[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Second Affiliated Hospital of Guangzhou Medical University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":634},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,45,0,25,[9,49,72,98,126,155,185,205,230,255,280,301,329,359,382,405,425,451,472,503,525,544,568,585,604],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100644898","early-phase-1-a-study-to-evaluate-the-safety-and-pharmacokinetics-of-rc001-in-children-with-dravet-syndrome-100644898",false,"NCT07675746","A Study to Evaluate the Safety and Pharmacokinetics of RC001 in Children With Dravet Syndrome","An Investigator-Initiated Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RC001 in Patients With Dravet Syndrome Aged 2 to 18 Years","Inclusion Criteria:\n\n1. Patients aged 2-18 years with Dravet syndrome caused by SCN1A mutations, with onset before 12 months of age characterized by focal seizures, hemiclonic seizures, generalized tonic-clonic seizures, or myoclonic seizures, and with MRI excluding progressive neurological disease either historically or at screening. Enrolled participants will be assigned as follows: 1 participant aged 13-18 years, 1 aged 7-12 years, and 1 aged 2-6 years will undergo intra-subject dose escalation; 5 participants aged 2-12 years will receive fixed-dose multiple administrations.\n2. Seizure frequency requirements: at least 6 cumulative seizures within 12 weeks prior to the day of signing the ICF, and at least 2 seizures within 4 weeks prior to ICF signing. For participants in Stage 2 (fixed-dose multiple administration), seizure frequency must also be ≥4 within 4 weeks after ICF signing.\n3. Documented pathogenic or likely pathogenic variants in the SCN1A gene associated with Dravet syndrome.\n4. Prior treatment with at least one anti-epileptic intervention, including anti-seizure medications (ASM), ketogenic diet, or vagus nerve stimulation (VNS), with inadequate seizure control or discontinuation due to adverse events (AEs).\n5. Use of at least one ASM prior to screening, with a stable dose for at least 4 weeks before screening.\n6. All epilepsy-related treatments, including ASM and other interventions (ketogenic diet and VNS), must be stable for at least 4 weeks prior to screening and are expected to remain stable throughout the study (medications adjusted by body weight are allowed).\n7. Willingness to participate and provision of written informed consent.\n\nExclusion Criteria:\n\n1. Presence of other known pathogenic gene mutations causing Dravet syndrome, or SCN1A gain-of-function mutations reported in the literature and\u002For experimentally validated, including but not limited to: Ala23Glu, Thr162Ile, Thr226Met, Ser228Pro, Val229Leu, Ile236Val, Ile236Thr, Val250Leu, Leu263Val, Thr398Met, Ala420Val, Val422Leu, Ile883Thr, Leu893Phe, Ala989Thr, Thr1174Ser, Trp1204Arg, Ala1339Asp, Pro1345Ser, Pro1345Leu, Ser1346Pro, Ile1347Val, Val1481Ile, Ile1483Met, Gln1489Lys, Ile1498Thr, Ile1498Met, Phe1499Leu, Met1500Val, Arg1575Cys, Val1611Phe, Leu1624Pro, Arg1636Gln, Arg1648Cys, Leu1649Gln, Leu1660Ile, Phe1661Leu, Ala1669Glu, Leu1670Trp, Gly1674Arg, Phe1774Ser, Asp1866Tyr.\n2. Current maintenance treatment with anti-epileptic drugs primarily acting as sodium channel blockers, including but not limited to carbamazepine, oxcarbazepine, lamotrigine, lacosamide, or rufinamide.\n3. Ongoing neuromodulation therapy (e.g., responsive neurostimulation or deep brain stimulation), excluding vagus nerve stimulation (VNS).\n4. Receipt of gene therapy or cell therapy within 1 year prior to screening.\n5. Receipt of any vaccination within 12 weeks prior to screening.\n6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>2× the upper limit of normal (ULN), or total bilirubin \\>1.5× ULN; renal insufficiency or serum creatinine \\>1.2× ULN.\n7. Presence of any severe uncontrolled disease other than Dravet syndrome.\n8. History of autoimmune disease, or uncontrolled infectious disease within 1 week prior to screening.\n9. History of brain or spinal cord disease (other than epilepsy, Dravet syndrome, or trauma), or history of bacterial meningitis.\n10. Spinal deformity or other conditions that may interfere with normal cerebrospinal fluid (CSF) flow, or implantation of a CSF shunt.\n11. Pregnant or breastfeeding females.\n12. Any other significant disease or condition that, in the investigator's judgment, may pose a risk to the patient, interfere with study results, or affect the patient's ability to participate in the study.","ALL","2 Years","18 Years",{"count":21,"type":22},8,"ESTIMATED","INTERVENTIONAL",[25],"EARLY_PHASE1","This is an open-label, single-center study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of intrathecal RC001 in patients with Dravet syndrome aged 2 to 18 years. The study includes a dose-escalation part followed by a fixed dose treatment part, with participant progression based on investigator-assessed safety and efficacy.",[28],"Dravet Syndrome (DS)",[30,31,32,33,34,35],"Dravet syndrome","Developmental and epileptic encephalopathy","RC001","Oligonucleotide drugs","ADAR RNA editing","SCN1A gene","RECRUITING","2026-06-23",{"date":39,"type":40},"2026-06-30","ACTUAL",{"date":42,"type":40},"2025-12-22",{"date":44,"type":22},"2027-12-31",{"name":46,"class":47},"Second Affiliated Hospital of Guangzhou Medical University","OTHER",1,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":48},"100641195","phase-2-yttrium-90-carbon-microsphere-radioembolization-in-previously-treated-hepatocellular-carcinoma-100641195","NCT07657273","Yttrium-90 Carbon Microsphere Radioembolization in Previously Treated Hepatocellular Carcinoma","A Prospective, Open-Label, Investigator-Initiated Study to Evaluate the Safety and Efficacy of NRT6003 Injection (Yttrium-90 Carbon Microspheres) Radioembolization in Previously Treated Patients With Hepatocellular Carcinoma","Inclusion Criteria:\n\n1\\. Age 18 years or older, male or female, with body weight greater than 30 kg. 2. Clinically, radiologically, and\u002For pathologically diagnosed hepatocellular carcinoma. 3. Previously treated with TACE, and\u002For HAIC, and considered by the investigator to be able to tolerate yttrium-90 carbon microsphere radioembolization. 4. Child-Pugh score ≤7, ECOG performance status \\\u003C2, and life expectancy \\>3 months. 5. Disease confined to the liver after systemic assessment. 6. At least one measurable lesion according to mRECIST and RECIST v1.1. 7. Adequate residual normal liver volume and adequate bone marrow, hepatic, renal, and coagulation function. 8. For participants with portal vein tumor thrombus, eligibility must be confirmed by the investigator based on hepatic angiography and 99mTc-MAA hepatic arterial perfusion imaging. 9. Suitable for SIRT based on hepatic vascular evaluation and 99mTc-MAA assessment. 10. Willing to use effective contraception as required by the protocol. 11. Able to understand and comply with the study requirements and willing to provide written informed consent.\n\nExclusion Criteria:\n\n1\\. Extrahepatic metastasis, including regional lymph node metastasis. 2. Uncontrolled biliary obstruction or recent biliary infection within 6 months before informed consent. 3. Prior internal or external radiotherapy to the liver or upper abdomen. 4. Anticancer therapy within 30 days before NRT6003 treatment, or small-molecule targeted therapy within 14 days before treatment. 5. Known allergy, intolerance, or contraindication to any study-related drug, contrast agent, anesthetic agent, or excipient. 6. Severe pulmonary dysfunction. 7. Untreated or inadequately treated esophageal or gastric varices considered by the investigator to have a high bleeding risk. 8. Uncontrolled disease or infection that may affect study safety or efficacy, as judged by the investigator. 9. Positive HIV antibody test. 10. 99mTc-MAA imaging or hepatic angiography showing inadequate coverage of target intrahepatic lesions, uncorrectable gastrointestinal shunting, or estimated single-session lung absorbed dose \\>30 Gy. 11. Pregnant or breastfeeding women. 12. Any other condition that, in the investigator's opinion, makes the participant unsuitable for this study.",{"count":57,"type":22},20,[59],"PHASE2","This is a prospective, open-label, single-arm, investigator-initiated study designed to evaluate the safety and efficacy of NRT6003 Injection, a yttrium-90 carbon microsphere product, administered by selective internal radiation therapy in previously treated patients with hepatocellular carcinoma.\n\nEligible participants will undergo protocol-specified screening assessments, hepatic vascular evaluation, 99mTc-MAA hepatic arterial perfusion imaging, and dosimetry assessment before treatment. Participants who meet the eligibility criteria and are considered suitable for selective internal radiation therapy will receive a single transarterial administration of NRT6003 Injection. Safety follow-up will be conducted for 12 months after treatment, and tumor response will be assessed using mRECIST and RECIST v1.1.",[62],"Hepatocellular Carcinoma","NOT_YET_RECRUITING","2026-06-15",{"date":66,"type":40},"2026-06-18",{"date":68,"type":22},"2026-06-22",{"date":70,"type":22},"2027-12-21",{"name":46,"class":47},{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":81,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},"100507078","phase-4-effect-of-heart-rate-control-with-ivabradine-on-hemodynamic-in-patients-with-sepsis-100507078","NCT05882708","Effect of Heart Rate Control With Ivabradine on Hemodynamic in Patients With Sepsis","Effect of Heart Rate Control With Ivabradine on Hemodynamic in Patients With Sepsis: a Prospective, Multicenter, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Adult patients aged 18 years or above.\n2. Being treated in an intensive care unit.\n3. Sepsis is diagnosed according to Sepsis-3.0 criteria, which is defined as patients requiring antimicrobial agents due to confirmed or suspected infection, acute increase in the SOFA score at least 2 points.\n4. Mean arterial pressure (MAP) is maintained ≥65 mmHg with adequate volume resuscitation and vasopressor therapy. Volume resuscitation is considered adequate when Central Venous Pressure (CVP) \\> 8mmHg, global end-diastolic volume index (GEDI) \\> 680ml\u002Fm2 and resting inferior vena cava (IVC) diameter \\> 1.5cm.\n5. Patients are in a relatively stable period of hemodynamics, as defined that the targe mean arterial pressure are maintained with the same dosage of vasopressors for at least 2 h.\n6. Sinus rhythm with heart rate ≥ 95bpm maintain for at least 2 hours but less than 72 hours.\n\nExclusion Criteria:\n\n1. Patients who had received ivabradine therapy or known allergy to it prior to randomization.\n2. Patients with severe liver dysfunction (Child-C grade).\n3. Patients with a history of pre-existing chronic renal failure (glomerular filtration rate less than 15 ml\u002Fmin\u002F1.73 m2), except patients treated with continuous renal replacement therapy (CRRT).\n4. Patients with known seizure disorder.\n5. Patients with any contraindication to gastrointestinal drug administration.\n6. Pregnant or lactating patients.\n7. patients requiring the use of potent cytochrome CYP3A4 inhibitors such as antifungals of the azole-type (specifically ketoconazole and itraconazole), macrolide antibiotics (specifically clarithromycin and erythromycin) and HIV protease inhibitors (specifically nelfinavir and ritonavir).\n8. Patients with active bleeding;\n9. Patients with cardiac dysfunction caused by non-septic causes such as recent (\\\u003C 2months) acute myocardial infarction, chronic cardiac dysfunction (NYHA Class Ⅳ), congenital heart disease, pericardial tamponade, severe aortic regurgitation and aortic coarctation before enrollment.\n10. Patients with sinoatrial block, sick sinus syndrome, atrioventricular block or heart rate dependence on pacemaker.\n11. Patients with refractory shock, which may be considered if one of the following conditions still exists in spite of active volume resuscitation, high doses of vasoactive drugs (VIS score \\>120), and other regular therapy: 1) Worsening hypotension (MAP\\\u003C65mmHg); 2) Lactate persistence\\>5mmol\u002FL (two times in a row with an interval of more than 30min), and a progressive upward trend; 3) Mixed venous blood oxygen saturation (SvO2) sustained \\\u003C55% (more than two consecutive times, more than 30min apart), and progressive deterioration. The above conditions lasted for more than 5 hours.\n12. Use of beta blockers within 24 hours before enrollment.\n13. Pheochromocytoma patients.\n14. After cardiopulmonary resuscitation.\n15. Patients who have been enrolled in another interventional clinical study.",{"count":80,"type":22},172,[82],"PHASE4","Sepsis, a life-threatening syndrome, is often accompanied by tachycardia in spite of adequate volume resuscitation to correct hypovolemia and vasopressor medication to correct hypotension. Recently, relevant studies have shown that sustained tachycardia in sepsis was also related to high mortality, and appropriate control of heart rate could improve prognosis. Ivabradine reduces heart rate directly without a negative inotropic effect through inhibition of the If ionic current，which is absent from the traditional rate control drug (beta-blockers). This is a prospective, multicenter, randomized, open label study designed to compare ivabradine with placebo on the difference of heart rate and haemodynamics in patients with sepsis.",[85,86,87,88],"Sepsis","Ivabradine","Hemodynamics","Heart Rate Control","2026-04-21",{"date":91,"type":40},"2026-04-24",{"date":93,"type":40},"2023-06-01",{"date":95,"type":22},"2027-05-31",{"name":46,"class":47},3,{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":106,"enrollmentInfo":107,"targetDuration":4,"studyType":23,"phases":109,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":48},"100621723","phase-1-triple-hypoglycemic-regimens-in-patients-with-newly-diagnosed-type-2-diabetes-mellitus-100621723","NCT07374328","Triple Hypoglycemic Regimens In Patients With Newly Diagnosed Type 2 Diabetes Mellitus","Comparison Of Two Triple Hypoglycemic Regimens In Achieving Glycemic Control And Diabetes Remission In Hospitalized Patients With Newly Diagnosed Type 2 Diabetes Mellitus: A Multicenter, Randomized, Clinical Study","TRED","Inclusion Criteria:\n\n* Patients with newly diagnosed type 2 diabetes.\n* Age between 18 and 65 years old.\n* HbA1c ≥ 9.0%.\n\nExclusion Criteria:\n\n* Type 1 diabetes.\n* Elevated creatinine or urinary albumin\u002Fcreatinine.\n* Combined with coronary heart disease, tumor or pregnancy.\n* Receiving glucocorticoids.","65 Years",{"count":108,"type":22},240,[110,59],"PHASE1","This study is a multicenter, randomized, controlled study. A sample size of 240 cases is proposed to be included. The inclusion criteria are: (1) patients with newly diagnosed type 2 diabetes; (2) age between 18 and 65 years old; (3) HbA1c ≥ 9.0%. The exclusion criteria include: (1) type 1 diabetes; (2) elevated creatinine or urinary albumin\u002Fcreatinine; (3) combined with coronary heart disease, tumor or pregnancy; (4) receiving glucocorticoids. The selected participants are randomly divided into two groups: one group is the semaglutide group, and the other isthe oral medication group. The treatment plan is as follows. Semaglutide group: 0.25 mg per week in the first month, 0.5 mg per week in the second month, and 1.0mg per week from the 3rd to the 8th month of semaglutide. Oral medication group: Sitagliptin 0.1g per day. Both groups were simultaneously treated with metformin (1.0g daily, divided into two doses) and empagliflozin (10mg daily). The first phase of the study was as follows: Semaglutide group: Treatment was initiated until 6 months after the titration dose of 1mg was reached; Oral medication group: Initiate treatment until 6 months after reaching a fixed dose. At the end of the first stage of the study, for the selected participants with HbA1c\\\u003C6.5%, the hypoglycemic drugs were discontinued and they entered the second stage of the study. The study was concluded after a 3-month follow-up. The evaluation indicators include: effectiveness indicators (HbA1c, diabetes remission rate, continuous glucose monitoring), safety indicators (hypoglycemia, adverse reactions, etc.).",[113],"Type 2 Diabetes",[115,116,117],"triple regimen","diabetes","remission","2026-01-25",{"date":120,"type":40},"2026-01-28",{"date":122,"type":40},"2025-06-01",{"date":124,"type":22},"2026-08-31",{"name":46,"class":47},{"id":127,"slug":128,"hasResults":12,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":12,"sex":17,"minAge":133,"maxAge":134,"enrollmentInfo":135,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":138,"conditions":139,"keywords":142,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":48},"100590393","lacosamide-intravenous-injection-for-emergency-termination-of-status-epilepticus-100590393","NCT06966830","Lacosamide Intravenous Injection for Emergency Termination of Status Epilepticus","A Multicenter, Prospective, Real-World Observational Study of Lacosamide Intravenous Injection for Emergency Termination of Status Epilepticus","Inclusion Criteria:\n\n1. Age 4-60 years old, gender is not limited;\n2. Status epilepticus meets the 2015 diagnostic criteria of the International League Against Epilepsy, i.e., a state of persistent seizures that may cause long-term impairment and manifests itself as:\n\n(1) Tonic-clonic seizures or convulsive seizures, lasting \\> 5min; (2) Between 2 or more seizures, consciousness is not restored; (3) Focal seizures with impaired consciousness, lasting \\>10min; (4) absence seizures, lasting \\>15min; 3. Informed consent of the patient and signed a written consent form.\n\nExclusion Criteria:\n\n1. Unstable vital signs;\n2. Electrocardiogram showing atrial flutter, atrial fibrillation, second-degree, third-degree atrioventricular block;\n3. History of allergy to the drugs used this time;\n4. Participants have a known history of past or present illness of non-epileptic seizures, and current seizures cannot be judged as status epilepticus based on symptomatology and\u002For electroencephalogram;\n5. Other patients who are considered by the investigator to be unsuitable to participate in the study;\n6. Incomplete clinical data or follow-up information","4 Years","60 Years",{"count":136,"type":22},100,"OBSERVATIONAL","Status epilepticus (SE) is an acute and critical form of neurological and systemic diseases involving multiple clinical disciplines, with an annual incidence of (20-73) per 100,000 people and a clinical case fatality rate of 20%. Although there are many causes of SE, the primary goal of treatment is to terminate the seizures quickly, and timely and standardized treatment can reduce mortality and improve prognosis. The prognosis is closely related to the duration of the episode, and the longer the episode, the worse the prognosis. If seizures of convulsive status epilepticus persist for more than 10 minutes and are not provided with optimal therapeutic intervention, serious adverse outcomes and even death are likely to occur. How to effectively terminate status epilepticus and actively find effective, reliable and safe treatment options is a key research problem at present. Due to critical illness, limited treatment options, and poor prognosis, new treatments are urgently needed to terminate persistent epileptic activity.\n\nLacosamide (LCM) is a third-generation new antiepileptic drug, which was approved in 2008 for the additive treatment of patients aged 16 years and older with focal seizures, with or without generalized seizures. In 2017, it was extended to patients over 4 years of age. Lacosamide is an anticonvulsant drug with a new dual mechanism of action: first, lacosamide antagonizes the glycine site of N-methyl-D-aspartate (NMDA) receptor; Second, lacosamide selectively acts on the slow inactivation of sodium channels and prolongs the inactivation time of sodium channels, which can more effectively reduce sodium influx and reduce the excitability of neurons, so as to achieve the purpose of treating epilepsy. Lacosamide exhibits linear pharmacokinetics, high oral bioavailability, protein binding of \\\u003C 15%, rapid and almost complete absorption in a single oral dose, and maximum plasma concentrations within 1 to 4 hours. A number of randomized controlled clinical studies and real-world studies abroad have shown that lacosamide can significantly improve the effective rate and seizure-free rate of epilepsy control, and it is well tolerated and has fewer adverse reactions. The 2022 Chinese Expert Consensus on the Diagnosis and Treatment of Post-stroke Epilepsy recommended lacosamide injection as a first-line drug for non-convulsive status epilepticus after stroke, and the Chinese Expert Consensus on the Diagnosis and Treatment of Status Epilepticus in Children (2022) recommended that lacosamide be considered as an additive treatment for refractory convulsive status epilepticus in children \\> 60 minutes . There is a lack of clinical research data on the efficacy and safety of intravenous bolus lacosamide for status epilepticus, including convulsive status epilepticus and non-convulsive epilepticus.",[140,141],"Epilepsy","Status Epilepticus",[143,144,145,146],"Lacosamide","Intravenous Injection","Emergency Termination","Efficacy","2025-05-26",{"date":149,"type":40},"2025-05-30",{"date":151,"type":22},"2025-06-06",{"date":153,"type":22},"2027-10-30",{"name":46,"class":47},{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":162,"enrollmentInfo":163,"targetDuration":4,"studyType":23,"phases":165,"briefSummary":166,"conditions":167,"keywords":169,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":48},"100585578","phase-2-lenvatinib-sintilimab-and-deb-tace-withwithout-haic-for-hcc-7-cm-with-pvtt-100585578","NCT06904183","Lenvatinib, Sintilimab, and DEB-TACE With\u002FWithout HAIC for HCC >7 cm With PVTT","Lenvatinib, Sintilimab, and Drug-Eluting Beads Transarterial Chemoembolization With or Without Hepatic Arterial Infusion Chemotherapy for Hepatocellular Carcinoma >7 cm With Portal Vein Tumor Thrombus: A Multicenter, Randomized Controlled Trial","Inclusion Criteria:\n\n* a confirmed diagnosis of HCC\n* the largest intrahepatic lesion \\>7 cm\n* presence of PVTT on imaging\n* tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment\n* Eastern Cooperative Oncology Group performance status ≤1\n* Child-Pugh class A\u002FB\n* adequate hematologic and organ function, with leukocyte count\\>3.0×10\\^9\u002FL, neutrophil count\\>1.5×10\\^9\u002FL, platelet count≥75×10\\^9\u002FL, hemoglobin 85 g\u002FL, alanine transaminase and aspartate transaminase≤5×upper limit of the normal, creatinine clearance rate≤1.5×upper limit of the normal; prothrombin time prolongation ≤4 seconds\n* life expectancy of at least 3 months\n\nExclusion Criteria:\n\n* accompanied with vena cava tumor thrombus\n* central nervous system involvement\n* previous treatment with TACE, HAIC, TAE, radiotherapy, or systemic therapy\n* organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment\n* history of other malignancies\n* uncontrollable infection\n* history of HIV\n* history of organ or cells transplantation","75 Years",{"count":164,"type":22},320,[59],"This study is conducted to evaluate the efficacy and safety of lenvatinib plus sintilimab, transarterial chemoembolization (TACE) with drug-eluting beads (DEB-TACE) and hepatic artery infusion chemotherapy (HAIC) with FOLFOX regemen (LEN+SIN+DEB-TACE+HAIC) versus lenvatinib plus sintilimab and DEB-TACE (LEN+SIN+DEB-TACE) for large hepatocellular carcinoma (\\> 7cm) with portal vein tumor thrombosis (PVTT).",[168],"Hepatocellular Carcinoma Non-resectable",[170,171,172,173,174,175,176],"hepatocellular carcinoma","lenvatinib","transarterial chemoembolization","drug-eluting bead","hepatic arterial infusion chemotherapy","portal vein tumor thrombosis","sintilimab","2025-04-28",{"date":179,"type":40},"2025-04-29",{"date":181,"type":40},"2025-04-01",{"date":183,"type":22},"2030-03-31",{"name":46,"class":47},{"id":186,"slug":187,"hasResults":12,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":162,"enrollmentInfo":192,"targetDuration":4,"studyType":23,"phases":194,"briefSummary":195,"conditions":196,"keywords":197,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":200,"startDateStruct":201,"completionDateStruct":202,"leadSponsor":204,"locationsCount":48},"100585579","phase-2-lenvatinib-plus-sirt-vs-lenvatinib-in-tace-refractory-hcc-100585579","NCT06904196","Lenvatinib Plus SIRT vs Lenvatinib in TACE-Refractory HCC","Lenvatinib Combined With Yttrium-90 Selective Internal Radiation Therapy (SIRT) Versus Lenvatinib Alone in TACE-Refractory Hepatocellular Carcinoma: A Prospective Non-Randomized Controlled Study","Inclusion Criteria:\n\n* Pathologically confirmed or clinically diagnosed HCC\n* Diagnosis of HCC with TACE refractoriness according to the criteria proposed by Japan Society of Hepatology (2021)\n* Patients who have Tumor recurrence after surgical resection or ablation are allowed to be included\n* At least one measurable intrahepatic target lesion\n* Child-Pugh class A\u002FB\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Tumor extent \\\u003C70% liver occupation\n* Candidates for SIRT must be confirmed suitable for SIRT after evaluation (including SPECT\u002FCT evaluation after arterial perfusion with 99Tc-MAA)\n* Adequate organ and hematologic function with platelet count ≥50×10\\^9\u002FL, leukocyte \\>3.0×10\\^9\u002FL, Neutrophil count ≥1.5×10\\^9\u002FL, haemoglobin ≥85 g\u002FL, ALT and AST≤5×ULN, albumin ≥28 g\u002FL, total bilirubin ≤3× ULN, creatinine≤1.5×ULN, and prolongation of prothrombin time ≤4 seconds\n* Life expectancy of at least 3 months\n\nExclusion Criteria:\n\n* Extrahepatic metastasis\n* Tumor thrombus involving main portal vein or both the first left and right branches of portal vein\n* Vena cava invasion\n* Patients who received prior hepatic arterial infusion chemotherapy (HAIC), radiotherapy, or systemic therapy, for HCC\n* History of organ and cell transplantation\n* History of esophageal or gastric variceal bleeding\n* History of hepatic encephalopathy\n* History of other malignancies\n* Human immunodeficiency virus infection",{"count":193,"type":22},78,[59],"This study is conducted to evaluate the efficacy and safety of lenvatinib plus SIRT (LEN+SIRT) compared with lenvatinib (LEN) alone for patients with hepatocellular carcinoma (HCC) refractory to transarterial chemoembolization (TACE).",[168],[170,198,199],"Lenvatinib","Yttrium-90",{"date":179,"type":40},{"date":181,"type":40},{"date":203,"type":22},"2029-03-31",{"name":46,"class":47},{"id":206,"slug":207,"hasResults":12,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":212,"enrollmentInfo":213,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":215,"conditions":216,"keywords":218,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":227,"leadSponsor":229,"locationsCount":4},"100588076","herpes-simplex-virus-type-1-infectionreactivation-of-patients-with-severe-pneumoniathe-hsv-sp-study-100588076","NCT06936683","Herpes Simplex Virus Type 1 Infection\u002FReactivation of Patients With Severe Pneumonia（the HSV-SP Study）","Prognostic Effect of Herpes Simplex Virus Type 1 Infection\u002FReactivation in the Lower Respiratory Tract of Critical Care Patients With Severe Pneumonia（the HSV-SP Study）: a Study Protocol for a Multicenter, Prospective Cohort Study","Inclusion Criteria:\n\n* 1: Age\\>18 years old. 2: Clinical diagnosis for severe pneumonia. 3: ICU stay time \\>72 hours. 4: A written informed consent form was obtained from the members of the patients' family.\n\nExclusion Criteria:\n\n* 1: severe ventilation dysfunction, and effective respiratory support has not been used; 2: Aortic aneurysm and esophageal varices at risk of rupture; 3: Recent acute coronary syndrome, uncontrolled severe hypertension, and malignant arrhythmia; 4: Irreversible bleeding tendencies, such as severe coagulation dysfunction, massive hemoptysis, or gastrointestinal bleeding; 5: Multiple pulmonary bullae at risk of rupture. 6: Estimated survival time\\\u003C24 hours. 7: Included in another interventional clinical study.","100 Years",{"count":214,"type":22},323,"Severe pneumonia(SP) is a one of the main causes of death for critically ill patients.Samples of bronchoalveolar lavage fluid (BALF) from SP patients often report positive for herpes simplex virus type 1 (HSV-1) DNA. However, to date, it is unclear the impact and significance of this positive result on SP patients. This study will evaluate the prognostic impact of lower respiratory tract HSV-1 infection\u002Freactivation on ICU severe pneumonia patients.At the same time, by analyzing the risk factors that affect prognosis, we will identify populations with the potential for intervention benefits and provide a basis for further intervention treatment.",[217],"Severe Pneumonia",[219,220,221,222],"Severe pneumonia","Herpes simplex virus type 1","infection\u002Freactivation","Prognostic effect","2025-04-22",{"date":225,"type":40},"2025-04-25",{"date":122,"type":22},{"date":228,"type":22},"2027-10-01",{"name":46,"class":47},{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":162,"enrollmentInfo":237,"targetDuration":4,"studyType":23,"phases":239,"briefSummary":240,"conditions":241,"keywords":242,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":48},"100546614","phase-2-deb-taceralox-haic-vs-deb-tace-for-large-hcc-100546614","NCT06397235","DEB-TACE+RALOX-HAIC vs DEB-TACE for Large HCC","DEB-TACE in Combination With or Without RALOX-based HAIC for Unresectable Large Hepatocellular Carcinoma: A Randomized, Controlled Trial","Inclusion Criteria:\n\n* HCC confirmed by histology\u002Fcytology or diagnosed clinically.\n* At least one measurable intrahepatic target lesion.\n* The largest tumor size \\> 7 cm.\n* Tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment.\n* Child-Pugh score 5-7.\n* ECOG performance status ≤ 1.\n* Adequate organ and hematologic function with platelet count ≥75×10\\^9\u002FL, leukocyte \\>3.0×10\\^9\u002FL, Neutrophil count ≥1.5×10\\^9\u002FL, ASL and AST≤5×ULN, creatinine clearance≤1.5×ULN, and prolongation of prothrombin time ≤4 seconds.\n\nExclusion Criteria:\n\n* Macrovascular invasion or extrahepatic metastasis.\n* Diffuse HCC.\n* Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy.\n* Previous palliative treatments, including TACE, transcatheter arterial embolization, HAIC, radiation therapy, systemic therapy.\n* Organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment.\n* History of other malignancies.\n* Uncontrollable infection.\n* History of HIV.\n* Gastrointestinal bleeding within 30 days, or other bleeding\\> CTCAE grade 3.\n* History of organ or cells transplantation.\n* Pregnant or lactating patients.",{"count":238,"type":22},130,[59],"This study is conducted to evaluate the efficacy and safety of transarterial chemoembolization with drug-eluting beads (DEB-TACE) combined with hepatic artery infusion chemotherapy (HAIC) with oxaliplatin and raltitrexed (RALOX-HAIC) versus DEB-TACE alone for unresectable large hepatocellular carcinoma (HCC).",[168],[62,172,243,244,245,246],"drug-eluting beads","hepatic artery infusion chemotherapy","oxaliplatin","raltitrexe","2025-02-18",{"date":249,"type":40},"2025-02-20",{"date":251,"type":40},"2024-05-01",{"date":253,"type":22},"2028-04-30",{"name":46,"class":47},{"id":256,"slug":257,"hasResults":12,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":162,"enrollmentInfo":262,"targetDuration":4,"studyType":23,"phases":264,"briefSummary":265,"conditions":266,"keywords":268,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":279},"100570437","phase-2-y-90-sirt-for-unresectable-hcc-larger-than-7cm-100570437","NCT06707233","Y-90 SIRT for Unresectable HCC Larger Than 7cm","Y-90 Selective Internal Radiation Therapy for Unresectable Hepatocellular Carcinoma Larger Than 7cm: a Prospective, Single Arm Trial","Inclusion Criteria:\n\n* Pathologically confirmed or clinically diagnosed HCC\n* Unresectable HCC as assessed by a team of surgeons\n* The largest tumor size \\> 7 cm\n* Tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment\n* At least one measurable intrahepatic target lesion\n* Appropriate for SIRT treatment after evaluation (including SPECT\u002FCT evaluation after arterial perfusion with 99Tc-MAA)\n* Child-Pugh score ≤ 7\n* ECOG PS ≤ 1\n* Adequate organ and hematologic function with platelet count ≥75×10\\^9\u002FL, leukocyte \\>3.0×10\\^9\u002FL, Neutrophil count ≥1.5×10\\^9\u002FL, haemoglobin ≥85 g\u002FL, ALT and AST≤5×ULN, creatinine≤1.5×ULN, and prolongation of prothrombin time ≤4 seconds\n* life expectancy of at least 6 months\n\nExclusion Criteria:\n\n* Macrovascular invasion or extrahepatic metastasis\n* Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy\n* Organ (heart and kidneys) dysfunction\n* History of other malignancies\n* Uncontrollable infection\n* History of organ or cells transplantation\n* History of HIV\n* Pregnant or lactating patients",{"count":263,"type":22},33,[59],"This is a phase II clinical study to evaluate the efficacy and safety of SIRT in patients with HCC greater than 7 cm. After enrollment, patients received yttrium-90 selective internal radiation therapy. The primary endpoint of the study is objective reponse rate (ORR) as assessed by mRECIST. Secondary endpoints were: objective response rate (ORR) as assessed by RECIST 1.1, disease control rate (DCR), progression-free survival (PFS), time to response (TTR), duration of response (DOR), overall survival (OS), and safety (incidence and severity of adverse events).",[267],"Hepatocellular Carcinoma Non-Resectable",[62,269,270],"yttrium-90","selective internal radiation therapy","2025-01-26",{"date":273,"type":40},"2025-01-28",{"date":275,"type":40},"2024-12-01",{"date":277,"type":22},"2027-11-30",{"name":46,"class":47},2,{"id":281,"slug":282,"hasResults":12,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":162,"enrollmentInfo":287,"targetDuration":4,"studyType":23,"phases":289,"briefSummary":291,"conditions":292,"keywords":293,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":48},"100553923","phase-3-lenvatinib-plus-deb-tace-and-haic-vs-lenvatinib-plus-deb-tace-for-large-hcc-with-pvtt-100553923","NCT06492395","Lenvatinib Plus DEB-TACE and HAIC vs. Lenvatinib Plus DEB-TACE for Large HCC With PVTT","A Multicentre, Randomised Controlled Study of Lenvatinib Plus Drug-eluting Bead Transarterial Chemoembolization and Hepatic Arterial Infusion Chemotherapy With FOLFOX Regimen Versus Lenvatinib Plus Drug-eluting Bead Transarterial Chemoembolization for Hepatocellular Carcinoma Larger Than 7 cm With Portal Vein Tumor Thrombosis","Inclusion Criteria:\n\n* a confirmed diagnosis of HCC\n* the largest intrahepatic lesion \\>7 cm\n* presence of PVTT on imaging\n* tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment\n* Eastern Cooperative Oncology Group performance status ≤1\n* Child-Pugh class A\u002FB\n* adequate hematologic and organ function, with leukocyte count\\>3.0×10\\^9\u002FL, neutrophil count\\>1.5×10\\^9\u002FL, platelet count≥75×10\\^9\u002FL, hemoglobin 85 g\u002FL, alanine transaminase and aspartate transaminase≤5×upper limit of the normal, creatinine clearance rate≤1.5×upper limit of the normal\n* life expectancy of at least 3 months\n\nExclusion Criteria:\n\n* Diffuse HCC\n* accompanied with vena cava tumor thrombus\n* central nervous system involvement\n* previous treatment with TACE, HAIC, TAE, radiotherapy, or systemic therapy\n* organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment\n* history of other malignancies\n* uncontrollable infection\n* history of HIV\n* history of organ or cells transplantation\n* prothrombin time prolongation \\>4 s",{"count":288,"type":22},178,[290],"PHASE3","This study is conducted to evaluate the efficacy and safety of lenvatinib plus transarterial chemoembolization (TACE) with drug-eluting beads (DEB-TACE) and hepatic artery infusion chemotherapy (HAIC) with FOLFOX regemen (Len+DEB-TACE+HAIC) versus lenvatinib plus DEB-TACE (Len+DEB-TACE) for large hepatocellular carcinoma (\\> 7cm) with portal vein tumor thrombosis (PVTT).",[168],[170,171,172,173,174,175],{"date":295,"type":40},"2025-01-29",{"date":297,"type":40},"2024-08-01",{"date":299,"type":22},"2027-07-31",{"name":46,"class":47},{"id":302,"slug":303,"hasResults":12,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":308,"enrollmentInfo":309,"targetDuration":4,"studyType":23,"phases":310,"briefSummary":311,"conditions":312,"keywords":314,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":48},"100421623","phase-2-intra-tumor-injection-of-drug-eluting-microspheres-with-multiple-drugs-100421623","NCT04770207","Intra-tumor Injection of Drug-eluting Microspheres With Multiple Drugs","Intra-tumor Injection of Drug-eluting Microspheres Loading With Chemodrug Plus Checkpoint Inhibitors and\u002For IL2 for Treatment of Advanced Solid Tumors","Inclusion Criteria:\n\n* Solid advanced malignant tumors\n* Age between18 and 99 years\n* Life expectancy is greater than three months\n\nExclusion Criteria:\n\n* Benign tumor\n* Life expectancy is less than three months\n* Serious medical comorbidity\n* Others","99 Years",{"count":136,"type":22},[59],"To study the safety and clinical effect of injection of drug-eluting microspheres with multiple chemodrug and\u002For protein drugs into advanced solid tumors.",[62,313],"Solid Tumor, Adult",[315,316,317,318,319,320],"Hepatocellular Carcinoma; Lung Cancer; Solid Tumors","Drug-eluting Beads","IL2; Kytruda; Opdivo; Imfinza; Atezolizumab; Ipilimumab;","Treprizolizumab; Tirelizumab; Carellizumab; Sintilimab;","Sugemalimab；Adebrelimab；Envafolimab；Cadonilimab；","Bevacizumab; Ramucirumab","2024-08-19",{"date":323,"type":40},"2024-08-21",{"date":325,"type":40},"2020-11-01",{"date":327,"type":22},"2035-11-01",{"name":46,"class":47},{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":4,"eligibilityCriteria":335,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":162,"enrollmentInfo":336,"targetDuration":4,"studyType":23,"phases":338,"briefSummary":339,"conditions":340,"keywords":343,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":48},"100553924","phase-2-neoadjuvant-intra-tumor-double-immunotherapy-for-hepatocellular-carcinoma-100553924","NCT06492408","Neoadjuvant Intra-tumor Double Immunotherapy for Hepatocellular Carcinoma.","Phase II Study of Neoadjuvant CT-Guided Intra-tumor Double Checkpoint Blockades for Untreated Hepatocellular Carcinoma (HCC) Amenable for Surgical Resection","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed previously untreated hepatocellular carcinoma (HCC). If a diagnostic biopsy is available, a pre-treatment biopsy is not required. Patients with a suspected HCC are eligible, but pathology must be confirmed prior to initiating treatment on study.\n2. The patient must be a suitable candidate for surgery, in the opinion of the treating physician.\n3. Signed and dated written informed consent must be provided by the patient prior to admission to the study in accordance with International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines and to the local legislation.\n4. Eastern Cooperative Oncology Group (ECOG) performance status score 0-1\n5. Absolute neutrophil count (ANC) \\>= 1.5 x 10\\^9\u002FL; Hemoglobin \\>= 8.0 g\u002FdL; Platelets \\>= 100 x 10\\^9\u002FL; Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) (except subjects with Gilbert syndrome who can have total bilirubin \\\u003C 3.0 mg\u002FdL); Creatinine =\\\u003C 1.5 x ULN or calculated creatinine clearance \\>= 50 mL\u002Fmin using Cockcroft-Gault formula for creatinine clearance calculation OR 24-hour urine creatinine clearance \\>= 50 mL\u002Fmin.\n6. Birth control.\n7. Willing and able to comply with scheduled visits, treatment plan and laboratory tests.\n\nExclusion Criteria:\n\n1. Patients participated in clinical trials of equipment or drugs (signed informed consent) within 4 weeks;\n2. Patients accompany by ascites, hepatic encephalopathy and esophageal and gastric varices bleeding;\n3. Any serious accompanying disease, which is expected to have an unknown, impact on the prognosis, include heart disease, inadequately controlled diabetes and psychiatric disorders;\n4. Patients accompanied with other tumors or past medical history of malignancy;\n5. Pregnant or lactating patients, all patients participating in this trial must adopt appropriate birth control measures during treatment;\n6. Patients have poor compliance. A.Impaired clotting test (platelet count \\\u003C 60000\u002Fmm3, prothrombin activity \\\u003C 50%).\n\n   B.Renal failure \u002F insufficiency requiring hemo-or peritoneal dialysis. C.Known severe atheromatosis. D.Known uncontrolled blood hypertension (\\> 160\u002F100 mm\u002FHg).\n7. Allergic to contrast agent;\n8. Any agents which could affect the absorption or pharmacokinetics of the study drugs\n9. Other conditions that investigator decides not suitable for the trial.",{"count":337,"type":22},90,[59],"This trial is designed to investigate the safety, response rates and survival outcomes of patients with hepatocellular carcinoma by delivery of CTLA4 and PD1 or PDL1 antibodies combination through CT-guided intra-tumor (IT) injection.",[341,342],"Hepatic Cancer","Surgery",[344,345,346,342,347,348,349,350],"Hepatocellular Carcinoma;","Intra-tumor injection","Neoadjuvant therapy","Immunotherapy","CTLA4 antibody","PD1 antibody","PDL1 antibody","2024-07-02",{"date":353,"type":40},"2024-07-09",{"date":355,"type":40},"2024-07-01",{"date":357,"type":22},"2033-12-30",{"name":46,"class":47},{"id":360,"slug":361,"hasResults":12,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":162,"enrollmentInfo":366,"targetDuration":4,"studyType":23,"phases":367,"briefSummary":368,"conditions":369,"keywords":372,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":377,"startDateStruct":378,"completionDateStruct":379,"leadSponsor":381,"locationsCount":48},"100553925","phase-2-neoadjuvant-intra-tumor-double-immunotherapy-for-lung-cancer-100553925","NCT06492421","Neoadjuvant Intra-tumor Double Immunotherapy for Lung Cancer.","Phase II Study of Neoadjuvant CT-Guided Intra-tumor Double Checkpoint Blockades for Untreated Stage I-IIIA Non-Small Cell Lung Cancers Amenable for Surgical Resection","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed previously untreated non-small cell lung cancer. If a diagnostic biopsy is available, a pre-treatment biopsy is not required. Patients with a suspected lung cancer are eligible, but pathology must be confirmed prior to initiating treatment on study.\n2. Patients with stage IIIA must not have more than one mediastinal lymph node station involved by tumor.\n3. All patients must have lymph node evaluation of contralateral stations 2 and\u002For 4 to exclude N3 disease.\n4. The patient must be a suitable candidate for surgery, in the opinion of the treating physician.\n5. Signed and dated written informed consent must be provided by the patient prior to admission to the study in accordance with International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines and to the local legislation.\n6. Eastern Cooperative Oncology Group (ECOG) performance status score 0-1.\n7. Absolute neutrophil count (ANC) \\>= 1.5 x 10\\^9\u002FL; Hemoglobin \\>= 8.0 g\u002FdL; Platelets \\>= 100 x 10\\^9\u002FL; Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) (except subjects with Gilbert syndrome who can have total bilirubin \\\u003C 3.0 mg\u002FdL); Creatinine =\\\u003C 1.5 x ULN or calculated creatinine clearance \\>= 50 mL\u002Fmin using Cockcroft-Gault formula for creatinine clearance calculation OR 24-hour urine creatinine clearance \\>= 50 mL\u002Fmin.\n\nExclusion Criteria:\n\n1. Prior systemic therapy or radiation therapy for treatment of the current lung cancer.\n2. Currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) or investigational anti-cancer drug.\n3. Pregnant or lactating female.\n4. Unwillingness or inability to follow the procedures required in the protocol.\n5. Patients with pre-existing sensorineural hearing impairment\u002Floss or newly diagnosed as documented by an audiology assessment performed prior to study enrollment may not be eligible for cisplatin and may be dispositioned to carboplatin, as determined by the treating physician.\n6. Patients with a history of severe hypersensitivity reaction to taxotere and or polysorbate 80 must be excluded.\n7. Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.\n8. Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n9. Subjects with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \\> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Subjects are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if \\> 10 mg\u002Fday prednisone equivalents. A brief course of corticosteroids for prophylaxis (eg, contrast dye allergy) or for treatment of non-autoimmune conditions (eg, delayed-type hypersensitivity reaction caused by contact allergen) is permitted.\n10. Prior treatment with an anti-PD-1, anti-PD-L1 or anti-CTLA-4 antibody.\n11. Known positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid indicating acute or chronic infection.\n12. Known history of testing positive for human immunodeficiency virus or known acquired immunodeficiency syndrome.\n13. History of severe hypersensitivity reaction to any monoclonal antibody and\u002For to study drug components.\n14. Serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the study.\n15. Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule.\n16. Allergic to contrast agent.\n17. Any agents which could affect the absorption or pharmacokinetics of the study drugs.\n18. Other conditions that investigator decides not suitable for the trial.",{"count":337,"type":22},[59],"This phase II trial studies how well intra-tumor injection of double checkpoint inhibitors work when given alone and in combination with chemotherapy or\u002Fand bevacizumab in treating patients with previously untreated stage I-IIIA non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as ipilimumab, pembrolizumab or durvalumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Drugs used in interventional radiological chemotherapy, such as idabubicin, can directly kill the cancer cell and release tumor antigens to activate DC function in situ. Giving intra-tumor injection of checkpoints inhibitors with or without chemotherapy and\u002For bevecizumab may work better than in vein infusion of the drugs in treating patients with non-small cell lung cancer.",[370,342,371],"Lung Cancer","Non-small Cell Lung Cancer",[373,345,346,374,375,376],"NSCLC","Double immunotherapy","Interventional radiology","Bevacizumab",{"date":353,"type":40},{"date":355,"type":40},{"date":380,"type":22},"2035-12-30",{"name":46,"class":47},{"id":383,"slug":384,"hasResults":12,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":162,"enrollmentInfo":389,"targetDuration":4,"studyType":23,"phases":390,"briefSummary":391,"conditions":392,"keywords":395,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":404,"locationsCount":48},"100553185","phase-2-checkpoint-inhibitor-combinations-therapy-as-first-line-for-hcc-via-it-100553185","NCT06482801","Checkpoint Inhibitor Combinations Therapy as First Line for HCC Via IT","Intra-tumor Delivery of Double Checkpoint Inhibitors, Chemodrug, and\u002For Bevacizumab Therapy as First Line for Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Cytohistological confirmation is required for diagnosis of cancer.\n2. Signed informed consent before recruiting.\n3. Age above 18 years with estimated survival over 3 months.\n4. Child-Pugh class A or B\u002FChild score \\> 7; ECOG score \\\u003C 2\n5. Tolerable coagulation function or reversible coagulation disorders\n6. Laboratory examination test within 7 days prior to procedure: WBC≥3.0×10E9\u002FL; Hb≥90g\u002FL； PLT ≥50×10E9\u002FL；INR \\\u003C 2.3 or PT \\\u003C 6 seconds above control；Cr ≤ 145.5 umul\u002FL；Albumin \\> 28 g\u002FL；Total bilirubin \\\u003C 51 μmol\u002FL\n7. At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1.\n8. Birth control.\n9. Willing and able to comply with scheduled visits, treatment plan and laboratory tests.\n\nExclusion Criteria:\n\n1. Patients participated in clinical trials of equipment or drugs (signed informed consent) within 4 weeks;\n2. Patients accompany by ascites, hepatic encephalopathy and esophageal and gastric varices bleeding;\n3. Any serious accompanying disease, which is expected to have an unknown, impact on the prognosis, include heart disease, inadequately controlled diabetes and psychiatric disorders;\n4. Patients accompanied with other tumors or past medical history of malignancy;\n5. Pregnant or lactating patients, all patients participating in this trial must adopt appropriate birth control measures during treatment;\n6. Patients have poor compliance.\n\n   Any contraindications for hepatic arterial infusion procedure:\n\n   A.Impaired clotting test (platelet count \\\u003C 60000\u002Fmm3, prothrombin activity \\\u003C 50%).\n\n   B.Renal failure \u002F insufficiency requiring hemo-or peritoneal dialysis. C.Known severe atheromatosis. D.Known uncontrolled blood hypertension (\\> 160\u002F100 mm\u002FHg).\n7. Allergic to contrast agent;\n8. Any agents which could affect the absorption or pharmacokinetics of the study drugs\n9. Other conditions that investigator decides not suitable for the trial.",{"count":337,"type":22},[59],"This trial is designed to investigate the safety, response rates and survival outcomes of patients with hepatocellular carcinoma by infusion of CTLA4, PD1 and PDL1 antibodies combination with chemodrug or\u002Fand bevacizumab through intra-tumor (IT).",[393,394],"Liver Cancer","Antibody",[62,345,396,348,349,350,397,398],"First line","chemodrug","anti-angiogenesis","2024-06-27",{"date":355,"type":40},{"date":402,"type":40},"2024-06-10",{"date":380,"type":22},{"name":46,"class":47},{"id":406,"slug":407,"hasResults":12,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":162,"enrollmentInfo":411,"targetDuration":4,"studyType":23,"phases":412,"briefSummary":413,"conditions":414,"keywords":416,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":419,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":424,"locationsCount":48},"100553227","phase-2-checkpoint-inhibitor-combinations-therapy-as-first-line-for-inoperable-lung-cancer-via-it-100553227","NCT06483347","Checkpoint Inhibitor Combinations Therapy as First Line for Inoperable Lung Cancer Via IT","Intra-tumor Delivery of Double Checkpoint Inhibitors, Chemodrug, and\u002For Bevacizumab Therapy as First Line for Inoperable Lung Cancer",{"count":337,"type":22},[59],"This trial is designed to investigate the safety, response rates and survival outcomes of patients with inoperable lung cancer by infusion of CTLA4, PD1 and PDL1 antibodies combination with chemodrug or\u002Fand bevacizumab through intra-tumor (IT).",[370,415],"Inoperable Disease",[417,345,347,418],"Inoperable lung cancer","First line therapy",{"date":420,"type":40},"2024-07-03",{"date":422,"type":40},"2024-04-04",{"date":357,"type":22},{"name":46,"class":47},{"id":426,"slug":427,"hasResults":12,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":432,"enrollmentInfo":433,"targetDuration":4,"studyType":23,"phases":435,"briefSummary":436,"conditions":437,"keywords":440,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":448,"completionDateStruct":449,"leadSponsor":450,"locationsCount":48},"100552979","phase-1-stem-cell-derived-exome-for-treatment-of-diabetic-foot-100552979","NCT06480123","Stem Cell Derived Exome for Treatment of Diabetic Foot","Skin Drug Prepared From Stem Cell Derived Exome for Treatment of Diabetic Foot: a Phase II Clinical Trial","Inclusion Criteria:\n\n1. Clinical diagnosis of diabetic foot.\n2. Signed informed consent before recruiting.\n3. Age above 18 years or less than 90 years.\n4. ECOG score \\\u003C 4\n5. Tolerable coagulation function or reversible coagulation disorders\n6. Laboratory examination test within 7 days prior to procedure: WBC≥3.0×10E9\u002FL; Hb≥90g\u002FL； PLT ≥50×10E9\u002FL；INR \\\u003C 2.3 or PT \\\u003C 6 seconds above control；Cr ≤ 145.5 umul\u002FL；Albumin \\> 28 g\u002FL；Total bilirubin \\\u003C 51 μmol\u002FL\n7. Willing and able to comply with scheduled visits, treatment plan and laboratory tests.\n\nExclusion Criteria:\n\n1. Patients participated in clinical trials of equipment or drugs (signed informed consent) within 4 weeks;\n2. Patients accompany by ascites, hepatic encephalopathy and esophageal and gastric varices bleeding;\n3. Any serious accompanying disease, which is expected to have an unknown, impact on the prognosis, include heart disease, inadequately controlled diabetes and psychiatric disorders;\n4. Patients have poor compliance.\n5. Allergic to the skin drug;\n6. Any agents which could affect the absorption or pharmacokinetics of the study drugs\n7. Other conditions that investigator decides not suitable for the trial.","90 Years",{"count":434,"type":22},50,[110,59],"This trial is designed to investigate the safety and efficacy of patients with diabetic foot by using stem cell derived exome.",[438,439],"Diabetic Foot","Stem Cell",[441,442,443,444],"Diabetic foot","Stem cell","Exome","Skin drug","2024-06-26",{"date":447,"type":40},"2024-06-28",{"date":297,"type":22},{"date":357,"type":22},{"name":46,"class":47},{"id":452,"slug":453,"hasResults":12,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":162,"enrollmentInfo":457,"targetDuration":4,"studyType":23,"phases":459,"briefSummary":460,"conditions":461,"keywords":462,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":467,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":471,"locationsCount":48},"100552824","phase-2-interventional-software-for-multi-immunotherapy-of-solid-tumors-100552824","NCT06478108","Interventional Software for Multi-immunotherapy of Solid Tumors","Interventional Software IRSW-MIM Guided Immunotherapy for Advanced Solid Tumors: a Phase II Clinical Trial.",{"count":458,"type":22},60,[59,290],"This trial is designed to investigate the safety, response rates and survival outcomes of patients with advanced solid tumors by intra-tumor (IT) injection of multiple drugs including CTLA4, PD1, and\u002For PDL1 antibodies combined with drugs-eluting beads loaded with IL2, chemodrug, anti-angiogenesis drug, et. al that will be recommended by an AI-based medical software named IRSW-MIM developed by a cooperating company.",[370,393,313],[463,464,465,347,375],"Solid Tumor","Medical device","Software","2024-06-23",{"date":399,"type":40},{"date":469,"type":40},"2024-04-01",{"date":357,"type":22},{"name":46,"class":47},{"id":473,"slug":474,"hasResults":12,"nctId":475,"briefTitle":476,"officialTitle":477,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":478,"enrollmentInfo":479,"targetDuration":4,"studyType":23,"phases":480,"briefSummary":481,"conditions":482,"keywords":492,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":496,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":48},"100453653","phase-1-triplex-checkpoint-inhibitors-therapy-for-advanced-solid-tumors-100453653","NCT05187338","Triplex Checkpoint Inhibitors Therapy for Advanced Solid Tumors","Triplex CTLA4\u002FPD1\u002FPDL1 Checkpoint Inhibitors Combination Therapy for Advanced Solid Tumors","70 Years",{"count":136,"type":22},[110,59],"This trial is designed to investigate the safety, response rates and survival outcomes of patients with advanced solid tumors by infusion of CTLA4, PD1 and PDL1 antibodies combination through venous (IV), artery (IA) or intra-tumor (IT).",[370,393,483,484,485,486,487,488,489,490,491],"Colorectal Cancer","Pancreas Cancer","Ovary Cancer","Head and Neck Cancer","Breast Cancer","Gastric Cancer","Cervical Cancer","Esophageal Cancer","Sarcoma",[493,348,349,350,494,495,345],"Solid tumor","Interventional Radiology","Trans-artery infusion",{"date":497,"type":40},"2024-06-25",{"date":499,"type":40},"2021-11-01",{"date":501,"type":22},"2035-10-30",{"name":46,"class":47},{"id":504,"slug":505,"hasResults":12,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":4,"eligibilityCriteria":509,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":510,"enrollmentInfo":511,"targetDuration":4,"studyType":23,"phases":512,"briefSummary":513,"conditions":514,"keywords":516,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":520,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":524,"locationsCount":48},"100552786","phase-1-anti-cancer-dc-cell-vaccination-to-treat-solid-tumors-100552786","NCT06477614","Anti-cancer DC Cell Vaccination to Treat Solid Tumors","Anti-cancer DC Cell Vaccination to Treat Advanced Solid Tumors: Phase I Clinical Trial","Inclusion Criteria:\n\n1\\. Patients with advanced cancer; 2. Life expectancy \\>12 weeks; 3. Adequate heart, lung, liver, kidney, and blood function; 4. Available high quality vaccine for human use; 5. Informed consent explained to, understood by and signed by patient\u002Fguardian. Patient\u002Fguardian given copy of informed consent.\n\n\\-\n\nExclusion Criteria:\n\n1. Had accepted gene therapy before;\n2. Severe virus infection such as HBV, HCV, HIV, et al;\n3. Known HIV positivity;\n4. Active infectious disease related to bacteria, virus,fungi,et al;\n5. Other severe diseases that the investigators consider not appropriate;\n6. Pregnant or lactating women;\n7. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent\u002Fkg\u002Fday);\n8. Other conditions that the investigators consider not appropriate.","80 Years",{"count":458,"type":22},[110],"Placental or tumor-derived heat shock protein gp96 is collected, purified, and stored. The DC cells are isolated from the patient's blood and then cocultured with the gp96 to obtain the activated DC cell product. The manufactured DC cells are subcutaneously or intra-tumor injected into the patient. Clinical studies will be performed to test anti-cancer function of the DC vaccination for immunotherapy of cancer patients. In this phase I study, the safety, tolerance, and preliminary efficacy of the DC vaccine immunotherapy on advanced cancers will firstly be evaluated.",[313,515],"DC",[463,517,518],"DC Vaccine","gp96","2024-06-22",{"date":399,"type":40},{"date":522,"type":40},"2024-06-05",{"date":380,"type":22},{"name":46,"class":47},{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":4,"eligibilityCriteria":509,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":162,"enrollmentInfo":531,"targetDuration":4,"studyType":23,"phases":533,"briefSummary":534,"conditions":535,"keywords":536,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":538,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":48},"100531092","phase-1-anti-cancer-neoantigen-polypeptide-vaccine-to-treat-solid-tumors-100531092","NCT06195293","Anti-cancer Neoantigen Polypeptide Vaccine to Treat Solid Tumors","Anti-cancer Neoantigen Polypeptide Vaccine to Treat Advanced Solid Tumors: Phase I Clinical Trial",{"count":532,"type":22},30,[110],"The WES and RAN-seq will be performed to identify and verify neoantigens and appropriate polypeptide sequences will be verified, manufactured and protected for vaccine production by multiple in vitro and in vivo studies. Clinical studies will be performed to test anti-cancer function of the polypeptide vaccine for immunotherapy of human cancer patients. In this phase I study, the safety, tolerance, and preliminary efficacy of the polypeptide vaccine immunotherapy on human cancers will firstly be evaluated.",[313],[463,537,347],"Polypeptide Vaccine",{"date":445,"type":40},{"date":540,"type":40},"2024-06-04",{"date":542,"type":22},"2037-12-30",{"name":46,"class":47},{"id":545,"slug":546,"hasResults":12,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":4,"eligibilityCriteria":550,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":162,"enrollmentInfo":551,"targetDuration":4,"studyType":23,"phases":552,"briefSummary":553,"conditions":554,"keywords":557,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":562,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":567,"locationsCount":48},"100531169","phase-1-gpc3mesothelin-car-t-cells-against-cancers-100531169","NCT06196294","GPC3\u002FMesothelin-CAR-γδT Cells Against Cancers","GPC3\u002FMesothelin Targeted CAR-γδT for Immunotherapy of Solid Cancer: Phase I Clinical Trial","Inclusion Criteria:\n\n1\\. Patients with advanced cancer that expresses GPC3 or Mesothelin protein; 2. Life expectancy \\>12 weeks; 3. Adequate heart, lung, liver, kidney, and blood function; 4. Available autologous transduced T cells with greater than or equal to 20% expression of GPC3\u002FMesothelin-CAR determined by flow-cytometry and killing of Mesothelin-positive targets greater than or equal to 20% in cytotoxicity assay; 5. Informed consent explained to, understood by and signed by patient\u002Fguardian. Patient\u002Fguardian given copy of informed consent.\n\n\\-\n\nExclusion Criteria:\n\n1. Had accepted gene therapy before;\n2. Severe virus infection such as HBV, HCV, HIV, et al;\n3. Known HIV positivity;\n4. Active infectious disease related to bacteria, virus,fungi,et al;\n5. Other severe diseases that the investigators consider not appropriate;\n6. Pregnant or lactating women;\n7. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent\u002Fkg\u002Fday);\n8. Other conditions that the investigators consider not appropriate. -",{"count":532,"type":22},[110],"The third generation of GPC3\u002Fmesothelin targeted CAR-γδT cells have been constructed and their anti-cancer function has been verified by multiple in vitro and in vivo studies. Clinical studies will be performed to test anti-cancer function of the CAR-γδT cells for immunotherapy of human cancer patients with GPC3 or Mesothelin expressions. In this phase I study, the safety, tolerance, and preliminary efficacy of the GPC3\u002FMesothelin-CAR-γδT cell immunotherapy on human cancers will firstly be evaluated.",[484,370,393,555,556,313],"Mesothelioma","CAR-T Cell Therapy",[463,558,559,560,561],"CAR-γδT","γδT","GPC3","Mesothelin",{"date":445,"type":40},{"date":564,"type":40},"2024-05-10",{"date":566,"type":22},"2036-12-30",{"name":46,"class":47},{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":4,"eligibilityCriteria":509,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":162,"enrollmentInfo":574,"targetDuration":4,"studyType":23,"phases":575,"briefSummary":576,"conditions":577,"keywords":578,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":580,"startDateStruct":581,"completionDateStruct":583,"leadSponsor":584,"locationsCount":48},"100531099","phase-1-anti-cancer-neoantigen-mrna-vaccine-to-treat-solid-tumors-100531099","NCT06195384","Anti-cancer Neoantigen mRNA Vaccine to Treat Solid Tumors","Anti-cancer Neoantigen mRNA Vaccine to Treat Advanced Solid Tumors: Phase I Clinical Trial",{"count":532,"type":22},[110],"The WES and RAN-seq will be performed to identify and verify neoantigens and appropriate mRNA sequences will be verified, manufactured and protected for vaccine production by multiple in vitro and in vivo studies. Clinical studies will be performed to test anti-cancer function of the mRNA vaccine for immunotherapy of human cancer patients. In this phase I study, the safety, tolerance, and preliminary efficacy of the mRNA vaccine immunotherapy on human cancers will firstly be evaluated.",[313],[579,463,347],"mRNA Vaccine",{"date":445,"type":40},{"date":582,"type":40},"2024-05-08",{"date":542,"type":22},{"name":46,"class":47},{"id":586,"slug":587,"hasResults":12,"nctId":588,"briefTitle":589,"officialTitle":590,"acronym":4,"eligibilityCriteria":591,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":162,"enrollmentInfo":592,"targetDuration":4,"studyType":23,"phases":593,"briefSummary":594,"conditions":595,"keywords":596,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":598,"startDateStruct":599,"completionDateStruct":601,"leadSponsor":603,"locationsCount":48},"100499181","phase-1-mesothelingpc3gucy2c-car-t-cells-against-cancers-100499181","NCT05779917","Mesothelin\u002FGPC3\u002FGUCY2C-CAR-T Cells Against Cancers","Mesothelin\u002FGPC3\u002FGUCY2C Targeted CAR-T for Immunotherapy of Pancreatic Cancer: Phase I Clinical Trial","Inclusion Criteria:\n\n1\\. Patients with advanced cancer that expresses Mesothelin protein; 2. Life expectancy \\>12 weeks; 3. Adequate heart, lung, liver, kidney, and blood function; 4. Available autologous transduced T cells with greater than or equal to 20% expression of Mesothelin-CAR determined by flow-cytometry and killing of Mesothelin-positive targets greater than or equal to 20% in cytotoxicity assay; 5. Informed consent explained to, understood by and signed by patient\u002Fguardian. Patient\u002Fguardian given copy of informed consent.\n\n\\-\n\nExclusion Criteria:\n\n1. Had accepted gene therapy before;\n2. Severe virus infection such as HBV, HCV, HIV, et al;\n3. Known HIV positivity;\n4. Active infectious disease related to bacteria, virus,fungi,et al;\n5. Other severe diseases that the investigators consider not appropriate;\n6. Pregnant or lactating women;\n7. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent\u002Fkg\u002Fday);\n8. Other conditions that the investigators consider not appropriate. -",{"count":532,"type":22},[110],"The second generation of mesothelin targeted CAR-T cells that secret a fusion protein of IL21 and scfv against PD1 have been constructed and their anti-cancer function has been verified by multiple in vitro and in vivo studies. Clinical studies will be performed to test anti-cancer function of the CAR-T cells for immunotherapy of human cancer patients with Mesothelin expressions. In this phase I study, the safety, tolerance, and preliminary efficacy of the Mesothelin-CAR-T cell immunotherapy on human cancers will firstly be evaluated.",[484,556,561,313],[484,597,561,463],"CAR-T",{"date":497,"type":40},{"date":600,"type":40},"2023-03-10",{"date":602,"type":22},"2036-03-10",{"name":46,"class":47},{"id":605,"slug":606,"hasResults":12,"nctId":607,"briefTitle":608,"officialTitle":609,"acronym":4,"eligibilityCriteria":610,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":162,"enrollmentInfo":611,"targetDuration":4,"studyType":23,"phases":613,"briefSummary":614,"conditions":615,"keywords":620,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":628,"startDateStruct":629,"completionDateStruct":631,"leadSponsor":633,"locationsCount":48},"100470811","phase-1-cldn6gpc3mesothelinaxl-car-nk-cell-therapy-for-advanced-solid-tumors-100470811","NCT05410717","CLDN6\u002FGPC3\u002FMesothelin\u002FAXL-CAR-NK Cell Therapy for Advanced Solid Tumors","Phase I Trial to Evaluate Safety and Preliminary Efficacy of CLDN6\u002FGPC3\u002FMesothelin\u002FAXL-CAR-NK in Patients With CLDN6\u002FGPC3\u002FMesothelin\u002FAXL-positive Advanced Solid Tumors","Inclusion Criteria:\n\n1. patients with advanced ovarian cancer or other cancers with expression of claudin6.\n2. Life expectancy \\>12 weeks\n3. Adequate heart,lung,liver,kidney function\n4. Available autologous transduced NK cells with greater than or equal to 20% expression of Claudin6, GPC3, Mesothelin, or AXL-CAR determined by flow-cytometry and killing of claudin6-positive targets greater than or equal to 20% in cytotoxicity assay\n5. Informed consent explained to, understood by and signed by patient\u002Fguardian. Patient\u002Fguardian given copy of informed consent. -\n\nExclusion Criteria:\n\n1. Had accepted gene therapy before;\n2. Tumor size more than 25cm;\n3. Severe virus infection such as HBV,HCV,HIV,et al\n4. Known HIV positivity\n5. History of liver\u002Frenal transplantation\n6. Active infectious disease related to bacteria, virus,fungi,et al\n7. Other severe diseases that the investigators consider not appropriate;\n8. Pregnant or lactating women\n9. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent\u002Fkg\u002Fday)\n10. Other conditions that the investigators consider not appropriate. -",{"count":612,"type":22},200,[110],"This study is an open, exploratory clinical study to evaluate the safety and preliminary efficacy of Claudin6, GPC3, Mesothelin, or AXL targeting CAR-NK cells in patients with Claudin6, GPC3, Mesothelin, or AXL-positive advanced solid tumors (ovarian cancer and others)",[616,617,618,619],"Stage IV Ovarian Cancer","Testis Cancer, Refractory","Endometrial Cancer Recurrent","CAR NK",[493,621,619,560,561,622,623,624,625,626,349,350,627],"Claudin6","AXL","Cannabidiol","Nicotinamide adenine dinucleotide","IL7","CCL19","CTLA1 antibody",{"date":497,"type":40},{"date":630,"type":40},"2022-06-01",{"date":632,"type":22},"2036-05-31",{"name":46,"class":47},""]