[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Peking University People's Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":643},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,183,0,25,[9,45,70,96,122,148,172,201,226,245,275,300,328,353,375,406,428,448,476,497,523,550,568,588,613],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100552063","fertility-sparing-therapy-for-patients-with-stage-ia-g2-endometrial-cancer-100552063",false,"NCT06468215","Fertility Sparing Therapy for Patients With Stage IA G2 Endometrial Cancer","Inclusion Criteria:\n\n* Endometrioid adenocarcinoma G2, diagnosis by pathological.\n* The lesion is limited to the endometrium.\n* FIGO (2009) staging is IA.\n* Age less than 45.\n* Strongly request to preserve fertility.\n* Sign informed consent.\n\nExclusion Criteria:\n\n* The tumor has invaded the muscle layer.\n* FIGO (2009) stage IB or higher.\n* Endometrioid adenocarcinoma G1, G3, or non-endometrioid cancer\n* There are malignant tumors in other systems.\n* Have contraindications for conservative treatment or drug use.\n* Have been judged by the researcher to be unsuitable for childbearing.","FEMALE","45 Years",{"count":19,"type":20},16,"ESTIMATED","INTERVENTIONAL",[23],"NA","Endometrial cancer (EC) is a prevalent gynecological cancer with an escalating global incidence and a decreasing age of onset. In the era of precision medicine, there is an increasing emphasis on tailoring treatments to different populations to optimize the positive impact of clinical interventions. Fertility-sparing therapies (FST) are gaining popularity for early-stage, low-grade endometrial cancer due to mounting evidence supporting favorable oncologic and pregnancy outcomes. However, consensus regarding the feasibility of fertility-sparing therapy for similar low-risk grade-2 (G2) endometrioid adenocarcinoma remains elusive. Given the uncertainties surrounding fertility-preserving therapy in patients with moderately differentiated endometrial cancer, this study aims to investigate the optimal regimen of fertility-preserving therapy for patients with IAG2.",[26,27],"Carcinoma, Endometrioid","Fertility Preservation",[29,30,31],"endometrial cancer","fertility-sparing treatment","grade 2","RECRUITING","2026-08-19",{"date":35,"type":36},"2026-08-21","ACTUAL",{"date":38,"type":36},"2024-06-21",{"date":40,"type":20},"2028-10",{"name":42,"class":43},"Peking University People's Hospital","OTHER",1,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":56,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":67,"leadSponsor":69,"locationsCount":44},"100652618","real-world-efficacy-and-safety-of-tenapanor-plus-phosphate-binders-in-hemodialysis-patients-with-hyperphosphatemia-100652618","NCT07776119","Real-World Efficacy and Safety of Tenapanor Plus Phosphate Binders in Hemodialysis Patients With Hyperphosphatemia","Inclusion Criteria:\n\n1. The subject has provided written informed consent prior to the initiation of any study-related activities.\n2. Male or female subjects aged ≥18 years at the time of signing the informed consent form.\n3. The subject is receiving regular maintenance hemodialysis (3 times per week, 4 hours per session) for at least 3 months.\n4. The patient has been on phosphate binder therapy for at least 3 weeks, with a stable dose.\n5. Serum phosphorus \\> 4.5 mg\u002FdL.\n\nExclusion Criteria:\n\n1. Hypersensitivity to Tenapanor or any excipients of the formulation.\n2. History of diarrhea within 1 week prior to the start of treatment. Diarrhea is defined as a Bristol Stool Form Scale (BSFS) score ≥6 (i.e., mushy or liquid stools with no solid pieces), a daily bowel movement frequency ≥3 times, and a duration of ≥2 days.\n3. Life expectancy \\\u003C 6 months.\n4. Expected or planned kidney transplantation during the study period.\n5. History of inflammatory bowel disease (IBD) or irritable bowel syndrome with diarrhea (IBS-D).\n6. Any other condition that, in the opinion of the Investigator, makes the patient unsuitable for enrollment.","ALL","18 Years","100 Years",{"count":55,"type":20},200,"6 Months","OBSERVATIONAL","The efficacy and safety of tenapanor plus PBs in Chinese patients are still unclear. Therefore, we aim to conduct a real-world study to explore the effect of combining two drugs with different mechanisms on hyperphosphatemia management.This real-world study will enroll hemodialysis patients with hyperphosphatemia who are on PBs therapy.",[60,61],"CKD 5D, Hemodialysis","Hyperphosphatemia Undergoing Hemodialysis","NOT_YET_RECRUITING","2026-08-17",{"date":65,"type":36},"2026-08-20",{"date":65,"type":20},{"date":68,"type":20},"2027-10-10",{"name":42,"class":43},{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":12,"sex":51,"minAge":52,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":21,"phases":80,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":44},"100648441","effect-of-inspired-oxygen-concentration-on-postoperative-atelectasis-after-vats-right-lobectomy-100648441","NCT07721558","Effect of Inspired Oxygen Concentration on Postoperative Atelectasis After VATS Lobectomy","Effect of Inspired Oxygen Concentration on Postoperative Atelectasis in Patients Undergoing Elective Thoracoscopic Pulmonary Lobectomy Based on Perioperative Lung Protection Strategy: A Randomized Controlled Trial","Inclusion Criteria:\n\nAge 18-65 years Elective thoracoscopic (VATS) pulmonary lobectomy Anticipated one-lung ventilation duration \\>1 hour ASA physical status I-III\n\nExclusion Criteria:\n\nPrevious pulmonary surgery (including lobectomy, lung volume reduction surgery, or other lung resection) Pre-existing significant atelectasis (large collapse on preoperative CT) Contraindications to PEEP: intracranial hypertension, bronchopleural fistula, hypovolemic shock, right heart failure, giant bullae, pneumothorax Preoperative continuous oxygen therapy or mechanical ventilation, moderate-severe COPD BMI ≥ 30 kg\u002Fm² Ischemic cardiovascular and cerebrovascular diseases, such as myocardial infarction, ischemic stroke, and patients with coronary or cerebrovascular stents Patient refusal to participate\n\nWithdrawal Criteria \u002F Major Protocol Deviations:\n\nSurgery changed to simple wedge resection Severe pleural adhesions (found intraoperatively) One-lung ventilation duration \\\u003C 50 minutes Intraoperative blood loss \\> 500 ml Severe hypotension (MAP \\\u003C 55 mmHg despite high-dose vasopressors) Unexpected non-thoracic surgical procedure Ventilation protocol interrupted (e.g., FiO₂ exposure \\\u003C 80% of planned time in the low-oxygen group) Postoperative CT not completed or image quality unusable Subject withdrawal of informed consent","65 Years",{"count":79,"type":20},100,[23],"This study aims to investigate whether using 50% FiO₂ during one-lung ventilation, compared with 100% FiO₂, reduces postoperative atelectasis in the non-dependent (healthy) lung of patients undergoing VATS pulmonary lobectomy, based on individualized PEEP titration. This is a single-center, prospective, assessor- and patient-blinded randomized controlled trial. A total of 100 patients (50 per group, including a pilot phase of 10 per group) will be enrolled and randomized 1:1 to the high-oxygen group (FiO₂=100%) and the low-oxygen group (FiO₂=50%). The primary endpoint is the percentage of atelectasis volume in the non-operated lung relative to the total non-operated lung volume, assessed by CT at 60±10 minutes after tracheal extubation.",[83,84],"Atelectasis","Postoperative Pulmonary Complications",[86,87,88],"Inspired oxygen concentration","One-lung ventilation","Lung recruitment maneuver","2026-08-16",{"date":33,"type":36},{"date":92,"type":20},"2026-09-01",{"date":94,"type":20},"2027-12-01",{"name":42,"class":43},{"id":97,"slug":98,"hasResults":12,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":103,"sex":51,"minAge":4,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":106,"conditions":107,"keywords":110,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":119,"leadSponsor":121,"locationsCount":4},"100651422","endotracheal-tube-intolerance-and-respiratory-airflow-perception-100651422","NCT07759284","Endotracheal Tube Intolerance and Respiratory Airflow Perception","Association Between Preoperative Oronasal Breathing Patterns and Endotracheal Tube Intolerance During Emergence From General Anesthesia: A Prospective Nested Case-Control Study","Inclusion Criteria:\n\n* Patients undergoing general anesthesia with endotracheal intubation;\n* Written informed consent obtained.\n\nExclusion Criteria:\n\n* Patients with severe psychiatric disorders;\n* Deaf or mute patients who are unable to answer questions;\n* Patients who develop postoperative cognitive dysfunction and are consequently unable to answer questions;\n* Patients who withdraw from the study prematurely;\n* Patients who are extubated after being transferred to the recovery room or intensive care unit (i.e., extubation not performed in the operating room).",true,{"count":105,"type":20},224,"This is a case-control study designed to enroll 224 patients who will undergo tracheal intubation for general anesthesia in the operating rooms of Peking University People's Hospital between July 20, 2026, and October 31, 2026. The case group will consist of patients who develop coughing before extubation (N=112), while the control group will comprise those without coughing before extubation (N=112).\n\nData to be collected include general demographic characteristics, smoking and smoking cessation history, comorbid conditions (with particular attention to snoring during sleep and sleep apnea-hypopnea syndrome \\[SAHS\\]), history of pulmonary diseases, mode of spontaneous breathing, surgical and anesthetic data, as well as blood pressure and heart rate before, during, and after extubation, pain scores, and sedation levels.\n\nContinuous variables will be presented as mean ± standard deviation (for normally distributed data) or median with interquartile range (IQR) (for non-normally distributed data). Categorical variables will be described using frequencies and percentages (e.g., sex, smoking history). Baseline differences between the case and control groups will be compared using the chi-square test (for categorical variables), Student's t-test (for normally distributed continuous variables), or the Mann-Whitney U test (for non-normally distributed continuous variables). Multivariable logistic regression analysis will be employed to evaluate the independent association between the mode of spontaneous breathing and coughing before extubation, with adjustment for potential confounding factors, and odds ratios (ORs) with their 95% confidence intervals (95%CI) will be calculated. All statistical analyses will be performed using SPSS or R software.",[108,109],"Coughing Responses at Tracheal Extubation","Breathing Patterns",[111,112,113,114],"Oronasal Breathing Pattern","Endotracheal Tube Intolerance","Emergence from General Anaesthesia","Nested Case-Control Study","2026-08-11",{"date":117,"type":36},"2026-08-12",{"date":92,"type":20},{"date":120,"type":20},"2026-10-31",{"name":42,"class":43},{"id":123,"slug":124,"hasResults":12,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":12,"sex":16,"minAge":52,"maxAge":17,"enrollmentInfo":129,"targetDuration":4,"studyType":21,"phases":131,"briefSummary":132,"conditions":133,"keywords":137,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":44},"100558341","pd-1-inhibitor-combined-with-progesterone-treatment-in-fst-for-patients-with-mmrd-endometrial-cancer-100558341","NCT06549855","PD-1 Inhibitor Combined With Progesterone Treatment in FST for Patients With MMRd Endometrial Cancer","PD-1 Inhibitor Combined With Progesterone Treatment in Fertility Sparing Therapy for Mismatch Repair-deficient Endometrial Cancer","Inclusion Criteria:\n\n* Be between the ages of 18-45 years old;\n* Stage IA (FIGO 2009) ;\n* Confirmed diagnosis of endometrial adenocarcinoma G1-G2 based upon D\\&C or hysteroscopy;\n* Molecular classification of MMRd, determined by immunohistochemical (IHC) for MMR proteins and by the second generation sequencing (NGS) or microsatellite polymerase chain reaction (PCR);\n* With a strong desire for fertility preservation;\n* Sign the informed consent.\n\nExclusion Criteria:\n\n* Stage IB(FIGO 2009) and above；\n* Tumour differentiation of G3 or non-endometrioid adenocarcinoma；\n* Complicated with any other malignancy；\n* Contraindicated to conservative treatment or the use of pharmaceuticals.\n* Contraindications to pregnancy, or judged by the researcher to be unfit for pregnancy or delivery.",{"count":130,"type":20},10,[23],"The objective of this study was to investigate the feasibility of a PD-1 inhibitor in combination with progesterone as a means of preserving fertility in patients with early-stage mismatch repair-deficient (MMRd) endometrial cancer who wish to preserve fertility.",[134,135,136],"Endometrial Cancer","Endometrioid Carcinoma","Mismatch Repair Deficiency",[138,135,139],"Fertility preservation","PD-1 inhibitor","2026-08-06",{"date":142,"type":36},"2026-08-10",{"date":144,"type":36},"2024-09-02",{"date":146,"type":20},"2029-10",{"name":42,"class":43},{"id":149,"slug":150,"hasResults":12,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":12,"sex":51,"minAge":155,"maxAge":156,"enrollmentInfo":157,"targetDuration":4,"studyType":21,"phases":159,"briefSummary":161,"conditions":162,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":4},"100649558","phase-3-prophylactic-nac-to-improve-platelet-engraftment-after-haploidentical-transplantation-in-severe-aplastic-anemia-patients-100649558","NCT07737262","Prophylactic NAC to Improve Platelet Engraftment After Haploidentical Transplantation in Severe Aplastic Anemia Patients","Prophylactic N-Acetylcysteine to Facilitate Platelet Engraftment Following Haploidentical Hematopoietic Stem Cell Transplantation for Patients With Severe Aplastic Anemia: A Prospective Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n1. Diagnosed with aplastic anemia and scheduled to receive first haplo-HSCT\n2. Aged 14 to 50 years\n3. Hematopoietic Cell Transplant Comorbidity Index (HCT-CI) ≤ 2\n4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n5. Negative donor-specific HLA antibodies\n6. No uncontrolled active infection before transplantation\n7. No irreversible severe organ dysfunction\n8. Voluntarily sign written informed consent and agree to complete scheduled follow-up\n\nExclusion Criteria:\n\n1. Confirmed allergy or hypersensitivity to NAC\n2. Medical history of bronchial asthma\n3. Uncontrolled severe psychiatric disorders unable to cooperate with treatment and follow-up\n4. Active peptic ulcer, gastrointestinal bleeding, inflammatory bowel disease or severe gastrointestinal dysfunction\n5. Female patients who are pregnant or breastfeeding","14 Years","50 Years",{"count":158,"type":20},142,[160],"PHASE3","This study aims to evaluate the efficacy and safety of prophylactic oral N-acetylcysteine (NAC) for facilitating platelet engraftment in patients with severe aplastic anemia (SAA) receiving haploidentical hematopoietic stem cell transplantation (haplo-HSCT). This is a prospective, multicenter, randomized controlled trial enrolling a total of 142 patients with SAA scheduled for their first haplo-HSCT, who will be randomly assigned at a 1:1 ratio to the NAC prophylaxis group or the control group, with 71 subjects in each arm. Patients in the intervention group will receive oral NAC 400 mg three times daily from Day -14 before transplantation to Day +60 post-transplant, while the control group will receive no prophylactic NAC, with all other transplant-related treatments identical between the two groups. The primary endpoint is the cumulative platelet engraftment rate at 2 months after transplantation. Secondary endpoints cover neutrophil engraftment rate, incidence of poor hematopoietic reconstitution, cumulative blood product transfusion volume, graft-versus-host disease (GVHD), overall survival, GVHD-free and failure-free survival, and biomarkers reflecting bone marrow hematopoietic microenvironment reconstruction. Safety outcomes will be assessed via adverse events graded per NCI CTCAE Version 5.0. Statistical analyses will be performed using R 4.4.0 software, primarily adopting competing risk models and the Kaplan-Meier method based on full analysis set, per-protocol set and safety set. This trial will clarify intergroup differences in platelet recovery, other efficacy endpoints and safety profiles, verify the clinical benefits and safety of NAC, and generate high-quality clinical evidence for prophylactic intervention targeting platelet engraftment after haplo-HSCT in SAA patients to optimize clinical management strategies.",[163],"Aplastic Anemia","2026-07-27",{"date":166,"type":36},"2026-07-30",{"date":168,"type":20},"2026-08-01",{"date":170,"type":20},"2029-07-31",{"name":42,"class":43},{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":12,"sex":51,"minAge":52,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":21,"phases":181,"briefSummary":183,"conditions":184,"keywords":187,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":200},"100618766","phase-2-sonrotoclax-plus-dexamethasone-with-or-without-daratumumab-regimen-in-patients-with-t1114-primary-al-amyloidosis-100618766","NCT07335887","Sonrotoclax Plus Dexamethasone With or Without Daratumumab Regimen in Patients With t(11;14) Primary AL Amyloidosis","An Optimized Treatment for Patients With Primary Systemic Light Chain Amyloidosis","Inclusion Criteria:\n\n1. Patients who meet the diagnostic criteria for Primary Systemic Light Chain Amyloidosis (according to the Systemic Light Chain Amyloidosis Diagnosis and Treatment Guidelines (2021 Revision)).\n2. Age ≥ 18 years.\n3. Confirmed FISH test result of t(11;14) positive by each center or a third-party laboratory, or a prior FISH test report indicating t(11;14) positivity\n4. ECOG Performance Status score of 0-2.\n5. Presence of measurable disease, defined by at least one of the following criteria:\n\n   1. Serum M-protein ≥ 0.5 g\u002FdL\n   2. Serum free light chain (FLC) level ≥ 40 mg\u002FL with an abnormal kappa\u002Flambda ratio.\n6. Adequate organ function, defined as:\n\n   1. Hemoglobin (HGB) \\> 80 g\u002FL\n   2. Platelet count \\> 50 × 10⁹\u002FL\n   3. Absolute neutrophil count (ANC) \\> 1.0 × 10⁹\u002FL\n   4. Total bilirubin ≤ 2.0 × ULN; AST and ALT ≤ 3.0 × ULN\n   5. Creatinine clearance (CrCl) ≥ 30 mL\u002Fmin\n   6. Oxygen saturation ≥ 90%\n7. Life expectancy greater than 6 months.\n8. Patient understands and voluntarily signs an informed consent form (ICF).\n9. Cohort Assignment:\n\n   * Cohort A: Includes patients who are newly diagnosed or have not been previously exposed to anti-CD38 monoclonal antibody therapy.\n   * Cohort B: Includes patients who are insensitive to or have relapsed after anti-CD38 monoclonal antibody therapy.Insensitivity to anti-CD38 monoclonal antibody therapy is defined as failure to achieve at least a Partial Response (PR) after 1 cycle, or failure to achieve at least a Very Good Partial Response (VGPR) after 3 cycles of an anti-CD38-containing regimen.\n\nExclusion Criteria:\n\n1. Meets the diagnostic criteria for active multiple myeloma or active lymphoplasmacytic lymphoma\n2. Presence of other malignancies at an advanced stage with systemic metastases.\n3. IgM-type AL amyloidosis.\n4. Prior treatment with a BCL-2 inhibitor (BCL-2i).\n5. Presence of any of the following severe cardiovascular diseases\n\n   1. Mayo 2004 stage IIIb: NT-proBNP \\>8500 ng\u002FL.\n   2. NYHA class IIIb-IV\n   3. Left ventricular ejection fraction (LVEF) \\\u003C40%.\n   4. QT interval corrected by Fridericia's formula (QTcF) \\>480 ms\n   5. Investigator assessment that heart failure is due to ischemic heart disease (e.g., prior history of myocardial infarction with elevated cardiac enzymes and ECG changes) or uncorrected valvular disease, rather than primarily caused by AL amyloidosis.\n   6. Hospitalization for unstable angina or myocardial infarction within 6 months prior to the first dose, or cardiac interventional therapy or coronary artery bypass grafting within 6 months.\n   7. For patients with congestive heart failure, hospitalization for cardiovascular disease within 4 weeks prior to Cycle 1 Day 1.\n   8. History of sustained ventricular tachycardia or aborted ventricular fibrillation, or history of atrioventricular node or sinus node dysfunction requiring a pacemaker\u002Fimplantable cardioverter-defibrillator (ICD) but not implanted.\n6. Severe or persistent infection that is not effectively controlled. (Acute infection requiring antibacterial, antifungal, or antiviral therapy that has not resolved within 14 days prior to dosing).\n7. Positive status for human immunodeficiency virus (HIV) antibody (HIVAb).\n8. Serological status reflecting active viral hepatitis B (HBV) or hepatitis C (HCV) infection, as follows:\n\n   1. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Patients who are positive for HBcAb but negative for HBsAg are eligible if HBV DNA is undetectable and they are willing to undergo monthly monitoring for HBV reactivation.\n   2. Positive for hepatitis C virus (HCV) antibody. Patients who are positive for HCV antibody are eligible if HCV RNA is undetectable.\n9. Patients receiving renal replacement therapy.\n10. Patients with known hypersensitivity to any component of the investigational regimen.\n11. Any condition that, in the investigator's judgment, would increase the risk to the subject or affect the study results.\n12. Patients with AL amyloidosis currently participating in other investigational drug clinical studies.\n13. Patients who are pregnant, breastfeeding, or planning to become pregnant during the study participation.\n14. Patients who are receiving any moderate or strong CYP3A4 inhibitors (within ≤7 days or 5 half-lives, whichever is shorter) or strong CYP3A4 inducers (within ≤14 days or 5 half-lives, whichever is shorter) prior to the first dose of the study drug; or patients who require continuous treatment with moderate or strong CYP3A inhibitors or strong CYP3A inducers",{"count":180,"type":20},39,[182],"PHASE2","The goal of this study is to evaluate the efficacy and safety of Sonrotoclax combined Regimen in patients with t(11;14) AL amyloidosis. Participants will receive the Sonrotoclax Plus Dexamethasone regimen with or without Daratumumab for 12 cycles. The Hematologic Response, Organ Response, Survival, and Safety will be evaluated.",[185,186],"AL Amyloidosis (AL)","t(11;14) Positive",[188,189,190,191],"sonrotoclax","AL amyloidosis","t(11;14)","BCL-2i","2026-07-25",{"date":194,"type":36},"2026-07-28",{"date":196,"type":36},"2026-02-10",{"date":198,"type":20},"2028-08-31",{"name":42,"class":43},3,{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":12,"sex":51,"minAge":207,"maxAge":208,"enrollmentInfo":209,"targetDuration":210,"studyType":57,"phases":4,"briefSummary":211,"conditions":212,"keywords":214,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":225,"locationsCount":44},"100648728","prospective-evaluation-of-dynamic-serum-progrp-for-treatment-response-monitoring-in-ewing-sarcoma-100648728","NCT07725783","Prospective Evaluation of Dynamic Serum ProGRP for Treatment Response Monitoring in Ewing Sarcoma","Inclusion Criteria:\n\n* Age 10 to 60 years.\n* Histologically confirmed Ewing sarcoma.\n* Newly diagnosed disease and scheduled to initiate first-line systemic therapy at Peking University People's Hospital.\n* No prior systemic chemotherapy for Ewing sarcoma and no prior radiotherapy to the primary tumor.\n* At least one evaluable lesion on baseline imaging; at least one measurable lesion according to RECIST version 1.1 is required for the primary outcome analysis.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Estimated life expectancy greater than 3 months.\n* Written informed consent provided by the participant or the participant's legally authorized representative.\n\nExclusion Criteria:\n\n* History of another malignant tumor within the previous 3 years, except for an adequately treated malignancy with a negligible risk of recurrence, as determined by the investigator.\n* New York Heart Association (NYHA) class III or IV heart failure.\n* Uncontrolled concomitant illness, including uncontrolled diabetes mellitus or an active infection.\n* Severe infection requiring intravenous antimicrobial treatment within 4 weeks before enrollment.\n* Clinically significant bleeding or a clear bleeding tendency within 3 months before enrollment.\n* Severe renal impairment, defined as an estimated glomerular filtration rate (eGFR) below 30 mL\u002Fmin\u002F1.73 m².\n* Pregnancy or breastfeeding.\n* Any condition that, in the investigator's judgment, may compromise participant safety, interfere with study assessments, or prevent compliance with the protocol.","10 Years","60 Years",{"count":79,"type":20},"5 Years","This single-center prospective observational study aims to evaluate whether longitudinal changes in serum pro-gastrin-releasing peptide (ProGRP) reflect treatment response in patients with newly diagnosed Ewing sarcoma. Serum ProGRP levels will be measured before systemic treatment, during neoadjuvant chemotherapy, before local treatment, and after local treatment. Changes in ProGRP will be compared with radiographic tumor response assessed according to RECIST version 1.1. The study will also explore the ability of early ProGRP changes to predict objective radiographic response and the association between ProGRP patterns and event-free survival. ProGRP results obtained for research purposes will not be used to guide clinical treatment decisions.",[213],"Ewing Sarcoma",[215,216,217,218],"ProGRP","Biomarker","Treatment Response","Neoadjuvant Chemotherapy","2026-07-21",{"date":221,"type":36},"2026-07-24",{"date":223,"type":36},"2025-09-01",{"date":92,"type":20},{"name":42,"class":43},{"id":227,"slug":228,"hasResults":12,"nctId":229,"briefTitle":230,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":12,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":21,"phases":234,"briefSummary":235,"conditions":236,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":44},"100483542","phase-2-fluzoparib-combined-with-camrelizumab-for-neoadjuvant-treatment-of-embryogenic-brca-mutation-her2-negative-breast-cancer-an-open-single-arm-multicenter-study-100483542","NCT05576389","Fluzoparib Combined With Camrelizumab for Neoadjuvant Treatment of Embryogenic BRCA Mutation HER2 Negative Breast Cancer: an Open, Single Arm, Multicenter Study","Inclusion Criteria:\n\n* According to the definition of the latest ASCO\u002FCAP guidelines, early or locally advanced HER2 negative invasive breast cancer confirmed by histopathology meets the following conditions:\n\n  * HER2 negative: IHC 0\u002F1+or IHC2+with no amplification of ISH;\n  * Primary tumor size: ≥ 1cm\n  * Lymph node status: N0-3\n  * Inflammatory breast cancer patients with measurable lesions (according to RECIST 1.1 standard)\n* Patients with bilateral breast cancer whose primary lesions all meet the inclusion criteria, or breast cancer with Tis-1bN0 and HER2 negative on the other side only meeting the inclusion criteria on one side;\n* The hormone receptor status is known;\n* ECOG score 0-1;\n* Carrying BRCA1 or BRCA2 germline pathogenic mutations or suspected pathogenic mutations;\n* According to RECIST 1.1 standard, at least one measurable lesion is present;\n\nExclusion Criteria:\n\n* Tumor related symptoms and treatment\n\n  * Recurrent or metastatic breast cancer;\n  * Participated in other drug trials or received any anti-tumor therapy, including endocrine therapy, bisphosphate therapy, immunotherapy, biological therapy, or tumor embolization, within 4 weeks prior to enrollment;\n  * Previously received treatment for PD-1\u002FPD-L1 antibodies, CTLA-4 antibodies, or other PD-1\u002FPD-L1 inhibitors;\n  * Previously received PARP inhibitor treatment (excluding those who have completed PARP inhibitor treatment for ovarian cancer for at least 5 years without recurrence or metastasis);\n* Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); active hepatitis or combined hepatitis B and C co-infection; autoimmune hepatitis;\n* Confirmed history of heart failure or systolic dysfunction (LVEF \\\u003C 50%); high risk uncontrolled cardiac arrhythmias, such as atrial tachycardia; angina requiring antianginal medication\n* Female patients who are pregnant or lactating\n* History of definite neurological or psychiatric disorders, including epilepsy or dementia\n* Presence of interstitial lung disease, pneumonitis, or uncontrolled systemic disease (eg, diabetes mellitus, pulmonary fibrosis, acute pneumonitis, etc.)",{"count":233,"type":20},64,[182],"This study is an open-label, single-arm, multicenter clinical study. 64 patients with germline BRCA-mutated HER2-negative early breast cancer are planned to be enrolled and treated with fluzoparib combined with camrelizumab to observe and evaluate the efficacy and safety of neoadjuvant fluzoparib combined with camrelizumab in the treatment of germline BRCA-mutated HER2-negative early breast cancer。",[237],"Germline BRCA-mutated HER2-negative Breast Cancer","2026-07-17",{"date":219,"type":36},{"date":241,"type":36},"2022-10-01",{"date":243,"type":20},"2028-12-31",{"name":42,"class":43},{"id":246,"slug":247,"hasResults":12,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":253,"enrollmentInfo":254,"targetDuration":4,"studyType":21,"phases":256,"briefSummary":257,"conditions":258,"keywords":262,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":44},"100647907","phase-2-orlistat-plus-progestin-for-fertility-sparing-treatment-of-endometrial-cancer-or-atypical-hyperplasia-100647907","NCT07714070","Orlistat Plus Progestin for Fertility-Sparing Treatment of Endometrial Cancer or Atypical Hyperplasia","A Single-Center, Randomized, Open-Label, Controlled Trial of Orlistat Combined With Progestin for Fertility-Sparing Treatment of Endometrial Cancer or Atypical Endometrial Hyperplasia With Low Progesterone Receptor Expression","PKUPH-ORLPP-EC","Inclusion Criteria:\n\n* Histologically confirmed grade 1-2 endometrioid endometrial adenocarcinoma or atypical endometrial hyperplasia (AEH), independently confirmed by two senior pathologists\n* Lesion confined to the endometrium on MRI or transvaginal ultrasound; FIGO (2009) stage IA without myometrial invasion (for G1, superficial invasion less than one half is allowed; G2 must have no myometrial invasion)\n* Age 45 years or younger\n* Received first-line MPA 250-500 mg\u002Fday or MA 160-320 mg\u002Fday for at least 3 months, with hysteroscopy plus curettage confirming failure to achieve complete response (persistent EC\u002FAEH lesion)\n* PR-positive cell percentage 25% or less and intensity grade 1 or lower (0 negative, 1 weak, 2 moderate, 3 strong), independently judged by two senior pathologists with a third adjudicating any disagreement\n* BMI 24 kg\u002Fm2 or higher; no severe comorbidity, specifically ALT\u002FAST 2.5x ULN or lower, serum creatinine 1.5x ULN or lower, and no history of active gastrointestinal bleeding\n* No contraindication to progestin therapy or to pregnancy\n* No evidence of distant metastasis on pelvic MRI and chest\u002Fabdominal CT\n* Clearly wishes to preserve fertility and provides signed informed consent\n* No use of orlistat or other lipase inhibitors within the past 6 months\n* Willing and able to comply with follow-up at this hospital\n\nExclusion Criteria:\n\n* Tumor invading more than one half of the myometrium; FIGO (2009) stage IB or higher\n* Grade G3 or non-endometrioid histology (serous, clear cell, carcinosarcoma, etc.)\n* Coexisting other endometrial cancer or other reproductive-system malignancy; coexisting breast cancer or other hormone-dependent tumor precluding progestin use\n* Allergy to orlistat or any formulation component, or prior severe adverse reaction (including severe hepatic injury) to orlistat\n* Chronic malabsorption syndrome (Crohn disease, celiac disease, short bowel syndrome) or cholestasis\n* Concurrent use of ciclosporin, warfarin, levothyroxine, antiepileptics (carbamazepine, phenytoin), or amiodarone that interact significantly with orlistat and cannot be replaced or dose-adjusted\n* Planned bariatric surgery (gastric bypass, sleeve gastrectomy, etc.) during the study\n* Pregnancy or lactation; unwilling to use reliable contraception during the study and for 3 months after study completion\n* Poor compliance or unable to complete 24 months of follow-up","46 Years",{"count":255,"type":20},48,[182],"This is a single-center, randomized, open-label, controlled clinical trial evaluating whether adding orlistat to standard progestin therapy can improve treatment response in patients receiving fertility-sparing treatment for early-stage endometrial cancer (grade 1-2) or atypical endometrial hyperplasia.\n\nProgestin is the standard drug used to preserve the uterus and fertility in these patients, but about 30% of patients respond poorly because the progesterone receptor (PR) in the endometrium is lost or reduced. Laboratory studies by the research team have shown that orlistat, a widely used oral weight-loss drug that blocks fat absorption, can raise PR levels and restore sensitivity to progestin.\n\nThe study will enroll 48 patients (age 45 years or younger, body mass index 24 kg\u002Fm2 or higher) who still have residual disease and low PR expression after at least 3 months of first-line progestin therapy. Participants will be randomly assigned in a 1:1 ratio to receive either progestin plus orlistat (experimental group) or progestin alone (control group) for 3 months, followed by 24 months of follow-up. The main goal is to compare the change in PR expression from baseline after 3 months of treatment. The study will also assess how many patients achieve complete disease reversal, time to complete response, recurrence, pregnancy and live-birth rates, safety, and changes in body weight and metabolic measures.",[259,134,260,261],"Endometrial Neoplasms","Atypical Endometrial Hyperplasia","Progestin Resistance",[27,263,264,265,266],"Fertility-Sparing Treatment","progestin","orlistat","progesterone receptor","2026-07-15",{"date":269,"type":36},"2026-07-20",{"date":271,"type":20},"2026-07",{"date":273,"type":20},"2029-12",{"name":42,"class":43},{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":12,"sex":51,"minAge":77,"maxAge":4,"enrollmentInfo":282,"targetDuration":4,"studyType":21,"phases":284,"briefSummary":285,"conditions":286,"keywords":292,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":299,"locationsCount":44},"100643642","clinical-study-of-a-new-treatment-model-for-elderly-lung-cancer-patients-100643642","NCT07632664","Clinical Study of a New Treatment Model for Elderly Lung Cancer Patients","A Multicenter Clinical Study on a New Treatment Model Combining New Surgical Techniques, Perioperative Comprehensive Treatment, and Postoperative Rehabilitation for Elderly Patients With Lung Cancer","Inclusion Criteria:\n\n1. Aged ≥65 years old\n2. Pathologically confirmed non-small cell lung cancer with clinical stage eligible for curative surgical resection\n3. Complete preoperative geriatric comprehensive assessment data available\n4. Capable of finishing planned surgery and long-term follow-up\n5. Voluntarily sign informed consent form\n\nExclusion Criteria:\n\n1. History of other malignant tumors within recent 5 years\n2. Severe organic dysfunction of heart, liver, renal or respiratory system that cannot tolerate thoracic surgery\n3. Preoperative confirmed distant metastasis preventing radical resection\n4. Uncontrolled active severe infection or obvious coagulation disorders\n5. Severe psychiatric disorder or cognitive dysfunction failing to cooperate with treatment and follow-up\n6. Refuse random grouping and postoperative regular monitoring",{"count":283,"type":20},1000,[23],"This multicenter prospective clinical study focuses on elderly patients with lung cancer. The investigators will build a standardized clinical registry database, develop perioperative risk stratification and surgical early-warning models, optimize individualized surgical regimens, construct multidisciplinary perioperative comprehensive therapy, integrated Chinese-Western medicine full-cycle management and personalized postoperative rehabilitation systems, so as to form a whole-process optimized treatment model for elderly lung cancer.",[287,288,289,290,291],"Lung Neoplasm","Thoracic Surgical Procedures","Perioperative Care","Postoperative Rehabilitation","Aged",[293],"Elderly lung cancer, Risk stratification, Multimodality therapy, Integrated Chinese and Western Medicine, Enhanced recovery after surgery","2026-07-14",{"date":267,"type":36},{"date":297,"type":36},"2024-08-01",{"date":198,"type":20},{"name":42,"class":43},{"id":301,"slug":302,"hasResults":12,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":4,"eligibilityCriteria":306,"healthyVolunteers":12,"sex":51,"minAge":52,"maxAge":4,"enrollmentInfo":307,"targetDuration":4,"studyType":21,"phases":309,"briefSummary":311,"conditions":312,"keywords":315,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":44},"100639594","phase-4-real-world-study-of-pyrotinib-containing-regimens-of-advanced-her2-positive-breast-cancer-100639594","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":308,"type":20},500,[310],"PHASE4","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.",[313,314],"HER2 + Breast Cancer","Advanced Breast Cancer",[316,317,318,319],"HER2-positive breast cancer","Advanced breast cancer","pyrotinib","Trastuzumab Rezetecan","2026-07-10",{"date":322,"type":36},"2026-07-13",{"date":324,"type":36},"2026-07-06",{"date":326,"type":20},"2031-12-30",{"name":42,"class":43},{"id":329,"slug":330,"hasResults":12,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":334,"eligibilityCriteria":335,"healthyVolunteers":12,"sex":16,"minAge":52,"maxAge":336,"enrollmentInfo":337,"targetDuration":4,"studyType":21,"phases":339,"briefSummary":340,"conditions":341,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":347,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":44},"100621091","phase-2-cdk46-inhibitors-combined-with-endocrine-therapy-for-neoadjuvant-treatment-100621091","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.","75 Years",{"count":338,"type":20},158,[182],"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",[342,343,344,345,346],"Hormone Receptor-Positive Breast Cancer","High-risk Breast Cancer","Early-Stage Breast Cancer","HER2-negative Breast Cancer","ctDNA Monitoring",{"date":322,"type":36},{"date":349,"type":36},"2026-04-20",{"date":351,"type":20},"2029-12-31",{"name":42,"class":43},{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":103,"sex":16,"minAge":52,"maxAge":360,"enrollmentInfo":361,"targetDuration":4,"studyType":21,"phases":362,"briefSummary":363,"conditions":364,"keywords":367,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":369,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":44},"100611308","a-cohort-study-of-combined-cryoablation-and-thermal-ablation-for-non-surgical-treatment-of-breast-cancer-patients-100611308","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.","80 Years",{"count":55,"type":20},[23],"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.",[365,366],"Ablation","Breast Cancer",[368],"Combined Cryoablation and Thermal Ablation",{"date":322,"type":36},{"date":371,"type":36},"2026-03-03",{"date":373,"type":20},"2028-10-01",{"name":42,"class":43},{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":381,"eligibilityCriteria":382,"healthyVolunteers":12,"sex":16,"minAge":52,"maxAge":336,"enrollmentInfo":383,"targetDuration":4,"studyType":21,"phases":385,"briefSummary":386,"conditions":387,"keywords":389,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":401,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":405,"locationsCount":44},"100590706","phase-2-ctdna-guided-de-escalation-of-adjuvant-chemotherapy-with-dalpiciclib-in-hr-positiveher2-negative-breast-cancer-100590706","NCT06970912","ctDNA-Guided De-Escalation of Adjuvant Chemotherapy With Dalpiciclib in HR-Positive\u002FHER2-Negative Breast Cancer","A Prospective, Multicenter, Randomized, Open-Label Phase II Study of ctDNA-Guided De-Escalation of Adjuvant Chemotherapy With Dalpiciclib in HR-Positive\u002FHER2-Negative Breast Cancer","DNADalHR","Inclusion Criteria:\n\n* Female breast cancer patients aged ≥18 years and ≤75 years, either postmenopausal or premenopausal\u002Fperimenopausal;\n* 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);\n* At least one evaluable lesion per RECIST 1.1, with clinical staging meeting:\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;\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;\n* Willing to participate in the study and voluntarily sign informed consent;\n* Agree to undergo ctDNA testing during treatment;\n* Adequate organ and bone marrow function defined as:\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;\n* 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* HER2-positive breast cancer confirmed by current pathological diagnosis;\n* Inflammatory breast cancer;\n* Stage IV (metastatic) breast cancer;\n* Bilateral breast cancer;\n* Prior history of breast cancer (including ductal carcinoma in situ or invasive breast cancer);\n* 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);\n* 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;\n* History of severe pulmonary diseases (e.g., interstitial pneumonia);\n* 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;\n* 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;\n* 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;\n* Known allergy to any component of the study drugs;\n* Current participation in another interventional drug clinical study;\n* Pregnancy or lactation;\n* Refusal to comply with follow-up;\n* Other severe physical\u002Fmental illnesses or laboratory abnormalities that may increase study risk, interfere with results, or render the patient unsuitable per investigator judgment.",{"count":384,"type":20},393,[182],"* This is a Phase II, multicenter, randomized clinical trial evaluating a ctDNA-guided approach to de-escalate adjuvant chemotherapy in patients with hormone receptor (HR)-positive, HER2-negative early-stage breast cancer. The study aims to determine if combining the CDK4\u002F6 inhibitor Dalpiciclib with endocrine therapy can reduce the need for chemotherapy while maintaining clinical benefits.\n* Key Details ：\n\n  1. Participants: 393 women (aged 18-75) with early-stage HR+\u002FHER2- breast cancer at high risk of recurrence (e.g., tumor size ≥2 cm, lymph node involvement, or high-grade tumors).\n  2. Design: Patients are randomized 1:4 to two groups:\n\n     Group A (Chemotherapy) : Receives 4 cycles of taxane-based chemotherapy before surgery.\n\n     Group B (Experimental) : Receives Dalpiciclib + aromatase inhibitor (AI) for 4 cycles pre-surgery.\n\n     Post-surgery, treatment is adjusted based on ctDNA results.\n  3. Primary Goals ： Assess ctDNA clearance rate (conversion from detectable to undetectable ctDNA) after neoadjuvant therapy in Group B.\n\n     Evaluate 3-year event-free survival (EFS) in Group B (e.g., freedom from cancer recurrence, progression, or death).\n\n     Secondary Goals ： Safety of Dalpiciclib + endocrine therapy. Tumor response rates (e.g., complete cell cycle arrest, pathological remission).\n\n     Correlation between ctDNA clearance and long-term outcomes.\n* Why This Matters ： Current guidelines recommend chemotherapy for high-risk HR+ breast cancer, but it often causes significant side effects. This study explores a personalized approach using ctDNA-a blood-based biomarker-to identify patients who may safely avoid chemotherapy without compromising survival. If successful, it could shift clinical practice toward less toxic, targeted therapies for eligible patients.",[342,343,344,345,346,388],"Breast Cancer Early Stage Breast Cancer (Stage 1-3)",[390,391,392,393,394,395,396,397,398,399,400],"HR-positive HER2-negative breast cancer","Early-stage breast cancer","Dalpiciclib","CDK4\u002F6 inhibitor","ctDNA-guided therapy","Adjuvant chemotherapy de-escalation","Circulating tumor DNA (ctDNA)","Event-free survival (EFS)","Chemotherapy sparing","Personalized therapy","Biomarker-guided therapy",{"date":322,"type":36},{"date":403,"type":36},"2025-08-01",{"date":351,"type":20},{"name":42,"class":43},{"id":407,"slug":408,"hasResults":12,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":4,"eligibilityCriteria":412,"healthyVolunteers":12,"sex":51,"minAge":413,"maxAge":208,"enrollmentInfo":414,"targetDuration":415,"studyType":57,"phases":4,"briefSummary":416,"conditions":417,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":44},"100638459","a-novel-conditioning-regimen-for-haplo-hsct-in-older-patients-with-saa-100638459","NCT07586735","A Novel Conditioning Regimen for Haplo-HSCT in Older Patients With SAA","A Novel Conditioning Regimen for Haploidentical Hematopoietic Stem Cell Transplant in Patients Aged ≥ 40 Years Old With Severe Aplastic Anemia: a Multicenter, Single-arm, Observational Clinical Trial","Inclusion Criteria:\n\n* Severe aplastic anemia;\n* Aged 40-60 years old;\n* Weight 45Kg-100Kg;\n* Eastern Cooperative Oncology Group (ECOG) score ≤3;\n* No major organ injury (ECG ejection fraction \\>45%; bilirubin \\\u003C 2 times the upper limit of normal value; AST and ALT \\\u003C 3 times the upper limit of normal value; serum creatinine \\\u003C 2 times the upper limit of normal value);\n* No severe infection;\n* Subjects voluntarily participated in this clinical trial and signed the informed consent.\n\nExclusion Criteria:\n\n* With other hematologic diseases;\n* Expected survival of less than 1 month;\n* Previous autologous or allogeneic hematopoietic stem cell transplantation;\n* Pregnant patients;\n* Patients with severe mental or neurological disorders that would affect the ability to provide informed consent and\u002For to report or observe adverse events;\n* Other conditions that the investigator determines to be inappropriate for enrollment.\n* Current or recent (\\\u003C4 weeks prior to screening) clinically serious viral, bacterial, fungal, or parasitic infection\n* A history of symptomatic herpes zoster infection within 12 weeks prior to screening\n* Active or chronic viral infection from hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)\n* Have evidence of active tuberculosis (TB), or have previously had evidence of active TB and did not receive appropriate and documented treatment, or have had household contact with a person with active TB and did not receive appropriate and documented prophylaxis for TB\n* Exposure to a live vaccine within 12 weeks prior to enrollment or expected to receive a live vaccine during the study\n* Clinically significant thrombotic event within 24 weeks of screening or are on anticoagulants and in the opinion of the investigator are not well controlled\n* Myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage IV heart failure\n* A history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, neurological, or neuropsychiatric disorders or any other serious and\u002For unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data\n* Any of the following specific abnormalities on screening laboratory tests:\n\n  1. ALT or AST \\>2 x ULN, or total bilirubin ≥1.5 x ULN\n  2. hemoglobin \\\u003C9 g\u002FdL, or total white blood cell (WBC) count \\\u003C2,500\u002FµL, or neutropenia (absolute neutrophil count \\\u003C1,200\u002FµL), or lymphopenia (lymphocyte count \\\u003C750\u002FµL)\n  3. eGFR \\\u003C50 mL\u002Fmin\u002F1.73 m2","40 Years",{"count":233,"type":20},"2 Years","The goal of this prospective, multicenter, single arm observational study is to evaluate the efficacy and safety of the BFCA regimen in ≥ 40 years old SAA patients undergoing haplo-HSCT.",[418,419,420],"Severe Aplastic Anemia","Aplastic Anaemia","Hematopoietic Cell Transplant","2026-07-01",{"date":324,"type":36},{"date":424,"type":20},"2026-06",{"date":426,"type":20},"2029-12-30",{"name":42,"class":43},{"id":429,"slug":430,"hasResults":12,"nctId":431,"briefTitle":432,"officialTitle":433,"acronym":4,"eligibilityCriteria":434,"healthyVolunteers":12,"sex":51,"minAge":52,"maxAge":77,"enrollmentInfo":435,"targetDuration":4,"studyType":21,"phases":437,"briefSummary":438,"conditions":439,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":444,"completionDateStruct":445,"leadSponsor":447,"locationsCount":44},"100644986","phase-2-age-stratified-conditioning-regimen-efficacy-for-mds-haplo-hsct-100644986","NCT07677306","Age-Stratified Conditioning Regimen Efficacy for MDS Haplo-HSCT","Prospective Cohort Study of Age-Stratified Busulfan-Based Conditioning Regimens in Adult Patients With Myelodysplastic Syndrome Receiving Haploidentical Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n* Patients who had low- and intermediate-risk MDS without ISD nor URD receiving haploidentical hematopoietic stem cell transplantation\n\nExclusion Criteria:\n\n* Patients having ISD or URD; patients having high-risk MDS; patients with active infection; patients with poor compliance; patients with organ failure",{"count":436,"type":20},120,[182],"This study plan aims to enroll adult patients diagnosed with myelodysplastic syndrome (MDS) who are scheduled to receive T-cell-replete haploidentical hematopoietic stem cell transplantation. After obtaining written informed consent, participants will receive either reduced-toxicity Bu\u002FFlu\u002FCy\u002FATG conditioning regimen (for patients aged ≥55 years) or standard myeloablative modified Bu\u002FCy+ATG conditioning regimen (for patients aged \\\u003C55 years) followed by unified post-transplant immunosuppression and supportive care. The objective is to prospectively characterize the 1-year transplant-related mortality and comprehensively evaluate hematopoietic engraftment, graft-versus-host disease, infection, relapse, survival outcomes and conditioning-related organ toxicity among all enrolled patients undergoing haploidentical transplantation.",[440],"Myelodysplastic Syndromes","2026-06-24",{"date":443,"type":36},"2026-06-30",{"date":267,"type":20},{"date":446,"type":20},"2028-06-30",{"name":42,"class":43},{"id":449,"slug":450,"hasResults":12,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":4,"eligibilityCriteria":454,"healthyVolunteers":12,"sex":51,"minAge":52,"maxAge":336,"enrollmentInfo":455,"targetDuration":4,"studyType":21,"phases":457,"briefSummary":458,"conditions":459,"keywords":461,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":473,"leadSponsor":475,"locationsCount":44},"100641248","phase-2-sintilimab-plus-gossypol-acetate-in-advanced-colorectal-cancer-100641248","NCT07656766","Sintilimab Plus Gossypol Acetate in Advanced Colorectal Cancer","A Single-Arm, Open-Label, Exploratory Phase II Clinical Trial of Sintilimab Plus Gossypol Acetate in Patients With Advanced pMMR\u002FMSS Colorectal Cancer After Failure of at Least Two Prior Lines of Therapy","Inclusion Criteria:\n\n1. Written informed consent provided before any study-specific procedures.\n2. Age 18 to 75 years, male or female.\n3. Histologically or cytologically confirmed advanced colorectal adenocarcinoma.\n4. Confirmed pMMR\u002FMSS tumor status. Participants without documented MSI\u002FMMR status must undergo MSI or MMR testing during screening.\n5. Disease progression after at least two prior lines of standard therapy.\n6. Availability of tumor tissue suitable for pathological evaluation and biomarker analysis.\n7. ECOG performance status of 0 or 1 within 7 days before the first dose of study treatment.\n8. At least one measurable lesion according to RECIST version 1.1.\n9. Adequate hematologic, hepatic, renal, coagulation, and organ function as defined in the protocol.\n10. Female participants of childbearing potential must have a negative pregnancy test before initiation of study treatment and agree to use effective contraception during the study and for the protocol-specified period after the last dose.\n\nExclusion Criteria:\n\n1. Histology of small cell carcinoma, squamous cell carcinoma, or mixed carcinoma.\n2. dMMR\u002FMSI-H tumor status.\n3. Complete bowel obstruction or clinical conditions likely to progress to bowel obstruction.\n4. Suspected bowel perforation based on clinical symptoms or imaging.\n5. History of malignancy other than colorectal cancer within 3 years before screening, except malignancies with negligible risk of metastasis or death and treated with expected curative outcome.\n6. Active autoimmune disease, history of autoimmune disease, or immunodeficiency requiring systemic treatment, except protocol-allowed conditions.\n7. Significant cardiovascular disease within 3 months before initiation of study treatment, including New York Heart Association class II or higher heart disease, myocardial infarction, cerebrovascular accident, unstable arrhythmia, or unstable angina.\n8. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT.\n9. Severe chronic or active infection within 4 weeks before initiation of study treatment.\n10. Active tuberculosis infection or inadequately treated prior active tuberculosis.\n11. Active hepatitis B or hepatitis C infection as defined by protocol criteria.\n12. Uncontrolled tumor-related pain, uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage.\n13. History of leptomeningeal disease.\n14. Prior treatment with CD137 agonists, T-cell co-stimulatory agents, or immune checkpoint inhibitors, including anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-TIGIT antibodies.\n15. Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives before initiation of study treatment, whichever is longer.\n16. Treatment with systemic immunosuppressive medications within 2 weeks before initiation of study treatment, except protocol-allowed medications.\n17. Prior allogeneic stem cell transplantation or solid organ transplantation.\n18. Receipt of a live attenuated vaccine within 4 weeks before initiation of study treatment or expected need for such vaccination during the study or within 5 months after the last dose of sintilimab.\n19. Major surgery or severe traumatic injury within 28 days before initiation of study treatment, abdominal surgery or abdominal intervention within 60 days before initiation of study treatment, or expected need for major surgery during the study.\n20. Receipt of any other investigational drug within 28 days before initiation of study treatment.\n21. Known contraindication, hypersensitivity, or severe allergic reaction to any study drug or its excipients.\n22. Pregnancy, breastfeeding, or intention to become pregnant during the study or within 5 months after the last dose of sintilimab.\n23. Any other disease, laboratory abnormality, social condition, or medical condition that, in the investigator's judgment, may compromise participant safety, interfere with study compliance, or affect interpretation of study results.",{"count":456,"type":20},32,[182],"This is a single-center, open-label, single-arm, exploratory phase II clinical trial designed to evaluate the preliminary efficacy and safety of sintilimab in combination with oral gossypol acetate in patients with advanced pMMR\u002FMSS colorectal cancer after failure of at least two prior lines of standard therapy. Eligible participants will have histologically or cytologically confirmed advanced colorectal adenocarcinoma, measurable disease according to RECIST version 1.1, ECOG performance status of 0 or 1, and adequate organ function. Participants will receive oral gossypol acetate once daily, followed by sintilimab administered intravenously every 3 weeks after a gossypol acetate lead-in period. The primary outcome is objective response rate assessed by RECIST version 1.1. Secondary outcomes include disease control rate, progression-free survival, overall survival, duration of response, and safety.",[460],"Advanced Colorectal Cancer",[462,463,464,465,139,466,467,468],"colorectal cancer","metastatic colorectal cancer","pMMR\u002FMSS","sintilimab","gossypol acetate","LRPPRC","immunotherapy","2026-06-22",{"date":471,"type":36},"2026-06-25",{"date":267,"type":20},{"date":474,"type":20},"2029-09-15",{"name":42,"class":43},{"id":477,"slug":478,"hasResults":12,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":4,"eligibilityCriteria":482,"healthyVolunteers":12,"sex":51,"minAge":52,"maxAge":4,"enrollmentInfo":483,"targetDuration":4,"studyType":21,"phases":484,"briefSummary":485,"conditions":486,"keywords":488,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":494,"completionDateStruct":495,"leadSponsor":496,"locationsCount":4},"100643933","phase-2-tpo-ra-plus-baricitinib-vs-tpo-ra-for-itp-100643933","NCT07669675","TPO-RA Plus Baricitinib vs. TPO-RA for ITP","TPO-RA Plus Baricitinib vs. TPO-RA in Patients With ITP : A Randomized, Open-label Trial","Inclusion Criteria:\n\n1. ≥18 years old;\n2. Patients diagnosed with primary ITP who failed to achieve a response after 14 days of full-dose TPO-RA therapy;\n3. Patients with baseline platelet count less than 30×10⁹\u002FL, or those with baseline platelet count ranging from 30×10⁹\u002FL to 50×10⁹\u002FL accompanied by clinically significant bleeding (WHO bleeding score ≥2).\n\nExclusion Criteria:\n\n* Pregnant or lactating women, and who were possibly pregnant, planning to become pregnant, or who had partners planning to become pregnant;\n* With active malignancy or a history of malignant tumor;\n* Having experienced severe bacterial, viral, fungal or parasitic infection within the past 4 weeks;\n* With a history of symptomatic herpes zoster infection within 12 weeks prior to screening;\n* Active or chronic HBV, HCV or HIV infection;\n* Evidence of active tuberculosis; or previous evidence of active tuberculosis without appropriate and documented treatment; or household contact with patients with active tuberculosis without appropriate and documented tuberculosis prophylaxis;\n* Receipt of live vaccines within the past 12 weeks, or planned live vaccination during the study period;\n* Prior baricitinib therapy;\n* History of solid organ transplant or planned surgery;\n* Myelodysplastic syndrome, aplastic anemia or myelofibrosis;\n* Patients with other diseases were undergoing treatment with immunosuppressants;\n* Clinically significant thromboembolic events within the past 24 weeks, or ongoing anticoagulant treatment, who are deemed ineligible for the study by the investigator;\n* History or presence of myocardial infarction, unstable ischemic heart disease, stroke, or NYHA Class IV heart failure;\n* History or active manifestations of severe or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, neurological, neuropsychiatric, or other medical conditions that, in the investigator's judgment, could confer unacceptable safety risks with the investigational product or confound the interpretation of study data;\n* AST \\> 2 times the upper limit of normal (ULN), ALT \\> 2×ULN, TBIL ≥ 1.5×ULN;\n* eGFR \\\u003C 50 mL\u002Fmin\u002F1.73m²;\n* Other patients deemed unsuitable for enrollment in this study by the investigator.",{"count":79,"type":20},[182],"This is a prospective, randomized, controlled trial. ITP patients who failed prior full-does TPO-RA monotheray for 14 days. Patients are randomly assigned at a 1:1 ratio to receive baricitinib plus TPO-RA or TPO-RA alone. Patients are randomly assigned at a 1:1 ratio to receive baricitinib plus TPO-RA or TPO-RA alone. The primary endpoint was the 14-day overall response rate without any rescue therapy.",[487],"ITP - Immune Thrombocytopenia",[489,490,491],"immune thrombocytopenia","baricitinib","TPO-RA","2026-06-20",{"date":471,"type":36},{"date":421,"type":20},{"date":198,"type":20},{"name":42,"class":43},{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":502,"acronym":4,"eligibilityCriteria":503,"healthyVolunteers":12,"sex":51,"minAge":52,"maxAge":4,"enrollmentInfo":504,"targetDuration":4,"studyType":21,"phases":506,"briefSummary":507,"conditions":508,"keywords":510,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":44},"100644385","atorvastatin-combined-with-nac-plus-romiplostim-for-management-of-itp-100644385","NCT07662525","Atorvastatin Combined With NAC Plus Romiplostim for Management of ITP","Atorvastatin Combined With N-Acetyl-L-Cysteine Plus Romiplostim for Management of Steroid-Resistant\u002FRelapsed Immune Thrombocytopenia","Inclusion Criteria:\n\n* Diagnosed with primary ITP;\n* Aged ≥18 years;\n* Patients with treatment failure or relapse after first-line corticosteriod therapy for ITP;\n* Platelet count \\\u003C30×10⁹\u002FL.\n\nExclusion Criteria:\n\n* Pregnant or lactating women, and who were possibly pregnant, planning to become pregnant, or who had partners planning to become pregnant;\n* Presence of active malignant tumors;\n* Active HBV, HCV or HIV infection;\n* Active infection requiring systematic treatment;\n* Leukemia, myelodysplastic syndrome, aplastic anemia, myelofibrosis or other hematological disorders that may cause thrombocytopenia;\n* History or presence of myocardial infarction, unstable ischemic heart disease, stroke, or NYHA Class IV heart failure;\n* AST \\> 2 times the upper limit of normal (ULN), ALT \\> 2×ULN, or TBIL ≥ 1.5×ULN;\n* eGFR \\\u003C 50 mL\u002Fmin\u002F1.73m²;\n* Any other subjects deemed ineligible for enrollment by the investigator.",{"count":505,"type":20},50,[23],"This is a prospective, single-arm, open-lable, single-center study and we aimed to determine whether atorvastatin combined with N-acetyl-L-cysteine (NAC) plus romiplostim could induce sustained response off-treatment (SRoT) in adult patients with ITP following CS failure.",[509],"Immune Thrombocytopenic Purpura",[489,511,512,513,514],"atorvastatin","N-acetyl-L-cysteine","romiplostim","sustained response off-treatment","2026-06-19",{"date":517,"type":36},"2026-06-23",{"date":519,"type":20},"2026-06-01",{"date":521,"type":20},"2028-12-30",{"name":42,"class":43},{"id":524,"slug":525,"hasResults":12,"nctId":526,"briefTitle":527,"officialTitle":528,"acronym":4,"eligibilityCriteria":529,"healthyVolunteers":12,"sex":51,"minAge":52,"maxAge":336,"enrollmentInfo":530,"targetDuration":4,"studyType":21,"phases":532,"briefSummary":534,"conditions":535,"keywords":537,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":549,"locationsCount":44},"100641170","early-phase-1-iaso207-injection-in-the-treatment-of-relapsedrefractory-b-cell-malignancies-100641170","NCT07574346","IASO207 Injection in the Treatment of Relapsed\u002FRefractory B-cell Malignancies","A Single-arm, Dose-escalation Clinical Study Evaluating the Safety, Pharmacokinetics and Preliminary Efficacy of IASO207 Injection in Subjects With Relapsed\u002FRefractory B-cell Malignancies","Inclusion Criteria:\n\n* 1\\. Age ≥ 18 years old and ≤ 75 years old.\n* 2\\. Previously diagnosed by histopathological biopsy as one of the following pathological types:\n\n  1. Diffuse large B-cell lymphoma, not otherwise specified (DLBCL NOS); high-grade B-cell lymphoma (HGBL);\n  2. DLBCL transformed from indolent lymphoma, including transformation from follicular lymphoma (FL) or marginal zone lymphoma (MZL), and DLBCL transformed from CLL\u002FSLL (Richter transformation);\n  3. Grade 3B follicular lymphoma (FL3B); primary mediastinal large B-cell lymphoma (PMBCL).\n* 3\\. Recurrent\u002Frefractory B-cell lymphoma patients who have failed standard treatment (including recurrence, non-response, progression) must have received a standard immunotherapy regimen containing CD20 monoclonal antibody and anthracycline drugs:\n\n  * Recurrent disease refers to the occurrence of disease recurrence or progression ≥ 12 months after treatment;\n  * Refractory disease refers to disease progression during treatment or best response of disease stability (SD), or recurrence within 12 months after autologous hematopoietic stem cell transplantation, or disease progression within 12 months after treatment.\n* 4\\. Before enrollment, it is confirmed that CD19 target expression is positive:\n\n  1. Previous pathological results indicate positive CD19 expression, and\u002For;\n  2. Can provide archived or fresh puncture specimens to the central laboratory for detection to confirm positive CD19 expression.\n* 5\\. According to the Lugano 2014 standard, there is at least one measurable lesion (lymph node lesion LDi \\> 1.5 cm, extranodal lesion LDi \\> 1.0 cm);( LDi is longest diameter)\n* 6\\. ECOG score 0-2;\n* 7\\. Expected survival period ≥ 12 weeks;\n* 8\\. Screening period examination confirms appropriate organ function: i. Blood routine: absolute neutrophil count (ANC) ≥ 1×109\u002FL; platelets (PLT) ≥ 50×109\u002FL; hemoglobin (Hb) ≥ 70g\u002FL (must not have received any G-CSF\u002FGM-CSF treatment or red blood cell and platelet transfusion within 7 days before laboratory examination); ii. Peripheral blood T lymphocyte absolute count ≥ 300 cells\u002FμL; iii. Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5× upper limit of normal (ULN); serum total bilirubin ≤ 1.5× ULN (for patients with tumor liver metastasis: ALT\u002FAST ≤ 5× ULN; TBil ≤ 3× ULN); iv. Cardiac function: left ventricular ejection fraction (LVEF) ≥ 50%; v. Pulmonary function: oxygen saturation at rest ≥ 91%; vi. Renal function: calculated creatinine clearance rate (CrCl) ≥ 40 ml\u002Fmin according to Cockcroft-Gault formula; vii. Coagulation function: fibrinogen ≥ 1.0g\u002FL; activated partial thromboplastin time (aPTT) ≤ 1.5× ULN, prothrombin time (PT) ≤ 1.5× ULN;\n* 9\\. Pregnant participants should agree to take effective contraceptive measures or drugs from the date of signing the informed consent form until at least 1 year after the last administration of IASO207 injection.\n\nExclusion Criteria:\n\n* 1\\. There is invasion of central nervous system tumors; and\u002For primary central nervous system DLBCL, primary testicular LBCL.\n* 2\\. The tumor involves the small intestine, colon, and\u002For imaging examination indicates that the tumor involves the sub-mucosal layer of the gastrointestinal tract, and the patient has been evaluated to have a risk of organ perforation.\n* 3\\. Within the past 5 years before screening, the subject has had other malignant tumors except for the disease under study, excluding cervical carcinoma in situ after radical treatment, basal cell or squamous cell skin cancer after radical treatment, local prostate cancer, breast duct carcinoma in situ or thyroid papillary carcinoma.\n* 4\\. Infectious disease screening meets one of the following conditions: i. The subject has positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and abnormal peripheral blood HBV DNA test (abnormal HBV DNA test is defined as: HBV DNA quantitative test higher than the detection center's lower limit or higher than the normal reference range of the detection center or HBV DNA qualitative test positive); ii. The subject has positive hepatitis C virus (HCV) antibody and positive peripheral blood HCV RNA; iii. The subject has positive human immunodeficiency virus (HIV) antibody; iv. The subject has syphilis; v. The subject is an active CMV infection patient.\n* 5\\. Before enrollment, there is uncontrollable active bacterial, fungal or viral infection: i. There are persistent symptoms\u002Fsigns related to infection that require intravenous anti-infection drug treatment; ii. After appropriate anti-infection treatment, the clinical symptoms and examinations do not indicate improvement.\n* 6\\. Severe heart disease: including but not limited to unstable angina pectoris, myocardial infarction (within 6 months before screening), congestive heart failure (NYHA functional classification standard ≥ III), severe arrhythmia.\n* 7\\. Within the past 6 months before screening, the subject has had central nervous system diseases or histories, such as epilepsy, paralysis, aphasia, cerebral infarction, cerebral hemorrhage, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome (such as cerebral aneurysm, epilepsy, stroke \\[except lacunar infarction\\], senile dementia, psychosis, etc.) or patients with consciousness disorders.\n* 8\\. The subject has received any CD19-targeted treatment before.\n* 9\\. The subject has received any allogeneic hematopoietic stem cell transplantation (Allo-HSCT), autologous CAR-T and other allogeneic donor cell adoptive therapy.\n* 10\\. The subject with a large mass (diameter of the lesion \\> 7.5 cm) is not included in this study; patients whose disease progresses too rapidly and is expected not to benefit from the treatment of this study will not be included in this study.\n* 11\\. Before enrollment, the subject does not meet the drug\u002Ftreatment washout period: i. The subject needs or is continuously using systemic corticosteroids or other immunosuppressants within 4 weeks before enrollment; ii. The subject has received bispecific antibody, autologous hematopoietic stem cell transplantation, autologous CAR-T treatment within 12 weeks before enrollment; iii. The subject has received radiotherapy or grade 4 major surgery within 4 weeks before enrollment; or plans to undergo general anesthesia surgery within 12 weeks after receiving the study treatment.\n\niv. Using monoclonal antibodies, cytotoxic chemotherapy, or ADC drugs within 4 weeks prior to enrollment; v. Having received vaccination or any off-label clinical study drug treatment within 4 weeks prior to enrollment.\n\n* 12\\. Judged by the investigator, there are other unstable systemic diseases: including but not limited to severe liver, kidney or metabolic diseases that require treatment.\n* 13\\. The adverse reactions caused by previous anti-tumor treatment have not been alleviated to ≤ grade 2 (NCI-CTCAE v5.0 version).\n* 14\\. Those with a history of allergic reactions to the excipient components of IASO207 injection.\n* 15\\. Those who have received solid organ transplantation in the past.\n* 16\\. Pregnant or lactating women.\n* 17\\. Other situations deemed by the investigator as not suitable for enrollment.",{"count":531,"type":20},18,[533],"EARLY_PHASE1","This is a single-center, open-label, exploratory clinical study to evaluate the efficacy and safety of IASO207 Injection in patients with Relapsed\u002FRefractory B-cell Malignancies。",[536],"Malignancies",[538,539,540,541],"Relapsed","Refractory","B-cell malignancies","IASO207","2026-06-16",{"date":544,"type":36},"2026-06-18",{"date":546,"type":36},"2026-05-29",{"date":548,"type":20},"2042-04-30",{"name":42,"class":43},{"id":551,"slug":552,"hasResults":12,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":4,"eligibilityCriteria":556,"healthyVolunteers":12,"sex":51,"minAge":557,"maxAge":77,"enrollmentInfo":558,"targetDuration":4,"studyType":21,"phases":560,"briefSummary":561,"conditions":562,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":564,"startDateStruct":565,"completionDateStruct":566,"leadSponsor":567,"locationsCount":4},"100544087","phase-4-efficacy-and-safety-of-anti-cd25-rhmab-in-the-treatment-of-steroid-refractory-cgvhd-100544087","NCT06364319","Efficacy and Safety of Anti-CD25 rhMAb in the Treatment of Steroid-Refractory cGVHD","Study on the Efficacy and Safety of Anti-CD25 rhMAb in the Treatment of Steroid-Refractory Chronic Graft-Versus-Host Disease (cGVHD) of the Liver Following Allogeneic Hematopoietic Stem Cell Transplantation.","Inclusion Criteria:\n\n1. Age 16 and 65 years\n2. Received allogeneic hematopoietic stem cell transplantation\n3. Developed chronic GVHD in the liver after transplantation\n4. Ineffective prednisone treatment prior to screening\n5. Received ≤4 lines of systemic therapy prior to screening\n6. After informed consent, the patient agreed to receive anti-CD25 rhMAb treatment\n\nExclusion Criteria:\n\n1. Elevation of bilirubin, ALT, or alkaline phosphatase due to reasons other than chronic GVHD\n2. No prior treatment with prednisone\n3. Overlap syndrome\n4. Uncontrolled active infection\n5. Organ failure\n6. Early progression or recurrence of hematologic diseases\n7. Allergy to anti-CD25 rhMAb\n8. Received other interleukin-2 receptor monoclonal antibody treatment due to various reasons within one month after transplantation\n9. Participated in other clinical studies within one month","16 Years",{"count":559,"type":20},30,[310],"The study plan aims to include patients who have been diagnosed with steroid-refractory chronic GVHD in the liver following allogeneic hematopoietic stem cell transplantation. After obtaining informed consent, the patients will receive a treatment regimen consisting of the Anti-CD25 rhMAb in combination with prednisone, cyclosporine, and ruxolitinib.The objective is to assess the effectiveness and safety of Anti-CD25 rhMAb in the treatment of severe chronic GVHD affecting the liver.",[563],"cGVHD",{"date":544,"type":36},{"date":267,"type":20},{"date":446,"type":20},{"name":42,"class":43},{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":4,"eligibilityCriteria":574,"healthyVolunteers":12,"sex":51,"minAge":52,"maxAge":4,"enrollmentInfo":575,"targetDuration":4,"studyType":21,"phases":576,"briefSummary":577,"conditions":578,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":581,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":44},"100642119","coated-aldehyde-oxystarch-for-protein-bound-uremic-toxin-reduction-in-end-stage-renal-disease-100642119","NCT07653711","Coated Aldehyde Oxystarch for Protein-Bound Uremic Toxin Reduction in End-Stage Renal Disease","An Exploratory, Single-Center, Self-Controlled Trial of Coated Aldehyde Oxystarch for Reducing Protein-Bound Uremic Toxins in Patients With End-Stage Renal Disease","Inclusion Criteria:\n\n* Age ≥ 18 years, no restriction on sex or ethnicity.\n* Receiving maintenance dialysis for at least 3 months, with dialysis regimen remaining unchanged during the trial period.\n* If taking other medications that do not interfere with gut microbiota prior to enrollment, they must have been stable for at least 1 month and the regimen must remain unchanged during the trial.\n* Ability to understand and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* Known allergy to Coated Aldehyde Oxystarch.\n* History of or planned kidney transplantation within 6 months, or change in dialysis regimen.\n* Use of medications or supplements that may affect gut microbiota (e.g., antibiotics, probiotics, prebiotics, laxatives) within the past 3 months.\n* Diagnosis of serious gastrointestinal diseases, including gastrointestinal bleeding, colitis, inflammatory bowel disease, irritable bowel syndrome, history of intestinal obstruction, history of gastrectomy or duodenectomy.\n* History of cardiovascular or cerebrovascular events within 3 months prior to screening, including hospitalization for stroke, myocardial infarction, unstable angina, congestive heart failure; severe valvular stenosis, uncontrolled atrial fibrillation or arrhythmia; QTc interval \\>500 ms on repeated ECG.\n* Concurrent severe primary diseases of cardiovascular, cerebrovascular, hepatic, hematopoietic systems, or other known life-threatening diseases (e.g., malignancy, AIDS), or patients with mental or legal disabilities.\n* Investigator judges life expectancy ≤6 months.\n* Inability to maintain stable dietary habits during the study period.\n* Inability to maintain original dialysis regimen during the study period.\n* Use of Chinese patent medicines for kidney disease (e.g., Shenkang Injection, Haikun Shenxi Capsule, Shenshuaining, Tripterygium preparations, Niaoduqing Granules) within 1 month prior to enrollment.\n* Participation in another clinical trial within the past 1 month.\n* Intellectual disability, psychiatric disorders, or suspected\u002Fconfirmed history of alcohol or drug abuse that may affect compliance.\n* Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study.",{"count":559,"type":20},[23],"The goal of this clinical trial is to learn if Coated Aldehyde Oxystarch (Xiqing) works to reduce protein-bound uremic toxins (PBUTs) in adults with end-stage renal disease (ESRD). It will also learn about the safety of Coated Aldehyde Oxystarch. The main questions it aims to answer are:\n\nDoes Coated Aldehyde Oxystarch lower the blood levels of protein-bound uremic toxins, such as indoxyl sulfate and p-cresyl sulfate?\n\nWhat medical problems do participants have when taking Coated Aldehyde Oxystarch?\n\nResearchers will compare the levels of PBUTs before treatment (baseline) with those after treatment with Coated Aldehyde Oxystarch to see if it works to reduce these toxins.\n\nParticipants will:\n\nTake Coated Aldehyde Oxystarch (Xiqing) 10 capsules per time, three times daily (each capsule 0.625 g, total daily dose 18.75 g) for 3 months.\n\nVisit the clinic every month for checkups and blood tests.\n\nProvide blood samples to measure protein-bound uremic toxin levels and routine safety parameters.",[579],"End Stage Renal Disease on Dialysis","2026-06-12",{"date":582,"type":36},"2026-06-17",{"date":584,"type":36},"2025-04-21",{"date":586,"type":20},"2026-08",{"name":42,"class":43},{"id":589,"slug":590,"hasResults":12,"nctId":591,"briefTitle":592,"officialTitle":593,"acronym":4,"eligibilityCriteria":594,"healthyVolunteers":12,"sex":51,"minAge":156,"maxAge":4,"enrollmentInfo":595,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":597,"conditions":598,"keywords":600,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":604,"lastUpdatePostDateStruct":605,"startDateStruct":607,"completionDateStruct":609,"leadSponsor":611,"locationsCount":612},"100642346","real-world-study-of-aflibercept-8-mg-in-namd-100642346","NCT07640997","Real-world Study of Aflibercept 8 mg in nAMD","REFLECTION-An Observational Study Program to Investigate the Effectiveness of Aflibercept 8 mg Used in Neovascular Age-related Macular Degeneration (nAMD) in a Real-world Setting.","Inclusion Criteria:\n\n* Patient aged ≥50 years\n* A diagnosis of nAMD\n* Signed informed patient consent before the start of data collection\n* Patients for whom the decision to initiate treatment with IVT aflibercept 8 mg according to a local product information was made as part of routine clinical practice\n\nExclusion Criteria:\n\n* Participation in an investigational program with interventions outside of clinical routine practice\n* Contraindications as listed in the intravitreal aflibercept 8 mg local product information (Ocular or periocular infections, severe active intraocular inflammation, and known allergy to aflibercept or any of its excipients)\n* The fellow eye has received intravitreal anti-VEGF treatment other than aflibercept within 28 days prior to enrollment\n* Intraocular pressure (IOP) in the study eye \\> 25 mmHg\n* Additional exclusion criteria for naïve nAMD patients:\n\n  * Any prior ocular treatment in the study eye or systemic treatment for nAMD\n* Additional exclusion criteria for pretreated nAMD patients:\n\n  * Prior intravitreal anti-VEGF treatments in the study eye within the last 28 days\n  * Prior treatment with intravitreal corticosteroid in the study eye within the last 3 months\n  * Dexamethasone implant in the study eye within the last 6 months\n  * Any concurrent drug releasing implant in the study eye",{"count":596,"type":20},300,"The goal of this observational study is to explore the effectiveness of aflibercept 8 mg in treating both treatment-naive and previously treated patients with neovascular age-related macular degeneration (nAMD) in a real-world setting. The main questions it aims to answer are:\n\nWhat are the short-term and long-term efficacy outcomes of aflibercept 8 mg in treatment-naive or previously treated nAMD patients? What are the safety characteristics and the treatment patterns of aflibercept 8 mg in these patient populations?\n\nParticipants will:\n\nReceive aflibercept 8 mg as part of their clinical treatment for nAMD. Undergo assessments to evaluate both the efficacy and safety of the treatment over the short and long term.\n\nProvide data on their visual acuity (BCVA) changes at multiple follow-up points (4 weeks, 8 weeks, 16 weeks, 6 months, and 12 months).\n\nReport any adverse events and treatment patterns during the study period. Have their central subfield thickness (CST) measured at specified intervals. This study will help inform clinical practices regarding the use of aflibercept in nAMD patients and contribute to understanding its effectiveness and safety in real-world settings.",[599],"Neovascular Age-Related Macular Degeneration (nAMD)",[601,602,603],"nAMD","Aflibercept 8mg","Real World Evidence","2026-06-10",{"date":606,"type":36},"2026-06-11",{"date":608,"type":36},"2025-11-11",{"date":610,"type":20},"2027-12-31",{"name":42,"class":43},27,{"id":614,"slug":615,"hasResults":12,"nctId":616,"briefTitle":617,"officialTitle":618,"acronym":619,"eligibilityCriteria":620,"healthyVolunteers":12,"sex":51,"minAge":52,"maxAge":4,"enrollmentInfo":621,"targetDuration":210,"studyType":57,"phases":4,"briefSummary":623,"conditions":624,"keywords":628,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":604,"lastUpdatePostDateStruct":637,"startDateStruct":639,"completionDateStruct":640,"leadSponsor":642,"locationsCount":44},"100641818","deep-learning-time-series-prediction-of-long-term-growth-patterns-of-pulmonary-ground-glass-nodules-using-serial-ct-100641818","NCT07647692","Deep Learning Time-Series Prediction of Long-Term Growth Patterns of Pulmonary Ground-Glass Nodules Using Serial CT","Development and Multi-Cohort Validation of a Deep Learning Spatiotemporal Model for Predicting Long-Term Progression of Pulmonary Ground-Glass Nodules Using Serial Thoracic CT","GGN-Trajectory","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Persistent pulmonary ground-glass nodule (pGGN or mGGN, 5-30 mm) on thin-slice chest CT (slice thickness ≤ 1.5 mm).\n* Baseline and follow-up thin-slice chest CTs of sufficient quality for 3D segmentation and registration.\n* Minimum interval between any two consecutive CTs \\> 1 month.\n* Complete baseline clinical data available (age, sex, smoking history, family history of malignancy, relevant comorbidities).\n\nCohort-specific inclusion\n\n* Group 1 (Development): surgical resection of the target GGN at PKUPH between Jan 2007 - Jun 2025, with ≥ 2 pre-operative thin-slice CTs available.\n* Group 2 (Surgical internal test): surgical resection at PKUPH between Jul 2025 - Jan 2026, with ≥ 2 pre-operative thin-slice CTs available.\n* Group 3 (Non-surgical internal test): non-operative management at PKUPH between Jan 2020 - Dec 2025, with ≥ 3 thin-slice CTs of the target GGN available.\n* Group 4 (Prospective external validation): prospective enrollment after model lock at participating centers, baseline CT plus ≥ 2 planned routine follow-up thin-slice CTs.\n\nExclusion Criteria:\n\n* Coexisting severe pulmonary disease that obscures evaluation of the target GGN (e.g., active pulmonary tuberculosis, severe interstitial lung disease).\n* Prior history of any other thoracic malignancy, or active extrathoracic malignancy under treatment within 5 years, that would confound interpretation of the target GGN.\n* CT image quality insufficient for registration and feature extraction (severe motion artifact, slice thickness \\> 1.5 mm at any required timepoint, or extensive metallic artifact projecting over the target GGN).\n* Pure solid nodule with no ground-glass component.\n* Target GGN already received treatment (resection, ablation, or radiotherapy) prior to the baseline CT used in this study.",{"count":622,"type":20},4750,"Pulmonary ground-glass nodules (GGNs) are commonly found on chest CT scans. Some stay stable for years, while others slowly or rapidly turn into lung cancer. Doctors currently follow these nodules with repeated CT scans, but it is difficult to tell ahead of time which nodules will progress, how fast they will progress, and which ones can be safely monitored rather than immediately treated.\n\nThis observational study aims to develop and validate an artificial intelligence (AI) model that uses each patient's series of CT scans over time to predict the long-term growth behavior of a GGN. The research team will collect three retrospective single-center cohorts from Peking University People's Hospital (a development cohort and two internal test cohorts, one from surgically resected patients and one from non-operated patients followed by serial CT) as well as a prospective multi-center validation cohort enrolled after the AI model is locked.\n\nFor every patient, each GGN is automatically segmented in three dimensions on every CT scan. A deep learning model extracts imaging features at each timepoint and feeds the sequence of features, together with the actual times between scans, into a time-aware sequence model. The model is trained to predict (i) whether the nodule will show radiological progression at 1, 3, and 5 years after baseline, and (ii) which of four long-term growth patterns the nodule will follow: stable, slow progression, slow-then-rapid progression, or rapid progression. In patients who were ultimately resected, the histopathological diagnosis serves as a secondary reference standard.\n\nThis is an observational study. No experimental treatment is given. All CT scans and clinical visits are part of routine clinical care.",[625,626,627],"Pulmonary Nodules","Lung Neoplasms","Adenocarcinoma of Lung",[629,630,631,632,633,634,635,636],"Ground Glass Opacity","Ground-Glass Nodule","Longitudinal CT","Time-Series Analysis","Growth Trajectory","Volume Doubling Time","Deep Learning","Radiomics",{"date":638,"type":36},"2026-06-15",{"date":519,"type":20},{"date":641,"type":20},"2031-06-01",{"name":42,"class":43},""]