-label, single-arm, single-center clinical study. Patients with neuroendocrine carcinoma who had not previously received standard therapy were enrolled in this study once they have signed the informed consent form (ICF) and been identified as eligible in screening. This clinical trial evaluates the efficacy and safety of surufatinib and serplulimab combined with standard chemotherapy (Platinum\u002FEtoposide) in neuroendocrine carcinoma.",[478],"Neuroendocrine Carcinoma",{"date":437,"type":40},{"date":481,"type":40},"2023-06-21",{"date":483,"type":22},"2027-07-28",{"name":46,"class":47},{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":4,"eligibilityCriteria":491,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":492,"targetDuration":4,"studyType":23,"phases":494,"briefSummary":495,"conditions":496,"keywords":498,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":505,"locationsCount":4},"100645873","endovascular-treatment-of-chronic-intracranial-artery-occlusion-100645873","NCT07699003","Endovascular Treatment of Chronic Intracranial Artery Occlusion","Endovascular Treatment of Chronic Intracranial Artery Occlusion: A Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age ≥18 years\n2. Occlusion of the unilateral middle cerebral artery, basilar artery, intracranial internal carotid artery, or vertebral artery, as confirmed by computed tomography angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA)\n3. Modified Rankin Scale (mRS) score of 0-2\n4. Presence of symptoms related to the occluded vessel, as determined by the physician, with the most recent symptom onset occurring more than 4 weeks and within 6 months prior to enrolment\n5. The subject or their legally authorised representative has provided written informed consent for the study\n\nExclusion Criteria:\n\n1. Evidence of hemorrhage on CT or MRI\n2. Large hemispheric infarction involving \\>50% of the middle cerebral artery territory on CT or MRI\n3. Severe pre-stroke disability (modified Rankin Scale score ≥2) or life expectancy \\\u003C12 months\n4. Major comorbidities that may interfere with outcome assessment and follow-up (e.g., severe heart failure, renal failure, etc.)\n5. Uncontrolled seizure at the time of stroke onset\n6. Baseline platelet count \\\u003C50,000\u002FμL\n7. Severe, persistent hypertension that remains uncontrolled despite active management (systolic blood pressure \\>220 mmHg or diastolic blood pressure \\>120 mmHg)\n8. Known inherited or acquired bleeding diathesis, coagulation factor deficiency, or recent oral anticoagulant therapy with an international normalized ratio (INR) \\>3\n9. Suspected septic emboli or suspected bacterial endocarditis\n10. Known allergy to iodine, heparin, or anaesthetics, or other definite contraindications to endovascular procedures\n11. Pregnant women\n12. Other severe, progressive, or terminal diseases (as judged by the investigator), or life expectancy \\\u003C24 months\n13. Prior attempted endovascular recanalization therapy before randomization\n14. Current participation in other studies involving investigational drugs or devices\n15. Evidence of intracranial tumour on CT or MRI (except meningioma)\n16. Excessive tortuosity of cervical vessels on CTA\u002FMRA that may preclude endovascular therapy",{"count":493,"type":22},382,[88],"Comparison of the efficacy and safety of endovascular treatment versus medical treatment in patients with chronic intracranial artery occlusion.",[497],"Chronic Intracranial Artery Occlusion",[497,301],"2026-07-10",{"date":501,"type":40},"2026-07-13",{"date":503,"type":22},"2026-08-01",{"date":308,"type":22},{"name":46,"class":47},{"id":507,"slug":508,"hasResults":12,"nctId":509,"briefTitle":510,"officialTitle":511,"acronym":4,"eligibilityCriteria":512,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":513,"enrollmentInfo":514,"targetDuration":4,"studyType":23,"phases":516,"briefSummary":517,"conditions":518,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":520,"lastUpdatePostDateStruct":521,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":526,"locationsCount":48},"100549630","efficacy-and-safety-of-ganciclovir-capsules-in-the-treatment-of-refractory-moderate-to-severe-allergic-rhinitis-100549630","NCT06436534","Efficacy and Safety of Ganciclovir Capsules in the Treatment of Refractory Moderate-to-severe Allergic Rhinitis","A Randomized, Double-blind, Placebo-controlled, Single-center Clinical Trial of Ganciclovir Capsules in the Treatment of Refractory Moderate-to-severe Allergic Rhinitis","Inclusion Criteria:\n\n1. Aged between 18 and 65 years.\n2. Diagnosed with moderate-to-severe perennial allergic rhinitis based on Chinese guideline for diagnosis and treatment of allergic rhinitis (2022, revision) with Allergic Rhinitis Control Test (ARCT) score \\\u003C20.\n3. Total Nasal Symptom Score (TNSS) ≥6 or at least two of the four subdomains(sneezing, rhinorrhea, nasal itching, and nasal obstruction) ≥2 at the time of both screening and randomization. And the improvement in TNSS was assessed as \\\u003C 30% at randomization compared to screening.\n4. The participant is allergic to dust mites or other perennial allergens\n5. Voluntarily participate in the clinical trial and sign the informed consent.\n\nExclusion Criteria:\n\n1. Participants with hypersensitivity to ganciclovir capsules and its excipients.\n2. Have symptoms of viral infection, fever and other systemic symptoms in the past 2 weeks.\n3. Pregnant or lactating women and participants who have pregnancy plan during the study period.\n4. Participants with severe neutropenia (absolute neutrophil count less than 0.5\\*10\\^9\u002FL) or severe thrombocytopenia (platelet count less than 2.5\\*10\\^10\u002FL).\n5. Comorbidities such as upper and lower respiratory tract infections, history of acute or chronic sinusitis, dry rhinitis, atrophic rhinitis, severe deviated septum and asthma.\n6. Participants with other severe heart, lung, liver and kidney disease.\n7. Participants who had received any live or attenuated vaccine within 4 weeks prior to baseline or intended to receive live or attenuated vaccine (or BCG treatment) during the study period or within 4 weeks after the last administration of the investigational drug product.\n8. Participants with a history of HIV infection or who test positive for HIV serology.\n9. Participants currently infected or chronically infected with hepatitis B virus (HBV) or hepatitis C virus (HCV).\n10. Participants with cirrhosis and\u002For chronic hepatitis.\n11. Participants who have been diagnosed with active parasitic infections or are at high risk of developing such infections.。\n12. Participants with a known or suspected history of immunosuppression, including a history of invasive opportunistic infections (e.g., histoplasmosis, listeriosis, coccidioidomycosis, pneumosporidiosis, aspergillosis). Or participants with what researchers believe to be unusually frequent, recurring, or prolonged infections.\n13. Participants with a known history of malignancy within 5 years prior to screening.\n14. Participants with severe co-morbidities that, in the opinion of the investigator, would adversely affect their participation in this study.\n15. Participants with combined neurological or psychiatric disorders who are unable or reluctant to cooperate.\n16. Participants with disabilities prescribed by law (blind, deaf, mute, mentally challenged, mentally handicapped, etc.).\n17. Participants suspected or having a history of alcohol and drug abuse.\n18. Other participants who have been involved in other clinical trials within 3 months before the screening.\n19. The researchers consider it inappropriate to participate in this clinical trial.","65 Years",{"count":515,"type":22},50,[88],"The goal of this clinical trial is to learn about the clinical efficacy and safety of ganciclovir (GCV) capsules in the treatment of refractory moderate-to-severe allergic rhinitis. The main questions it aims to answer are:\n\n1. Whether ganciclovir improve nasal symptoms and life quality in patients with refractory moderate-to-severe allergic rhinitis.\n2. Whether ganciclovir is safe for the treatment of allergic rhinitis.\n\nParticipants with refractory moderate-to-severe allergic rhinitis will be included in the trial based on the inclusion and exclusion criteria, and randomized into experimental and control groups.\n\nThe two groups will be treated with blinded ganciclovir capsules or placebo for two weeks, with the background therapy of mometasone furoate aqueous nasal spray. A placebo is a look-alike capsule that contains no active drug. Nasal symptom scores, nasal secretions, blood samples and adverse events will be collected during the visits.\n\nResearchers will compare the experimental and control groups to see whether ganciclovir improve symptoms and is safe for the treatment of refractory moderate-to-severe allergic rhinitis.",[519],"Rhinitis, Allergic","2026-07-09",{"date":501,"type":40},{"date":523,"type":40},"2024-05-24",{"date":525,"type":22},"2026-12",{"name":46,"class":47},{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":4,"eligibilityCriteria":533,"healthyVolunteers":12,"sex":534,"minAge":18,"maxAge":535,"enrollmentInfo":536,"targetDuration":4,"studyType":23,"phases":537,"briefSummary":538,"conditions":539,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":541,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":546,"locationsCount":48},"100646561","phase-1-a-clinical-study-of-68gaga-eli421-injection-pet-imaging-in-patients-with-prostate-cancer-100646561","NCT07689656","A Clinical Study of [68Ga]Ga-ELI421 Injection PET Imaging in Patients With Prostate Cancer","A Clinical Study on the Safety and Tolerability, Biodistribution, Radiation Dosimetry, and Diagnostic Efficacy of [68Ga]Ga-ELI421 Injection PET Imaging in Patients With Prostate Cancer","Inclusion Criteria:\n\n1. Has been fully informed about the study and voluntarily provided written informed consent prior to initiation of any study-related procedures;\n2. Aged ≥ 18 years;\n3. In generally good condition with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;\n4. Patients with histopathologically and\u002For cytologically confirmed prostate cancer;\n5. Has an indication for PSMA PET imaging;\n6. No clinically significant abnormal findings on physical examination, vital signs, laboratory tests, 12-lead ECG, or other examinations that may compromise subject safety or imaging results.\n7. Subjects of reproductive potential agree to refrain from pregnancy, sperm donation, and voluntarily use highly effective contraceptive methods (including by their partner) for 6 months after study drug administration, such as condoms, oral or injectable contraceptives, intrauterine devices (IUDs), etc.\n\nExclusion Criteria:\n\n1. Presence of comorbidities that may compromise subject safety or interfere with imaging results;\n2. Concomitant medications that may compromise subject safety or interfere with imaging results;\n3. Insufficient washout period following prior anti-tumor therapies (including cytotoxic chemotherapy, immunotherapy, radiotherapy, etc.), which may compromise subject safety or interfere with imaging results;\n4. Known hypersensitivity to ionizing radiation or alcohol, or hypersensitivity to \\[⁶⁸Ga\\]Ga-ELI421 injection or its excipients, or other history of severe allergic reactions;\n5. Inability to complete PET imaging as required;\n6. Any other conditions deemed inappropriate by the investigator for participation in this study.","MALE","80 Years",{"count":515,"type":22},[259,25],"Primary Objective:\n\nTo evaluate the safety and tolerability of PET imaging following a single intravenous infusion of \\[⁶⁸Ga\\]Ga-ELI421 injection in patients with prostate cancer.\n\nSecondary Objectives:\n\nTo evaluate the biodistribution characteristics of \\[⁶⁸Ga\\]Ga-ELI421 injection; To evaluate the radiation dosimetry characteristics of \\[⁶⁸Ga\\]Ga-ELI421 injection; To evaluate the diagnostic efficacy of PET imaging with \\[⁶⁸Ga\\]Ga-ELI421 injection.",[540],"Prostate Cancer",{"date":542,"type":40},"2026-07-08",{"date":544,"type":40},"2026-06-08",{"date":175,"type":22},{"name":46,"class":47},{"id":548,"slug":549,"hasResults":12,"nctId":550,"briefTitle":551,"officialTitle":552,"acronym":4,"eligibilityCriteria":553,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":554,"targetDuration":4,"studyType":23,"phases":556,"briefSummary":558,"conditions":559,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":562,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":566,"locationsCount":48},"100646445","phase-3-anti-cd25-monoclonal-antibody-for-prevention-of-acute-gvhd-after-haploidentical-hsct-100646445","NCT07689630","Anti-CD25 Monoclonal Antibody for Prevention of Acute GVHD After Haploidentical HSCT","A Randomized, Open-Label, Parallel-Controlled, Multicenter Phase III Clinical Trial of Anti-CD25 Monoclonal Antibody Versus Methotrexate for the Prevention of Acute Graft-Versus-Host Disease After Haploidentical Hematopoietic Stem Cell Transplantation","Inclusion Criteria：\n\n1. Patients with confirmed hematologic malignancies who are scheduled to undergo haploidentical allogeneic hematopoietic stem cell transplantation.\n2. Age 18 to 75 years.\n3. Willing to provide written informed consent and accept random assignment.\n4. Willing and able to comply with the study procedures throughout the study period.\n\nExclusion Criteria:\n\n1. Patients scheduled to undergo fully matched donor transplantation, unrelated donor transplantation, or umbilical cord blood transplantation.\n2. Patients receiving grafts from maternal donors or collateral relative donors.\n3. Patients with strongly positive donor-specific antibodies.\n4. Patients whose transplantation regimen includes post-transplant cyclophosphamide for graft-versus-host disease prophylaxis.\n5. Patients undergoing a second transplantation.\n6. Patients who refuse to provide written informed consent.",{"count":555,"type":22},186,[557],"PHASE3","Acute graft-versus-host disease remains a major complication after haploidentical hematopoietic stem cell transplantation. Methotrexate is commonly used as part of graft-versus-host disease prophylaxis, but it may be associated with delayed hematopoietic recovery and transplant-related toxicities, including oral mucositis.\n\nThis is a prospective, multicenter, randomized, open-label, parallel-controlled Phase III clinical trial designed to evaluate an anti-CD25 monoclonal antibody regimen compared with methotrexate for the prevention of acute graft-versus-host disease after haploidentical hematopoietic stem cell transplantation. Eligible patients with hematologic malignancies scheduled to undergo haploidentical allogeneic hematopoietic stem cell transplantation will be randomly assigned in a 1:1 ratio to receive either methotrexate-based prophylaxis or anti-CD25 monoclonal antibody-based prophylaxis, in combination with standard graft-versus-host disease prophylaxis including anti-thymocyte globulin, calcineurin inhibitor, and mycophenolate mofetil.\n\nThe primary objective is to compare 12-month graft-versus-host disease-free, relapse-free survival between the two groups. Secondary objectives include comparison of acute graft-versus-host disease, chronic graft-versus-host disease, oral mucositis, hematopoietic recovery, cytomegalovirus and Epstein-Barr virus reactivation, infection, relapse, non-relapse mortality, overall survival, and leukemia-free survival.",[560,561],"Graft Versus Host Disease","Hematologic Neoplasms",{"date":542,"type":40},{"date":564,"type":40},"2026-05-01",{"date":284,"type":22},{"name":46,"class":47},{"id":568,"slug":569,"hasResults":12,"nctId":570,"briefTitle":571,"officialTitle":572,"acronym":4,"eligibilityCriteria":573,"healthyVolunteers":207,"sex":17,"minAge":18,"maxAge":535,"enrollmentInfo":574,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":576,"conditions":577,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":584,"startDateStruct":586,"completionDateStruct":588,"leadSponsor":590,"locationsCount":4},"100645274","metabolic-and-functional-study-of--t-cells-in-critically-ill-patients-100645274","NCT07680816","Metabolic and Functional Study of γδ T Cells in Critically Ill Patients","Subset-specific Metabolic Adaptation and Functional Remodeling of Gamma Delta T (γδ T) Cells in Critically Ill ICU Patients: A Single-center, Prospective, Observational Cohort Study.","Inclusion Criteria:\n\n1. Healthy Control Group (NHC):\n\n   * Age ≥ 18 years.\n   * No acute or chronic major diseases.\n   * Provide written informed consent.\n2. Non-septic Critical Illness Group (CI-NS):\n\n   * Age ≥ 18 years.\n   * Admitted to the ICU and meeting the definition of critical illness.\n   * Excluded from sepsis according to the Sepsis-3 criteria (infection + ΔSOFA ≥ 2 points).\n   * Written informed consent provided by the participant or legally authorized representative.\n3. Septic Critical Illness Group (CI-Sep):\n\n   * Age ≥ 18 years.\n   * Admitted to the ICU and meeting the Sepsis-3 criteria (infection + ΔSOFA ≥ 2 points).\n   * Written informed consent provided by the participant or legally authorized representative.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years.\n* Known immunodeficiency, HIV infection, active hematologic malignancy, or history of hematopoietic stem cell or solid organ transplantation within the past 3 months.\n* Receipt of T-cell-targeted immunosuppressive therapy (e.g., antithymocyte globulin, calcineurin inhibitors, mycophenolate mofetil, methotrexate, or high-dose corticosteroids \\>1 mg\u002Fkg\u002Fday prednisone equivalent) before ICU admission or within 24 hours after ICU admission.\n* Use of immune checkpoint inhibitors (e.g., anti-PD-1\u002FPD-L1\u002FCTLA-4 antibodies) within the past 6 weeks.\n* Expected ICU stay \\\u003C 24 hours or imminent risk of death (moribund state).\n* Pregnancy or breastfeeding.\n* Active major bleeding.\n* Inability to obtain informed consent.",{"count":575,"type":22},105,"This prospective observational cohort study investigates the subset-specific metabolic adaptation and functional remodeling of cytotoxic γδT cells in critically ill patients with and without sepsis. Emerging evidence indicates that γδT cells, as a bridge between innate and adaptive immunity, play a critical role in early anti-infection defense during sepsis. However, the functional status and underlying regulatory mechanisms of cytotoxic γδT cells in septic patients remain incompletely understood. Our preliminary single-cell transcriptomic analysis revealed that cytotoxic γδT cells from septic patients exhibit significant alterations in cytotoxicity-associated molecules (GZMB, PRF1, GNLY) and mitochondrial oxidative phosphorylation (OXPHOS) pathway genes, particularly COX6C, which correlates with cytotoxic effector molecule expression. This study aims to systematically characterize the proportion, cytotoxicity, and mitochondrial metabolic function of circulating cytotoxic γδT cells across three cohorts: healthy controls, critically ill non-septic patients, and critically ill septic patients. By integrating flow cytometry, mitochondrial function assays, and functional validation experiments, we seek to elucidate the role of COX6C-mediated mitochondrial metabolic abnormalities in cytotoxic γδT cell dysfunction, providing theoretical basis for understanding immune dysregulation in sepsis and identifying novel therapeutic targets.",[213,578,579,580,581,582,583],"Critical Illness","Immunosuppression","MODS","Mitochondrial Diseases","Dysbiosis","γδ T Cells",{"date":585,"type":40},"2026-07-02",{"date":587,"type":22},"2026-07-15",{"date":589,"type":22},"2027-07-15",{"name":46,"class":47},{"id":592,"slug":593,"hasResults":12,"nctId":594,"briefTitle":595,"officialTitle":596,"acronym":597,"eligibilityCriteria":598,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":133,"enrollmentInfo":599,"targetDuration":4,"studyType":23,"phases":600,"briefSummary":601,"conditions":602,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":605,"lastUpdatePostDateStruct":606,"startDateStruct":608,"completionDateStruct":609,"leadSponsor":611,"locationsCount":4},"100644582","fmt-for-90-day-outcome-of-clinical-use-in-icu-sepsis-100644582","NCT07670299","FMT for 90-Day Outcome of Clinical Use in ICU Sepsis","Fecal Microbiota Transplantation for 90-Day Outcome of Clinical Use in ICU Sepsis: a Single-Center, Open-Label, Randomized Controlled Trial","FOCUS","Inclusion Criteria:\n\n* Age ≥ 18 years, any ethnicity, any gender.\n* Diagnosis of sepsis according to the Sepsis-3 criteria (infection with an acute change in SOFA score ≥ 2 points).\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Patients whom the attending clinician considers to have a high risk of death within 5 days, or patients with treatment limitations in place.\n* Active major gastrointestinal bleeding, perforation, or other severe impairment of the intestinal barrier.\n* Patients unable to tolerate enteral nutrition meeting ≥50% of caloric requirements due to severe diarrhea, significant fibrotic intestinal stricture, severe gastrointestinal bleeding, or high-output intestinal fistula.\n* Planned or recent abdominal surgery (within 14 days).\n* Current diagnosis of fulminant colitis or toxic megacolon.\n* Recent receipt of high-risk immunosuppressive or cytotoxic therapy, such as rituximab, doxorubicin, or moderate-to-high-dose corticosteroids (≥20 mg\u002Fday of prednisone or equivalent) for more than 4 consecutive weeks.\n* Pregnant or breastfeeding women.\n* Participation in another clinical trial as a subject at the time of enrollment or within 3 months prior to enrollment.\n* Subjects for whom the validity of informed consent is questionable, including those with psychiatric disorders, intellectual disability, poor motivation, or other conditions that may limit their ability to provide informed consent.",{"count":235,"type":22},[88],"Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection, representing one of the leading causes of death in intensive care units (ICUs) worldwide. Gut microbiota disruption is increasingly recognized as a key driver of persistent inflammation and multiple organ dysfunction in septic patients. Fecal microbiota transplantation (FMT) has emerged as a promising approach to restore gut microbial homeostasis. This study hypothesizes that FMT acts not through long-term engraftment of donor microbes, but via a \"functional pulse\" - a potent, transient biological intervention that delivers high-dose microbial metabolites (e.g., short-chain fatty acids), competitively inhibits pathogens, and rapidly modulates intestinal immune cell functions.\n\nThis is a single-center, open-label, randomized controlled trial conducted in the ICU of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. A total of 60 adult patients diagnosed with sepsis according to Sepsis-3 criteria within 24 hours of ICU admission will be randomized in a 1:1 ratio to receive either ICU standard care alone (control group) or ICU standard care plus FMT administered via a nasojejunal tube for three consecutive days (intervention group). The primary endpoint is all-cause mortality at 90 days. Secondary endpoints include ICU mortality, in-hospital mortality, 28-day mortality, changes in gut microbiota composition and metabolites, serum citrulline levels as a marker of intestinal barrier function, Sequential Organ Failure Assessment (SOFA) and Acute Physiology and Chronic Health Evaluation II (APACHE II) scores, vasopressor requirements, C-reactive protein and procalcitonin levels, fluid balance, incidence of ICU delirium and feeding intolerance, and 90-day hospital readmission rate. Safety outcomes include gastrointestinal symptoms and transient fever.",[213,578,603,582,604],"Gastrointestinal Dysfunction","Fecal Microbiota Transplantation","2026-06-25",{"date":607,"type":40},"2026-06-26",{"date":587,"type":22},{"date":610,"type":22},"2028-10-15",{"name":46,"class":47},""]