[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Anhui Provincial Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":610},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,71,0,25,[9,48,78,100,123,146,174,201,224,248,271,290,313,339,366,385,407,431,454,479,502,523,544,568,589],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100638170","phase-4-low--vs-standard-dose-tmp-smx-for-prevention-of-pneumocystis-pneumonia-after-kidney-transplantation-100638170",false,"NCT07619027","Low- vs Standard-Dose TMP-SMX for Prevention of Pneumocystis Pneumonia After Kidney Transplantation","A Prospective Randomized Controlled Study of Low-Dose Versus Standard-Dose Trimethoprim-Sulfamethoxazole for the Prevention of Pneumocystis Jirovecii Pneumonia After Kidney Transplantation","TMP-SMX PJP","Inclusion Criteria:\n\n-Age: Between 18 and 70 years old. Transplant Status: Recipients of a first-time kidney transplant. Renal Function: Serum creatinine levels have stabilized with a creatinine -----clearance (CrCl) \\> 30 mL\u002Fmin.\n\nConsent \\& Compliance: Voluntarily agree to participate in this study, are capable of cooperating with the investigators, and have signed the informed consent form.\n\nExclusion Criteria:\n\n-HIV Infection: Known HIV positive status. Drug Allergy: History of allergy or hypersensitivity to TMP-SMX (Trimethoprim-Sulfamethoxazole).\n\nPrior PJP: History of Pneumocystis jirovecii pneumonia (PJP) before transplantation.\n\nG6PD Deficiency: Glucose-6-phosphate dehydrogenase deficiency. Multi-organ Transplant: Recipients of multi-organ transplants. Active Infection: Presence of other severe concurrent infections. Immune System Disorders: Concomitant diseases affecting the immune system (e.g., malignancies\u002Ftumors, connective tissue diseases, hematological system diseases).\n\nPregnancy: Pregnant women. Anemia: Megaloblastic anemia. Non-compliance: Inability to adhere to regular follow-up schedules or poor compliance.","ALL","18 Years","70 Years",{"count":22,"type":23},1084,"ESTIMATED","INTERVENTIONAL",[26],"PHASE4","This study is a prospective randomized controlled trial designed to evaluate the efficacy and safety of low-dose versus standard-dose trimethoprim-sulfamethoxazole (TMP-SMX) for the prevention of Pneumocystis jirovecii pneumonia (PJP) in kidney transplant recipients.\n\nParticipants will be randomly assigned to receive either low-dose or standard-dose TMP-SMX for 12 months after kidney transplantation. The primary outcome is the incidence of PJP during the prophylaxis period. Secondary outcomes include adverse events related to TMP-SMX, dose reduction or discontinuation rates, incidence and timing of PJP after discontinuation, and other post-transplant complications.\n\nParticipants will be followed for a total of 24 months, including a 12-month prophylaxis period and an additional 12-month follow-up period after discontinuation. This study aims to provide evidence for optimizing prophylactic strategies against PJP in kidney transplant recipients.",[29,30],"Pneumocystis Jirovecii Pneumonia","Kidney Transplantation",[32,33,34,35],"PJP prophylaxis","Kidney transplant recipients","Trimethoprim-Sulfamethoxazole","Low-dose","NOT_YET_RECRUITING","2026-05-26",{"date":39,"type":40},"2026-06-01","ACTUAL",{"date":42,"type":23},"2026-06",{"date":44,"type":23},"2030-06",{"name":46,"class":47},"Anhui Provincial Hospital","OTHER_GOV",{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":54,"enrollmentInfo":55,"targetDuration":57,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":67,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100637253","china-metastatic-liver-cancer-clinical-registry-cohort-database-100637253","NCT07602504","China Metastatic Liver Cancer Clinical Registry Cohort Database","Inclusion Criteria:\n\n1. Patients with histologically or radiologically confirmed metastatic liver cancer.\n2. Age ≥ 18 years.\n3. Patients who have voluntarily signed the informed consent form.\n4. Patients with complete baseline clinical data.\n\nExclusion Criteria:\n\n1. Patients with primary liver cancer (e.g., hepatocellular carcinoma).\n2. Patients with other malignant tumors that may interfere with the evaluation of liver metastasis.\n3. Patients who have previously participated in other interventional clinical trials.\n4. Patients with severe cognitive disorders or communication barriers that prevent informed consent.\n5. Patients with incomplete or missing key clinical data.","80 Years",{"count":56,"type":23},2000,"10 Years","OBSERVATIONAL","This study is led by the Department of Hepatobiliary Surgery of the First Affiliated Hospital of the University of Science and Technology of China (USTC), in close collaboration with multiple participating centers nationwide. The primary objective is to establish a standardized, large-scale clinical cohort database specifically for metastatic liver cancer. By collecting comprehensive data on patient demographics, primary tumor characteristics, systemic therapies, and local interventions, this registry aims to elucidate the clinical patterns and prognostic factors of secondary liver malignancies. This database will serve as a robust platform for conducting high-quality real-world studies and advancing evidence-based clinical research in the management of metastatic liver cancer.",[61,62,63,64,65,66],"Liver Metastases","Metastases to Liver","Liver Cancer","Neoplasms","Liver Diseases","Colorectal Cancer Metastatic",[68],"Liver Metastases; Metastatic Colorectal Cancer","RECRUITING","2026-05-16",{"date":72,"type":40},"2026-05-22",{"date":39,"type":23},{"date":75,"type":23},"2036-05-31",{"name":46,"class":47},3,{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":85,"targetDuration":4,"studyType":24,"phases":87,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},"100604523","phase-4-the-treatment-of-liver-injury-after-liver-resection-with-polyene-phosphatidylcholine-100604523","NCT07150624","The Treatment of Liver Injury After Liver Resection With Polyene Phosphatidylcholine","Polyene Phosphatidylcholine Injection for the Treatment of Perioperative Liver Injury With Laparoscopic Hepatectomy in Hepatocellular Carcinoma: a Multicenter Randomized Controlled Study","Inclusion Criteria:\n\n1. Diagnosed as HCC through imaging and laboratory tests, and capable of undergoing laparoscopic anatomical resection.\n2. Surgical scope (defined by randomization stratification):Stratum 1: Major hepatectomy, involving the resection of at least 3 Couinaud liver segments, including right hemihepatectomy and extended right hemihepatectomy, etc.Stratum 2: Minor hepatectomy, involving the resection of no more than 2 Couinaud liver segments. This includes right posterior sectorectomy, right anterior sectorectomy, left lateral sectionectomy, single segmentectomy, etc.\n3. During the operation, the Pringle method is used to block the first hepatic portal. Each block lasts ≤ 15 minutes, and the blocking procedure is performed 2 to 4 times.\n4. Age: 18 - 80 years old. Gender: Open to both male and female. Body Mass Index (BMI): 18.5 - 28 kg\u002Fm².\n5. Child-Pugh grade A or B, with a score of ≤ 7; ASA grades I to III.\n6. Preoperative ICG R15 \\\u003C 10%, and the residual liver volume\u002Fstandard liver volume \\> 40%.\n7. A single HCC (hepatocellular carcinoma), with a tumor diameter of less than 10 cm, without distant metastasis or invasion of the portal vein system.\n8. Preoperative ALT \\\u003C 2x ULN (upper limit of normal).\n9. No history of portal vein embolization prior to enrollment. If TACE treatment was previously received, it must have been completed \\> 6 months ago; if systemic anti-tumor drug therapy was previously received, it must have been completed \\> 4 weeks ago.\n10. No liver-damaging treatment drugs were used within two weeks prior to enrollment.\n\nExclusion Criteria:\n\n1. Reserve liver vascular damage, including: reconstruction after severance, ligation, embolization, thrombosis, etc\n2. Combined with abnormal coagulation function (prothrombin time prolonged by more than 3 seconds)\n3. Combining obstructive jaundice, severe heart disease, severe kidney disease and other serious illnesses\n4. During the operation, microwave treatment or a combination of microwave treatment was adopted\n5. More than 4 times of blocking at the first hepatic hilum, or a single blocking duration longer than 15 minutes\n6. Non-anatomic liver resection, where the remaining liver contains large areas of ischemic\u002Fedematous regions\n7. More than 1000ml of blood transfusion during the operation\n8. During the operation, an extra-hepatic disease was discovered. Other organs except the gallbladder needed to be removed simultaneously\n9. During the operation, other intrahepatic lesions were discovered, which required combination with other surgeries, such as ablation or choledochojejunostomy\n10. Diseases that have previously received systemic treatment with glucocorticoids, such as chronic kidney disease, inflammatory diseases, or other immune system-related disorders\n11. Psychosis, severe neurosis, those who cannot cooperate with this experiment\n12. Participated in other clinical trials within the previous 3 months before enrollment\n13. Allergy or intolerance to benzoic acid, or to the study drug\n14. Pregnant and lactating women\n15. The researchers believe that any participants who have any other factors that would make them unsuitable for this trial should not be included",{"count":86,"type":23},96,[26],"A multicenter, open-label, randomized, controlled study. It is proposed to evaluate the treatment plan of receiving 930mg polyene phosphatidylcholine injection one day before the operation, twice a day, and 930mg polyene phosphatidylcholine injection twice a day,combined with 100mg of magnesium isoglycyrrhizinate injection once a day,from the 1st to the 5th day after the operation. Compared with the monotherapy regimen of no liver protection treatment before the operation and receiving magnesium isoglycyrrhizinate injection 100mg once a day from the 1st to the 5th day after the operation.The efficacy and safety of treating postoperative liver function injury in patients undergoing laparoscopic hepatectomy for hepatocellular carcinoma were compared.",[90,65],"Hepatocellular Carcinoma (HCC)","2026-05-06",{"date":93,"type":40},"2026-05-11",{"date":95,"type":40},"2025-11-10",{"date":97,"type":23},"2026-12-31",{"name":46,"class":47},1,{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":24,"phases":110,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":120,"leadSponsor":122,"locationsCount":4},"100633190","phase-1-centrally-confined-8gy1f-to-tumor-core-followed-by-concurrent-chemoradiotherapy-for-unresectable-stage-iii-nsclc-100633190","NCT07523464","Centrally Confined 8Gy\u002F1f to Tumor Core Followed by Concurrent Chemoradiotherapy for Unresectable Stage III NSCLC","A Single-Arm Phase I Clinical Study of Centrally Confined 8 Gy\u002F1 Fraction Immune-Priming Radiotherapy to the Tumor Core Followed by Definitive Concurrent Chemoradiotherapy in Unresectable Stage III Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Age 18 to 75 years;\n* Histologically or cytologically confirmed NSCLC;\n* Unresectable stage III disease according to the AJCC 8th edition;\n* Negative for driver gene alterations;\n* Considered suitable for definitive cCRT by MDT discussion or investigator judgment;\n* ECOG performance status 0-1;\n* Presence of a clearly delineable pulmonary primary lesion allowing centrally confined priming treatment planning;\n* Adequate major organ function as required by the study;\n* Willingness to participate and provision of written informed consent.\n\nExclusion Criteria:\n\n* Presence of distant metastasis;\n* Positive driver gene alterations;\n* Prior definitive thoracic radiotherapy or prior systemic antitumor treatment for the current disease;\n* Active autoimmune disease or need for long-term systemic immunosuppressive therapy;\n* Active interstitial lung disease, prior severe radiation pneumonitis, or immune-related pneumonitis;\n* Special primary tumor location such that safety constraints for centrally confined priming radiotherapy cannot be met;\n* Primary lesion immediately adjacent to the main bronchus, carina, major vessels, or esophagus, such that the investigator judges the lead-in intervention to be excessively risky;\n* Pregnancy or lactation;\n* Any other condition that, in the opinion of the investigator, makes the patient unsuitable for this study.","75 Years",{"count":109,"type":23},24,[111],"PHASE1","This is a single-center, prospective, open-label, single-arm phase I exploratory study designed to evaluate the safety and feasibility of a novel central immune-priming radiotherapy strategy in patients with unresectable stage III non-small cell lung cancer (NSCLC). The investigational approach consists of a single 8 Gy\u002F1 fraction radiotherapy dose delivered to the central subregion of the primary tumor, with rapid dose fall-off to keep the peripheral tumor margin dose below 4 Gy, followed by one cycle of PD-(L)1 inhibitor, and then standard concurrent chemoradiotherapy (cCRT) approximately one week later. Patients without disease progression after cCRT will subsequently receive consolidation immune checkpoint inhibitor therapy.\n\nThe primary objective is to assess the safety and feasibility of this lead-in immune-priming strategy, particularly whether it can be integrated into standard cCRT and subsequent immunotherapy without unacceptable toxicity or treatment delay. The primary endpoint is the dose-limiting toxicity (DLT) rate, with the DLT observation window defined from initiation of the priming radiotherapy to 6-8 weeks after completion of cCRT. Secondary objectives include the on-time initiation rate of cCRT, cCRT completion rate, initiation rate of consolidation immunotherapy, acute and subacute toxicity profile, preliminary efficacy signals, and dynamic changes in peripheral lymphocyte counts. Exploratory analyses will investigate peripheral immune cell subsets, circulating tumor DNA (ctDNA), T-cell receptor (TCR) clonality, cytokine changes, and their associations with toxicity and clinical outcomes. The study will adopt a safety run-in plus expansion design, with an initial cohort of 6 patients and expansion to 24 patients if safety is acceptable.",[114,115],"Locally-Advanced Non-Small Cell Lung Cancer","Radiotherapy","2026-04-05",{"date":118,"type":40},"2026-04-13",{"date":39,"type":23},{"date":121,"type":23},"2028-12-30",{"name":46,"class":47},{"id":124,"slug":125,"hasResults":12,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":12,"sex":18,"minAge":130,"maxAge":20,"enrollmentInfo":131,"targetDuration":4,"studyType":24,"phases":133,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":99},"100540773","a-trial-to-evaluate-the-safety-and-preliminary-efficacy-of-imesenchymal-stromal-cellsimsc-in-subjects-with-sr-agvhd-100540773","NCT06321198","A Trial to Evaluate the Safety and Preliminary Efficacy of iMesenchymal Stromal Cells(iMSC) in Subjects With SR-aGVHD","A Trial to Evaluate the Safety and Preliminary Efficacy of Human Induced Pluripotent Stem Cell Derived Mesenchymal Stromal Cells in Subjects With Steroid-refractory Acute Graft-Versus-Host Disease","Inclusion Criteria:\n\n1.Subjects who understand and voluntarily sign the Informed Consent Form(ICF); 2.4-70 years; 3.Subjects with SR-aGVHD; 4.ECOG≤2; 5.Subjects with II to IV grades of steroid hormone resistance;\n\nExclusion Criteria:\n\n1. Accepted systemic or local treatment of mesenchymal stem cells;\n2. Have severe allergy to blood products or have allergy history of heterologous protein;\n3. Expected survival period within 3 months;\n4. Alanine transaminase(ALT)or Aspartate aminotransferase(AST)\\>2\\*upper limit of normal(ULN);Creatinine clearance rate≤30ml\u002Fmin or Blood Urea Nitrogen(BUN)\\>2\\*upper limit of normal(ULN), International Normalized Ratio (INR)\\>1.5\\*upper limit of normal(ULN);\n5. Have severe hepatic veno-occlusive disease(HVOD);\n6. Have severe lung disease like severe lung infection;\n7. Have history of severe acute myocardial infarction or have uncontrolled angina pectoris,arrhythmia and severe heart failure;\n8. Proved having resistant hypertension within 6 months before enrollment;\n9. Have active thrombus;\n10. Have untreated or uncertain active solid tumors within 5 years;\n11. Have alcohol or drug addiction or with a clear history of mental disorders or with a history of drug abuse or drug use of psychotropic substances;\n12. Human immunodeficiency virus(HIV)antibody positive, treponema pallidum (TP) antibody positive;\n13. Have active hepatitis B or hepatitis C;\n14. Have gastrointestinal symptoms which not caused by GVHD\n15. Pregnant or lactating female subjects, or subjects who are unable to comply with contraceptives from the study period to 6 months after the end of this study;\n16. Subjects who have participated in other clinical trials and have used other study products within 12 weeks before screening;\n17. Not suitable for this clinical trial for other reasons.","4 Years",{"count":132,"type":23},12,[134],"NA","A study to evaluate the safety and preliminary efficacy of iMSC in subjects with SR-aGVHD",[137],"Steroid-refractory Acute Graft-versus-host Disease(SR-aGVHD)","2026-03-24",{"date":140,"type":40},"2026-03-27",{"date":142,"type":40},"2024-02-10",{"date":144,"type":23},"2027-03-02",{"name":46,"class":47},{"id":147,"slug":148,"hasResults":12,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":12,"sex":18,"minAge":154,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":24,"phases":157,"briefSummary":158,"conditions":159,"keywords":162,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":99},"100629975","phase-4-effects-of-recombinant-human-growth-hormone-in-elderly-patients-with-moderate-to-severe-acute-brain-injury-gh-abi-rct-100629975","NCT07481656","Effects of Recombinant Human Growth Hormone in Elderly Patients With Moderate to Severe Acute Brain Injury (GH-ABI-RCT)","A Multicenter, Randomized Controlled Trial Evaluating Recombinant Human Growth Hormone in Elderly Patients With Moderate to Severe Acute Brain Injury and Hypoalbuminemia","GH-ABI-RCT","Inclusion Criteria:\n\n1. Age ≥ 60 years, male or female.\n2. Hospitalized patients with acute brain injury (including traumatic brain injury, ischemic stroke, intracerebral hemorrhage, or subarachnoid hemorrhage) who had a Glasgow Coma Scale (GCS) score ≤ 12 at any time during hospitalization.\n3. Presence of hypoalbuminemia, defined as serum albumin \\\u003C 35 g\u002FL and\u002For prealbumin \\\u003C 200 mg\u002FL after admission.\n4. Willing and able to provide informed consent (by patient or legal representative).\n\nExclusion Criteria:\n\n1. Unstable vital signs, defined as deviations in body temperature, respiration, pulse, blood pressure, or oxygen saturation from normal ranges that, in the clinical judgment of the investigator, may jeopardize vital organ perfusion or indicate disease progression.\n2. Active malignancy or history of malignancy with a disease-free interval of less than 5 years.\n3. Diabetes mellitus with retinopathy.\n4. Any other condition deemed unsuitable for participation by the investigator (e.g., severe renal\u002Fhepatic dysfunction, active infection, known hypersensitivity to growth hormone, or participation in another interventional trial).","60 Years",{"count":156,"type":23},160,[26],"This study is a multicenter, randomized controlled trial aimed at evaluating the effectiveness and safety of recombinant human growth hormone (rhGH) in elderly patients who have suffered moderate to severe acute brain injuries complicated by hypoproteinemia.\n\nEligible participants, aged 60 and older, with acute brain injuries and low serum albumin levels will be randomly assigned to either the growth hormone treatment group or the control group. The treatment group will receive recombinant human growth hormone in addition to standard medical care, while the control group will receive standard medical care alone.\n\nClinical data will be collected at baseline and weekly for four weeks. The primary outcome measure will be the change in plasma albumin levels from baseline to Week 2. Secondary outcome measures will include changes in total protein, prealbumin, insulin-like growth factor-1 levels, cumulative albumin infusion, infection rates, hemoglobin levels, length of hospital stays, length of intensive care unit stays, and functional outcomes.\n\nSafety outcomes and adverse events will be monitored throughout the study period. The results of this study are expected to provide evidence that can help optimize nutritional support and rehabilitation strategies for elderly patients with acute brain injuries.This study is a multicenter, randomized controlled clinical trial designed to evaluate the effectiveness and safety of recombinant human growth hormone (rhGH) in elderly patients with moderate to severe acute brain injury complicated by hypoproteinemia.\n\nEligible participants aged 60 years and older with acute brain injury and low serum albumin levels will be randomly assigned to either the growth hormone treatment group or the control group. The treatment group will receive recombinant human growth hormone in addition to standard medical care, while the control group will receive standard medical care alone.\n\nClinical data will be collected at baseline and weekly for four weeks. The primary outcome is the change in plasma albumin level from baseline to Week 2. Secondary outcomes include changes in total protein, prealbumin, insulin-like growth factor-1 levels, cumulative albumin infusion, infection rate, hemoglobin level, length of hospital stay, intensive care unit stay, and functional outcomes.\n\nSafety outcomes and adverse events will be monitored throughout the study period. The results of this study are expected to provide evidence for optimizing nutritional support and rehabilitation strategies in elderly patients with acute brain injury.",[160,161],"Acute Brain Injuries","Moderate to Severe Traumatic Brain Injury",[163,164,165,161],"recombinant human growth hormone","rhGH","hypoproteinemia","2026-03-16",{"date":168,"type":40},"2026-03-19",{"date":170,"type":23},"2026-04-10",{"date":172,"type":23},"2028-10-30",{"name":46,"class":47},{"id":175,"slug":176,"hasResults":12,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":181,"targetDuration":4,"studyType":24,"phases":183,"briefSummary":184,"conditions":185,"keywords":188,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":99},"100628518","simultaneous-vs-staged-vps-and-cp-a-multi-cnter-rct-100628518","NCT07462676","Simultaneous Vs Staged VPS and CP :A Multi-cnter RCT.","A Multicenter, Randomized Trial Comparing Simultaneous and Staged Surgical Management for Ventriculoperitoneal Shunt and Cranioplasty.","Inclusion Criteria:\n\n* 1.Patients who have undergone decompressive craniectomy (DC) for conditions such as Traumatic Brain Injury (TBI), Intracerebral Hemorrhage (ICH), Subarachnoid Hemorrhage (SAH), or Ischemic Stroke (IS), and present with a skull defect concurrent with hydrocephalus. Hydrocephalus must be confirmed by cranial CT\u002FMRI and cerebrospinal fluid pressure measurement.\n\n  2.A definitive diagnosis of hydrocephalus must meet the following criterion: presence of ventriculomegaly (Evans Index \\> 0.3), accompanied by either elevated intracranial pressure (or high bone flap pressure) OR clinical symptoms such as headache, vomiting, or impaired consciousness.\n\n  3.Baseline characteristics: Age between 18 and 70 years, any gender, stable vital signs, and medically fit to tolerate surgery.\n\n  4.Informed consent: The patient or their legal guardian must provide written informed consent.\n\nExclusion Criteria:\n\n1. Patients with a history of prior cranioplasty (CP) or ventriculoperitoneal shunt (VPS) surgery (i.e., re-operation cases).\n2. Patients requiring bilateral cranioplasty.\n3. Patients deemed unsuitable for simultaneous surgery, such as those with excessively bulging or tense bone flaps that preclude safe cranioplasty.\n4. Patients with severe organ failure, coagulation dysfunction, or other systemic conditions that render them unable to tolerate major surgery.\n5. Patients with active intracranial infection, abdominal infection, or systemic infection during the acute phase.\n6. Patients with a known allergy or hypersensitivity to the surgical materials used (e.g., PEEK implants, shunt components).\n7. Pregnant or lactating women.\n8. Patients unable or unwilling to comply with the required follow-up schedule. -",{"count":182,"type":23},300,[134],"The purpose of this prospective, multi-center randomized controlled trail is to compare the safety and efficacy of sequential surgery or staged surgery in patients with skull defect and hydrocephalus. The main observation will be the occurrence of complications such as postoperative infection, reoperation, shunt tube obstruction, hematoma, and subdural effusion. This will provide high-quality evidence for clinical selection of appropriate strategies.The concurrent surgery group needs to complete the VPS and CP in the same operation, and the sequence of the surgeries is determined based on the patient's condition and is recorded.However, the staged surgery group requires two surgeries, with an interval of 2 to 8 weeks and the operation order is determined by randomization.Within 1 week after surgery, participants should cooperate to monitor vital signs, assess neurological function ( such as GCS、GOS, etc.), conduct head CT examinations regularly to observe the postoperative intracranial condition, and record the occurrence of postoperative complications.Postoperative follow-up should last for at least 6 months.Outpatient or telephone follow-ups should be conducted at 1 week, 1 month, 3 months, and 6 months after the surgery.During each follow-up, a neurological function assessment and quality of life score (such as the SF-36 Health Survey) should be completed, and the occurrence of postoperative complications should be recorded.",[186,187],"Ventriculoperitoneal Shunt (VPS)","Cranioplasty",[189,190,191,192],"Ventriculoperitoneal Shunt","cranioplasty","Postoperative Complications","Hydrocephalus","2026-03-06",{"date":195,"type":40},"2026-03-10",{"date":197,"type":23},"2026-04-01",{"date":199,"type":23},"2026-11-30",{"name":46,"class":47},{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":24,"phases":210,"briefSummary":211,"conditions":212,"keywords":214,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":99},"100609168","anti-cd19-gene-therapy-for-b-cell-lymphoma-100609168","NCT07211048","Anti CD19 Gene Therapy for B-cell Lymphoma","Early Exploratory Clinical Study of CD19-targeted Gene Injection (LCAR02) in Patients With Relapsed\u002FRefractory B-cell Lymphoma","Inclusion Criteria:\n\n* (1)Age 18 years or older, any gender; (2)Patients diagnosed with any of the following conditions: diffuse large B-cell lymphoma (DLBCL), germinal center or activated B-cell type; primary cutaneous DLBCL; primary mediastinal (thymic) large B-cell lymphoma; ALK-positive anaplastic large B-cell lymphoma; high-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements; high-grade B-cell lymphoma; T-cell-rich B-cell lymphoma; transformed follicular lymphoma; or any aggressive B-cell lymphoma arising from indolent lymphoma; follicular lymphoma; mantle cell lymphoma; large cell transformation of CLL. Patients must have previously received at least second-line standard treatment and either did not achieve remission or relapsed after remission; (3) For B-cell lymphoma patients, according to the preliminary assessment, staging, and response evaluation recommendations for Hodgkin and non-Hodgkin lymphomas (2014 edition), there must be at least one measurable lesion at baseline, which is defined as a lymph node lesion with a long diameter \\>15 mm or an extranodal lesion with a long diameter \\>10 mm, diagnosed by PET-CT or CT imaging; (4) B-cell lymphoma patients must have tumor cells confirmed CD19 positive by immunohistochemistry; (5) Adequate vital organ function: liver function meeting: ALT ≤3×ULN, AST ≤3×ULN; serum creatinine ≤140 μmol\u002FL; total bilirubin ≤2×ULN, or ≤3×ULN in patients with Gilbert's syndrome; hemodynamically stable as determined by echocardiography or multi-gated radionuclide angiography (MUGA) with left ventricular ejection fraction (LVEF) ≥45%; no active pulmonary infection, and percutaneous arterial oxygen saturation ≥92% without supplemental oxygen; (6) ECOG performance status: 0-2; (7) Expected survival of more than 3 months; (8) Female and male participants of childbearing potential must agree to use reliable and effective contraception from the time of signing the informed consent form until 2 years after receiving LCAR02 infusion (excluding natural family planning methods).\n\nExclusion Criteria:\n\n* (1) Patients who have experienced central nervous system diseases or pathological changes within 6 months before screening, including but not limited to: stroke, cerebrovascular accident, aneurysm, epilepsy, convulsions, aphasia, severe traumatic brain injury, dementia, Parkinson's disease, cerebellar diseases, organic brain syndrome, or mental disorders.\n\n  (2) Patients with malignant tumors other than B-cell lymphoma. (3) Patients who received vaccines or B-cell targeted therapy within 4 weeks before screening.\n\n  (4) Patients with systemic autoimmune diseases or immunodeficiency. (5) Patients with grade 2-4 acute graft-versus-host disease (GVHD) or moderate to severe chronic GVHD within 4 weeks before screening.\n\n  (6) Patients with relatively severe heart disease, such as angina, myocardial infarction, heart failure, or arrhythmia.\n\n  (7) Patients with a history of severe allergies to the drugs or excipients used in the clinical study or investigational drugs.\n\n  (8) Patients with active hepatitis B, HCV antibody positivity, HIV antibody positivity, or positive for syphilis.\n\n  (9) Patients with active infections requiring intravenous antibiotics or hospitalization.\n\n  (10) Pregnant or breastfeeding women.",{"count":209,"type":23},18,[134],"This is an open label, single-site, dose-escalation study in up to 18 participants with treatment of relapsed\u002Frefractory B-cell lymphoma. This study aims to evaluate the safety and efficacy of the treatment with an Anti- CD19 gene injection",[213],"B-cell Lymphoma",[215],"B-cell lymphoma","2026-01-19",{"date":218,"type":40},"2026-01-21",{"date":220,"type":23},"2026-03-20",{"date":222,"type":23},"2029-12-31",{"name":46,"class":47},{"id":225,"slug":226,"hasResults":12,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":24,"phases":233,"briefSummary":235,"conditions":236,"keywords":238,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":99},"100596591","phase-3-effect-of-stem-cell-infusion-time-on-agvhd-in-patients-with-hematological-malignancies-post-ucbt-100596591","NCT07047456","Effect of Stem Cell Infusion Time on aGVHD in Patients With Hematological Malignancies Post UCBT","Prospective Randomized Controlled Phase III Clinical Study on the Impact of Stem Cell Infusion Timing on the Incidence of Acute Graft-versus-host Disease in Patients With Hematologic Malignancies Following Single-unit Umbilical Cord Blood Transplantation","Inclusion Criteria:\n\n* Definite diagnosis of malignant hematologic disease before transplantation, age, gender and race are not limited;\n* Participants were required to have achieved complete remission with negative minimal residual disease (MRD) prior to transplantation;\n* Participants who are proposed to receive sUCBT for the first time;\n* Eastern Cooperative Oncology Group (ECOG) score 0-2;\n* No serious organ failure and active infection;\n* Voluntary open randomized controlled study to observe whether the time of stem cell infusion affects the occurrence of aGVHD after transplantation;\n* Each subject must sign an informed consent form (ICF) indicating that he\u002F she understands the purpose and procedures of the study and is willing to participate in the study; in view of the subject's condition, if the participant's own signature is not conducive to the treatment of his\u002Fher condition, the ICF will be signed by the legal representative.\n\nExclusion Criteria:\n\n* Those with severe organ dysfunction or disease, such as severe disease and dysfunction of the heart, liver, kidneys and pancreas;\n* Any life-threatening disease, physical condition, or organ system dysfunction that, in the opinion of the investigator, may compromise participant safety and put the results of the study at unnecessary risk; drug-dependent individuals; participants with uncontrolled psychiatric disorders; and individuals with cognitive dysfunction;\n* Participants in other clinical studies that may affect aGVHD within 3 months;\n* Those whom the investigator considers unsuitable for enrollment (e.g., those who anticipate that patients will not be able to adhere to the examination and treatment due to financial and other issues).",{"count":232,"type":23},134,[234],"PHASE3","To observe the effect of stem cell infusion on the development of acute graft- versus-host disease (aGVHD) in patients with malignant hematologic diseases after single-unit unrelated cord blood transplantation (sUCBT).",[237],"Acute Graft Versus Host Disease",[239],"Time of umbilical cord blood infusion","2025-12-17",{"date":242,"type":40},"2025-12-23",{"date":244,"type":40},"2025-07-11",{"date":246,"type":23},"2027-12-31",{"name":46,"class":47},{"id":249,"slug":250,"hasResults":12,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":254,"eligibilityCriteria":255,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":256,"targetDuration":4,"studyType":24,"phases":258,"briefSummary":259,"conditions":260,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":99},"100610760","sulfamethoxazole-prophylaxis-duration-after-renal-transplantation-100610760","NCT07231770","Sulfamethoxazole Prophylaxis Duration After Renal Transplantation","A Controlled Study on the Prophylaxis of Pneumocystis Jirovecii Pneumonia With Fixed-dose Compound Sulfamethoxazole Tablets of Different Maintenance Durations After Renal Transplantation","SPDART","Diagnostic Criteria for PJP (meeting one of the following criteria is sufficient):\n\n1. Detection of Pneumocystis jirovecii via sputum Gomori methenamine silver (GMS) stain.\n2. According to guidelines\u002Fconsensus: Positive direct immunofluorescence assay and\u002For positive polymerase chain reaction (PCR) assay on induced sputum or bronchoalveolar lavage fluid (BALF) specimens.\n3. Detection of Pneumocystis jirovecii strains in sputum, blood, or bronchoalveolar lavage fluid (BALF) by metagenomic next-generation sequencing (mNGS).\n\nInclusion Criteria:\n\n* Subjects must meet all the following conditions to be enrolled: (1) Age: 18-70 years old; (2) Post-renal transplantation; (3) Voluntarily participate in this clinical study, be able to cooperate with researchers to conduct the study, and sign the informed consent form.\n\nExclusion Criteria:\n\n* Criteria: Subjects with any of the following conditions shall be excluded from the trial: (1) HIV-positive; (2) History of TMP-SMX allergy; (3) Glucose-6-phosphate dehydrogenase (G6PD) deficiency; (4) Megaloblastic anemia; (5) Multiorgan transplantation; (6) Complicated with tumor; (7) Complicated with connective tissue disease; (8) Pregnant patients.",{"count":257,"type":23},450,[134],"Renal transplantation is the most ideal and effective treatment for end-stage renal disease. Pneumocystis jirovecii pneumonia (PJP) is one of the most common pulmonary infections after renal transplantation, with high morbidity and mortality that seriously affects patients' prognosis and survival. PJP can be prevented with drugs, and trimethoprim-sulfamethoxazole (TMP-SMX) is the first-choice prophylactic agent. However, there is no clear definition of the prophylactic course of TMP-SMX in domestic and international guidelines. Most of the prophylactic durations for PJP are based on the clinical experience of physicians, ranging from 6 to 12 months across different transplant centers. Multiple studies have shown that some patients still develop PJP more than one year after renal transplantation. Previous research by our team found that PJP has a peak incidence around 9 months after renal transplantation, with a second peak occurring between 10 and 15 months. This study aims to adopt a single-center, randomized, parallel-controlled trial design, planning to enroll 450 patients after renal transplantation. It will investigate the impact of different prophylactic courses of TMP-SMX on the incidence of PJP, and explore whether long-term prophylaxis is more reasonable and effective than short-term prophylaxis. Meanwhile, during follow-up, the peak serum concentration of SMZ in patients will be measured to analyze the relationship between SMZ serum concentration and the occurrence of PJP as well as adverse reactions. A clinical prediction model will be constructed to reveal the effective concentration range of TMP-SMX for prophylactic use. This will further optimize the prophylactic regimen, provide practical guidance for clinical practice, reduce the morbidity and mortality of PJP, and improve prognosis.",[261,262],"Fever","Chest Tightness","2025-12-15",{"date":265,"type":40},"2025-12-16",{"date":267,"type":40},"2024-05-28",{"date":269,"type":23},"2027-08-08",{"name":46,"class":47},{"id":272,"slug":273,"hasResults":12,"nctId":274,"briefTitle":275,"officialTitle":275,"acronym":4,"eligibilityCriteria":276,"healthyVolunteers":12,"sex":18,"minAge":277,"maxAge":20,"enrollmentInfo":278,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":280,"conditions":281,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":287,"leadSponsor":289,"locationsCount":4},"100614457","an-open-label-observational-long-term-follow-up-study-evaluating-the-safety-and-efficacy-of-rgl-193-putamen-injection-in-patients-with-primary-parkinsons-disease-100614457","NCT07279844","An Open-label, Observational, Long-term Follow-up Study Evaluating the Safety and Efficacy of RGL-193 Putamen Injection in Patients With Primary Parkinson's Disease","Inclusion Criteria:\n\n1. Subjects who have previously participated in RGL-193-related studies and have received RGL-193 treatment；\n2. Those who voluntarily participate in this trial and sign a written informed consent form -\n\nExclusion Criteria:\n\nNone\n\n\\-","45 Years",{"count":279,"type":23},6,"To evaluate the long-term safety of RGL-193 capsid injection in patients with primary Parkinson's disease over 5 years",[282],"Parkinson's Disease","2025-12-01",{"date":285,"type":40},"2025-12-12",{"date":263,"type":23},{"date":288,"type":23},"2029-12-14",{"name":46,"class":47},{"id":291,"slug":292,"hasResults":12,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":12,"sex":18,"minAge":297,"maxAge":107,"enrollmentInfo":298,"targetDuration":4,"studyType":24,"phases":300,"briefSummary":302,"conditions":303,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":99},"100608960","early-phase-1-intravenous-infusion-of-umbilical-cord-blood-as-an-adjunctive-treatment-for-alzheimers-disease-100608960","NCT07208344","Intravenous Infusion of Umbilical Cord Blood as an Adjunctive Treatment for Alzheimer's Disease","A Randomized Double-blind Clinical Study on the Use of Umbilical Cord Blood as an Adjuvant Therapy to Improve Cognitive Function in Alzheimer's Disease and Its Mechanism of Action","Inclusion Criteria:\n\n* Age range: 50 - 75 years old, gender not restricted;\n* Patients diagnosed with Alzheimer's disease (AD) according to the AT(N) diagnostic framework (with positive amyloid protein PET test results);\n* MMSE score between 15 and 30 points, patients with mild to moderate Alzheimer's disease;\n* The patient has a fixed caregiver who is willing to accompany the patient throughout the corresponding program;\n* The patient has a literacy level above primary school, sufficient to complete the tests stipulated in the program;\n* The patient or the guardian consents to participate in this clinical trial voluntarily and signs the informed consent form.\n\nExclusion Criteria:\n\n* Dementia caused by other diseases, such as vascular dementia, frontotemporal dementia, and Lewy body dementia, etc.;\n* The patient has other major systemic diseases, malignant tumors, chronic obstructive pulmonary disease or pulmonary fibrosis, etc. related to the lungs;\n* The patient's white blood cell and neutrophil levels are below the normal lower limit;\n* The patient has active infectious diseases, such as syphilis, AIDS, hepatitis B, hepatitis C;\n* The patient has a history of stroke, epilepsy, alcohol abuse, or abuse of psychotropic drugs;\n* Severe visual or hearing impairment, or those who cannot complete the relevant assessment due to other reasons;\n* Patients who have participated in other clinical trials within the last 2 months;\n* Other situations that the researchers consider not suitable for participating in clinical research.","50 Years",{"count":299,"type":23},30,[301],"EARLY_PHASE1","This study is a single-center, prospective, double-blind, randomized controlled clinical trial (RCT).\n\nEmploying a parallel-group design, the trial plans to enroll 30 clinically diagnosed AD patients, who will be randomly assigned via a computerized randomization tool into three equal groups: low-dose, high-dose, and control (10 patients per group).\n\nThe blinded clinical trial consists of three phases:\n\n\\*\\*Screening Phase\\*\\*: All enrolled patients must provide fully informed consent and meet inclusion criteria while avoiding exclusion criteria. Baseline assessments will be recorded, and single-cell omics samples will be collected. Patients may voluntarily opt for cerebrospinal fluid (CSF) sampling.\n\nThe umbilical cord blood (UCB) used clinically is sourced from the Shandong Cord Blood Hematopoietic Stem Cell Bank. Following erythrocyte and granulocyte depletion via lymphocyte separation and density gradient centrifugation, the UCB is purified to reduce immunogenicity and undergoes genetic screening to exclude the APOE4 risk allele.\n\n\\*\\*Treatment Phase\\*\\*: In addition to standard care, patients will receive intravenous infusions at weekly intervals for four sessions. A fifth infusion will be administered one month after the fourth. The low-dose group receives 1×10⁸ UCB-derived mononuclear cells (UCB-MNCs) per infusion, the high-dose group receives 3×10⁸ UCB-MNCs, and the control group receives an equivalent volume of saline placebo.\n\nAll clinically administered UCB-MNCs undergo genetic screening to exclude the APOE4 risk allele.\n\n\\*\\*Follow-up Phase\\*\\*:\n\nAssessments will be conducted at 30 days (1 month), 60 days (2 months), 90 days (3 months), and 180 days (6 months) post-initial infusion, including:\n\n1. CDR-SB scale scoring;\n2. Total and subdomain scores of the Activities of Daily Living (ADL) scale;\n3. Serum inflammatory cytokines (IL-1, IL-2, IL-6, IL-8, IL-10, TNF-α), AD biomarkers (P-tau181, P-tau217), and other relevant markers;\n4. Single-cell omics sample collection;\n5. Optional CSF sampling per patient preference.\n\nAfter database lock, unblinding will occur for subsequent analysis.",[304],"Alzheimer Disease (AD)","2025-09-28",{"date":307,"type":40},"2025-10-06",{"date":309,"type":40},"2025-07-31",{"date":311,"type":23},"2026-06-30",{"name":46,"class":47},{"id":314,"slug":315,"hasResults":12,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":4,"eligibilityCriteria":319,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":54,"enrollmentInfo":320,"targetDuration":4,"studyType":24,"phases":322,"briefSummary":324,"conditions":325,"keywords":327,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":99},"100607403","phase-2-ivonescimab-plus-short-course-hypofractionated-radiotherapy-as-second-line-therapy-for-esophageal-squamous-cell-carcinoma-100607403","NCT07188103","Ivonescimab Plus Short-Course Hypofractionated Radiotherapy as Second-Line Therapy for Esophageal Squamous Cell Carcinoma","Efficacy and Safety of Ivonescimab Combined With Short-Course Hypofractionated Radiotherapy as Second-Line Therapy for Locally Advanced\u002FMetastatic Esophageal Squamous Cell Carcinoma: A Prospective, Single-Center, Single-Arm Phase II Clinical Study","Inclusion Criteria:\n\n* a. Patients with histologically confirmed esophageal squamous cell carcinoma (ESCC) , aged 18-80 years;\n* b. Unresectable locally advanced, postoperative recurrent, or metastatic ESCC that has progressed on or is intolerant to first-line systemic therapy. For patients who received definitive concurrent chemoradiotherapy (CCRT) , disease progression during or within 6 months post-treatment is considered first-line treatment failure;\n* c. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) . All positive regional lymph nodes are counted as a single lesion, while non-regional metastatic lymph nodes are counted per station;\n* d. Adequate major organ function, defined as:\n\n  1. Hematology:\n\n     1. Hemoglobin (Hb) ≥ 90 g\u002FL\n     2. White blood cell (WBC) count ≥ 1.5 × 10⁹\u002FL\n     3. Platelet count ≥ 60 × 10⁹\u002FL\n  2. Serum biochemistry:\n\n     1. Albumin ≥ 25 g\u002FL\n     2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN)\n     3. Total bilirubin ≤ 1.5 × ULN\n     4. Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 60 mL\u002Fmin\n  3. Echocardiography:\n\nLeft ventricular ejection fraction (LVEF) ≥ 50% (lower limit of normal)\n\n* e. Eastern Cooperative Oncology Group (ECOG) performance status: 0-2;\n* f. Expected survival ≥ 3 months;\n* g. Voluntarily enrolled, with signed informed consent, and willing to comply with study protocols and follow-up.\n\nExclusion Criteria:\n\n* a. Patients with severe organ dysfunction, uncontrolled acute infection, or significant comorbidities;\n* b. Patients with vertebral metastases accompanied by spinal cord compression symptoms;\n* c. Patients with esophagotracheal or esophagomediastinal fistulas;\n* d. Patients with uncontrolled pleural, pericardial, or pelvic effusions requiring repeated drainage;\n* e. Patients with esophageal primary\u002Fmetastatic lesions invading the heart or great vessels, as assessed by the responsible physician, with a risk of life-threatening hemorrhage;\n* f. Patients with esophageal primary\u002Fmetastatic lesions invading the trachea or bronchi, as assessed by the responsible physician, with a risk of esophagotracheal fistula;\n* g. Patients not suitable for short-course hypofractionated radiotherapy, as evaluated by the responsible physician;\n* h. Pregnant or lactating women;\n* i. Patients with mental disorders, or those with a history of psychotropic drug abuse and unable to quit;\n* j. Patients who have participated in other drug clinical trials within the past 4 weeks;\n* k. Patients or their families who refuse to participate in the study.",{"count":321,"type":23},37,[323],"PHASE2","In the era of immunotherapy, the standard second-line treatment regimen for locally advanced\u002Fmetastatic esophageal squamous cell carcinoma (ESCC) remains controversial. This prospective, single-center, single-arm phase II clinical study aims to evaluate the efficacy and safety of Ivonescimab combined with short-course hypofractionated radiotherapy as a second-line therapy for patients with locally advanced\u002Fmetastatic ESCC. The study plans to enroll 37 patients who have failed first-line treatment, without grouping, all of whom will receive Ivonescimab combined with short-course hypofractionated radiotherapy. The primary endpoints are progression-free survival (PFS) and safety, while the secondary endpoints include overall survival (OS), duration of response (DOR), and objective response rate (ORR). The study duration is 2 years.",[326],"Esophageal Squamous Cell Carcinoma",[328,329,330],"Esophageal cancer","Hypofractionated Radiotherapy","Ivonescimab","2025-09-16",{"date":333,"type":40},"2025-09-23",{"date":335,"type":40},"2025-07-01",{"date":337,"type":23},"2027-06-30",{"name":46,"class":47},{"id":340,"slug":341,"hasResults":12,"nctId":342,"briefTitle":343,"officialTitle":343,"acronym":4,"eligibilityCriteria":344,"healthyVolunteers":12,"sex":18,"minAge":345,"maxAge":20,"enrollmentInfo":346,"targetDuration":4,"studyType":24,"phases":348,"briefSummary":349,"conditions":350,"keywords":352,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":99},"100601155","early-phase-1-safety-and-efficacy-of-metabolically-armed-tumor-lnfiltrating-lymphocytes-meta10-til-for-the-treatment-of-advanced-solid-tumors-100601155","NCT07106814","Safety and Efficacy of Metabolically Armed Tumor-lnfiltrating Lymphocytes (Meta10-TIL) for the Treatment of Advanced Solid Tumors","Inclusion Criteria:\n\n* The patient or his\u002Fher guardian voluntarily signed the informed consent;\n* Age \\>18 years and ≤70 years, male or female;\n* Patients with advanced solid tumors who have been confirmed by histopathology or cytology and have received at least first-line of treatment:\n\n  1. Recurrent\u002Fmetastatic\u002Fpersistent (persistent defined as disease progression after initial treatment) cervical cancer, including squamous cell carcinoma (SCC), adenosquamous carcinoma (ASC), and adenocarcinoma (AC), and not eligible for curative surgery and\u002For radiotherapy:\n\n     1. Recurrent\u002Fmetastatic\u002Fpersistent cervical cancer with prior failure (disease progression or intolerable toxicity) of at least 1 but no more than 3 systemic therapies;\n     2. Systemic therapy is defined as any chemotherapy or multi-drug combination chemotherapy regimen recommended by guidelines used for cervical cancer;\n     3. Chemotherapy or chemoradiotherapy administered as neoadjuvant or adjuvant therapy is not counted as a prior line of systemic therapy.\n  2. Or, classified as Stage Ⅳ cervical cancer according to the International Federation of Gynecology and Obstetrics (FIGO 2018) staging criteria (studies have shown that patients with early-stage cancer may have better outcomes after TIL therapy. After confirming significantly superior efficacy compared to marketed TIL products, researchers can relax staging criteria according to their judgment);\n  3. Histologically or cytologically confirmed locally advanced\u002Fmetastatic liver malignancies (including hepatocellular carcinoma, intrahepatic cholangiocarcinoma, and metastatic liver cancer):\n\n     1. For hepatocellular carcinoma (HCC), classified as Barcelona Clinic Liver Cancer (BCLC) Stage C or Stage B unsuitable for local therapy or progressed after local therapy;\n     2. For locally advanced liver cancer, patients must have failed at least first-line systemic therapies recommended by guidelines (disease progression or intolerable toxicity);\n     3. Unresectable intrahepatic cholangiocarcinoma patients must have failed at least 1 but no more than 3 prior systemic therapies recommended by guidelines(disease progression or intolerable toxicity);\n     4. Metastatic liver cancer ineligible for curative surgery based on primary tumor TNM (Tumor Node Metastasis) staging; for metastatic liver cancer, patients must have failed at least 2 but no more than 3 guideline-recommended systemic therapies (disease progression or intolerable toxicity);\n     5. Liver function Child-Pugh score ≤7;\n     6. Or patients deemed by the investigator to be unsuitable for existing standard treatments, or who refuse standard therapy.\n  4. Advanced solid tumors that have progressed after prior standard therapy or are intolerant to toxicity, for which no standard treatment options are currently available, or for other reasons cannot receive the current standard treatment, including but not limited to primary or metastatic triple-negative breast cancer (TNBC), non-small cell lung cancer (NSCLC) (excluding neuroendocrine tumors or mixed types with \\>10% neuroendocrine components), ovarian cancer (OC), head and neck cancer (HNC), and colorectal cancer (CRC).\n* The subject has residual lesions suitable for surgical resection (≥1.5 cm) or biopsy (core needle biopsy specimens: ≥4 passes with 16G needle or ≥6 passes with 18G needle) to generate tumor-infiltrating lymphocytes (TILs). For cervical cancer subjects, tumor tissue meeting either ≥0.5 cm in diameter or ≥400 mm³ in volume is acceptable. Fresh tumor tissue for TIL production should preferably be obtained from proximal metastatic lymph nodes or the periphery of tumor lesions. The sampled lesion has not received local therapy (e.g., radiotherapy, radiofrequency ablation, oncolytic virus, etc.) or such interventions have occurred ≥3 months prior and the lesion has progressed after local treatment;\n* Expected life expectancy ≥3 months;\n* After tumor resection\u002Fpuncture, the subject must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) for efficacy evaluation;\n* Eastern Cooperative Oncology Group (ECOG) performance status was 0-1 (subjects with stable brain metastases require investigator assessment);\n* Adequate organ function:\n\n  1. Hematological (no transfusions, platelet infusions, or growth factor support \\[except recombinant erythropoietin\\] within 7 days prior to enrollment):\n\n     1. Absolute neutrophil count (ANC)≥1x10\\^9\u002FL;\n     2. Platelet count (PLT) ≥80 × 10\\^9\u002FL;\n     3. Hemoglobin (Hb) ≥90.0 g\u002FL;\n  2. Blood chemistry:\n\n     1. Estimated creatinine clearance ≥40 mL\u002Fmin (calculated by Cockcroft-Gault formula);\n     2. Alanine aminotransferase (ALT) ≤3 × upper limit of normal (ULN);\n     3. Aspartate aminotransferase (AST) ≤3 × ULN;\n     4. Total bilirubin (TBIL) ≤2 mg\u002FdL (subjects with Gilbert-Meulengracht syndrome ≤3 mg\u002FdL);\n     5. Serum AST and ALT ≤5 × ULN (subjects with liver metastasis);\n  3. Adequate pulmonary reserve defined as ≤Grade 1 dyspnea and oxygen saturation \\>91% on room air;\n  4. Left ventricular ejection fraction (LVEF) ≥45% by echocardiography or multigated acquisition (MUGA) scan, with hemodynamic stability;\n* In the investigator's judgment, the subject must have recovered from prior anticancer therapy toxicities to Grade 1 or lower (except for specific Grade 2 or lower toxicities deemed irreversible in a short period of time as judged by the investigator, e.g., alopecia) and be eligible for preconditioning chemotherapy and TIL therapy;\n* Subjects with documented ≥Grade 2 diarrhea or colitis from prior immune checkpoint inhibitor therapy must be asymptomatic for ≥6 months before tumor resection, with normal colonoscopy (visual assessment) post-immunotherapy (excluding colorectal cancer patients);\n* Subjects with immune-related endocrinopathies (e.g., hypothyroidism) may enroll if stable for ≥6 weeks and controlled with hormone replacement therapy (non-corticosteroid);\n* Women of childbearing potential and all male subjects must agree to use highly effective methods of contraception at the time of informed consent, and continue within 1 year after Meta10-TILs infusion.\n\nExclusion Criteria:\n\n* Presence of bone metastases only.\n* Active central nervous system (CNS) metastases (except for stable brain metastases not requiring medication or steroid dependence for ≥3 months).\n* Use of Chinese herbal medicine or botanical drugs with antitumor indications within 1 week before preconditioning.\n* Systemic corticosteroid therapy (≥10 mg\u002Fday prednisone or equivalent) or other immunosuppressive drugs within 2 weeks before preconditioning (excluding inhaled, topical, or physiological replacement therapy).\n* Subjects who have undergone major surgery within 4 weeks before enrollment (as assessed by the investigator) or planned major surgery during the study (excluding scheduled surgery for Meta10-TILs preparation); Major surgery refers to Grade 3 \\& 4 surgeries as defined by China's Administrative Measures for Clinical Application of Medical Technology (effective on May 1, 2009).\n* History of other malignancies within 3 years before screening or concurrent malignancies (except for locally treated malignancies with no recurrence risk for ≥1 year, e.g., non-melanoma skin cancer, bladder cancer).\n* Any form of primary immunodeficiency disorder (e.g., severe combined immunodeficiency \\[SCID\\] or acquired immunodeficiency syndrome \\[AIDS\\]).\n* History of organ transplantation.\n* Active hepatitis B (HBsAg positive or anti-HBc positive with HBV-DNA \\>1000 copies\u002FmL) or hepatitis C (HCV-RNA positive).\n* Anti-HIV antibody positive or anti-syphilis antibody positive.\n* Uncontrolled acute life-threatening bacterial, viral, or fungal infections (e.g., positive blood culture ≤72 hours before Meta10-TILs infusion).\n* Patients who have received a live or attenuated vaccination within 4 weeks before preconditioning.\n* Unstable angina and\u002For myocardial infarction within 6 months before signing informed consent; Uncontrolled thrombotic events, severe bleeding, or deep vein thrombosis (DVT) within 12 months before signing informed consent.\n* History of neurological or psychiatric disorders, including epilepsy or dementia.\n* History of hypersensitivity to drugs (e.g., cyclophosphamide, fludarabine, IL-2, Meta10-TILs components, gentamicin, etc.).\n* High bleeding risk per investigator assessment, including but not limited to: tumor encasement\u002Finfiltration of major blood vessels (e.g., carotid artery, jugular vein, bronchial artery); other high-risk features (e.g., fistula, cavitary lesions, history of previous bleeding \\[≤60 days\\]).\n* Patients who have received other investigational therapies within 30 days before signing informed consent.\n* Other conditions deemed ineligible for the study by the investigator (e.g., Grade ≥3 adverse events in previous immunotherapy).","19 Years",{"count":347,"type":23},36,[301],"A Study of Metabolically Armed Tumor-Infiltrating Lymphocytes (Meta10-TIL) Therapy for Patients With Advanced Solid Tumors",[351],"Advanced Solid Tumors",[353,354,355,356,357],"Meta10-TIL","Advanced solid tumors","Liver cancer","Cervical cancer","IL-2","2025-09-09",{"date":360,"type":40},"2025-09-15",{"date":362,"type":40},"2025-08-29",{"date":364,"type":23},"2027-12-30",{"name":46,"class":47},{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":370,"acronym":4,"eligibilityCriteria":371,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":372,"targetDuration":57,"studyType":58,"phases":4,"briefSummary":374,"conditions":375,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":384},"100575838","china-liver-cancer-clinical-registry-cohort-database-heal-100575838","NCT06777485","China Liver Cancer Clinical Registry Cohort Database (HEAL)","Inclusion Criteria:\n\n* Age ≥ 18 years, no gender limit\n* Patients without surgery are initially diagnosed with hepatocellular carcinoma, intrahepatic cholangiocarcinoma, mixed hepatocellular carcinoma-cholangiocarcinoma, or metastatic hepatocellular carcinoma based on the results of imaging and laboratory tests, or patients with surgery are diagnosed with hepatocellular carcinoma, intrahepatic cholangiocarcinoma, mixed hepatocellular carcinoma-cholangiocarcinoma, or metastatic hepatocellular carcinoma based on the results of pathologic tests\n* Signed informed consent, good compliance, willingness to accept follow-up and provide blood and postoperative pathology residual samples\n\nExclusion Criteria:\n\n* Combination of severe central nervous system disease, respiratory disease, autoimmune disease, chronic renal insufficiency, long-term use of immunosuppressive drugs, combination of severe uncontrolled infections\n* Concurrent active cardiovascular disease, cerebrovascular accident within 6 months, myocardial infarction, unstable angina pectoris, or congestive heart failure of class II or greater according to the New York Heart Association criteria, severe arrhythmia requiring medication\n* Pregnant or breastfeeding women\n* Participation in other therapeutic clinical trials during the course of the patient's illness in which the treatment cannot be specified or information about the treatment cannot be collected",{"count":373,"type":23},10000,"This study was led by the Department of Hepatobiliary Surgery of the First Affiliated Hospital of the University of Science and Technology of China (USTC), in close cooperation with many participating units across the country, to establish a standardized clinical information database of hepatocellular carcinoma cohorts, which will provide a guarantee for conducting high-quality real-world clinical studies and clinical research.",[63],"2025-08-15",{"date":378,"type":40},"2025-08-20",{"date":380,"type":40},"2025-01-01",{"date":382,"type":23},"2035-01-01",{"name":46,"class":47},38,{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":107,"enrollmentInfo":391,"targetDuration":4,"studyType":24,"phases":393,"briefSummary":394,"conditions":395,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":404,"leadSponsor":406,"locationsCount":4},"100602802","phase-2-a-single-arm-multicenter-exploratory-clinical-study-of-transarterial-chemoembolization-tace-combined-with-iparomlimab-and-tuvonralimab-injection-and-bevacizumab-injection-for-the-treatment-of-unresectable-non-metastatic-hepatocellular-carcinoma-hcc-100602802","NCT07128251","A Single-Arm, Multicenter, Exploratory Clinical Study of Transarterial Chemoembolization (TACE) Combined With Iparomlimab and Tuvonralimab Injection and Bevacizumab Injection for the Treatment of Unresectable, Non-Metastatic Hepatocellular Carcinoma (HCC)","Inclusion Criteria:\n\n1. Voluntarily participate in the study and provide written informed consent.\n2. Age 18-75 years, inclusive (male or female).\n3. Histologically or cytologically confirmed HCC, or clinically diagnosed HCC according to the \\*Clinical Practice Guidelines for Primary Liver Cancer (2024 Edition)\\*.\n4. Barcelona Clinic Liver Cancer (BCLC) Stage A, B, or C, not amenable to curative treatment (e.g., surgical resection, liver transplantation, or ablation).\n5. At least one measurable lesion according to RECIST v1.1 criteria.\n6. Suitable candidate for Transarterial Chemoembolization (TACE) with no known allergy or contraindication to iodized oil or epirubicin.\n7. Child-Pugh Liver Function Class A.\n8. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.\n9. Life expectancy ≥ 3 months.\n10. Adequate organ and bone marrow function.\n11. If positive for Hepatitis B Virus (HBV) infection, HBV DNA must be \\\u003C 2000 IU\u002FmL (\\\u003C 10,000 copies\u002FmL if only copies\u002FmL units available at the site) and the subject must be willing to receive continuous antiviral therapy throughout the study period. Subjects positive for Hepatitis C Virus (HCV) RNA must receive antiviral therapy according to clinical guidelines.\n12. Subjects with esophageal\u002Fgastric varices must undergo evaluation and appropriate management prior to enrollment.\n13. Women of childbearing potential (WOCBP): Must have a negative serum human chorionic gonadotropin (hCG) test within 7 days prior to initiation of study treatment; must be non-lactating; must agree to use highly effective contraception methods from signing informed consent until 120 days after the last dose of study treatment. A woman is considered of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (hysterectomy, bilateral salpingectomy\u002Foophorectomy). Male subjects with female partners of childbearing potential: Must agree to use highly effective contraception methods from signing informed consent until 120 days after the last dose of study treatment; must agree to refrain from sperm donation. Male subjects with pregnant partners must use condoms; no additional contraception is required.\n\nExclusion Criteria:\n\n1. Known fibrolamellar HCC, sarcomatoid HCC, mixed hepatocellular cholangiocarcinoma, or cholangiocarcinoma; history of other active malignancies within 5 years or concurrently with HCC. Cured localized tumors (e.g., basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder carcinoma, carcinoma \\*in situ\\* of the prostate, cervix, or breast) are permitted.\n2. Presence of Vp3 or Vp4 portal vein tumor thrombosis (PVTT), any grade of hepatic vein or inferior vena cava invasion; any grade of bile duct invasion. \\*Note: Vp1 or Vp2 PVTT is permitted.\\*\n3. Presence of extrahepatic spread (EHS).\n4. Intrahepatic lesion(s) with maximum diameter ≥ 10 cm, \\> 10 intrahepatic lesions, or intrahepatic tumor burden ≥ 70% of liver volume, per RECIST v1.1.\n5. Prior systemic anti-cancer therapy for HCC, including molecular targeted agents, cytotoxic chemotherapy, immunotherapy (e.g., immune checkpoint inhibitors, immune checkpoint agonists, cellular therapies), or biologic therapy (e.g., cancer vaccines, cytokines, growth factors).\n6. Prior locoregional therapy for HCC, including therapeutic TACE, transarterial embolization (TAE), hepatic arterial infusion chemotherapy (HAIC), transarterial radioembolization (TARE).\n\n1\\) Prior curative surgery or ablation is permitted; one session of prophylactic TACE following curative resection is permitted.\n\n2\\) Prior percutaneous ethanol injection (PEI) or radiotherapy with curative intent is permitted.\n\n7\\. Prior or planned organ transplantation or allogeneic bone marrow transplantation.\n\n8\\. Current interstitial lung disease (ILD)\u002Fpneumonitis, history of ILD\u002Fpneumonitis requiring steroid treatment, or other pulmonary conditions that may interfere with the detection or management of immune-mediated pneumonitis (e.g., pulmonary fibrosis, organizing pneumonia \\[e.g., bronchiolitis obliterans\\], pneumoconiosis, drug-induced pneumonitis, idiopathic pneumonitis, or active pneumonia evidenced by screening chest computed tomography \\[CT\\] scan). Prior radiation pneumonitis within the radiation field is permitted. Active tuberculosis.\n\n9\\. Active autoimmune disease or history of autoimmune disease with potential for recurrence (e.g., autoimmune hepatitis, interstitial pneumonitis, uveitis, colitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; subjects with hypothyroidism stable on hormone replacement are eligible). Conditions not requiring systemic therapy (e.g., vitiligo, psoriasis, alopecia), controlled Type I diabetes on insulin, or childhood asthma in complete remission without adult intervention are permitted. Asthma requiring bronchodilator therapy is excluded.\n\n10\\. Clinically significant ascites requiring therapeutic paracentesis or drainage (Child-Pugh score \\>2 for ascites; asymptomatic ascites detected only radiographically is permitted); uncontrolled or moderate\u002Flarge pleural effusion or pericardial effusion.\n\n11\\. Uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg based on ≥2 measurements) despite antihypertensive therapy; history of hypertensive crisis or hypertensive encephalopathy.\n\n12\\. Clinically significant cardiac disease. 13. History of spontaneous rupture of hepatic tumor(s). 14. History of hepatic encephalopathy. 15. History or presence of central nervous system metastases. 16. Congenital or acquired immunodeficiency (e.g., HIV infection). 17. Thromboembolic event within 3 months prior to treatment (e.g., cerebrovascular accident \\[including transient ischemic attack, cerebral hemorrhage, cerebral infarction\\], deep vein thrombosis, pulmonary embolism).\n\n18\\. History of gastrointestinal (GI) bleeding within 6 months prior to treatment or high risk of GI bleeding (e.g., high-risk or severe esophageal\u002Fgastric varices, active GI ulceration, persistent fecal occult blood positivity). \\*Note: If fecal occult blood positive at baseline, repeat test; if persistently positive, esophagogastroduodenoscopy \\[EGD\\] required; exclusion if EGD shows varices\u002Flesions with bleeding risk.\\* 19. Abdominal fistula, GI perforation, intra-abdominal abscess, or bowel obstruction within 6 months prior to treatment.\n\n20\\. Major surgical procedure within 4 weeks prior to treatment or anticipated during study; unhealed wound, ulcer, or fracture within 4 weeks prior to treatment.\n\n21\\. Coagulopathy or bleeding diathesis (e.g., hemophilia); use of antiplatelet agents (e.g., aspirin \\>325 mg\u002Fday, dipyridamole, ticlopidine, clopidogrel, cilostazol) or anticoagulants (e.g., warfarin, low molecular weight heparin) within 10 days prior to treatment.\n\n22\\. Significant vascular disease within 6 months prior to treatment (e.g., aortic aneurysm requiring surgical repair, recent peripheral arterial thrombosis).\n\n23\\. Severe infection within 4 weeks prior to treatment (e.g., requiring hospitalization for infection, bacteremia, or severe pneumonia complications); therapeutic antibiotics administered orally or intravenously within 2 weeks prior to treatment (prophylactic antibiotics, e.g., for UTI or COPD prevention, are permitted).\n\n24\\. Known hypersensitivity to the active substances or excipients of \\*\\*Iparomlimab and Tuvonralimab Injection\\*\\*, \\*\\*Bevacizumab Injection\\*\\*, or epirubicin; history of severe hypersensitivity to any other monoclonal antibody or anti-angiogenic targeted therapy.\n\n25\\. Use of immunosuppressive agents or systemic corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) for immunosuppressive purposes within 2 weeks prior to treatment.\n\n26\\. Administration of live attenuated vaccines within 4 weeks prior to treatment or planned during Iparomlimab and Tuvonralimab Injection treatment or within 60 days after the last dose.\n\n27\\. Treatment with any investigational agent within 4 weeks or 5 half-lives (whichever is longer) prior to treatment initiation.Subjects with any other condition deemed by the investigator to potentially affect study results or lead to premature study termination (e.g., alcoholism, drug abuse, other severe medical\u002Fpsychiatric disorders requiring concomitant therapy, significant laboratory abnormalities, or familial\u002Fsocietal factors compromising subject safety).",{"count":392,"type":23},47,[323],"This is a single-arm, multicenter, exploratory clinical study designed to evaluate the efficacy and safety of TACE combined with Iparomlimab and Tuvonralimab Injection and Bevacizumab Injection in patients with unresectable, non-metastatic HCC. The primary endpoint is PFS as assessed by the investigator based on RECIST v1.1 criteria.",[90,396,397,398,399],"Immunotherapy","PD-1","CTLA-4","TACE","2025-08-13",{"date":402,"type":40},"2025-08-17",{"date":378,"type":23},{"date":405,"type":23},"2029-12-30",{"name":46,"class":47},{"id":408,"slug":409,"hasResults":12,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":4,"eligibilityCriteria":413,"healthyVolunteers":12,"sex":18,"minAge":414,"maxAge":4,"enrollmentInfo":415,"targetDuration":4,"studyType":24,"phases":417,"briefSummary":418,"conditions":419,"keywords":421,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":430,"locationsCount":4},"100602215","phase-1-allogeneic-cd7-car--t-cells-therapy-recurrentrefractory-leukemia-100602215","NCT07120607","Allogeneic CD7 CAR γδ T Cells Therapy Recurrent\u002FRefractory Leukemia","Clinical Study on the Safety and Efficacy of CD7 CAR-γδT Cell Injection for the Treatment of Relapsed\u002FRefractory Leukemia","Inclusion criteria:\n\n1. Age ≥ 14 years, no gender restrictions;\n2. Diagnosed with TALL\u002FLBL according to the NCCN Acute Lymphoblastic Leukemia Clinical Practice Guidelines (2023.V2); or diagnosed with AML according to the NCCN Acute Myeloid Leukemia Clinical Practice Guidelines (2023.V6);\n3. Meet the criteria for relapsed or refractory T-ALL\u002FLBL, including any of the following:\n\n   1. Relapsed: after achieving complete remission(CR), peripheral blood or bone marrow shows \\>5% blast cells or extramedullary lesions in any site;\n   2. Refractory: primary refractory cases that did not achieve CR after standard induction chemotherapy.\n\n   Or meets the criteria for relapsed or refractory AML, including any of the following:\n   1. Relapsed: leukemic cells reappear in peripheral blood or ≥5% of blast cells in bone marrow (excluding other causes such as bone marrow regeneration after consolidation chemotherapy) or extramedullary leukemic cell infiltration after achieving CR;\n   2. Refractory: primary cases that remain unresponsive after two cycles of standard treatment; Patients who relapse within 12 months after consolidation therapy following CR; patients who relapse after 12 months and are unresponsive to conventional chemotherapy; patients with two or more relapses; patients with persistent extramedullary leukemia;\n4. Cytological confirmation of tumor cell immunophenotyping as CD7-positive during screening;\n5. Expected survival time exceeding 3 months;\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;\n7. Organ function meets the following requirements:\n\n   * Liver function: ALT ≤ 3 × ULN; AST ≤ 3 × ULN; Total bilirubin ≤ 3.0 × ULN.\n   * Renal function must meet the following criteria: serum creatinine ≤ 1.5 × upper limit of normal (ULN);\n   * Cardiac function: echocardiogram showing left ventricular ejection fraction ≥ 50%;\n   * Pulmonary function: normal oxygen saturation without oxygen supplementation.\n8. Female participants of childbearing potential and male participants whose partners are of childbearing potential must use medically approved contraceptive measures or abstain from sexual intercourse during the study treatment period and for at least 6 months after the study treatment period. Female participants of childbearing potential must have a negative serum HCG test within 7 days prior to study enrollment and must not be breastfeeding.\n9. No significant genetic disorders;\n10. The subject or their legal guardian voluntarily participates in this study, understands the trial information, objectives, and risks described in the informed consent form, and can provide a signed and dated informed consent form;\n11. The subject or their legal guardian is willing and able to comply with all trial requirements.\n\nExclusion criteria:\n\n1. Patients with a history of severe central nervous system disorders, such as uncontrolled epileptic seizures, stroke, severe brain injury with aphasia, paralysis, dementia, Parkinson's disease, or mental disorders;\n2. Heart failure classified as NYHA functional class III or IV;\n3. Any of the following unstable cardiovascular conditions occurring within the past 6 months prior to screening (including but not limited to): unstable angina, cerebral ischemia or cerebrovascular accident, myocardial infarction, severe arrhythmias requiring medication (such as rapid atrial fibrillation, high-degree atrioventricular block, ventricular tachycardia, ventricular fibrillation, or torsades de pointes); Undergone coronary angioplasty, coronary artery stent implantation, or coronary artery bypass surgery; experienced thrombosis or embolism events (e.g., cerebrovascular events \\[including transient ischemic attacks, but excluding lacunar cerebral infarction\\], deep vein thrombosis \\[excluding deep vein thrombosis caused by PICC catheter placement\\], pulmonary embolism, etc.);\n4. Presence of disseminated intravascular coagulation;\n5. Presence of severe autoimmune diseases or immunodeficiency disorders;\n6. Presence of active graft-versus-host disease requiring ongoing systemic treatment;\n7. Subjects currently receiving systemic steroid or other immunosuppressive therapy prior to screening, and who, as determined by the investigator, will require long-term use of such therapy after enrollment (excluding inhaled or topical use);\n8. Other severe medical conditions deemed inappropriate for enrollment by the investigator (e.g., uncontrolled hypertension or diabetes, severe renal insufficiency, severe pulmonary dysfunction, etc.);\n9. Active HBV or HCV infection (HBV-DNA positive or HCV-RNA positive), HIV-positive status, or positive syphilis test results;\n10. Other severe or persistent active infections;\n11. Adverse events related to systemic immunotherapy (including other investigational drugs or medical device interventions) prior to screening have not yet decreased to Grade 1 severity or returned to baseline status;\n12. Immunosuppressive agents have been discontinued for less than 2 weeks;\n13. Those who have received CAR-T cell therapy in the past;\n14. History of allergy to any component of the cell product;\n15. Vaccination or any surgical procedure within 4 weeks prior to screening;\n16. Other conditions deemed by the investigator to potentially increase the risk to the subject or interfere with trial results.","14 Years",{"count":416,"type":23},9,[111],"CD7 is highly expressed in T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoma. Approximately 10-30% of cute myeloid leukemia(AML) patients exhibit CD7 expression, particularly in early myeloid progenitor cell-derived AML (e.g., M0\u002FM1 subtypes), mixed-phenotype acute leukemia (MPAL), and AML with high-risk genetic abnormalities (such as TP53 mutations or complex karyotypes). CD7-positive AML patients typically have poor prognosis, poor response to standard chemotherapy, and shorter overall survival (OS). Targeted CD7 cell therapies may represent a promising direction for the treatment of these diseases.",[420],"Leukemia",[422,423,424],"CAR γδ T cells","CD7 positive","Recurrent refractory","2025-08-12",{"date":400,"type":40},{"date":428,"type":23},"2025-08-18",{"date":246,"type":23},{"name":46,"class":47},{"id":432,"slug":433,"hasResults":12,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":12,"sex":18,"minAge":414,"maxAge":4,"enrollmentInfo":438,"targetDuration":4,"studyType":24,"phases":439,"briefSummary":440,"conditions":441,"keywords":444,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":450,"startDateStruct":451,"completionDateStruct":452,"leadSponsor":453,"locationsCount":4},"100603020","phase-1-qh101-cell-therapy-relapsedrefractoryrr-acute-myeloid-leukemiaaml-and-myelodysplastic-syndromesmds-100603020","NCT07131085","QH101 Cell Therapy Relapsed\u002FRefractory(R\u002FR) Acute Myeloid Leukemia(AML) and Myelodysplastic Syndromes(MDS)","Clinical Study on the Safety and Efficacy of QH101 in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia(R\u002FR AML) and Relapsed\u002FRefractory Myelodysplastic Syndromes(R\u002FR MDS)","Selection criteria:\n\n1. Age ≥ 14 years, no gender restrictions;\n2. Diagnosed with AML according to the standards of the NCCN (2024 V2), ELN (2023), and the Chinese \"Guidelines for the Diagnosis and Treatment of AML (2024 Edition)\"; or diagnosed with MDS according to the standards of the NCCN (2024 V2), ELN (2023), and the Chinese \"Expert Consensus on the Diagnosis and Treatment of MDS (2024 Edition)\"; （1） Meets the criteria for R\u002FR AML, including any of the following:\n\n   1. Relapsed: Leukemic cells reappear in the peripheral blood after complete remission, or Leukemic blasts≥5% in the bone marrow (excluding other causes such as bone marrow regeneration after consolidation chemotherapy), or leukemic cell infiltration in extramedullary sites;\n   2. Refractory: Primary cases that fail to respond to two cycles of standard treatment, or cases that relapse within 12 months after consolidation intensive therapy following complete remission (CR), or cases that relapse after 12 months and fail to respond to conventional chemotherapy, or cases with two or more relapses, or cases with persistent extramedullary leukemia; （2）Meets the criteria for R\u002FR MDS, including any of the following conditions:\n\n   \u003C!-- -->\n\n   1. Relapsed: Patients who have achieved hematologic improvement or CR but subsequently experience hematologic decline (e.g., hemoglobin \\\u003C10 g\u002FdL, platelets \\\u003C50×10⁹\u002FL, neutrophils \\\u003C1.0×10⁹\u002FL), or an increase in the proportion of blast cells in the bone marrow (≥5%), or the emergence of new cytogenetic abnormalities or molecular progression (e.g., increased TP53 mutation burden);\n   2. Refractory: No hematologic or bone marrow improvement after ≥4-6 cycles of hypomethylating agent (HMA) therapy (e.g., azacitidine or decitabine), or low-risk MDS resistant to erythropoietin or immunomodulatory agents (e.g., lenalidomide).\n3. Expected survival time exceeds 3 months;\n4. Eastern Cooperative Oncology Group (ECOG) performance status is 0-2;\n5. Organ function meets the following requirements: 1)Liver function must meet: ALT ≤ 3 × ULN; AST ≤ 3 × ULN; Total bilirubin ≤ 3.0 × ULN. 2)Renal function must meet the following criteria: Serum creatinine ≤ 1.5 × upper limit of normal (ULN); 3)Cardiac function: Echocardiogram showing left ventricular ejection fraction ≥ 50%; 4)Pulmonary function: Normal oxygen saturation without oxygen supplementation.\n6. Female participants of childbearing potential and male participants whose partners are of childbearing potential must use medically approved contraceptive measures or abstain from sexual intercourse during the study treatment period and for at least 6 months after the study treatment period. Female participants of childbearing potential must have a negative serum HCG test within 7 days prior to study enrollment and must not be breastfeeding.\n7. No significant genetic disorders;\n8. The subject or their legal guardian voluntarily participates in this study, understands the trial information, objectives, and risks described in the informed consent form, and can provide a signed and dated informed consent form;\n9. The subject or their legal guardian is willing and able to comply with all trial requirements.\n\nExclusion criteria:\n\n1. Patients with a history of severe central nervous system disorders, such as uncontrolled epileptic seizures, stroke, severe brain injury with aphasia, paralysis, dementia, Parkinson's disease, or mental disorders;\n2. New York Heart Association (NYHA) Class III or IV heart failure;\n3. Undergone coronary angioplasty, coronary stent implantation, or coronary artery bypass surgery; or experienced thrombotic or embolic events (e.g., cerebrovascular events \\[including transient ischemic attacks, but excluding lacunar cerebral infarction\\], deep vein thrombosis \\[excluding deep vein thrombosis caused by PICC catheter placement\\], pulmonary embolism, etc.);\n4. Presence of disseminated intravascular coagulation;\n5. Presence of severe autoimmune diseases or immunodeficiency disorders;\n6. Presence of active graft-versus-host disease requiring ongoing systemic treatment;\n7. Subjects currently receiving systemic steroid or other immunosuppressive therapy prior to screening, and who are determined by the investigator to require long-term use of such therapy after enrollment (excluding inhaled or topical use);\n8. Other severe medical conditions deemed inappropriate for enrollment by the investigator (e.g., uncontrolled hypertension or diabetes, severe renal insufficiency, severe pulmonary dysfunction, etc.);\n9. Active HBV or HCV infection (HBV-DNA positive or HCV-RNA positive), HIV-positive, or positive syphilis test results;\n10. Other severe or persistent active infections;\n11. Adverse events related to systemic immunotherapy (including other investigational drugs or medical device interventions) prior to screening have not yet decreased to Grade 1 severity or returned to baseline status;\n12. Discontinuation of immunosuppressive agents for less than 2 weeks;\n13. History of allergy to any component of the cellular product;\n14. Vaccination or any surgical procedure within 4 weeks prior to screening;\n15. Other conditions deemed by the investigator to potentially increase the risk to the subject or interfere with trial results.",{"count":416,"type":23},[111],"QH101 is an allogeneic TCR-enhanced Vδ2 T cell therapy product engineered to express BTN protein-specific binding elements on the cell surface. This innovative approach harnesses the natural cytotoxic capabilities of Vδ2 T cells while augmenting their ability to recognize BTN proteins, thereby significantly improving tumor cell elimination efficiency. Notably, QH101 is designed without co-stimulatory signal domains or the CD3ζ domain, which prevents T cell exhaustion from overactivation and effectively enhances in vivo persistence.\n\nPatients with R\u002FR AML face particularly poor prognoses, with conventional chemotherapy and targeted therapies achieving suboptimal complete remission rates and long-term survival below 10%. Similarly, R\u002FR MDS patients typically demonstrate median overall survival of less than one year (with TP53-mutated cases showing even poorer outcomes of 3-6 months), making clinical trial participation the most viable therapeutic option.\n\nThe development of effective treatments for R\u002FR AML\u002FMDS presents significant challenges due to:1)The paucity of disease-specific molecular targets;2)The slow progress in drug development. Allogeneic γδ T-cell therapy featuring enhanced TCR functionality and multi-mechanism tumoricidal activity represents a promising investigational approach for addressing R\u002FR AMLMDS. This innovative strategy combines the advantages of: 1)Improved target recognition through TCR enhancement; 2)Multi-faceted tumor-killing mechanisms; 3)Potential for better safety and persistence profiles.",[442,443],"MDS","AML",[445,446,447,448,449],"TCR","BTN","γδT","allogeneic","cell therapy",{"date":378,"type":40},{"date":376,"type":23},{"date":246,"type":23},{"name":46,"class":47},{"id":455,"slug":456,"hasResults":12,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":460,"eligibilityCriteria":461,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":462,"targetDuration":4,"studyType":24,"phases":463,"briefSummary":464,"conditions":465,"keywords":467,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":473,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":99},"100602305","anti-cd19bcma-car-gene-therapy-for-autoimmune-diseases-100602305","NCT07121777","Anti CD19\u002FBCMA CAR Gene Therapy for Autoimmune Diseases","An Exploratory Clinical Study of Anti-CD19\u002FBCMA CAR Gene Vector Injection (LCAR1901) for the Treatment of Refractory Autoimmune Diseases","LCAR1901","Inclusion Criteria:\n\n* ( 1) At the time of signing the informed consent form, be at least 18 years of age, both male and female.\n\n  (2) Bone marrow hematopoietic function satisfies: white blood cell count≥3×10\\^9\u002FL; Centrocyte count ≥1×10\\^9\u002FL (no colony-stimulating factor received within 2 weeks prior to screening); Hemoglobin ≥ 60g\u002FL.\n\n  (3)ALT≤3×ULN; AST≤3×ULN； TBIL≤3×ULN。 (4) Renal function satisfaction: creatinine clearance CrCl≥30mL\u002Fmin. (5) INR≤1.5×ULN , PT≤1.5×ULN. (6)RA:Documented diagnosis of RA which fulfills the 2010 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) Classification Criteria ; 3 months after use of 1 or more csDMARDs and 1 or more bDMARDs prior to screening: 1) DAS28-ESR\\>3.2 or CDAI\\>10; or 2) the dose of the hormone (prednisone or equivalent) cannot be reduced to less than 7.5 mg\u002Fday; or 3) the number of swollen and\u002For tender joints ≥3; Treatment with stable 1 or more cs DMARD(s) and\u002For bDMARDs prior to enrollment as follows: methotrexate for at least 12 weeks and at a dose of 7.5-25mg\u002Fweek for at least 4 weeks; Stable use of hydroxychloroquine dose ≤ 400 mg\u002Fday for at least 4 weeks; Stable oral sulfasalazine for at least 4 weeks 1\\~3 g\u002Fd; Stable oral leflunomide 10-20 mg\u002Fday for at least 4 weeks.\n\n  (7)systemic lupus erythematosus : Diagnosis of systemic lupus erythematosus according to the SLE classification criteria of the 2019 EULAR\u002FACR; History of systemic lupus erythematosus for at least 6 months prior to screening and active disease for 2 months after use of standard treatment regimens prior to screening; BILAG-2004 assesses the presence of at least 1 Grade A or 2 Grade B organ scores; Positive antinuclear antibody, or positive anti-ds-DNA antibody, or positive anti-Sm antibody; SLEDAI-2000 score ≥8 during the screening period.\n\n  (8)Sjögren's syndrome : Diagnosis of Sjögren's syndrome according to the 2002 International Classification of Primary Sjögren's Syndrome or the 2016 ACR\u002FEULAR classification criteria; Diagnosed with pSS-TP and platelet count \\\u003C 30×10\\^9\u002FL; Sjögren's syndrome Disease Activity Index (ESSDAI) score ≥5 during the screening period; Sjögren's syndrome for at least 6 months prior to screening and active disease 2 months after use of conventional treatment regimens prior to screening. Use of immunomodulatory drugs for more than 6 months.\n\n  (9)systemic sclerosis : Diagnosis of systemic sclerosis according to the 2013 ACR classification criteria for systemic sclerosis. Positive antinuclear antibody at screening. Presence of clear evidence of HRCT progression. History of systemic sclerosis prior to screening for at least 6 months and active disease for 2 months after use of conventional treatment regimens prior to screening.\n\nExclusion Criteria:\n\n* (1) Clinically significant central nervous system diseases or pathological changes not caused by the disease itself before screening, including but not limited to: stroke, stroke, aneurysm, epilepsy, convulsions, aphasia, severe head injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome or mental disorder.\n\n  (2) Those with relatively serious heart disease, such as angina, myocardial infarction, heart failure and arrhythmia.\n\n  (3) History of major organ transplantation or hematopoietic stem cell\u002Fbone marrow transplantation.\n\n  (4) Vaccination, B-cell targeted therapy within 4 weeks prior to screening. (5) History of any malignant neoplastic disease. (6) Patients with end-stage renal failure. (7) The presence or suspicion of uncontrollable fungal, bacterial, viral, or other infections.\n\n  (8) History of severe allergy to drugs used in clinical studies or raw and excipient materials of experimental drugs, such as cyclophosphamide, fludarabine, DMSO, etc.\n\n  (9) Patient has active HBV infection or HCV antibody positivity or HIV antibody positivity or syphilis positivity or CMV DNA positivity or EBV DNA positivity.\n\n  (10) Pregnant or lactating females, or planning to become pregnant within 2 years after reinfusion of the trial drug; The partner of the male patient plans to become pregnant within 2 years of receiving the trial drug.\n\n  (11) Evidence of active tuberculosis infection. (12) Other conditions assessed by the investigator as unsuitable for enrollment.",{"count":209,"type":23},[134],"This is an open label, single-site, dose-escalation study in up to 18 participants with treatment of Refractory Autoimmune Diseases. This study aims to evaluate the safety and efficacy of the treatment with an Anti- CD19\u002FBCMA CAR gene vector injection",[466],"Autoimmune Diseases",[468,469,470,471],"systemic sclerosis","dry syndrome","rheumatoid arthritis","systemic lupus erythematosus","2025-08-07",{"date":400,"type":40},{"date":475,"type":23},"2025-08-25",{"date":477,"type":23},"2029-08-31",{"name":46,"class":47},{"id":480,"slug":481,"hasResults":12,"nctId":482,"briefTitle":483,"officialTitle":484,"acronym":460,"eligibilityCriteria":485,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":486,"targetDuration":4,"studyType":24,"phases":487,"briefSummary":488,"conditions":489,"keywords":491,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":99},"100590894","anti-cd19bcma-car-gene-therapy-for-relapsedrefractory-immune-thrombocytopenia-100590894","NCT06973356","Anti CD19\u002FBCMA CAR Gene Therapy for Relapsed\u002FRefractory Immune Thrombocytopenia","An Exploratory Clinical Study of Anti-CD19\u002FBCMA CAR Gene Vector Injection (LCAR1901) for the Treatment of Relapsed and Refractory Immune Thrombocytopenia","Inclusion Criteria:\n\n* 1\\. Age≥ 18 years old, regardless of gender. 2. Clinical diagnosis of primary immune thrombocytopenia for at least 6 months, platelet count \\\u003C 30×10\\^9\u002FL within 48 hours before participating in the study.\n\n  3\\. Positive anti-platelet glycoprotein autoantibodies (such as GPIIb\u002FIIIa). 4. Prior second-line ITP therapy (first-line treatment includes: corticosteroids or immunoglobulins; Second-line therapies include thrombopoietin receptor agonists (eg, eltrombopag, romiplostim) and\u002For rituximab, but are ineffective (platelet count \\\u003C 30×10\\^9\u002FL after treatment, or platelet count does not increase twice as much as baseline, or there is bleeding), or relapse after effective treatment (platelet count falls below 30×109\u002FL after effective treatment, or falls below baseline, or bleeding symptoms) or is difficult to maintain after discontinuation of TPO agonists.\n\n  5\\. Bone marrow examination shows megakaryocytosis or normal. 6. Basic normal functions of important organs:Echocardiography shows an ejection fraction of ≥50% and no significant abnormalities on ECG.Creatinine clearance (CrCl) (Cockcroft-Gault formula) ≥ 30 mL\u002Fmin.Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × upper limit of normal (ULN).Total bilirubin (TBIL) and alkaline phosphatase (AKP or ALP) ≤ 2.0× ULN (Gilbert's syndrome ≤3.0×ULN).Absolute lymphocyte count (ALC) ≥ 0.5×10\\^9\u002FL; Absolute neutrophil count (ANC) ≥1×10\\^9\u002FL; Hemoglobin (Hb) ≥ 60 g\u002FL; Platelet count ≥ 10×10\\^9\u002FL.Oxygen saturation \\> 92%.ECOG performance status ≤2 7. Males and women of childbearing potential must agree to use effective contraception from the time of signing the informed consent form until 1 year after the use of the study drug. Women of childbearing potential must have a negative blood pregnancy test at screening and prior to drug infusion and must not be breastfeeding.\n\nExclusion Criteria:\n\n* 1\\. Thrombocytopenia caused by myelodysplastic syndrome, early aplastic anemia, atypical aplastic anemia, thrombotic thrombocytopenic purpura, etc.\n\n  2\\. During the screening period, bone marrow examination showed myelofibrosis MF≥2 (European consensus scoring standard Thieleja 2005) or bone marrow examination showed the presence of a primary disease other than ITP that can lead to thrombocytopenia.\n\n  3\\. History of hypersensitivity to any component of the therapeutic medication. 4. Major organs: NYHA class III to IV congestive heart failure. Myocardial infarction or coronary artery bypass grafting (CABG) or coronary artery stent implantation within 6 months. Ventricular arrhythmias, or history of unexplained syncope (excluding vasovagal syncope or dehydration). History of severe non-ischemic cardiomyopathy.\n\n  5\\. Malignant disease within 3 years prior to screening, except for the following: malignant disease that has been curatively treated before enrollment and has no known active disease for 3 years ≥; or well-treated non-melanoma skin cancer with no evidence of disease.\n\n  6\\. Symptomatic deep vein thrombosis or pulmonary embolism within the past 6 months or currently requiring anticoagulation.\n\n  7\\. Participated in other interventional clinical studies within 1 month prior to screening.\n\n  8\\. Vaccination of live attenuated vaccine within 4 weeks prior to screening. 9. Stroke or seizure within 6 months prior to signing the ICF (excluding old lacunar cerebral infarction).\n\n  10\\. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood hepatitis B virus (HBV) DNA titer test exceeds the normal range; Hepatitis C virus (HCV) antibody is positive and the hepatitis C virus (HCV) RNA titer in peripheral blood exceeds the normal range; positive for human immunodeficiency virus (HIV) antibodies; Positive syphilis test.\n\n  11\\. Known history of bone marrow stem cell disease 12. Other conditions that the investigators consider unsuitable to participate in the study.",{"count":209,"type":23},[134],"This is an open label, single-site, dose-escalation study in up to 18 participants with treatment of relapsed and refractory immune thrombocytopenia. This study aims to evaluate the safety and efficacy of the treatment with an Anti- CD19\u002FBCMA CAR gene vector injection",[490],"Immune Thrombocytopenia (ITP)",[492,493],"immune thrombocytopenia","Autoimmune diseases","2025-08-06",{"date":496,"type":40},"2025-08-08",{"date":498,"type":23},"2025-08-16",{"date":500,"type":23},"2029-06-30",{"name":46,"class":47},{"id":503,"slug":504,"hasResults":12,"nctId":505,"briefTitle":506,"officialTitle":506,"acronym":4,"eligibilityCriteria":507,"healthyVolunteers":12,"sex":18,"minAge":508,"maxAge":107,"enrollmentInfo":509,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":511,"conditions":512,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":77},"100600545","artificial-intelligence-for-pathology-diagnosis-and-prognosis-prediction-of-lung-nodule-using-smartphone-photos-100600545","NCT07098884","Artificial Intelligence for Pathology Diagnosis and Prognosis Prediction of Lung Nodule Using Smartphone Photos","Inclusion Criteria: (1) Participants scheduled for surgery for radiological finding of pulmonary lesions from the preoperative thin-section CT scans; (2) Age ranging from 20-75 years.\n\nExclusion Criteria: (1) Participants with incomplete clinical information; (2) Participants who have received anti-tumor therapy.","20 Years",{"count":510,"type":23},600,"The current study aims to develop and validate a deep learning signature for diagnosing pathology and predicting prognosis of lung nodule using smartphone photos of resected tumor specimens.",[513,514],"Artificial Intelligence","Lung Nodule","2025-07-30",{"date":517,"type":40},"2025-08-01",{"date":519,"type":40},"2025-06-01",{"date":521,"type":23},"2025-10-30",{"name":46,"class":47},{"id":524,"slug":525,"hasResults":12,"nctId":526,"briefTitle":527,"officialTitle":528,"acronym":4,"eligibilityCriteria":529,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":530,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":532,"conditions":533,"keywords":535,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":538,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":542,"locationsCount":543},"100600360","telpegfilgrastim-injection-to-reduce-the-risk-of-neutropenia-in-patients-with-solid-tumor-100600360","NCT07096479","Telpegfilgrastim Injection to Reduce the Risk of Neutropenia in Patients With Solid Tumor","A Real World Study on the Efficacy and Safety of Telpegfilgrastim Injection for Prophylaxis of Chemotherapy-Induced Neutropenia in Patients With Solid Tumor","Inclusion Criteria:\n\n1. Male or female, age ranging from 18 to 70 years old (excluding 70 years old);\n2. body weight ≥45 kg;\n3. Histologically or cytologically confirmed diagnosis of malignant solid tumor;\n4. Solid tumor patients who receive a 3-week chemotherapy regimen have been evaluated as high-risk for FN or evaluated as having moderate risk for FN, but with an increased risk factor for neutropenia associated with the chemotherapy regimen;(The risk assessment of FN in tumor chemotherapy is based on \" Chinese Society of Clinical Oncology (CSCO) guidelines for standardized management of tumor chemoradiotherapy related neutropenia(2021 edition)\" and \" Consensus on clinical diagnosis, treatment, and prevention of chemotherapy-induced neutropenia in China(2023 edition)\";\n5. Karnofsky Performance Scale(KPS) score≥70;\n6. The total number of white blood cells and absolute value of neutrophils before chemotherapy should not be lower than normal values: WBC ≥ 3.5 × 109\u002FL, ANC ≥ 1.5 × 109\u002FL;\n7. Subject has a life Expectation of at least 6 month；\n8. Subjects voluntarily and strictly comply with the research protocol requirements and sign a written informed consent for.\n\nExclusion Criteria:\n\n1. Received any other PEG-rhG-CSF within 4 weeks prior to participating in this study;\n2. Patients receiving intermittent or continuous chemotherapy regimens such as albumin paclitaxel and capecitabine;\n3. Previously or expected to receive extensive radiation therapy (\\>25% of total bone marrow);\n4. Individuals with significant functional impairments in important organs such as the heart, lungs, liver, and kidneys:\n\n   Liver function indicators (ALT, TBil)\\>2.5 ULN; Tumor patients with liver metastasis have liver function indicators (ALT,TBil)\\>5ULN; Hepatitis B virus infection, hepatitis C virus infection, or cirrhosis; Renal function Cr\\>1.5ULN;\n5. Pregnant or breastfeeding woman ;\n6. hypersensitive to rhG-CSF or other biological agents;\n7. Investigators judged other situations that may affect the progress and results of clinical research.",{"count":531,"type":23},318,"The objective of this real world study is to confirm the efficacy and saftey of Telpegfilgrastim injection for the prevention of chemotherapy-induced Neutropenia in Patients With Malignant solid tumor.",[534],"Chemotherapy-induced Neutropenia",[536],"Drug Therapy","2025-07-24",{"date":309,"type":40},{"date":540,"type":40},"2024-08-15",{"date":376,"type":23},{"name":46,"class":47},2,{"id":545,"slug":546,"hasResults":12,"nctId":547,"briefTitle":548,"officialTitle":548,"acronym":4,"eligibilityCriteria":549,"healthyVolunteers":12,"sex":18,"minAge":345,"maxAge":107,"enrollmentInfo":550,"targetDuration":4,"studyType":24,"phases":551,"briefSummary":552,"conditions":553,"keywords":557,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":561,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":567,"locationsCount":99},"100599520","early-phase-1-safety-and-efficacy-of-metabolically-armed-bcma-car-t-cells-meta10-bcma-in-the-treatment-of-rr-plasma-cell-neoplasms-clinical-research-100599520","NCT07085559","Safety and Efficacy of Metabolically Armed BCMA CAR-T Cells (Meta10-BCMA) in the Treatment of r\u002Fr Plasma Cell Neoplasms Clinical Research","Inclusion Criteria:\n\n* Age 19 to 75 years old, male or female. The subject or his\u002Fher guardian voluntarily signed the informed consent;\n* Subjects with relapsed or refractory Plasma Cell Neoplasms（including Multiple Myeloma, Plasma Cell Leukemia, AL Amyloidosis）according to IMWG criteria and have had at least 3 prior lines of therapy (including chemotherapy based on proteasome inhibitors and immunomodulatory agents). Disease progression must be documented during or within 12 months following the most recent anti-myeloma treatment (for subject whose last-line treatment was CAR-T, disease progression was not limited to occurring within 12 months after treatment).\n* Evidence of cell membrane BCMA expression, as determined by a validated immunohistochemistry (IHC) or flow cytometry of tumor tissue.\n* The subjects were unable to receive autologous hematopoietic stem cell transplantation treatment, or relapsed after autologous hematopoietic stem cell transplantation, and the researchers determined that treatment was needed.\n* ECOG performance score 0-2 (except for subjects with central nervous system invasion, which needs to be confirmed by the investigator).\n* Estimated life expectancy≥12 weeks.\n* Subjects should have adequate organ function:\n\n  1. Complete blood count (CBC) test \\[the following criteria should be met within 24 hours prior to apheresis, and supportive treatment such as transfusion, platelet transfusion, cell growth factor (except recombinant erythropoietin) should be avoided within 7 days prior to detection\\]: Absolute neutrophil count (ANC) ≥1×10\\^9 \u002FL; hemoglobin ≥70 g\u002FL.; platelets ≥50×10\\^9 \u002FL; absolute lymphocyte count (ALC) ≥0.3×10\\^9 \u002FL;\n  2. Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×upper limit of normal (ULN); total serum bilirubin ≤ 1.5×ULN.\n  3. Kidney function: Serum creatinine ≤2.5×upper limit of normal (ULN), or； Creatinine clearance rate (CrCl) calculated according to Cockcroft-Gault formula ≥ 60 ml\u002Fmin.\n  4. Electrolytes: Serum potassium ≥ 3.0 mmol\u002FL; Serum calcium ≥ 2.0 mmol\u002FL; Serum magnesium ≥ 0.5 mmol\u002FL.\n  5. Coagulation function: Fibrinogen ≥ 1.0 g\u002FL; activated partial thromboplastin time (APTT) ≤ ULN+10s, prothrombin time (PT) ≤ ULN+3s.\n  6. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%.\n* The subjects must be willing to provide valid initial diagnostic evidence and undergo bone marrow examinations before and after treatment.\n* Women of childbearing age and all male patients must consent to use a effective contraception for at least 12 months after Meta10-BCMA infusion and until two consecutive PCR tests show no more CAR T cells in vivo；\n* The subjects should have measurable disease based on at least one of the following parameters:\n\n  1. The proportion of primitive naive or monoclonal plasma cells ≥ 5% by bone marrow cytology, bone marrow biopsy histology or flow cytometry;\n  2. Serum monoclonal protein (M-protein) level: M protein ≥10 g\u002FL for IgG type, M protein ≥5g\u002FL for IgA, IgD, IgM, and IgE type;\n  3. Urine M protein level ≥200 mg\u002F24 hours;\n  4. Light chain multiple myeloma without measurable lesions in serum or urine: the affected serum free light chain ≥100 mg\u002FL with abnormal serum κ\u002Fλ free light chain ratio;\n  5. There are measurable extramedullary plasmacytoma lesions.\n\nExclusion Criteria:\n\n* Treatment with the following therapies within the specified period:\n\n  1. Any hematopoietic stem cell transplant(HSCT) within 2 months prior to the start of infusion of Meta10-BCMA, or any immunosuppressive therapy due to graft-versus-host disease after HSCT within the screening period;\n  2. Any major surgery within 4 weeks prior to screening;\n  3. Any radiotherapy 2 weeks prior to screening;\n  4. Any intrathecal treatment within 1 week prior to the start of infusion of Meta10-BCMA;\n  5. Any live vaccination within 4 weeks prior to the start of infusion of Meta10-BCMA and\u002For plan to receive live vaccines after participation in the trial;\n  6. Any clinical trial therapy within 4 weeks prior to the start of infusion of Meta10-BCMA, or ongoing participation in other clinical trials.\n* Following disease or surgical history:\n\n  1. ≥ grade 2 arrhythmia according to NCI CTCAE 5.0 grade or QTc\\> 450 ms (male), QTc\\> 470ms (female) (QTc is calculated using Fridericia correction formula QTc = QT \u002F RR0.33) subjects with a history of Torsades de pointes ventricular tachycardia or congenital prolonged QT syndrome;\n  2. Subjects with any of the following diseases within 12 months before the screening: including but not limited to unstable angina pectoris, myocardial infarction, congestive heart failure and severe arrhythmia, coronary artery bypass grafting or peripheral artery bypass grafting surgery, cerebrovascular events (including transient ischemic attacks), etc.;\n  3. Uncontrollable and active infections during the screening period regarded by the investigators;\n  4. Subjects infected with human immunodeficiency virus (HIV);\n  5. Subjects with active hepatitis B (defined as hepatitis B surface antigen positive or hepatitis B core antibody positive, concomitant hepatitis B virus DNA level \\> 100 IU\u002Fml);\n  6. The hepatitis C virus (HCV) antibody is positive, and the peripheral blood HCV RNA is positive;\n  7. Subjects with severe electrolyte disturbance regarded by the investigators;\n  8. Subjects with a clear gastrointestinal bleeding tendency, including the following: active local ulcer lesions, and fecal occult blood (≥ ++); subjects with a history of melena and hematemesis within two months prior to screening; Subjects who may have a major gastrointestinal bleeding history;\n  9. Subjects with a history of solid organ transplantation;\n  10. Subjects with other acute, severe, or chronic medical or psychological conditions regarded by investigators as not suitable for enrollment;\n  11. Pregnant or lactating women.\n* Prohibited treatment and\u002For medication:\n\n  1. Ongoing therapy with other anti-tumor drugs, including traditional Chinese medicine;\n  2. On-going therapy with drugs that extend the QT interval (including Class Ia and III antiarrhythmic drugs);\n  3. Subjects who need to receive oxygen daily;\n  4. Long-term use of corticosteroids (except for local inhalation).\n* Others:\n\n  1. Subject with a history of psychotropic substance abuse who are unable to quit or have mental disorders;\n  2. Subjects with concomitant diseases or comorbidities that could seriously endanger the safety of the patient or affect the completion of the trial as judged by the investigators;\n  3. There are not enough unmobilized mononuclear cells available for collection for CAR-T cell production.",{"count":347,"type":23},[301],"A Study of Metabolically Armed BCMA CAR-T Cells Therapy for Patients With Relapsed and\u002For Refractory Plasma Cell Neoplasms.",[554,555,556],"Multiple Myeloma (MM)","Plasma Cell Leukemia (PCL)","AL Amyloidosis (AL)",[558,559,560],"Meta10-BCMA","CAR-T Cells Therapy","r\u002Fr plasma cell neoplasms",{"date":562,"type":40},"2025-07-25",{"date":564,"type":40},"2025-06-23",{"date":566,"type":23},"2027-10-15",{"name":46,"class":47},{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":572,"acronym":4,"eligibilityCriteria":573,"healthyVolunteers":12,"sex":574,"minAge":19,"maxAge":575,"enrollmentInfo":576,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":578,"conditions":579,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":581,"lastUpdatePostDateStruct":582,"startDateStruct":584,"completionDateStruct":586,"leadSponsor":588,"locationsCount":99},"100598937","discovery-of-hpv-t-cell-epitopes-and-development-of-multi-epitope-vaccines-100598937","NCT07077980","Discovery of HPV T Cell Epitopes and Development of Multi-epitope Vaccines","Inclusion Criteria:\n\n1. Females aged between 18 and 65 who can receive standard treatment, including those who only undergo surgery or those who receive radiotherapy and chemotherapy after surgery.\n2. Cervical carcinoma caused by HPV16 or HPV18 infection.\n3. The pathological stage is from IB1 to IV, and informed consent is obtained.\n4. If the tumor tissue of patients with stage IB1 is not obvious, samples can be taken or not taken without affecting subsequent pathological examinations.\n\nExclusion Criteria:\n\n1. Patients with other malignancies\n2. Patients with any uncontrolled systemic disease, including active infection, uncontrolled hypertension, diabetes mellitus, unstable angina and congestive heart failure, myocardial infarction (1 year) before starting treatment, severe arrhythmia requiring medical treatment, coagulation abnormalities, liver or kidney or metabolic disease.","FEMALE","65 Years",{"count":577,"type":23},50,"Based on the trend that the incidence and mortality of cervical carcinoma among female cancers worldwide are increasing year by year, the investigators aim to develop a multi-epitope therapeutic vaccine capable of simultaneously activating humoral and cellular immune responses, which is achieved by fusing multiple T-cell epitope immunostimulatory proteins. To obtain information on functional T-cell epitopes to be included in the vaccine, the investigators conducted research starting from clinical cases. By collecting peripheral blood and cancerous tissues from clinical patients, the investigators isolated reactive T-cells and screened for information on T-cell epitopes of HPV antigens.",[580],"Cervical Cancer","2025-07-13",{"date":583,"type":40},"2025-07-22",{"date":585,"type":23},"2025-09-01",{"date":587,"type":23},"2033-09-01",{"name":46,"class":47},{"id":590,"slug":591,"hasResults":12,"nctId":592,"briefTitle":593,"officialTitle":594,"acronym":595,"eligibilityCriteria":596,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":597,"targetDuration":4,"studyType":24,"phases":598,"briefSummary":599,"conditions":600,"keywords":601,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":602,"lastUpdatePostDateStruct":603,"startDateStruct":605,"completionDateStruct":607,"leadSponsor":609,"locationsCount":99},"100596983","car-t-cells-therapy-for-patients-with-autoimmune-diseases-100596983","NCT07052565","CAR-T Cells Therapy for Patients With Autoimmune Diseases","An Exploratory Clinical Study of Enhanced Autologous CAR-T Cell Injection (ECAR01) Targeting BCMA and CD19 in the Treatment of Refractory Autoimmune Diseases","ECAR01","Inclusion Criteria:\n\n* ( 1) At the time of signing the informed consent form, be at least 18 years of age, both male and female.\n\n  (2) Bone marrow hematopoietic function satisfies: white blood cell count≥3×10\\^9\u002FL; Centrocyte count ≥1×10\\^9\u002FL (no colony-stimulating factor received within 2 weeks prior to screening); Hemoglobin ≥ 60g\u002FL.\n\n  (3)ALT≤3×ULN; AST≤3×ULN； TBIL≤3×ULN。 (4) Renal function satisfaction: creatinine clearance CrCl≥30mL\u002Fmin. (5) INR≤1.5×ULN , PT≤1.5×ULN. (6)RA:Documented diagnosis of RA which fulfills the 2010 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) Classification Criteria ; 3 months after use of 1 or more csDMARDs and 1 or more bDMARDs prior to screening: 1) DAS28-ESR\\>3.2 or CDAI\\>10; or 2) the dose of the hormone (prednisone or equivalent) cannot be reduced to less than 7.5 mg\u002Fday; or 3) the number of swollen and\u002For tender joints ≥3; Treatment with stable 1 or more cs DMARD(s) and\u002For bDMARDs prior to enrollment as follows: methotrexate for at least 12 weeks and at a dose of 7.5-25mg\u002Fweek for at least 4 weeks; Stable use of hydroxychloroquine dose ≤ 400 mg\u002Fday for at least 4 weeks; Stable oral sulfasalazine for at least 4 weeks 1\\~3 g\u002Fd; Stable oral leflunomide 10-20 mg\u002Fday for at least 4 weeks.\n\n  (7)systemic lupus erythematosus : Diagnosis of systemic lupus erythematosus according to the SLE classification criteria of the 2019 EULAR\u002FACR; History of systemic lupus erythematosus for at least 6 months prior to screening and active disease for 2 months after use of standard treatment regimens prior to screening; BILAG-2004 assesses the presence of at least 1 Grade A or 2 Grade B organ scores; Positive antinuclear antibody, or positive anti-ds-DNA antibody, or positive anti-Sm antibody; SLEDAI-2000 score ≥8 during the screening period.\n\n  (8)Sjögren's syndrome : Diagnosis of Sjögren's syndrome according to the 2002 International Classification of Primary Sjögren's Syndrome or the 2016 ACR\u002FEULAR classification criteria; Diagnosed with pSS-TP and platelet count \\\u003C 30×10\\^9\u002FL; Sjögren's syndrome Disease Activity Index (ESSDAI) score ≥5 during the screening period; Sjögren's syndrome for at least 6 months prior to screening and active disease 2 months after use of conventional treatment regimens prior to screening. Use of immunomodulatory drugs for more than 6 months.\n\n  (9)systemic sclerosis : Diagnosis of systemic sclerosis according to the 2013 ACR classification criteria for systemic sclerosis. Positive antinuclear antibody at screening. Presence of clear evidence of HRCT progression. History of systemic sclerosis prior to screening for at least 6 months and active disease for 2 months after use of conventional treatment regimens prior to screening.\n\nExclusion Criteria:\n\n* (1) Clinically significant central nervous system diseases or pathological changes not caused by the disease itself before screening, including but not limited to: stroke, stroke, aneurysm, epilepsy, convulsions, aphasia, severe head injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome or mental disorder.(2) Those with relatively serious heart disease, such as angina, myocardial infarction, heart failure and arrhythmia.(3) History of major organ transplantation or hematopoietic stem cell\u002Fbone marrow transplantation.(4) Vaccination, B-cell targeted therapy within 4 weeks prior to screening.(5) History of any malignant neoplastic disease.(6) Patients with end-stage renal failure.(7) The presence or suspicion of uncontrollable fungal, bacterial, viral, or other infections.(8) History of severe allergy to drugs used in clinical studies or raw and excipient materials of experimental drugs, such as cyclophosphamide, fludarabine, DMSO, etc.(9) Patient has active HBV infection or HCV antibody positivity or HIV antibody positivity or syphilis positivity or CMV DNA positivity or EBV DNA positivity.(10) Pregnant or lactating females, or planning to become pregnant within 2 years after reinfusion of the trial drug; The partner of the male patient plans to become pregnant within 2 years of receiving the trial drug.(11) Evidence of active tuberculosis infection.(12) Other conditions assessed by the investigator as unsuitable for enrollment.",{"count":209,"type":23},[134],"This is an open label, single-site, dose-escalation study in up to 18 participants with refractory autoimmune diseases. This study aims to evaluate the safety and efficacy of the treatment with Anti-BCMA and CD19 CART",[466],[468,469,470,471],"2025-07-04",{"date":604,"type":40},"2025-07-08",{"date":606,"type":23},"2025-07-20",{"date":608,"type":23},"2028-11-01",{"name":46,"class":47},""]