[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"China\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":620},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,15375,0,25,[9,44,65,88,109,130,160,187,210,231,253,278,306,337,359,382,406,429,451,483,506,528,556,575,595],{"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":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100053563","phase-2-a-phase-ii-clinical-study-of-multimodal-ablation-combined-with-systemic-drug-therapy-for-advanced-solid-tumors-100053563",false,"NCT06889610","A Phase II Clinical Study of Multimodal Ablation Combined With Systemic Drug Therapy for Advanced Solid Tumors.","A Single-center,Multi-cohort,Prospective Phase II Clinical Study of Multimodal Ablation Combined With Systemic Drug Therapy for Advanced Solid Tumors.","Inclusion Criteria i. Common eligibility criteria for all cohorts:\n\n1\\. Age between 18-80 years,gender not limited; 2. Patients with hepatic lesions amenable to ablation, all hepatic lesions \\\u003C5 cm in diameter; 3. Expected survival≥3 months; 4. ECOG performance status score of 0-1; 5. Within 14 days before the first dose,laboratory tests indicate adequate organ function:\n\na) Hematology:WBC≥3.0×10\\^9\u002FL;ANC≥1.5×10\\^9\u002FL;PLT≥75×10\\^9\u002FL;HGB≥90 g\u002FL b) Liver function:Child-Pugh score≤7,AST≤5.0×ULN;ALT≤5.0×ULN;TBIL≤1.5×ULN c) Renal function:Cr≤1.5×ULN or CrCl≥60 mL\u002Fmin d) Coagulation function:INR≤1.5×ULN(for patients on anticoagulant therapy,≤3×ULN,anticoagulants must be discontinued one week before ablation);APTT≤1.5×ULN ii. Additional eligibility criteria for each cohort:\n\n1. Colorectal Cancer：\n\n   a) Clinically or pathologically confirmed colorectal cancer with liver metastases that are unresectable, or the patient is intolerant to or refuses surgery; b) Patients who have failed standard second-line drug therapy.\n2. Triple-negative breast cancer :\n\n   1. Clinically or pathologically confirmed triple-negative breast cancer(triple-negative defined as\\\u003C1% nuclear staining for ER and PR expression and HER2 negative);\n   2. Patients who have failed standard second-line drug therapy(including those who have failed PD-1 monoclonal antibody therapy, with progression within six months of adjuvant or neoadjuvant therapy considered as first-line therapy failure).\n3. Melanoma :\n\n   1. Clinically or pathologically confirmed melanoma liver metastasis, with inoperable or intolerable liver lesions or refusal of surgical resection;\n   2. Patients who have failed standard first-line drug therapy.\n\nExclusion Criteria:\n\ni. Common exclusion criteria for all cohorts:\n\n1. Patients with known allergy or suspected allergy to the study drugs or similar drugs;\n2. Patients who have participated in another clinical study and received at least one treatment within 4 weeks prior to enrollment;\n3. History or concurrent presence of other malignant tumors(except for cured basal cell carcinoma of the skin,superficial bladder cancer,carcinoma in situ of the cervix,and papillary thyroid carcinoma);\n4. Patients with immunodeficiency diseases within 7 days prior to the first dose,or currently receiving systemic corticosteroid therapy(≥10mg\u002Fday prednisone or equivalent dose of other corticosteroids),or other forms of immunosuppressive therapy;\n5. Symptomatic central nervous system(CNS)metastases,or other evidence indicating that the CNS metastases have not been controlled,and deemed unsuitable for enrollment by the investigator;\n6. Patients who have previously undergone organ or bone marrow transplantation;\n7. Uncontrollable pleural effusion,pericardial effusion,or ascites causing respiratory syndrome(≥CTCAE grade 2 dyspnea);\n8. Esophageal(gastric fundus)variceal rupture bleeding within the last month;\n9. Other antitumor treatments outside the combined regimen,such as radiotherapy,systemic chemotherapy,etc.;\n10. Clinically significant electrolyte abnormalities as judged by the investigator;\n11. Insufficiency or failure of major organs;\n12. Patients who have received systemic drug therapy,radiotherapy,or local liver treatment,with a time interval of less than 1 month since the last systemic treatment or local liver treatment;\n13. Patients who have received immunotherapy and experienced grade 3 or higher immune-related adverse events(irAEs)(except for thyroid function abnormalities,blood sugar abnormalities);\n14. Active or uncontrolled severe infections(≥CTCAE grade 2 infections);\n15. Any other disease,clinically significant metabolic abnormalities,physical examination abnormalities,or laboratory test abnormalities that,in the investigator's judgment,may have a disease or condition that makes the patient unsuitable for the study drug,or may affect the interpretation of the study results,or may place the patient at high risk;\n16. Pregnant or breastfeeding women,or women of childbearing age with a positive baseline pregnancy test;\n17. Known human immunodeficiency virus(HIV)infection;known clinically significant liver disease history,including viral hepatitis\\[known carriers of hepatitis B virus(HBV)must exclude active HBV infection,i.e.,HBV DNA positive(\\>1×10\\^4 copies\u002FmL or\\>2000 IU\u002FmL);known hepatitis C virus(HCV)infection and HCV RNA positive(\\>1×10\\^3 copies\u002FmL),or other hepatitis,cirrhosis;\n18. Patients with severe heart,lung,liver,or kidney dysfunction,irreversible coagulation disorders,or other uncontrolled diseases(including hypertension or diabetes,active infections,mental illness,or social conditions that may affect patient compliance);\n19. Other factors that may affect patient safety or trial compliance as judged by the investigator.\n\nii. Additional exclusion criteria for each cohort:\n\n1. Colorectal Cancer :\n\n   a) Patients with uncontrolled hypertension, defined as: patients with hypertension that cannot be well-controlled with a single antihypertensive agent (SBP ≥150 mmHg or DBP ≥100 mmHg); or patients who require two or more antihypertensive medications to control blood pressure.\n\n   b）Patients with urine dipstick proteinuria ≥2+ and a 24-hour urinary protein level \\>1.0 g.\n\n   c）Patients with gastrointestinal diseases such as active gastric or duodenal ulcers, ulcerative colitis, or active bleeding from an unresected tumor; or other conditions judged by the investigator as potentially causing gastrointestinal bleeding or perforation.\n\n   d）Patients with evidence or history of a significant bleeding tendency within 3 months prior to enrollment (e.g., bleeding \\>30 mL, hematemesis, melena, hematochezia), hemoptysis (\\>5 mL of fresh blood within 4 weeks), or a thromboembolic event (including stroke and\u002For transient ischemic attack) within the past 12 months.\n\n   e）Patients with clinically significant cardiovascular disease, including but not limited to, acute myocardial infarction, severe\u002Funstable angina, or coronary artery bypass grafting within 6 months prior to enrollment.\n\n   f）Congestive heart failure of New York Heart Association (NYHA) class \\> II; ventricular arrhythmias requiring medication; or an ECG showing a QTc interval ≥480 milliseconds.\n\n   g）Patients who are unable to take fruquintinib orally.\n2. Triple-negative breast cancer :\n\n   a) Patients who have previously received pucotenlimab treatment;\n3. Melanoma :\n\n   1. Patients who have previously received pembrolizumab or toripalimab treatment;\n   2. Patients currently have uncontrolled hypertension,defined as:patients with hypertension that cannot be well controlled with monotherapy(systolic blood pressure≥150 mmHg,or diastolic blood pressure≥100 mmHg);or patients using two or more antihypertensive drugs to control blood pressure;\n   3. Urine routine indicates proteinuria≥2+,and 24-hour urine protein\\>1.0g;\n   4. Significant clinically meaningful cardiovascular diseases,including but not limited to acute myocardial infarction,severe\u002Funstable angina,or coronary artery bypass grafting within 6 months before enrollment;\n   5. Congestive heart failure New York Heart Association(NYHA)classification\\>2;ventricular arrhythmias requiring drug treatment;electrocardiogram(ECG)showing QTc interval≥480 milliseconds.","ALL","18 Years","80 Years",{"count":21,"type":22},95,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This study focuses on the treatment of liver metastases from three common cancers: colorectal cancer, triple-negative breast cancer and melanoma. Currently, there are limitations in the treatment of liver metastases of these cancers. Multimodal thermophysical ablation therapy can reshape the tumor microenvironment, release neoantigens, and act as an in-situ vaccine. On this basis, the combination of multimodal ablation with immunotherapeutic drugs such as pucotenlimab will be explored. The efficacy and safety of this combination therapy in patients with liver metastases of solid tumors will be investigated, with the expectation of breaking through the existing treatment limitations.",[28,29,30],"Triple Negative Breast Cancer Metastatic","Melanoma Metastatic","Colorectal Cancer Metastatic","RECRUITING","2026-07-10",{"date":34,"type":35},"2026-07-13","ACTUAL",{"date":37,"type":35},"2026-03-30",{"date":39,"type":22},"2028-12-30",{"name":41,"class":42},"Fudan University","OTHER",1,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":58,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":43},"100054229","phase-2-a-study-of-glofitamab-plus-gemox-compared-with-standard-of-care-in-patients-with-relapsedrefractory-diffuse-large-b-cell-lymphoma-100054229","NCT07599423","A Study of Glofitamab Plus GemOx Compared With Standard of Care in Patients With Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma","An Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Glofitamab in Combination With Gemcitabine Plus Oxaliplatin Versus Standard of Care in Patients With Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma","Inclusion Criteria:\n\n* Signed Informed Consent Form.\n* Age 18 years or older at the time of signing the Informed Consent Form.\n* Histologically proven diffuse large B-cell lymphoma (DLBCL), including transformation from follicular lymphoma.\n* Relapsed or refractory disease after first-line chemoimmunotherapy, defined as refractory disease (no complete remission to first-line therapy, progressive disease as best response, stable disease after 3-4 cycles, or partial response after 6-8 cycles\u002Fprogression within 12 months of first-line therapy) or relapsed disease (complete remission followed by biopsy-proven relapse within 12 months of first-line therapy).\n* No known history or suspicion of central nervous system (CNS) involvement by lymphoma.\n* Life expectancy of at least 12 weeks.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* At least one bi-dimensionally measurable nodal lesion (1.5 cm or larger) or extranodal lesion (1 cm or larger) as measured on a CT scan.\n* Negative HIV test at screening.\n* Adequate hematologic function defined as hemoglobin 9.0 g\u002FdL or higher without transfusion in the past 7 days, absolute neutrophil count 1.0 x 10\\^9\u002FL or higher, and platelet count 75 x 10\\^9\u002FL or higher.\n* Adequate organ function defined as estimated creatinine clearance 60 mL\u002Fmin or higher, ALT\u002FAST 2.5 times the upper limit of normal (ULN) or lower, and total bilirubin 1.5 mg\u002FdL or lower (or 3 x ULN or lower in subjects with Gilbert's syndrome).\n* Cardiac ejection fraction greater than 50%, no evidence of pericardial effusion, and no clinically significant electrocardiogram findings.\n* No clinically significant pleural effusion.\n* Baseline oxygen saturation greater than 92% on room air.\n* Able to understand and complete study-related questionnaires.\n* Agreement to remain abstinent or use adequate contraceptive methods for both female and male participants during the treatment period and for the protocol-specified duration after the final dose.\n\nExclusion Criteria:\n\n* Contraindication to glofitamab components or a history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.\n* Not eligible for autologous stem cell transplantation (ASCT).\n* Prior solid organ transplantation.\n* History of Richter's transformation or of indolent disease to diffuse large B-cell lymphoma (DLBCL) or primary mediastinal B-cell lymphoma (PMBCL).\n* Peripheral neuropathy assessed to be greater than Grade 1 at enrollment.\n* Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3.\n* Use of any investigational therapy for treating cancer within 28 days prior to Cycle 1, any monoclonal antibody within 3 months, or systemic immunotherapeutic agents within 4 weeks or five half-lives (whichever is shorter).\n* Prior radiotherapy to the mediastinal or pericardial region.\n* History of autologous or allogeneic stem cell transplant.\n* Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or better, except for alopecia and anorexia.\n* Administration of a live, attenuated vaccine within 4 weeks before the first study treatment administration.\n* Received more than one line of therapy for DLBCL.\n* Corticosteroid use greater than 50 mg\u002Fday of prednisone or equivalent for purposes other than lymphoma symptom control.\n* Recent major surgery within 4 weeks before the first study treatment.\n* History of other malignancy that could affect compliance or interpretation of results, with exceptions for adequately treated low-grade or in situ carcinomas and malignancies in remission for at least 2 years.\n* Significant cardiovascular disease, such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 3 months, unstable arrhythmias, or unstable angina.\n* Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, neurodegenerative disease, or CNS lymphoma.\n* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH).\n* Current or past history of Waldenstrom macroglobulinemia.\n* History or presence of a clinically significant abnormal ECG.\n* Known or suspected active infection, reactivation of a latent infection, or any major episode of infection requiring hospitalization or IV antibiotics within 4 weeks of dosing.\n* History of severe treatment-emergent immune-related adverse events associated with prior immunotherapeutic agents.\n* History of autoimmune disease, with specific protocol-defined exceptions for well-controlled conditions.\n* Clinically significant liver disease, including active viral\u002Fother hepatitis or cirrhosis.\n* Abnormal coagulation laboratory values defined as INR or PT greater than 1.5 x ULN, or PTT\u002FaPTT greater than 1.5 x ULN.\n* Suspected active or latent tuberculosis.\n* Positive test results for chronic hepatitis B infection (HBsAg positive) or positive test results for hepatitis C with positive HCV RNA.\n* Diagnosis with SARS-CoV-2 infection within 30 days prior to first study treatment, or documented infection within 6 months with persistent respiratory symptoms.\n* History of progressive multifocal leukoencephalopathy (PML).\n* Pregnancy, breastfeeding, or intention of becoming pregnant during the study.",{"count":52,"type":22},96,[25],"The purpose of this study is to evaluate the efficacy and safety of glofitamab in combination with gemcitabine plus oxaliplatin (GemOx) versus standard of care (SOC) in patients with relapsed\u002Frefractory diffuse large B-cell lymphoma (R\u002FR DLBCL) who have relapsed early (within 1 year) or are primary refractory to first-line therapy. Participants will be randomly assigned in a 1:1 ratio to receive either the Glofitamab-GemOx combination regimen or SOC. The SOC arm consists of investigator's choice of salvage chemoimmunotherapy followed by autologous stem cell transplantation (ASCT) for eligible patients. The primary endpoint of the study is event-free survival (EFS).",[56],"Diffuse Large B Cell Lymphoma (DLBCL)","NOT_YET_RECRUITING",{"date":34,"type":35},{"date":60,"type":22},"2026-07-22",{"date":62,"type":22},"2030-12-31",{"name":64,"class":42},"The First Affiliated Hospital of Soochow University",{"id":66,"slug":67,"hasResults":12,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":12,"sex":17,"minAge":72,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":23,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":79,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":87},"100054056","phase-2-podomount-basket-a-study-to-test-whether-bi-764198-helps-adults-and-adolescents-with-different-types-of-kidney-disease-100054056","NCT07355296","PODOMOUNT-Basket, a Study to Test Whether BI 764198 Helps Adults and Adolescents With Different Types of Kidney Disease","PODOMOUNT-Basket, a Phase II, Multicentre, Randomised, 2-arm Parallel-group, Double-blind, Placebo-controlled Basket Trial to Assess Safety, Tolerability, PK, and Efficacy of BI 764198 in Four Proteinuric Kidney Diseases","Inclusion Criteria:\n\n* Male or female participants ≥18 years of age (≥12 years of age for Treatment resistant primary Minimal Change Disease (TR-pMCD)) on the day of signing informed consent\u002Fassent (Visit 1)\n* Body Mass Index (BMI) of ≤40 kg\u002Fm2 at screening visit (Visit 1)\n* Weight of ≥40 kg at screening\n* Estimated glomerular filtration rate (eGFR) ≥25 mL\u002Fmin\u002F1.73 m2 (chronic kidney disease (CKD) EPI formula based on serum cystatin C) at screening visit\n\n  * For adult participants (≥18); ≥25 mL\u002Fmin\u002F1.73 m2 (CKD-EPI formula based on serum cystatin C) at the screening visit\n  * For adolescent participants (\\\u003C18); ≥25 mL\u002Fmin\u002F1.73 m2 (chronic kidey disease under 25 years (CKiD U25) formula using height and serum cystatin C) at the screening visit\n* Seated blood pressure (mean of 3 values) systolic blood pressure (SBP) ≤160 mmHg (adult participants ≥18) or SBP ≤140 mmHg (participants \\\u003C18) at the screening visit (Visit 1). A participant with a documented history of white coat hypertension may be included as long as the participant is considered medically stable by the investigator and \"true\" blood pressure can be considered to be ≤160 mmHg (adult participants ≥18) or ≤140 mmHg (adolescent participants \\\u003C18)\n* Participants should be treated with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), at a stable optimised dose for at least 8 weeks prior to the screening visit (Visit 1), with no plan to change the dose until the end of the randomised treatment period (i.e. end of trial (EoT), Week 20) unless not tolerated or indicated as per the discretion of the investigator\n* If treated with (non-steroidal) mineralocorticoid receptor antagonist (MRA), endothelin receptor antagonists (ERA), glucagon-like peptide-1 (GLP-1) or Sodium-glucose co-transporter-2 (SGLT2) inhibitors (SGLT2i), participants must be on a stable dose for at least 8 weeks prior to the screening visit (Visit 1), preferably with no plan to change the dose until the end of the randomised double-blind treatment period (i.e. EoT, Week 20)\n* Participants treated with oral immunosuppressive therapy except glucocorticoids (e.g. Calcineurin inhibitor(s) (CNI), mycophenolate mofetil\u002F-sodium, cyclophosphamide) must be on a stable dose for at least 12 weeks prior to the screening visit (Visit 1) with no plans to change their dose during the trial treatment period\n* Patients treated\u002Fto be treated with oral glucocorticoids have to be at a dose ≤10 mg\u002Fd prednisolone or equivalent for ≥4 weeks prior to screening with no plan to increase the dose during the treatment period.\n\nFurther inclusion criteria apply.\n\nExclusion Criteria:\n\n* A history of organ transplantation or planned transplantation during the course of the study\n* Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the past 6 months prior to screening visit (Visit 1)\n* Participants in whom initiation of oral or IV immunosuppression is anticipated during the course of the trial\n* Treatment with metformin or dofetilide (multidrug and toxin extrusion protein 1 (MATE1) substrates) within one week prior to randomisation visit (Visit 2) through 5 days after the EoT visit\n* Treatment with strong inhibitors or strong inducers of cytochrome P450 3A4\u002F5 (CYP3A4\u002F5) within one week or 5 half-lives (whichever is longer) prior to randomisation visit (Visit 2)\n* Alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) \\>3X the upper limit of normal (ULN) at screening visit (Visit 1)\n* Clinically significant laboratory abnormalities or medical conditions which pose a safety risk for the participant or may interfere with the trial objectives in the investigator's opinion (except for renal function tests or deviation of clinical laboratory values that are related to the podocytopathy in question) at screening visit\n* QTc intervals (QTcF) greater than 450 ms in males or greater than 470 ms in females, or any other clinically relevant ECG findings (at the investigator's discretion) at screening visit (Visit 1) Further exclusion criteria apply.","12 Years",{"count":74,"type":22},132,[25],"This study is open to adults with certain kidney conditions, including secondary focal segmental glomerulosclerosis (sFSGS), treatment-resistant primary minimal change disease (TR-pMCD), Alport Syndrome (AS), and treatment-resistant primary membranous nephropathy (TR-pMN). Adolescents with treatment-resistant primary MCD can also participate in this study. The purpose of this study is to find out whether a medicine called BI 764198 helps people with these kidney conditions.\n\nParticipants are put into 2 groups randomly, which means by chance. One group takes BI 764198 tablets, and the other group takes placebo tablets. Placebo tablets look like BI 764198 tablets but do not contain any medicine. Participants take a tablet once a day for 20 weeks. All participants also continue their standard medication for their kidney condition during the study. Participants have twice the chance of being placed in the BI 764198 group than in the placebo group.\n\nParticipants are in the study for about 7 months. During this time, they visit the study site 6 times and have 3 phone calls. Doctors regularly test the protein levels in participants' urine by collecting urine samples. They also check kidney function by taking blood samples. The results are compared between the two groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.",[78],"Proteinuric Kidney Diseases",{"date":34,"type":35},{"date":81,"type":35},"2026-03-23",{"date":83,"type":22},"2028-02-17",{"name":85,"class":86},"Boehringer Ingelheim","INDUSTRY",161,{"id":89,"slug":90,"hasResults":12,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":23,"phases":97,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":102,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},"100054317","phase-3-dareon-nec-1-a-study-in-people-with-advanced-extrapulmonary-neuroendocrine-cancer-epnec-to-compare-obrixtamig-plus-carboplatin-and-etoposide-treatment-with-standard-chemotherapy-100054317","NCT07544654","DAREON®-NEC-1: A Study in People With Advanced Extrapulmonary Neuroendocrine Cancer (epNEC) to Compare Obrixtamig Plus Carboplatin and Etoposide Treatment With Standard Chemotherapy","A Phase III, Multi-center, Open-label, Randomised, Controlled Trial of Intravenous Obrixtamig in Combination With Carboplatin and Etoposide vs. Carboplatin and Etoposide as First-line Therapy in DLL3-positive Patients With Unresectable Locally Advanced or Metastatic Extrapulmonary Neuroendocrine Carcinomas","Inclusion Criteria:\n\n1. Patients with poorly differentiated unresectable locally advanced or metastatic extrapulmonary neuroendocrine carcinoma (epNEC) with Ki-67 \\>20% or mitotic rate mitotic rate with number of mitoses \\>20 per 2 mm2, regardless of primary site (including site of unknown origin)\n2. Patients with tumours with mixed histologies are eligible only if neuroendocrine carcinoma component is predominant and represents more than 70% of the overall tumour tissue\n3. No prior systemic treatment for unresectable locally advanced or metastatic epNEC (except for the completed one cycle of standard platinum + etoposide). Prior peri-operative chemotherapy or -radiation for curative intention is allowed if at least 6 months have elapsed between completion of this therapy and diagnosis of unresectable locally advanced or metastatic disease\n4. Patients who have finished one cycle of standard platinum + etoposide regimen as first-line treatment (Cycle 0: etoposide with carboplatin or cisplatin, administered at a minimum dose of cisplatin 75 mg\u002Fm2 or carboplatin area under the curve (AUC) 5 and etoposide 80 mg\u002Fm2) prior to randomisation\n5. Patients must comply with criteria for receiving further chemotherapy treatment as first-line standard of care (SoC) treatment within 28 days after the start of the initial chemotherapy (Cycle 0)\n6. Adequate archival Formalin-Fixed Paraffin-Embedded (FFPE) tumour tissue, as specified in the Laboratory Manual, must be available for central laboratory analysis of Delta-like ligand 3 (DLL3) expression status. Tumours must be positive (as defined in the diagnostic study protocol) for DLL3 expression status assessed by investigational VENTANA DLL3 (SP347) RxDx Assay\n7. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1\n8. Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF) Further inclusion criteria apply.\n\nExclusion Criteria:\n\n1. Presence of leptomeningeal disease and\u002For carcinomatous meningitis\n2. Patients with diagnosis of Merkel cell carcinoma or medullary thyroid carcinoma\n3. Patients with neuroendocrine prostate cancer\n4. Patients with well-differentiated neuroendocrine tumours of any grade according to the world health organization (WHO) classification, 5th edition\n5. Patients with a history of well differentiated Neuroendocrine tumour (NET) tumour that transformed into poorly differentiated Neuroendocrine carcinoma (NEC)\n6. Previous treatment with obrixtamig or other DLL3-targeting therapies (e.g. T-cell engager (TcEs), cell therapies, antibody-drug conjugates, or radiopharmaceuticals)\n7. Previous treatment with anti-PD-1 or programmed death ligand 1 (PD-L1) therapies during the one cycle of standard platinum + etoposide first-line chemotherapy (Cycle 0)\n8. Toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or grade prior to Cycle 0. Participants with alopecia any grade, CTCAE ≤Grade 2 asthenia\u002Ffatigue, amenorrhea\u002Fmenstrual disorders any grade, CTCAE ≤Grade 2 peripheral neuropathy, and\u002For CTCAE ≤Grade 2 endocrinopathies controlled by replacement therapy, and toxicities, which are considered irreversible but stable for at least 4 weeks, per Investigator judgement may be eligible Further exclusion criteria apply.",{"count":96,"type":22},390,[98],"PHASE3","This study is open to adults with advanced extrapulmonary neuroendocrine cancer. The purpose of this study is to find out if a study medicine called obrixtamig plus standard chemotherapy (carboplatin and etoposide) improves survival when compared to standard chemotherapy (carboplatin and etoposide) alone. Obrixtamig is an antibody-like molecule that may help the immune system fight cancer. Another purpose of the study is to test a medical device being developed to measure levels of the tumour marker delta-like ligand 3 (DLL3).\n\nParticipants are put into 2 groups randomly, which means by chance. One group (treatment arm) receives obrixtamig and standard chemotherapy followed by obrixtamig alone for up to 3 years. The other group (control arm) receives standard chemotherapy without obrixtamig for about 4 months. All treatments are given as infusions into a vein.\n\nDuring the study, participants in both groups visit the study site regularly. Participants in the treatment arm stay overnight at the study site following the first 2 obrixtamig treatments. The doctors regularly check participants' health and take note of any unwanted effects. At some of the visits, doctors check the size of the tumour(s). The results are compared between the 2 groups to see whether the treatment works.",[101],"Extrapulmonary Neuroendocrine Cancer (epNEC)",{"date":34,"type":35},{"date":104,"type":22},"2026-07-07",{"date":106,"type":22},"2031-03-11",{"name":85,"class":86},165,{"id":110,"slug":111,"hasResults":12,"nctId":112,"briefTitle":113,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":23,"phases":118,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":129},"100053916","phase-2-targeted-therapies-for-immunological-non-responders-in-people-with-hiv-a-multicenter-clinical-study-100053916","NCT07637877","Targeted Therapies for Immunological Non-Responders in People With HIV: A Multicenter Clinical Study","Inclusion Criteria:\n\n1. Patients with incomplete immune reconstitution, aged between 18 and 65 years (inclusive).\n2. At enrollment, have received antiretroviral therapy (ART) for more than 4 years, with plasma HIV-RNA below the lower limit of detection (VL \\\u003C 50 copies\u002FmL) for more than 3 years, while CD4⁺ T cell count remains persistently below 350 cells\u002FμL.\n3. Within 1 year prior to enrollment, CD4⁺ T cell count remains persistently below 350 cells\u002FμL but above 200 cells\u002FμL.\n4. Currently receiving a dolutegravir (DTG)-based ART regimen (e.g., DTG plus lamivudine, or the fixed-dose combination DTG\u002F3TC\u002FABC) for ≥ 1 year, with no relevant drug resistance detected by high-precision resistance testing; no change in the core ART regimen within 1 year prior to enrollment (adjustments of auxiliary medications for side effect management are permitted); and agree to continue the current integrase inhibitor-based regimen for at least 1 year after enrollment.\n5. Willing and able to provide written informed consent prior to any study-related procedures, and to comply with all study requirements.\n\nExclusion Criteria:\n\n1. Co-infection with other viruses: positive for any of HBV, HCV, HDV, or HEV; or CMV\u002FEBV viral load \\> 1000 copies\u002FmL.\n2. HIV-2 infection alone or co-infection with HIV-1 and HIV-2.\n3. History of using efavirenz or rilpivirine within 2 years prior to enrollment.\n4. History of NNRTI resistance.\n5. Clinical signs suggestive of other serious diseases.\n6. Long-term use of corticosteroids or other immunosuppressive agents.\n7. Co-existing severe AIDS-related or non-AIDS-related events.\n8. Co-existing severe underlying diseases of other systems not related to AIDS.\n9. Other severe organic diseases or psychiatric disorders, including any uncontrolled clinically significant disease of the urinary, circulatory, respiratory, nervous, psychiatric, digestive, endocrine, immune systems, or malignancy.\n10. Receipt of immunosuppressive or systemic cytotoxic therapy within 6 months prior to screening.\n11. Evidence of substance abuse within 6 months prior to enrollment, or a positive urine drug screen.\n12. Current participation in another clinical trial that may conflict with the treatment protocol or outcome measures of this study.\n13. Pregnancy, breastfeeding, or women who have a desire to become pregnant.\n14. Inability or unwillingness to provide informed consent or comply with study requirements.\n15. Any other serious condition that may interfere with the conduct of the clinical trial.","60 Years",{"count":117,"type":22},21,[25],"This study focuses on people with HIV who experience incomplete immune reconstitution despite suppressive antiretroviral therapy (ART), characterized by persistently low CD4⁺ T cell counts and residual inflammation. The underlying cause is largely attributed to the persistent HIV latent reservoir. Recent evidence indicates that rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) commonly used in ART, has an immunomodulatory function beyond its antiviral activity. It activates the CARD8 inflammasome - an intracellular \"kill switch\" - triggering pyroptosis selectively in HIV-infected cells. In this study, rilpivirine will be added to suppressive ART in patients with incomplete immune reconstitution. The investigators hypothesize that this strategy will reduce the latent reservoir, restore CD4⁺ T cell counts and function, attenuate excessive immune activation, and ultimately improve long-term clinical outcomes.",[121],"Immunological Non-Responders in People With HIV",{"date":34,"type":35},{"date":124,"type":35},"2026-06-15",{"date":126,"type":22},"2029-01-30",{"name":128,"class":42},"Beijing 302 Hospital",5,{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":12,"sex":17,"minAge":138,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":23,"phases":141,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":152,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":159},"100053313","phase-3-study-to-evaluate-the-efficacy-and-safety-of-abelacimab-in-high-risk-patients-with-atrial-fibrillation-who-have-been-deemed-unsuitable-for-oral-anticoagulation-lilac-timi-76-100053313","NCT05712200","Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76)","A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76)","LILAC-TIMI 76","Inclusion Criteria:\n\n* Patient is able to understand and has provided written informed consent to participate in the trial\n* Diagnosed Atrial Fibrillation (AF) or atrial flutter (documented on an electrocardiogram (ECG) or monitor recording)\n* Age 65-74 and a CHA2DS2VASc ≥4 OR age ≥75 and a CHA2DS2VASc ≥3\n* Patient is judged by the responsible physician to be unsuitable for oral anticoagulation because the risks outweigh the benefits or the patient is unwilling to take oral anticoagulation AND this determination was made prior to and independent of the study\n* At least 1 bleeding risk factor such as severe renal insufficiency, planned daily use of antiplatelet medication for the duration of the trial, history of bleeding from a critical area, or other conditions associated with increased risk of bleeding such as chronic nonsteroidal anti-inflammatory drug (NSAID) use, frailty or multiple falls\n* Patient is judged by the responsible physician to be unsuitable for left atrial appendage (LAA) closure or occlusion device, an approved device is not available, or the patient is unwilling to undergo the procedure AND this determination was made prior to and independent of the study\n\nExclusion Criteria:\n\n* AF due to an ongoing acute reversible cause (e.g., cardiac surgery, pulmonary embolism (PE), untreated hyperthyroidism, alcohol use)\n* Patients who within 60 days prior to randomization (1) received a vitamin K antagonists (VKA) (e.g., warfarin, phenprocoumon, acenocoumarol) or a direct oral anticoagulant (DOAC) such as, dabigatran, rivaroxaban, apixaban, or edoxaban or (2) were newly diagnosed with AF\n* Patients with an intracranial or intraocular bleed within the 3 months prior to screening or any history of spontaneous intracerebral hemorrhage at any time in the absence of antithrombotic treatment\n* Any stroke within 14 days before randomization or transient ischemic attack (TIA) within 3 days before randomization\n* Mechanical heart valve or valve disease that is expected to require mechanical valve replacement intervention (surgical or invasive) during the course of the study\n* Patients on dialysis at screening or who are planned to start dialysis within 6 months\n\nOther protocol defined Inclusion\u002FExclusion criteria may apply","65 Years",{"count":140,"type":22},2500,[98],"A study to evaluate the effect of abelacimab relative to placebo on the rate of ischemic stroke or systemic embolism (SE) in patients with Atrial Fibrillation (AF) who have been deemed by their responsible physicians or by their own decision to be unsuitable for oral anticoagulation therapy.",[144],"Atrial Fibrillation (AF)",[146,147,148,149,150,151],"abelacimab","randomized","placebo-controlled","double-blind","endpoint evaluation","atrial fibrillation",{"date":34,"type":35},{"date":154,"type":35},"2022-12-27",{"date":156,"type":22},"2027-12-30",{"name":158,"class":86},"Anthos Therapeutics, Inc.",789,{"id":161,"slug":162,"hasResults":12,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":12,"sex":168,"minAge":18,"maxAge":169,"enrollmentInfo":170,"targetDuration":4,"studyType":23,"phases":172,"briefSummary":173,"conditions":174,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":180,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":43},"100053974","phase-2-cdk46-inhibitors-combined-with-endocrine-therapy-for-neoadjuvant-treatment-100053974","NCT07366112","CDK4\u002F6 Inhibitors Combined With Endocrine Therapy for Neoadjuvant Treatment","CDK4\u002F6 Inhibitors Combined With Endocrine Therapy for Neoadjuvant Treatment of Breast Cancer: ctDNA-Guided Personalized Therapy","DNACDKHR","Inclusion Criteria:\n\n* 1.Female breast cancer patients aged ≥18 years and ≤75 years, either postmenopausal or premenopausal\u002Fperimenopausal; 2.Pathologically confirmed hormone receptor-positive (HR+), HER2-negative invasive breast cancer:\n\n  1. ER-positive and\u002For PR-positive defined as: ≥10% of tumor cells showing positive staining;\n  2. HER2-negative defined as: standard immunohistochemistry (IHC) result of 0\u002F1+; or IHC 2+ with negative in situ hybridization (ISH) (confirmed by the central pathology laboratory); 3. At least one evaluable lesion per RECIST 1.1, with clinical staging meeting:\n\n  \u003C!-- -->\n\n  1. T1c-2N0M0 with high-risk factors (Grade 3, or Grade 2 with Ki67 ≥20%);\n  2. T3N0M0;\n  3. Any TN+M0; 4.Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; 5.Willing to participate in the study and voluntarily sign informed consent; 6.Agree to undergo ctDNA testing during treatment; 7.Adequate organ and bone marrow function defined as:\n\n  \u003C!-- -->\n\n  1. Absolute neutrophil count (ANC) ≥1,500\u002Fmm³ (1.5 × 10⁹\u002FL) (without granulocyte colony-stimulating factor \\[G-CSF\\] treatment within 14 days);\n  2. Platelet count (PLT) ≥100,000\u002Fmm³ (100 × 10⁹\u002FL) (without corrective therapy within 7 days);\n  3. Hemoglobin (Hb) ≥9 g\u002FdL (90 g\u002FL) (without corrective therapy within 7 days);\n  4. Serum creatinine ≤1.5× upper limit of normal (ULN) or creatinine clearance ≥60 mL\u002Fmin (without corrective therapy within 7 days);\n  5. Total bilirubin (TBIL) ≤1.5×ULN (without corrective therapy within 7 days);\n  6. Aspartate aminotransferase (AST\u002FSGOT) and alanine aminotransferase (ALT\u002FSGPT) ≤1.5×ULN (without corrective therapy within 7 days);\n  7. Cardiac function: left ventricular ejection fraction (LVEF) ≥55%; QTc interval corrected by Fridericia's formula (QTcF) \\\u003C470 msec on 12-lead ECG; Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization and agree to use non-hormonal contraception from informed consent signing until 2 months after the last treatment.\n\nExclusion Criteria:\n\n* 1.Bilateral breast cancer; 2.Prior history of breast cancer (including ductal carcinoma in situ or invasive breast cancer); 3.Any prior antitumor therapy for the current breast cancer, including systemic therapies (endocrine, chemotherapy, immunotherapy, biological therapy) or local therapies (radiotherapy, vascular embolization, axillary lymph node biopsy); 4.Diagnosis of any malignancy within 5 years prior to randomization, except cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin; 5.History of severe pulmonary diseases (e.g., interstitial pneumonia); 6. HIV infection, acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥500 IU\u002FmL), hepatitis C (HCV antibody-positive with HCV RNA above the lower limit of detection), or co-infection with HBV and HCV; 7.Within 6 months prior to randomization: myocardial infarction, severe\u002Funstable angina, NYHA Class ≥II heart failure, ≥Grade 2 persistent arrhythmia (per NCI CTCAE v5.0), atrial fibrillation of any grade, coronary\u002Fperipheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack), or symptomatic pulmonary embolism; 8.Severe active infection within 4 weeks prior to randomization (requiring intravenous antibiotics, antifungals, or antivirals) or unexplained fever \\>38.5°C during screening\u002Fbefore first dose; 9.Known allergy to any component of the study drugs; 10.Current participation in another interventional drug clinical study; 11.Pregnancy or lactation; 12.Refusal to comply with follow-up; 13.Other severe physical\u002Fmental illnesses or laboratory abnormalities that may increase study risk, interfere with results, or render the patient unsuitable per investigator judgment.","FEMALE","75 Years",{"count":171,"type":22},158,[25],"Exploring the dynamics of ctDNA following neoadjuvant therapy with CDK4\u002F6 inhibitors combined with endocrine treatment, and its potential to guide de-escalation of adjuvant chemotherapy",[175,176,177,178,179],"Hormone Receptor-Positive Breast Cancer","High-risk Breast Cancer","Early-Stage Breast Cancer","HER2-negative Breast Cancer","ctDNA Monitoring",{"date":34,"type":35},{"date":182,"type":35},"2026-04-20",{"date":184,"type":22},"2029-12-31",{"name":186,"class":42},"Peking University People's Hospital",{"id":188,"slug":189,"hasResults":12,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":12,"sex":194,"minAge":18,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":23,"phases":197,"briefSummary":198,"conditions":199,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":202,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":209},"100054324","phase-3-a-clinical-study-of-ifinatamab-deruxtecan-i-dxd-in-people-with-metastatic-prostate-cancer-mk-2400-001-100054324","NCT06925737","A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)","A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology\n* Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months prior to Screening\n* Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and\u002For soft tissue disease by computed tomography (CT)\u002Fmagnetic resonance imaging (MRI)\n* Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after at least 8 weeks of treatment\n* Has provided tumor tissue from a core or excisional biopsy from soft tissue not previously irradiated and obtained after disease progression on the most recent prior therapy\n* Has recovered from adverse events (AEs) due to previous anticancer therapies\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Is unable to swallow tablets\u002Fcapsules\n* Has any of the following indicators of interstitial lung disease (ILD)\u002Fpneumonitis:\n\n  1. Has any history of ILD\u002Fpneumonitis that required steroid use, except for a history of radiation pneumonitis that did not require steroids\n  2. Has current ILD\u002Fpneumonitis\n  3. Has a clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out\n* Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses\n* Has uncontrolled or significant cardiovascular disease\n* Has received prior treatment with a taxane-based chemotherapy agent for metastatic castration-resistant prostate cancer (mCRPC)\n* Has had prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities\n* Has a \"superscan\" bone scan","MALE",{"count":196,"type":22},1440,[98],"Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if people who receive I-DXd live longer overall and live longer without the cancer growing or spreading than people who receive chemotherapy.",[200,201],"Prostate Cancer","Prostatic Neoplasms",{"date":34,"type":35},{"date":204,"type":35},"2025-05-13",{"date":206,"type":22},"2031-01-06",{"name":208,"class":86},"Merck Sharp & Dohme LLC",290,{"id":211,"slug":212,"hasResults":12,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":169,"enrollmentInfo":217,"targetDuration":4,"studyType":23,"phases":219,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":223,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":230},"100053537","phase-2-skb264-in-combination-with-skb118-for-non-small-cell-lung-cancer-100053537","NCT07697586","SKB264 in Combination With SKB118 for Non-Small Cell Lung Cancer","A Phase II Clinical Study to Evaluate Sacituzumab Tirumotecan (SKB264) in Combination With SKB118 for the Treatment of Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed locally advanced or metastatic NSCLC\n* Without epidermal growth factor receptor (EGFR) sensitizing mutation, and anaplastic lymphoma kinase (ALK) fusion gene.\n* Provide a tumor tissue sample.\n* At least one measurable lesion as assessed by the investigator according to RECIST v1.1.\n* ECOG performance status of 0 or 1.\n* Life expectancy ≥ 12 weeks.\n* Adequate bone marrow, liver, kidney, and coagulation function.\n* Male and female participants must agree to use highly effective methods of contraception during the specified period of the study.\n\nExclusion Criteria:\n\n* Histologically or cytologically confirmed co-existing small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components.\n* Participants with known metastases to meninges, brainstem metastases, metastases to spinal cord and\u002For compression, or active metastases to central nervous system (CNS).\n* Uncontrolled systemic disease as judged by the investigator.\n* Presence of uncontrolled, clinically symptomatic, or requiring repeated drainage pleural effusion, pericardial effusion, or ascites.\n* Presence of other moderate to severe lung disorders.\n* History of haemorrhagic diathesis or coagulopathy and\u002For clinically significant bleeding symptoms or risks.\n* Previous or co-existing gastrointestinal diseases, surgery, and wound healing complications.\n* Active hepatitis b or hepatitis c or co-infection with HBV and HCV.\n* Known history of allogeneic organ transplantation or hematopoietic stem cell transplantation.\n* Known hypersensitivity to the study drug or any of its components.\n* Pregnant or lactating women.",{"count":218,"type":22},206,[25],"This is an open-label, multi-center, Phase II clinical study to evaluate the safety, tolerability, and efficacy of SKB264 in combination with SKB118 in participants with NSCLC. The study includes a dose escalation phase and an expansion phase.",[222],"NSCLC",{"date":34,"type":35},{"date":225,"type":22},"2026-08",{"date":227,"type":22},"2029-08",{"name":229,"class":86},"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.",2,{"id":232,"slug":233,"hasResults":12,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":12,"sex":17,"minAge":238,"maxAge":239,"enrollmentInfo":240,"targetDuration":4,"studyType":23,"phases":242,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":246,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":171},"100053295","phase-3-a-phase-3-study-to-evaluate-the-safety-and-efficacy-of-karxt--karx-ec-for-the-treatment-of-agitation-associated-with-alzheimers-disease-adagio-1-100053295","NCT07011732","A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease","Inclusion Criteria\n\n\\- A diagnosis of Alzheimer's disease (AD) in accordance with the 2024 Alzheimer's Association criteria with one of the following confirmations of AD pathology: i) Historical evidence of AD diagnosis with amyloid positron emission tomography (PET), Aβ42\u002F40 ratio in CSF, pTau181\u002FAβ42 ratio in CSF or pTau217\u002FAβ42 ratio in plasma using an Health Authority (HA)-authorized diagnostic assay.\n\nii) If no historical evidence available: A. A plasma biomarker will be assessed for eligibility if allowed per regulatory requirements. The test cutoff(s) will be based on diagnostic use approval.\n\nB. If a plasma biomarker assay cannot be used or if the assay result is inconclusive, conduct one the following:\n\n* Amyloid PET.\n* Aβ42\u002F40 ratio or pTau181\u002FAβ42 ratio in CSF using an HA-authorized diagnostic assay.\n\n  * Mini-Mental State Examination (MMSE) score of ≤ 24 at Screening (Visit 1).\n  * Have an identified caregiver who has sufficient contact (approximately 8 hours over a week) and is willing to:\n\n    i) Attend all visits and report on participant's status. ii) Oversee participant compliance with medication and study procedures. iii) Participate in the study assessments and provide informed consent to participate in the study.\n  * History of agitation that meets the International Psychogeriatric Association (IPA) consensus definition for agitation in cognitive disorders with onset at least two weeks prior to Screening (Visit 1).\n  * AD participants are required to have NPI\u002FNPI-NH Agitation\u002FAggression score ≥ 4 at Screening (Visit 1) and Baseline (Visit 2).\n  * CMAI-IPA Total Score ≥ 30 at Screening (Visit 1) and Baseline (Visit 2).\n\nExclusion Criteria\n\n\\- Medical Conditions: i) Agitation symptoms that are primarily attributable to a condition other than the AD causing the dementia.\n\nii) History of bipolar disorder, schizophrenia, or schizoaffective disorder. iii) History of (or at high risk for) urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator.\n\niv) Risk of suicidal behavior during the study as determined by the Investigator's clinical assessment and\u002For C-SSR.\n\n\\- Prior\u002FConcomitant Therapy: i) Recent history of receiving monoamine oxidase inhibitors, anticonvulsants (eg, lamotrigine, divalproex), mood stabilizers (eg, lithium), tricyclic antidepressants (eg, imipramine, desipramine), or any other psychoactive medications except for as needed anxiolytics (eg, lorazepam).\n\nA. Selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors taken at a stable dose for at least 8 weeks prior to Screening (Visit 1) may be permitted.\n\nB. Trazodone may be used as a hypnotic or for agitation if started at least 8 weeks prior to Screening (Visit 1).\n\nC. Mirtazapine may be used as a hypnotic if started at least 8 weeks prior to Screening (Visit 1).\n\n\\- Other protocol-defined Inclusion\u002FExclusion criteria apply.","55 Years","90 Years",{"count":241,"type":22},426,[98],"The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.",[245],"Alzheimer Disease",{"date":34,"type":35},{"date":248,"type":35},"2025-07-10",{"date":250,"type":22},"2028-12-08",{"name":252,"class":86},"Bristol-Myers Squibb",{"id":254,"slug":255,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":169,"enrollmentInfo":260,"targetDuration":4,"studyType":23,"phases":262,"briefSummary":264,"conditions":265,"keywords":267,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":271,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":43},"100053499","early-phase-1-car-bcma-70-car-t-cells-for-the-treatment-of-high-risk-plasma-cell-neoplasms-100053499","NCT07416682","CAR BCMA-70 CAR-T Cells for the Treatment of High-risk Plasma Cell Neoplasms","Clinical Study on the Safety and Efficacy of CAR BCMA-CD70 Dual-target CAR-T Therapy for High-risk Plasma Cell Neoplasms","Inclusion Criteria:\n\n1. The subject or their legally acceptable representative has provided written informed consent and is willing and able to comply with all scheduled study visits, study treatment administration, laboratory tests, and other required trial procedures.\n2. Clinically diagnosed with high-risk plasma cell neoplasm, meeting any one of the following molecular\u002Fcytogenetic or clinical criteria:\n\n   1. Deletion of the short arm of chromosome 17 (del(17p)) with clonal proportion ≥ 20%, and\u002For TP53 gene mutation;\n   2. IgH translocation (t(4;14), t(14;16), or t(14;20)) combined with 1q amplification (1q+) and\u002For deletion of the short arm of chromosome 1 (del(1p32));\n   3. Chromosome 1 abnormalities: monoallelic del(1p32) plus 1q+, or biallelic del(1p32);\n   4. β₂-microglobulin ≥ 5.5 mg\u002FL with normal serum creatinine (\\\u003C 1.2 mg\u002FdL).\n3. Age 18 to 75 years (inclusive), male or female.\n4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n5. Life expectancy \\> 3 months from the date of signed informed consent.\n6. Hemoglobin (HGB) ≥ 60 g\u002FL (transfusion permitted).\n7. Adequate hepatic, renal, and cardiopulmonary function as defined by:\n\n   1. Serum creatinine ≤ 2 × ULN;\n   2. Left ventricular ejection fraction (LVEF%) ≥ 50%;\n   3. Blood oxygen saturation \\> 90%;\n   4. Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN.\n8. Subject agrees to use highly effective contraception from the date of informed consent until 1 year after CAR-T cell infusion.\n\nExclusion Criteria:\n\n1. Severe cardiac insufficiency with left ventricular ejection fraction (LVEF%) \\\u003C 50%.\n2. History of severe chronic lung disease associated with impaired pulmonary function.\n3. Concurrent active or progressive malignant tumors other than the target plasma cell neoplasm.\n4. Concurrent severe infection that cannot be effectively controlled with standard therapy.\n5. Concurrent severe autoimmune disease or congenital immunodeficiency disorders.\n6. Active viral hepatitis, defined as hepatitis B virus DNA (HBV-DNA) or hepatitis C virus RNA (HCV-RNA) levels above the lower limit of detection (LLOD).\n7. Human immunodeficiency virus (HIV) infection, known acquired immunodeficiency syndrome (AIDS), or syphilis infection.\n8. History of severe allergic reactions to biological products, including antibiotics.\n9. Recipients of allogeneic hematopoietic stem cell transplantation (allo-HSCT) with persistent acute graft-versus-host disease (aGVHD) that does not resolve within 1 month after discontinuing immunosuppressive therapy.\n10. Presence of other severe physical or psychiatric illnesses, or significant laboratory abnormalities, that may increase the risks of study participation, interfere with study outcomes, or render the subject otherwise unsuitable for enrollment as determined by the investigator.\n11. Female subjects of childbearing potential who are pregnant or breastfeeding.",{"count":261,"type":22},20,[263],"EARLY_PHASE1","This is a single arm study to evaluate the safety and efficacy of CAR BCMA-CD70 CAR-T cell therapy for high-risk plasma cell neoplasms.",[266],"High-risk Plasma Cell Neoplasms",[266,268,269,270],"BCMA","CD70","CAR-T",{"date":34,"type":35},{"date":273,"type":35},"2026-04-14",{"date":275,"type":22},"2028-01-30",{"name":277,"class":42},"Affiliated Hospital to Academy of Military Medical Sciences",{"id":279,"slug":280,"hasResults":12,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":23,"phases":287,"briefSummary":288,"conditions":289,"keywords":293,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":298,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":305},"100053390","phase-2-a-study-to-evaluate-safety-tolerability-and-efficacy-of-ap306-at-fixed-doses-in-dialysis-participants-with-hyperphosphatemia-100053390","NCT06712654","A Study to Evaluate Safety, Tolerability and Efficacy of AP306 at Fixed Doses in Dialysis Participants With Hyperphosphatemia","A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Serum Phosphate Lowering Effect of Fixed Dose AP306 in Participants With Hyperphosphatemia Receiving Maintenance Hemodialysis","Important Inclusion Criteria:\n\n* Signs a written informed consent form (ICF) and is willing to comply with all study requirements in the study\n* Receiving a stable hemodialysis (including hemodialysis, hemodiafiltration, and hemoadsorption) regimen, which is defined as a frequency of three times per week for at least 12 weeks before signing the ICF, and does not plan to change in the study\n* Who has a blood phosphate level within the study-required range\n* Who has a dialysis adequacy, assessed by single pooled Kt\u002FV (SpKt\u002FV, estimated with blood urea) ≥1.20, at screening or any documented value ≥1.20 within 12 weeks prior to signing the ICF\n* If the participant is receiving etelcalcetide, their doses must be unchanged for at least 4 weeks prior to signing the ICF\n* If the participant is receiving any of the following therapies, their doses are stable for at least 14 days prior to signing the ICF: phosphate-lowering products other than tenapanor or phosphate binders, active vitamin D and analogs, cinacalcet, calcitonin, and P-glycoprotein inhibitors\n* Agreement to use highly effective contraception for women of childbearing potentially and non-sterile sexually active males throughout the study and for 90 days after the final dose of study drug\n\nImportant Exclusion Criteria:\n\n* Pregnant or breastfeeding\n* Scheduled for a living donor kidney transplant in the next 6 months, planned change to peritoneal dialysis or home hemodialysis in the study; planned relocation to another dialysis center in the study\n* Any history of a non-pharmacological parathyroid intervention within 6 months prior to the ICF sign off, or planned parathyroid intervention in the study\n* Blood calcium or blood intact parathyroid hormone abnormality\n* Adequate organ and bone marrow function\n* Acute hepatitis or significant chronic liver disease\n* Any clinically significant GI disorders within 4 weeks prior to signing the ICF; or any history of gastrectomy; or any GI tract surgery (excluding appendectomy and polypectomy), within 12 weeks of signing the ICF\n* Uncontrolled hypertension\n* Hospitalization for cardiac or cardiocerebrovascular disease within 24 weeks prior to signing the ICF\n* Significant abnormalities of QT interval and heart rhythm on an electrocardiograph (ECG) test\n* Any clinically significant active infection or infestation or any treatment with systemic antimicrobial treatment within 2 weeks prior to signing the ICF\n* History or presence of malignancy within 3 years prior to signing the ICF, except basal cell skin cancer, in-situ carcinoma of the cervix, and in-situ prostate cancer\n* Taking moderate or strong cytochrome P450 (CYP) 3A inhibitors within 2 weeks or 5 half-lives, whichever is longer, prior to signing the ICF (topical use is allowed)\n* Treatment with any investigational medication or medical device within 30 days prior to signing the ICF\n* Life expectancy less than 12 months",{"count":286,"type":22},168,[25],"This study is being conducted to characterize the safety, tolerability, and efficacy of AP306 at fixed doses in adults with hyperphosphatemia receiving maintenance hemodialysis.",[290,291,292],"Hyperphosphatemia","Chronic Kidney Disease Requiring Chronic Dialysis","End Stage Renal Disease on Dialysis",[294,295,296,297],"AP306","AP-306","EOS789","pan-phosphate transporter inhibitor",{"date":34,"type":35},{"date":300,"type":35},"2026-06-01",{"date":302,"type":22},"2027-03-31",{"name":304,"class":86},"R1 Therapeutics",31,{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":4,"eligibilityCriteria":312,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":313,"targetDuration":4,"studyType":23,"phases":315,"briefSummary":317,"conditions":318,"keywords":322,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":329,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":336},"100054019","phase-1-a-study-of-bgb-11417-in-participants-with-myeloid-malignancies-100054019","NCT04771130","A Study of BGB-11417 in Participants With Myeloid Malignancies","A Phase 1b\u002F2, Open-Label, Dose Finding, and Expansion Study of the Bcl-2 Inhibitor BGB-11417 in Patients With Myeloid Malignancies","Key Inclusion Criteria:\n\n1. Confirmed diagnosis of one of the following by 2016 World Health Organization criteria:\n\n   * AML, nonacute promyelocytic leukemia\n   * MDS\n   * MDS\u002FMPN\n2. Eastern Cooperative Oncology Group performance status of 0 to 2.\n3. Adequate organ function defined as:\n\n   * Creatinine clearance ≥ 50 milliliters\u002Fminute (mL\u002Fmin) (or between 30 and 49 mL\u002Fmin in unfit AML cohort)\n   * Adequate liver function\n4. Life expectancy of \\> 12 weeks.\n5. Ability to comply with the requirements of the study.\n\nKey Exclusion Criteria:\n\n1. A diagnosis of acute promyelocytic leukemia.\n2. History of prior malignancy, with the exception of either a history of MDS or MDS\u002FMPN that has transformed to AML, or other prior malignancy that was treated with a full curative intent and no evidence of recurrence within the past 2 years (eg, localized skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer)\n3. Antecedent MPN including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation.\n4. Prior therapy with a B-cell lymphoma-2 inhibitor\n5. Known central nervous system involvement by leukemia.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":314,"type":22},260,[316,25],"PHASE1","The study will determine the safety, tolerability, recommended Phase 2 dose (RP2D) and preliminary efficacy of BGB-11417 as monotherapy and in combination with azacitidine in participants with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)or MDS\u002Fmyeloproliferative neoplasm (MPN) .",[319,320,321],"Acute Myeloid Leukemia","Myelodysplastic Syndromes","Myelodysplastic\u002FMyeloproliferative Neoplasm",[323,324,325,326,327,328],"BGB-11417","Azacitidine","Posaconazole","AML","MDS","MDS\u002FMPN",{"date":34,"type":35},{"date":331,"type":35},"2021-05-24",{"date":333,"type":22},"2028-02-08",{"name":335,"class":86},"BeOne Medicines",46,{"id":338,"slug":339,"hasResults":12,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":343,"eligibilityCriteria":344,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":345,"targetDuration":4,"studyType":23,"phases":347,"briefSummary":348,"conditions":349,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":351,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":358},"100053586","phase-1-a-study-to-evaluate-the-effect-of-gdc-4198-alone-and-in-combination-with-giredestrant-versus-abemaciclib-and-giredestrant-in-participants-with-locally-advanced-or-metastatic-estrogen-receptor-positive-er-human-epidermal-growth-factor-receptor-negative-her2--breast-cancer-100053586","NCT07100106","A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer","A Phase Ib\u002FII Multicenter, Open-Label, Randomized Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-4198 Alone and in Combination With Giredestrant in Comparison With Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive, HER2-Negative Breast Cancer Who Have Previously Progressed During or After a CDK4\u002F6 Inhibitor","MoonROSE","Inclusion Criteria:\n\n* Histologically and\u002For cytologically confirmed adenocarcinoma of the breast that is locally advanced or metastatic.\n* Previously documented ER+ and HER2- tumor according to American Society of Clinical Oncology (ASCO)\u002F College of American Pathologists (CAP) or European Society of Medical Oncology (ESMO) guidelines or any national guidelines with criteria conforming to ASCO\u002FCAP or ESMO guidelines.\n* Disease progression during or after treatment with an approved cyclin-dependent kinase 4\u002F6 (CDK4\u002F6) inhibitor and approved endocrine therapy (ET) in the locally advanced or metastatic setting.\n* Measurable or non-measurable evaluable, disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Life expectancy \\>= 6 months.\n\nExclusion Criteria:\n\n* Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term appropriate for treatment with cytotoxic chemotherapy at time of entry into the study, as per national or local treatment guidelines.\n* Have received more than one-line of therapy for locally advanced or metastatic disease.\n* Have received prior chemotherapy for metastatic breast cancer.\n* Treatment with an approved oral ET within 7 days prior to initiation of study drug; treatment with fulvestrant or an approved CDK4\u002F6 inhibitor within 21 days prior to initiation of study drug.\n* Malabsorption condition or other gastrointestinal (GI) conditions\u002Fsurgeries that the investigator assesses may significantly interfere with enteral absorption\n* History of malignancy within 3 years prior to screening, except for cancer under investigation in this study and malignancies with a negligible risk of metastasis or death.\n* Known allergy or hypersensitivity to any component of the study treatments.",{"count":346,"type":22},285,[316,25],"The purpose of this study is to assess the safety of GDC-4198 alone and in combination with giredestrant and also the efficacy of GDC-4198 + giredestrant versus abemaciclib + giredestrant in participants with locally advanced or metastatic ER+, HER2- breast cancer. The study consists of 2 phases: Phase Ib and Phase II. Phase Ib will evaluate the safety and pharmacokinetics (PK) of GDC-4198 alone and in combination with giredestrant. Phase II stage will compare the activity and safety of GDC-4198 and giredestrant with abemaciclib and giredestrant.",[350],"Breast Cancer",{"date":34,"type":35},{"date":353,"type":35},"2025-10-07",{"date":355,"type":22},"2028-08-31",{"name":357,"class":86},"Genentech, Inc.",52,{"id":360,"slug":361,"hasResults":12,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":366,"sex":168,"minAge":18,"maxAge":19,"enrollmentInfo":367,"targetDuration":4,"studyType":23,"phases":369,"briefSummary":371,"conditions":372,"keywords":374,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":376,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":43},"100053386","a-cohort-study-of-combined-cryoablation-and-thermal-ablation-for-non-surgical-treatment-of-breast-cancer-patients-100053386","NCT07238894","A Cohort Study of Combined Cryoablation and Thermal Ablation for Non-surgical Treatment of Breast Cancer Patients","Peking University People's Hospital Breast Surgery Department","Inclusion Criteria:\n\n* 1\\) Aged 18 or above; 2) Breast cancer confirmed by core needle biopsy; 3) Tumor lesions clearly visible on ultrasound; 4) No contraindications for cryoablation such as coagulation disorders; 5) Presence of reasons unsuitable for conventional surgical resection: patient's condition cannot tolerate general anesthesia or surgical treatment; due to unresectable and\u002For metastatic disease; patient refuses surgery, etc.; 6) Agree to undergo ablation surgery and sign the consent form.\n\nExclusion Criteria:\n\n* 1\\) Missing clinical and pathological data (such as imaging and pathological materials); 2) Pregnant or lactating women; 3) Known allergies, intolerances, or contraindications to cryotherapy (such as cryoglobulinemia, presence of implanted electronic devices); 4) Vulnerable populations, including those with neurological disorders, cognitive impairments, critically ill patients, etc.",true,{"count":368,"type":22},200,[370],"NA","Although surgical resection is the gold standard for early breast cancer treatment, some patients cannot tolerate surgery due to medical conditions or refuse surgical treatment for cosmetic reasons. In recent years, the rapid development of ablation technology has provided new directions for breast cancer patients who are not suitable for surgical treatment. Ablation uses high or low temperatures to deactivate lesions or tissues, which are gradually absorbed by the body, achieving local treatment purposes. Its safety and efficacy have been preliminarily confirmed. As an advanced minimally invasive medical device independently developed in China, the combined cryo-thermal ablation system treats tumors using a combined mode of deep cryogenic freezing and high-intensity heating. It has been approved for ablation treatment of various solid tumors including lung cancer, pancreatic cancer, kidney cancer, prostate cancer, breast cancer, bone and soft tissue sarcomas.\n\nThis project proposes a prospective cohort design, based on the breast disease cohort database of Peking University People's Hospital Breast Center. It will enroll patients pathologically diagnosed with breast cancer, determined unsuitable for surgical treatment, and have received combined cryo-thermal ablation. The registered data will be used to evaluate the effectiveness and safety of percutaneous ultrasound-guided cryo-thermal composite ablation in this population.",[373,350],"Ablation",[375],"Combined Cryoablation and Thermal Ablation",{"date":34,"type":35},{"date":378,"type":35},"2026-03-03",{"date":380,"type":22},"2028-10-01",{"name":186,"class":42},{"id":383,"slug":384,"hasResults":12,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":388,"eligibilityCriteria":389,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":23,"phases":392,"briefSummary":393,"conditions":394,"keywords":396,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":399,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":117},"100053708","phase-1-a-study-of-azd3470-a-prmt5-inhibitor-given-as-monotherapy-and-in-combination-in-patients-with-mtap-deficient-advancedmetastatic-solid-tumors-100053708","NCT06130553","A Study of AZD3470, a PRMT5 Inhibitor, Given as Monotherapy and in Combination in Patients With MTAP Deficient Advanced\u002FMetastatic Solid Tumors","PRIMROSE: A Modular Phase I\u002FIIa, Multi-centre, Dose Escalation, and Expansion Study of AZD3470, a MTA Cooperative PRMT5 Inhibitor, as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced\u002FMetastatic Solid Tumors That Are MTAP Deficient","PRIMROSE","Inclusion Criteria (All Modules) Participants are ≥ 18 years (or the legal age of consent in the jurisdiction) at the time of signing the informed consent form.\n\nParticipants are able to provide written informed consent and are willing and able to comply with study procedures.\n\nParticipants are willing to provide archival and\u002For newly obtained (baseline) tumor tissue for central testing, including required biomarker assessment(s) (and any module-specific biomarker requirements).\n\nParticipants have tumors meeting the protocol-defined MTAP-deficiency requirement, based on acceptable prior testing and\u002For central testing per protocol.\n\nParticipants have received prior systemic therapy appropriate for the tumor type and disease stage and have disease progression on or after prior therapy; participants must have had ≥ 1 prior line of systemic treatment in the recurrent\u002Fmetastatic (advanced) setting.\n\nParticipants have ECOG performance status 0-1. Participants have life expectancy ≥ 12 weeks, in the opinion of the Investigator.\n\nParticipants have measurable disease per RECIST v1.1. Participants have adequate organ and bone marrow function per protocol-defined laboratory\u002Fassessment criteria.\n\nParticipants have a treatment-free interval ≥ 3 weeks from prior anticancer therapy before starting study drug (with any additional protocol-defined washout requirements for certain therapies\u002Fprocedures).\n\nContraception use by men and women is consistent with local regulations and protocol-defined requirements.\n\nAdditional Inclusion Criteria (Module 2: Non-squamous NSCLC) Participants have histologically or cytologically confirmed non-squamous NSCLC, Stage IIIB\u002FIIIC not amenable to curative therapy or Stage IV.\n\nParticipants have documented radiographic extracranial disease progression while on or after the most recent treatment regimen for advanced\u002Fmetastatic NSCLC (CNS-only progression is not eligible).\n\nNSCLC of mixed histology is allowed if not predominantly squamous; no small cell or large cell neuroendocrine components.\n\nParticipants meet one of the following:\n\nTumor has a documented EGFR alteration eligible for EGFR-directed therapy (per protocol-defined criteria) and the participant has received prior systemic therapy appropriate for EGFR-altered advanced\u002Fmetastatic NSCLC (per protocol), OR Tumor is negative for EGFR alterations eligible for EGFR-directed therapy, has no other known actionable genomic alterations for which locally approved\u002Favailable targeted therapies exist (per protocol-defined criteria), meets any additional protocol-required biomarker criteria for this cohort (as applicable), and the participant has received prior systemic therapy appropriate for non-actionable-alteration advanced\u002Fmetastatic NSCLC (per protocol).\n\nExclusion Criteria (All Modules) Participants have spinal cord compression, or symptomatic and unstable brain metastases, leptomeningeal disease, or primary CNS malignancy. Participants with asymptomatic, radiographically stable brain metastases who do not require steroids (or who have completed definitive therapy and are neurologically stable off steroids, per protocol) may be eligible.\n\nParticipants have a history of allogeneic organ transplantation. Participants have any clinically significant abnormal laboratory finding or severe and uncontrolled medical condition that, in the Investigator's opinion, makes participation unsafe, including active infection requiring systemic treatment.\n\nParticipants have clinically significant cardiovascular disease or risk factors (including reduced LVEF, cardiomyopathy, clinically active cardiovascular disease, recent major ischemic events or revascularization procedures, uncontrolled angina, severe valvular disease, uncontrolled hypertension, clinically significant heart failure, or recent stroke\u002FTA clinically significant ECG abnormalities, prolonged QTc, or conditions\u002Fmedications that increase risk of QTc prolongation or arrhythmic events)..\n\nParticipants require therapeutic anticoagulation for treatment of acute thromboembolic events, per protocol.\n\nParticipants have active hepatitis B or hepatitis C infection (including detectable viral load, per protocol-defined testing).\n\nParticipants have known HIV infection. Participants have current ILD\u002Fpneumonitis, or a history of (non-infectious) ILD\u002Fpneumonitis requiring systemic steroids or supplemental oxygen, or suspected ILD\u002Fpneumonitis that cannot be ruled out by screening imaging.\n\nParticipants have active gastrointestinal disease, malabsorption, or other GI condition\u002Fsurgery that would significantly interfere with oral drug absorption or tolerability.\n\nParticipants have a history of another primary malignancy. Participants have unresolved clinically significant toxicity from prior anticancer therapy (typically Grade ≥ 2).\n\nParticipants have had prior treatment with a PRMT5 inhibitor Participants are pregnant, breastfeeding, or intend to become pregnant during study participation.\n\nAdditional Exclusion Criteria (Module 2 Only) Participants have inaccessible veins and\u002For inability to place required venous access (e.g., port), per Investigator judgment.\n\nParticipants have contraindication to required CNS imaging (brain MRI preferred or CT with contrast).\n\nParticipants have clinically significant corneal disease. Participants have known active tuberculosis infection, per clinical evaluation and local practice.\n\nParticipants have significant third-space fluid (e.g., pleural effusion\u002Fascites) not amenable to required repeated drainage, per Investigator judgment.\n\nParticipants have severe pulmonary function compromise due to intercurrent pulmonary illness (e.g., severe COPD\u002Fasthma\u002Frestrictive lung disease, recent pulmonary embolism), per protocol.\n\nParticipants have recent radiotherapy that does not meet protocol-defined washout requirements and\u002For ongoing radiation-related toxicities requiring corticosteroids.\n\nParticipants have had prior treatment with protocol-prohibited anticancer therapies.",{"count":391,"type":22},334,[316,25],"This is a first time in human (FTiH) Phase I\u002FIIa, open-label, multi-centre study of AZD3470 in participants with advanced or metastatic solid tumors with MTAP deficiency. The study consists of several study modules, evaluating the safety, tolerability, pharmacokinetic (PK), pharmacodynamics, and preliminary efficacy of AZD3470 as monotherapy or in combination with other anti-cancer agents.",[395],"Advanced Solid Tumors That Are MTAP Deficient",[397,398],"solid tumor","MTAP deficient",{"date":34,"type":35},{"date":401,"type":35},"2024-01-18",{"date":403,"type":22},"2028-12-04",{"name":405,"class":86},"AstraZeneca",{"id":407,"slug":408,"hasResults":12,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":4,"eligibilityCriteria":412,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":413,"enrollmentInfo":414,"targetDuration":4,"studyType":23,"phases":416,"briefSummary":417,"conditions":418,"keywords":420,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":422,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":43},"100054297","phase-2-a-research-study-to-evaluate-the-efficacy-and-safety-of-sgc001-in-patients-with-anterior-wall-st-segment-elevation-myocardial-infarction-100054297","NCT07306182","A Research Study to Evaluate the Efficacy and Safety of SGC001 in Patients With Anterior Wall ST-Segment Elevation Myocardial Infarction","A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Characteristics of SGC001 Injection in Chinese Patients With Anterior Wall ST-Segment Elevation Myocardial Infarction and Planned for Primary Percutaneous Coronary Intervention (pPCI)","Inclusion Criteria\n\n1.18-79 years of age (including boundary values), male or female;\n\n2.Anterior wall STEMI: (a) history of persistent chest pain\u002Fprecordial discomfort (\\>30 minutes); (b) upon admission, the ECG must meet the following requirements: i.For male participants \\>40 years old, ST-segment elevation ≥2 mm in leads V2 and V3; ii.For male participants ≤40 years old, ST-segment elevation ≥2.5 mm in leads V2 and V3; iii.For female participants, ST-segment elevation ≥1.5 mm in leads V2 and V3; If clinical symptoms of (a) are atypical, then (c) a positive point-of-care troponin test is required.\n\n3.Planned for pPCI treatment;\n\n4.Assessed as being able to complete dosing within 6 hours of the onset of persistent chest pain\u002Fprecordial discomfort symptoms;\n\n5.The participant or their legal guardian fully understands the objectives, nature, methods, and potential adverse reactions of the study, voluntarily agrees to participate, and has signed the informed consent form (ICF).\n\nExclusion Criteria\n\n1. History of the following cardiac conditions:\n\n   1. History of myocardial infarction, coronary revascularization (including percutaneous coronary intervention \\[PCI\\] and coronary artery bypass grafting \\[CABG\\], etc.);\n   2. History of cardiopulmonary resuscitation;\n   3. History of stroke within 6 months;\n   4. Presence of severe cardiac structural abnormalities such as aortic dissection, and ventricular aneurysm;\n2. Patients who have received thrombolysis;\n3. Patients with a life expectancy of less than 1 year;\n4. Febrile infection requiring systemic treatment within 2 weeks prior to screening;\n5. Concomitant left bundle branch block;\n6. Cardiogenic shock or hemodynamic instability;\n7. Concomitant severe arrhythmia (including high-degree atrioventricular block, sick sinus syndrome, sustained ventricular tachycardia, etc.) or implanted cardiac pacemaker;\n8. Definitive diagnosis of acute heart failure (Killip classification ≥ III; for details on Killip classification, see Appendix);\n9. Unable to undergo cardiac magnetic resonance (CMR) imaging according to the study protocol, or known allergy to any radiocontrast agent;","79 Years",{"count":415,"type":22},210,[25],"This is a multicenter, randomized, double-blind, placebo-controlled, single-dose, Phase II clinical study to evaluate the efficacy, safety, and pharmacokinetic (PK) characteristics of SGC001 injection administered in addition to standard clinical care in Chinese patients with acute anterior ST-segment elevation myocardial infarction (STEMI) who are planned for primary percutaneous coronary intervention (pPCI).",[419],"Acute Anterior ST-Segment Elevation Myocardial Infarction",[419,421],"ST-Segment Elevation Myocardial Infarction(STEMI)",{"date":34,"type":35},{"date":424,"type":35},"2026-03-09",{"date":426,"type":22},"2027-10",{"name":428,"class":86},"Beijing Sungen Biomedical Technology Co., Ltd",{"id":430,"slug":431,"hasResults":12,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":435,"eligibilityCriteria":436,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":437,"targetDuration":4,"studyType":23,"phases":439,"briefSummary":440,"conditions":441,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":443,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":450},"100053627","phase-3-a-study-to-test-the-efficacy-and-safety-of-riliprubart-against-the-usual-treatment-of-intravenous-immunoglobulin-ivig-in-people-with-chronic-inflammatory-demyelinating-polyneuropathy-cidp-100053627","NCT06290141","A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","A Phase 3, Randomized, Double-blind, Study Evaluating Efficacy and Safety of Riliprubart Versus Intravenous Immunoglobulin (IVIg) in Participants With Chronic Inflammatory Demyelinating Polyneuropathy","VITALIZE","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n* Participant must have CIDP or possible CIDP criteria, based on European Academy of Neurology (EAN)\u002FPeripheral Nerve Society (PNS) Task Force CIDP guidelines, second revision (2021).\n* Participant must have either typical CIDP, or one of the following 2 CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis Sumner Syndrome). Diagnosis must be confirmed by the study adjudication committee.\n* Participants must have responded to IVIg in the past 5 years.\n* Participant must be on a stable maintenance dosage of IVIg.\n* Participant must have residual disability, defined as an INCAT score of 2 to 9 at Screening that is confirmed at baseline (a score of 2 should be exclusively from leg disability component of INCAT).\n* Participant must be receiving treatment with IVIg within a standard maintenance dosing regimen, defined as per EAN\u002FPNS 2021 CIDP guidelines.\n* Participants receiving IVIg infusions at home are eligible, as long as IVIg infusions are switched to a hospital or infusion center setting at least 1 cycle prior to baseline.\n* Participant must have active disease, defined by a CIDP disease activity score (CDAS) of ≥2 points at Screening.\n* Participant must have documented vaccinations against encapsulated bacterial pathogens given within 5 years prior to Day 1 or initiated a minimum of 14 days prior to first dose of study intervention.\n* Contraception for sexually active male or female participants; not pregnant or breastfeeding; no sperm donating for male participant\n* Participant must have a body weight at Screening of 35 kg to 154 kg (77 to 340 lbs) inclusive.\n* Evidence of at least one clinically meaningful deterioration within 2 years, or at least 2 clinically meaningful deteriorations within 5 years prior to screening which occurred during period of interrupted dosing, reduced dosage, or extended intervals between doses of immunoglobin therapy, as verified by clinical examination or medical records.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Polyneuropathy of other causes, including but not limited to acute demyelinating polyneuropathies (eg, Guillain-Barré syndrome), hereditary demyelinating neuropathies, neuropathies secondary to infection or systemic disease, diabetic neuropathy, drug- or toxin-induced neuropathies, multifocal motor neuropathy, polyneuropathy related to IgM monoclonal gammopathy, POEMS syndrome, lumbosacral radiculoplexus neuropathy.\n* Sensory CIDP, distal CIDP and focal CIDP variants.\n* Any other neurological or systemic disease that can cause symptoms and signs interfering with treatment or outcome assessments.\n* Poorly controlled diabetes\n* Serious infections requiring hospitalization within 30 days prior to Screening, any active infection requiring antimicrobial treatment during Screening, or presence of a condition that may predispose the participant to increased risk of infection (eg, medical history such as known immunodeficiency or history of recurrent infections).\n* Clinical diagnosis of Systemic Lupus Erythematosus (SLE) or family history of SLE. For a participant with an antinuclear antibody (ANA) titer ≥1:160 and a positive anti double-stranded DNA (anti-dsDNA) at Screening, SLE diagnosis must be ruled out prior to enrollment.\n* Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study. Specifically, history of any hypersensitivity reaction to riliprubart or its components or of a severe allergic or anaphylactic reaction to any humanized or murine monoclonal antibody.\n* Any contraindication related to the administration of immunoglobulins (eg hypersensitivity, chronic kidney disease, thromboembolic diseases or recent thromboembolic event, known history of IgA deficiency at the time of Screening).\n* Any other clinically meaningful medical history or ongoing medical condition (as determined by the Investigator at Screening) that might impact the benefit-risk assessment, jeopardize the safety of the participant, or compromise the quality of the data collected in this study; or history or presence of other significant concomitant illness that would adversely affect participation in this study, per the Investigator's judgment.\n* Documented history of attempted suicide over the 6 months prior to the Screening visit, presence of suicidal ideation of category 4 or 5 on the C-SSRS during Screening, OR if in the Investigator's judgment, the participant is at risk for a suicide attempt.\n* Evidence of CIDP worsening within the 6 weeks following a prior vaccination that, in the opinion of the Investigator, constituted a relapse.\n* Recent or planned major surgery that could confound the results of the trial or put the participant at undue risk.\n* Recent treatment with plasma exchange\n* Treatment within 3 months prior to dosing with immunosuppressive\u002F immunomodulator medication, or corticosteroids (with exception of maintenance dose, which is allowed), or prior treatment (at any time) with highly immunosuppressive\u002F chemotherapeutic medications with sustained effects (eg, mitoxantrone, alemtuzumab, or cladribine).\n* Prior treatment with riliprubart.\n* Recent use of any specific complement system inhibitor (eg, eculizumab).\n* Prior treatment (any time) with total lymphoid irradiation or bone marrow transplantation.\n* Prior treatment with B-cell depleting agents such as rituximab within 6 months.\n* Any vaccination received within 28 days prior to dosing (with few exceptions to be confirmed at screening).\n* Participation in another clinical trial with an investigational drug or receipt of an investigational product within 12 weeks or 5 times the half-life of the product (whichever is longer) prior to Screening.\n* Any Screening laboratory values outside normal limits or abnormal ECG considered in the Investigator's judgment to be clinically significant in the context of this trial.\n* Positive result of any of the following tests:\n\n  * hepatitis B surface antigen (HbsAg).\n  * anti-hepatitis B core antibodies (anti-HBc Ab) (unless anti-hepatitis B surface antibodies \\[anti-HBs Ab\\] are also positive, indicating natural immunity).\n  * anti-hepatitis C virus (anti-HCV) antibodies. Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis RNA test is obtained.\n  * anti-human immunodeficiency virus 1 and 2 (anti-HIV1 and anti-HIV2) antibodies.\n* Pregnancy, defined as a positive result of a highly sensitive urine or serum pregnancy test, or lactation.\n* Accommodation in an institution because of regulatory or legal order; imprisoned or legally institutionalized.\n* Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.\n* Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals.\n* Any country-related specific regulation that would prevent the participant from entering the study as defined by the protocol.\n* Recent treatment with efgartigimod.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":438,"type":22},160,[98],"The purpose of the study is to evaluate efficacy of riliprubart compared to IVIg in adult participants with CIDP who are receiving maintenance treatment with IVIg. The study duration will be for a maximum of 109 weeks including screening, treatment phases, and follow-up.",[442],"Chronic Inflammatory Demyelinating Polyneuropathy",{"date":34,"type":35},{"date":445,"type":35},"2024-08-21",{"date":447,"type":22},"2029-01-12",{"name":449,"class":86},"Sanofi",129,{"id":452,"slug":453,"hasResults":12,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":457,"eligibilityCriteria":458,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":459,"targetDuration":4,"studyType":23,"phases":461,"briefSummary":462,"conditions":463,"keywords":465,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":475,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":482},"100053442","phase-3-a-study-to-evaluate-mezigdomide-bortezomib-and-dexamethasone-mezivd-versus-pomalidomide-bortezomib-and-dexamethasone-pvd-in-participants-with-relapsed-or-refractory-multiple-myeloma-rrmm-100053442","NCT05519085","A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)","A Phase 3, Two-Stage, Randomized, Multicenter, Open-Label Study Comparing Mezigdomide (CC-92480), Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM): SUCCESSOR-1","SUCCESSOR-1","Inclusion Criteria\n\n\\- Participant has documented diagnosis of MM and measurable disease, defined as any of the following:.\n\ni) M-protein ≥ 0.5 grams per deciliter (g\u002FdL) by serum protein electrophoresis (sPEP) or.\n\nii) M-protein ≥ 200 milligrams (mg) per 24-hour urine collection by urine protein electrophoresis (uPEP).\n\niii) For participants without measurable disease in sPEP or uPEP: serum free light chain (sFLC) levels \\> 100 mg\u002FL (10 mg\u002FdL) involved light chain and an abnormal kappa\u002Flambda FLC ratio.\n\n* Participants received 1 to 3 prior lines of antimyeloma therapy.\n* Participants achieved minimal response \\[MR\\] or better to at least 1 prior antimyeloma therapy.\n\nExclusion Criteria\n\n\\- Participant has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor, except as noted below:.\n\ni) Subjects who progressed while being treated with, or within 60 days of last dose of bortezomib maintenance given once every 2 weeks (or less frequently) are not excluded.\n\nii) Participants who progressed while being treated with ixazomib monotherapy maintenance ≥ 6 months prior to the time of starting study treatment are not excluded.\n\n* For participants with prior treatment of a bortezomib containing regimen, the best response achieved was not a minimal response (MR) or better, or participant discontinued bortezomib due to toxicity.\n* Participant has had prior treatment with mezigdomide or pomalidomide.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":460,"type":22},810,[98],"The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure.",[464],"Relapsed or Refractory Multiple Myeloma",[466,467,468,469,470,471,472,473,474],"Multiple myeloma","RRMM","MeziVd","PVd","CC92480","pomalidomide","bortezomib","dexamethasone","mezigdomide",{"date":34,"type":35},{"date":477,"type":35},"2022-09-20",{"date":479,"type":22},"2033-11-30",{"name":481,"class":86},"Celgene",266,{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":487,"acronym":4,"eligibilityCriteria":488,"healthyVolunteers":12,"sex":17,"minAge":489,"maxAge":72,"enrollmentInfo":490,"targetDuration":4,"studyType":23,"phases":492,"briefSummary":494,"conditions":495,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":500,"startDateStruct":501,"completionDateStruct":502,"leadSponsor":504,"locationsCount":43},"100054244","phase-4-the-ed95-of-ciprofol-for-laryngeal-mask-airway-insertion-with-fentanyl-in-children-a-biased-coin-dose-finding-trial-100054244","NCT07697404","The ED95 of Ciprofol for Laryngeal Mask Airway Insertion With Fentanyl in Children: A Biased-Coin Dose-Finding Trial","Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status I or II\n* Aged 1 to 12 years\n* Scheduled for elective surgery requiring general anesthesia with laryngeal mask airway (LMA) insertion (e.g., ophthalmic surgery, skin lesion excision, minor abdominal or urological procedures, with expected surgical duration ≤ 2 hours)\n* Written informed consent obtained from parents or legal guardians\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to ciprofol, fentanyl, or any study-related drugs\n* Intellectual disability, cognitive-affective disorders, psychiatric or neurological diseases\n* Inability to cooperate with peripheral intravenous cannulation\n* History of reactive airway disease or suspected difficult airway\n* Body mass index (BMI) ≥ 30 kg\u002Fm² or ≤ 15 kg\u002Fm²\n* History of sedative medication use\n* Inability to understand the study protocol or participation in another clinical trial within the past 30 days","1 Year",{"count":491,"type":22},180,[493],"PHASE4","Ciprofol is a novel intravenous anesthetic with a pharmacological profile similar to propofol but with a lower incidence of injection pain, hypotension, and respiratory depression. For pediatric day-case surgeries, laryngeal mask airway (LMA) insertion without neuromuscular blockers is increasingly preferred. While opioids are often combined with hypnotics to optimize insertion conditions, the optimal bolus dose of ciprofol when co-administered with a standard dose of fentanyl for LMA insertion in children remains unknown. This study aims to determine the 95% effective dose (ED95) of a single intravenous bolus of ciprofol, combined with a fixed dose of fentanyl (1 μg\u002Fkg), for successful LMA insertion in children aged 1-12 years during general anesthesia induction.",[496,497,498,499],"Pediatric","Anesthesia Induction","Ciprofol","Laryngeal Mask Airway",{"date":34,"type":35},{"date":124,"type":35},{"date":503,"type":22},"2028-12-01",{"name":505,"class":42},"Huazhong University of Science and Technology",{"id":507,"slug":508,"hasResults":12,"nctId":509,"briefTitle":510,"officialTitle":511,"acronym":512,"eligibilityCriteria":513,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":514,"targetDuration":4,"studyType":516,"phases":4,"briefSummary":517,"conditions":518,"keywords":520,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":522,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":527,"locationsCount":43},"100053914","choicedecision-factor-of-egfr-tki-in-chinese-iv-nsclc-100053914","NCT07413757","CHOICE:Decision Factor of EGFR-TKI in Chinese IV NSCLC","A Cross-sectional Survey-based Study Using Preference Elicitation Method to Assess Decision-making Impact Factor of Chinese Patients and Physicians for First-line EGFR-TKIs Treatment of Stage IV NSCLC (CHOICE)","CHOICE","Inclusion Criteria:\n\nThe following inclusion criteria must be met in order to be enrolled in the stage 1:\n\nPatient:\n\n* Provide informed consent\n* 18 years or older\n* Diagnosed with stage IV NSCLC\n* Currently receiving or previously received 1L EGFR-TKI treatment\n* Without communication barrier\n* Do not exhibit signs of cognitive impairment that would prevent participation in an interview, as informally assessed during screening by the recruiter\n\nPhysician:\n\n* Provide informed consent\n* Specialized in departments of medical oncology, respiratory medicine, or thoracic surgery at tertiary hospitals\n* Manage at least 3 stage IV NSCLC patients with 1L EGFR-TKI per month\n* Holding the title of associate chief physician or higher\n\nThe following inclusion criteria must be met in order to be enrolled in the stage 2:\n\nPatient:\n\n* Provide informed consent\n* 18 years or older\n* Diagnosed with stage IV NSCLC\n* Currently receiving or previously received 1L EGFR-TKI treatment\n* Without communication barrier\n* Do not exhibit signs of cognitive impairment that would prevent participation in a survey, as informally assessed during screening by the recruiter\n\nPhysician:\n\n* Provide informed consent\n* Specialized in departments of medical oncology, respiratory medicine, or thoracic surgery at tertiary hospitals\n* Manage at least 3 stage IV NSCLC patients with 1L EGFR-TKI per month\n* Holding the title of attending physician or higher\n\nExclusion Criteria:\n\nNot applicable.",{"count":515,"type":22},590,"OBSERVATIONAL","This non-interventional, cross-sectional study aims to investigate treatment preferences from a sample of physicians and patients with experience of 1L EGFR-TKI for stage IV NSCLC by administering a survey, which primarily includes a DCE approach.",[519],"Non-Small Cell Lung Cancer",[521],"NSCLC;patients and physicians;survey;EGFR-TKI;patient preference;physician preference",{"date":34,"type":35},{"date":524,"type":35},"2026-03-02",{"date":526,"type":22},"2026-07-31",{"name":405,"class":86},{"id":529,"slug":530,"hasResults":12,"nctId":531,"briefTitle":532,"officialTitle":533,"acronym":534,"eligibilityCriteria":535,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":536,"targetDuration":4,"studyType":23,"phases":538,"briefSummary":539,"conditions":540,"keywords":544,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":548,"startDateStruct":549,"completionDateStruct":551,"leadSponsor":553,"locationsCount":555},"100053764","phase-3-a-study-of-vepugratinib-ly3866288-in-participants-with-cancer-in-the-urinary-tract-100053764","NCT07218380","A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary Tract","FORAGER-2: A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Vepugratinib Combined With Enfortumab Vedotin and Pembrolizumab in Adults With Untreated Locally Advanced or Metastatic Urothelial Carcinoma With an FGFR3 Genetic Alteration","FORAGER-2","Inclusion Criteria:\n\n* Have histologically confirmed, unresectable locally advanced or metastatic urothelial cancer (mUC). Individuals with mixed histology other than small cell or neuroendocrine carcinoma are eligible if a urothelial component is present.\n* Have a qualifying fibroblast growth factor receptor 3 (FGFR3) genetic alteration determined via molecular testing from a tumor or blood sample obtained at or any time after diagnosis of advanced or metastatic urothelial cancer.\n* Have measurable disease by investigator assessment defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Have adequate laboratory parameters\n\nExclusion Criteria:\n\n* Have received prior systemic therapy for locally advanced or metastatic urothelial cancer (mUC).\n* Have any unresolved toxicities greater than Grade 1 Common Terminology Criteria for Adverse Events (\\[CTCAE\\] version 5.0) from prior neoadjuvant or adjuvant systemic therapy.\n* Have ongoing sensory or motor neuropathy of Grade 2 or higher\n* Have untreated or uncontrolled central nervous system (CNS) involvement or any history of leptomeningeal disease.\n* Current evidence corneal keratopathy or retinal disorder confirmed by ocular examination at screening.",{"count":537,"type":22},450,[98],"The purpose of this study is to test a new medicine, vepugratinib, in comparison with placebo, to see if it is safe and can help people with a bladder cancer that is advanced or has spread.\n\nVepugratinib or placebo will be administered in combination with enfortumab vedotin and pembrolizumab.\n\nStudy participation could last up to approximately 6 years.",[541,542,543],"Carcinoma, Transitional Cell","Urinary Bladder Neoplasms","Neoplasm Metastasis",[545,546,547],"FGFR3","Advanced Urothelial Carcinoma","Metastatic Urothelial Carcinoma",{"date":34,"type":35},{"date":550,"type":35},"2025-12-12",{"date":552,"type":22},"2033-05",{"name":554,"class":86},"Eli Lilly and Company",286,{"id":557,"slug":558,"hasResults":12,"nctId":559,"briefTitle":560,"officialTitle":561,"acronym":562,"eligibilityCriteria":563,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":169,"enrollmentInfo":564,"targetDuration":4,"studyType":23,"phases":566,"briefSummary":567,"conditions":568,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":569,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":573,"locationsCount":491},"100053951","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-dnth103-in-adults-with-chronic-inflammatory-demyelinating-polyneuropathy-captivate-100053951","NCT06858579","A Study to Evaluate the Efficacy and Safety of DNTH103 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)","A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of DNTH103 In Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)","CAPTIVATE","Inclusion Criteria:\n\n1. Must have given written informed consent before any study-related activities are carried out.\n2. Weight range between 40 kilograms (kg) and 120 kg.\n3. Confirmed diagnosis of CIDP or possible CIDP. Participants must have either typical CIDP or one of the following variants: motor or multifocal CIDP. Diagnosis must be confirmed by the Independent CIDP Review Panel.\n4. CIDP Disease Activity Status (CDAS) score ≥ 3 at screening.\n5. Must be neurologically stable.\n6. Must have an INCAT score between 2 and 9 inclusive.\n7. Must fulfill one of the following treatment conditions for CIDP:\n\n   1. Currently treated with and responded to immunoglobulin (Ig) (intravenous immunoglobulin \\[IVIg\\] or subcutaneous immunoglobulin \\[SCIg\\]) alone or Ig (IVIg or SCIg) plus oral corticosteroids, or previously treated with and responded to, but are no longer being treated with (eg, lost access to), a maintenance regimen of Ig (IVIg or SCIg) alone or Ig (IVIg or SCIg) plus oral corticosteroids.\n   2. Currently treated with and responded to oral corticosteroids alone or oral corticosteroids in combination with azathioprine or mycophenolate mofetil.\n   3. Refractory participants who have had treatment failure (worsening) or an inadequate response to Ig and\u002For oral corticosteroids (defined as no clinically meaningful improvement after a period of a minimum of 12 weeks, which may include both active treatment and observation to assess response), or who at any time were unable to tolerate these treatments, experienced adverse effects, or have documented contraindications.\n   4. Treatment naïve with no history of prior treatment for CIDP.\n8. Documented vaccinations against encapsulated bacteria in accordance with local requirements and vaccine availability.\n9. Female participants must be of nonchildbearing potential or if of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use a highly effective method of contraception.\n10. Male participants must agree not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception or be surgically sterile for at least 90 days prior to Screening.\n\nExclusion Criteria:\n\n1. Clinical signs or symptoms suggestive of polyneuropathy of causes other than CIDP.\n2. Known evidence of central demyelination or known history of myelopathy.\n3. History or presence of significant medical\u002Fsurgical condition including any acute illness or major surgery considered to be clinically significant or that could have a potential impact on safety\u002Fefficacy or study procedures.\n4. Any other condition, including mental illness or prior therapy that would make the participant unsuitable for this study.\n5. Known complement deficiency or history of positive titer for anti-C1 antibodies.\n6. Diagnosis of systemic lupus erythematosus (SLE) or family history of SLE (defined as a parent, sibling, or child).\n7. Participants with an autoimmune disease affecting joints, muscle or nervous system.\n8. Any coexisting or overlapping condition, which may interfere with outcome assessments, such as severe diabetic neuropathy, fibromyalgia, inflammatory arthritis or osteoarthritis affecting the hands and feet.\n9. Prior history of N. meningitidis infection.\n10. History of active malignancy within 5 years prior to screening, except basal cell carcinoma of the skin, curatively resected squamous cell carcinoma of the skin, cervical carcinoma in situ curatively treated or low-grade prostate adenocarcinoma for which appropriate management is observation alone.\n11. Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies.",{"count":565,"type":22},256,[98],"The purpose of this Phase 3 study is to demonstrate the efficacy of claseprubart (DNTH103) as compared to placebo in participants with chronic inflammatory demyelinating polyneuropathy (CIDP).",[442],{"date":34,"type":35},{"date":571,"type":35},"2025-02-10",{"date":62,"type":22},{"name":574,"class":86},"Dianthus Therapeutics",{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":580,"acronym":4,"eligibilityCriteria":581,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":582,"targetDuration":4,"studyType":23,"phases":584,"briefSummary":585,"conditions":586,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":588,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":594},"100053698","phase-2-a-clinical-study-of-tulisokibart-mk-7240-to-treat-radiographic-axial-spondyloarthritis-mk-7240-013-100053698","NCT07133633","A Clinical Study of Tulisokibart (MK-7240) to Treat Radiographic Axial Spondyloarthritis (MK-7240-013)","A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Radiographic Axial Spondyloarthritis (Ankylosing Spondylitis)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has a clinical diagnosis of axial spondyloarthritis (axSpA) and meets the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axSpA including ≥3 months of back pain with age at symptom onset \\\u003C45 years\n* Meets the radiographic criterion of the modified New York criteria for ankylosing spondylitis (AS) as determined by central reading at Screening\n* Has active disease at Screening and Randomization\n* Has a history of inadequate response (IR)\u002Fintolerance to nonsteroidal anti-inflammatory drugs (NSAIDs) and is biologic disease-modifying antirheumatic drug (bDMARD)-naive, or has a history of IR\u002Fintolerance to up to a maximum of 2 bDMARD classes\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has any arthritis with onset before age 17 years or current diagnosis of inflammatory joint disease other than radiographic axial spondyloarthritis (r-axSpA) (such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis (PsA), systemic sclerosis, myositis, etc.), or any other conditions that may, in the judgment of the investigator, interfere with the assessment of r-axSpA\n* Has a history of cancer (except fully treated non-melanoma skin cancers or cervical carcinoma in situ after complete surgical removal) within the last 5 years\n* Has any active infection\n* Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients",{"count":583,"type":22},315,[25],"Researchers are looking for new ways to treat radiographic axial spondyloarthritis (r-axSpA). R-axSpA is a type of arthritis that causes pain, stiffness, and inflammation (swelling) in the spine and joints in the pelvis (hip bone). Radiographic means the damage it causes can be seen on X-rays.\n\nThis study will help find out if a study medicine called tulisokibart can treat symptoms of r-axSpA. Researchers will look at different doses of tulisokibart.\n\nResearchers want to know if at least one of the study doses of tulisokibart works better than a placebo to improve r-axSpA symptoms. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of the study medicine.",[587],"Radiographic Axial Spondyloarthritis",{"date":34,"type":35},{"date":590,"type":35},"2025-09-26",{"date":592,"type":22},"2030-02-05",{"name":208,"class":86},104,{"id":596,"slug":597,"hasResults":12,"nctId":598,"briefTitle":599,"officialTitle":600,"acronym":4,"eligibilityCriteria":601,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":602,"targetDuration":4,"studyType":23,"phases":604,"briefSummary":605,"conditions":606,"keywords":609,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":614,"startDateStruct":615,"completionDateStruct":617,"leadSponsor":619,"locationsCount":43},"100053594","phase-4-real-world-study-of-pyrotinib-containing-regimens-of-advanced-her2-positive-breast-cancer-100053594","NCT07600164","Real-world Study of Pyrotinib-containing Regimens of Advanced HER2-positive Breast Cancer","Real-world Study of Pyrotinib-containing Regimens in First-line or Second-line Treatment of Advanced HER2-positive Breast Cancer","Inclusion Criteria:\n\n1. Aged ≥ 18 years old;\n2. Histopathologically confirmed HER2-positive inoperable locally advanced or metastatic breast cancer;\n3. Patients with first-line or second-line advanced disease:\n\n   First-line advanced disease: no prior systemic therapy for locally advanced or metastatic disease. For patients who received neoadjuvant or adjuvant therapy, the disease-free interval (DFI) after the completion of the last chemotherapy or HER2-targeted therapy was more than 12 months; Second-line advanced disease: prior treatment with taxane combined with trastuzumab, with or without pertuzumab, in the advanced setting; or recurrence occurring during neoadjuvant\u002Fadjuvant therapy, or a disease-free interval (DFI) of ≤ 12 months after completion of the last neoadjuvant\u002Fadjuvant chemotherapy and HER2-targeted therapy;\n4. Planned to receive pyrotinib-containing regimen, and judged by investigators based on clinical practice to have potential subsequent treatment with Ruikang trastuzumab after failure of pyrotinib-containing therapy;\n5. Traceable medical records available throughout the treatment period.\n\nExclusion Criteria:\n\n1. Failure to sign the informed consent form;\n2. Pregnant or lactating females;\n3. Patients participating in any interventional clinical trial involving investigational drugs or marketed drugs at enrollment;\n4. Other conditions deemed ineligible for enrollment by the investigator's judgment.",{"count":603,"type":22},500,[493],"Given that pyrotinib has been proven to exert significant efficacy against HER2-positive advanced breast cancer in multiple Phase III studies, and the novel ADC drug disitamab vedotin has demonstrated potent anti-tumor activity, there remains insufficient real-world data on their sequential administration. This multicenter, prospective real-world study plans to enroll 500 patients with HER2-positive advanced breast cancer receiving first-line or second-line treatment. It aims to evaluate the efficacy and safety of sequential disitamab vedotin treatment after disease progression or intolerance to pyrotinib-based regimens (first-line: pyrotinib plus trastuzumab combined with chemotherapy; second-line: pyrotinib plus capecitabine). The primary endpoint is real-world second progression-free survival (rwPFS2), while secondary endpoints cover real-world progression-free survival (rwPFS), tumor response, overall survival (OS), time to treatment failure, safety profiles and patient-reported outcomes. It is currently expected to further validate the efficacy and safety of pyrotinib in patients with advanced HER2-positive breast cancer in the real-world setting, and to evaluate the efficacy and safety of recindopril trastuzumab following pyrotinib-containing regimens.",[607,608],"HER2 + Breast Cancer","Advanced Breast Cancer",[610,611,612,613],"HER2-positive breast cancer","Advanced breast cancer","pyrotinib","Trastuzumab Rezetecan",{"date":34,"type":35},{"date":616,"type":35},"2026-07-06",{"date":618,"type":22},"2031-12-30",{"name":186,"class":42},""]