[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Harbin Medical University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":614},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,28,0,25,[9,43,66,89,119,145,170,193,222,244,266,291,317,337,362,388,407,434,456,480,502,524,546,564,588],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100635416","oral-paclitaxel-plus-fruquintinib-verus-investigators-choice-in-second-line-advanced-gastric-cancer-100635416",false,"NCT07552402","Oral Paclitaxel Plus Fruquintinib Verus Investigator's Choice in Second-Line Advanced Gastric Cancer","Paclitaxel Oral Solution Plus Fruquintinib Versus Investigator's Choice as Second-Line Treatment for Advanced Gastric Cancer: A Multicenter, Open-Label, Randomized Controlled Trial","FREEDOM","Inclusion Criteria:\n\n1. Age 18 to 75 years, regardless of sex;\n2. Histologically and\u002For cytologically confirmed advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma that has failed first-line therapy or developed intolerable toxicity to first-line treatment.\n3. Presence of at least one measurable lesion per RECIST v1.1 criteria (Note: Previously irradiated lesions cannot be used as target lesions unless unequivocal progression of the lesion after radiotherapy is documented);\n4. Body weight ≥40 kg or BMI \\>18.5 kg\u002Fm²;\n5. No severe hematologic, hepatic, or renal abnormalities:\n\n   1. Hematology: Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL; Platelet count (PLT) ≥100×10⁹\u002FL; Hemoglobin (Hb) ≥90 g\u002FL;\n   2. Chemistry: Total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); ALT and AST ≤2.5×ULN in the absence of liver metastases, or ≤5×ULN if liver metastases are present; Serum creatinine (Cr) ≤1.5×ULN;\n   3. Urinalysis: Urine protein ≤1+; If urine protein is ≥2+, a 24-hour urine protein test must be performed, and enrollment is permitted only if the 24-hour urine protein is \\\u003C1.0 g;\n6. ECOG Performance Status (PS) 0-1;\n7. Life expectancy ≥12 weeks;\n8. Signed informed consent.\n\nExclusion Criteria:\n\n1. Known HER2-positive status without prior anti-HER2 therapy (patients who progressed after anti-HER2 therapy are eligible);\n2. History of another primary malignancy within 3 years prior to the first study drug administration, except for adequately treated basal cell or squamous cell carcinoma of the skin, or in situ carcinomas of the cervix, breast, or other sites;\n3. Receipt of radiotherapy (except palliative radiotherapy), chemotherapy, or small-molecule targeted anticancer therapy within 4 weeks or within 5 half-lives of the agent (whichever is shorter) prior to the first dose of study drug. Patients who discontinued other investigational agents for more than 5 half-lives are eligible for screening. Additionally, treatment with large-molecule targeted anticancer agents within 4 weeks prior to the first study drug dose is prohibited;\n4. Toxicity from prior anticancer therapy not recovered to ≤ Grade 1 or baseline levels (except alopecia; neurotoxicity must have resolved to ≤ Grade 2) within 2 weeks prior to the first study drug administration;\n5. Presence of dysphagia, uncontrolled nausea, vomiting, diarrhea, or known malabsorption syndrome that may interfere with oral drug absorption;\n6. Active gastrointestinal conditions such as gastric\u002Fduodenal ulcer, ulcerative colitis, or bowel obstruction, or any other condition deemed by the investigator to carry a risk of gastrointestinal hemorrhage or perforation; history of gastrointestinal perforation or fistula within the past 6 months; or incomplete recovery from surgery related to gastrointestinal perforation or fistula;\n7. Evidence of significant bleeding or history of bleeding (e.g., hematemesis, hemoptysis) within 2 months prior to randomization. Patients with melena and positive fecal occult blood test must undergo gastroenteroscopy to rule out active bleeding or active ulcer before enrollment;\n8. Requirement for long-term use of proton pump inhibitors (PPIs) or H2-receptor antagonists during the trial; or use of strong inducers or inhibitors of cytochrome P450 (CYP) 3A4 or CYP2C8 within 2 weeks prior to the first study drug dose;\n9. Known active central nervous system (CNS) metastases and\u002For leptomeningeal carcinomatosis;\n10. Active infections or serious infectious diseases, including but not limited to: HIV infection (positive HIV antibody), active hepatitis (active HCV infection defined as positive HCV RNA; HCV antibody-positive but RNA-negative patients are allowed), active HBV infection (HBsAg-positive with HBV DNA \\>2000 IU\u002FmL), bacteremia, severe pneumonia requiring systemic therapy, or active tuberculosis;\n11. Any of the following cardiovascular conditions: myocardial infarction, unstable angina, congestive heart failure (New York Heart Association Class ≥2), or other clinically significant cardiac disease within 6 months prior to the first study drug dose; clinically significant ECG abnormalities (e.g., arrhythmias, QTc interval \\>450 ms); left ventricular ejection fraction (LVEF) \\\u003C50% on echocardiography; or uncontrolled hypertension despite treatment with ≥2 antihypertensive agents (systolic BP \\>140 mmHg or diastolic BP \\>90 mmHg);\n12. Prior systemic therapy targeting VEGF or VEGFR; or prior treatment with paclitaxel, docetaxel, nab-paclitaxel, liposomal paclitaxel, or polymeric micelle paclitaxel;\n13. Known hypersensitivity to any component of the investigational product;\n14. Pregnant or lactating women;\n15. Uncontrolled symptomatic pleural, peritoneal, or pericardial effusion requiring repeated drainage. Asymptomatic patients with minimal effusions detected only on imaging and who have not received drainage or other intervention within 2 weeks prior to enrollment are eligible;\n16. Major surgery (e.g., craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to first dosing, or presence of non-healed surgical wounds, ulcers, or fractures. Patients may be enrolled if the investigator determines they are fit to receive study drug ≥2 weeks post-surgery;\n17. History of deep vein thrombosis, pulmonary embolism, or other significant thromboembolic events within 3 months prior to study entry; ongoing anticoagulation therapy with warfarin, low-molecular-weight heparin, or similar agents. Prophylactic low-dose anticoagulation is permitted if INR ≤1.5 per inclusion criteria;\n18. Chronic use of nonsteroidal anti-inflammatory drugs (e.g., indomethacin, ibuprofen) or antiplatelet agents (e.g., clopidogrel, ticlopidine, dipyridamole). Low-dose aspirin (≤325 mg\u002Fday) is allowed;\n19. Any other condition deemed by the investigator as unsuitable for participation in this study.","ALL","18 Years","75 Years",{"count":22,"type":23},150,"ESTIMATED","INTERVENTIONAL",[26],"NA","The goal of this study is to evaluate the efficacy and safety of oral paclitaxel solution plus fruquintinib as second-line therapy in adult subjects with advanced or metastatic gastric (G) or gastroesophageal junction (GEJ) cancer.",[29],"Gastric Cancer or Gastroesophageal Junction Adenocarcinoma","RECRUITING","2026-06-29",{"date":33,"type":34},"2026-07-01","ACTUAL",{"date":36,"type":34},"2026-06-10",{"date":38,"type":23},"2028-12-30",{"name":40,"class":41},"Harbin Medical University","OTHER",3,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":24,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100637142","phase-2-trastuzumab-rezetecan-and-adebrelimab-as-neoadjuvant-therapy-for-her2-positive-muscle-invasive-bladder-cancer-100637142","NCT07624201","Trastuzumab Rezetecan and Adebrelimab as Neoadjuvant Therapy for HER2-Positive Muscle-Invasive Bladder Cancer","Neoadjuvant Trastuzumab Rezetecan and Adebrelimab for HER2-positive Muscle-invasive Bladder Cancer: a Phase II, Prospective, Single-arm, Multicenter Trial","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. ECOG performance status of 0 or 1.\n3. Histopathologically diagnosed muscle-invasive bladder cancer (MIBC) (cT2-T4a, N0-1, M0).\n4. Tumor tissue with HER2 expression (IHC 2+ or 3+) and suitable for radical cystectomy (RC) and transurethral resection of bladder tumor (TURBT).\n5. No prior systemic chemotherapy.\n6. At least one measurable lesion per RECIST v1.1 (spiral CT long diameter ≥10 mm or short diameter of enlarged lymph node ≥15 mm) before diagnostic surgery.\n7. Adequate organ function (no transfusion or hematopoietic growth factor within 2 weeks before blood count screening):\n\n   ANC ≥1.5×10⁹\u002FL\n\n   PLT ≥100×10⁹\u002FL\n\n   Hb ≥90 g\u002FL\n\n   TBIL ≤1.5×ULN (except subjects with Gilbert's syndrome)\n\n   ALT and AST ≤2.5×ULN\n\n   Cr ≤1.5×ULN\n\n   LVEF ≥50%\n\n   QTcF ≤450 ms\n8. Females of childbearing potential must agree to abstain from heterosexual intercourse or use reliable, effective contraception from signing informed consent until at least 120 days after the last dose of study drug; serum HCG must be negative within 7 days before starting study treatment; and must be non-lactating.\n9. A female is considered of childbearing potential if she has reached menarche, is not postmenopausal (≥12 consecutive months of amenorrhea without other cause), and has not undergone sterilization surgery (e.g., hysterectomy, bilateral tubal ligation, or bilateral oophorectomy).\n10. Male patients with partners of childbearing potential must agree to abstain from heterosexual intercourse or use reliable, effective contraception from signing informed consent until at least 120 days after the last dose of study drug. During the same period, male subjects must also agree not to donate sperm. Male subjects with pregnant partners must use a condom and no additional contraception is required.\n11. Subjects voluntarily join the study, sign written informed consent, and are expected to have good compliance with the study protocol.\n\nExclusion Criteria:\n\n1. Patients with any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, etc.); patients with vitiligo; patients with childhood asthma that has completely resolved and requires no intervention in adulthood may be included; patients with asthma requiring bronchodilators for medical intervention are excluded.\n2. Patients currently using immunosuppressants or systemic corticosteroids for immunosuppressive purposes (dose \\>10 mg\u002Fday prednisone or equivalent) and continuing use within 2 weeks before the first dose.\n3. History of severe allergic reactions to other monoclonal antibodies.\n4. Subjects with untreated central nervous system (CNS) metastases; subjects who have received prior systemic, radical treatment for brain or leptomeningeal metastases (radiotherapy or surgery) may be included if imaging confirms stability for at least 1 month, systemic corticosteroid therapy (dose \\>10 mg\u002Fday prednisone or equivalent) has been discontinued for more than 2 weeks, and they are asymptomatic.\n5. Hypertension that cannot be well controlled with antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).\n6. Poorly controlled cardiac clinical symptoms or diseases, including: 1) NYHA class ≥2 heart failure; 2) unstable angina; 3) myocardial infarction within 1 year; 4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; 5) QTc \\>450 ms (male) or QTc \\>470 ms (female); 6) Left ventricular ejection fraction (LVEF) ≤50% (i.e., EF \\>50% is required for inclusion).\n7. Abnormal coagulation function (INR \\>2.0, PT \\>16 s), bleeding tendency, or currently receiving thrombolytic or anticoagulant therapy; prophylactic use of low-dose aspirin or low molecular weight heparin is permitted.\n8. Bleeding events of grade ≥2 per CTCAE v6.0 within 4 weeks before the first dose.\n9. Imaging shows tumor invasion into major blood vessels, or the investigator judges that the tumor has a very high possibility of invading major blood vessels during treatment, leading to fatal massive hemorrhage.\n10. Arterial\u002Fvenous thrombotic events within 6 months before the first dose, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism.\n11. Patients who received prior chemotherapy (including platinum-based chemotherapy) or surgery less than 4 weeks before study drug administration; palliative radiotherapy less than 2 weeks before study drug administration; molecular targeted therapy (including other oral targeted drugs in clinical trials) within less than 5 half-lives before the first study drug dose, or prior treatment-related adverse events (excluding alopecia) not recovered to ≤CTCAE grade 1.\n12. Patients with radiation enteritis caused by pelvic radiotherapy within 12 months before study drug administration.\n13. Active infection, unexplained fever ≥38.5°C within 7 days before dosing, or baseline white blood cell count \\>15×10⁹\u002FL.\n14. Known history or evidence of interstitial lung disease or non-infectious pneumonitis that has required corticosteroid therapy; or patients who may interfere with the detection or management of suspected drug-related pulmonary toxicity.\n15. History of immunodeficiency, including positive HIV serology, or other acquired or congenital immunodeficiency diseases, or known active tuberculosis.\n16. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (HBV reference: HBsAg positive and HBV DNA ≥500 IU\u002Fml; HCV reference: HCV antibody positive and HCV viral load \\> upper limit of normal).\n17. Patients with another malignancy within the past 5 years or concurrently (excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; for patients with recurrent ovarian cancer with prior history of breast cancer, those with no recurrence for \\>3 years after radical breast cancer surgery are excluded).\n18. Prior treatment with anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies (or any other antibodies targeting T-cell co-stimulatory or checkpoint pathways).\n19. Receipt of live vaccine within 4 weeks before the first dose or possible receipt during the study period.\n20. Pregnant or breastfeeding female patients.\n21. Patients judged by the investigator to have other conditions that may affect the conduct of the clinical study, inability to comply with the protocol, or lack of cooperation, or patients at risk of study participation.",{"count":51,"type":23},58,[53],"PHASE2","This study aims to evaluate the efficacy and safety of neoadjuvant trastuzumab rezetecan combined with adebrelimab for the treatment of HER2-positive muscle-invasive bladder cancer.",[56],"Muscle-Invasive Bladder Cancer (MIBC)","NOT_YET_RECRUITING","2026-05-31",{"date":60,"type":34},"2026-06-03",{"date":62,"type":23},"2026-06-01",{"date":64,"type":23},"2029-06-01",{"name":40,"class":41},{"id":67,"slug":68,"hasResults":12,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":24,"phases":76,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},"100605510","time-restricted-eating-for-weight-loss-maintenance-100605510","NCT07163455","Time-Restricted Eating for Weight-Loss Maintenance","Time-Restricted Eating (10-Hour Window) for Weight-Loss Maintenance in Adults With Recent Intentional Weight Loss: A Multicenter, 12-Month Randomized Controlled Trial","Inclusion Criteria:\n\n* Participants who meet all the following conditions will be included in the trial:\n\n  1. BMI ≥ 28.0 kg\u002Fm², or BMI between 24.0-27.9 kg\u002Fm² with at least one weight-related comorbidity.\n  2. Age: 18-65 years.\n  3. Weight Loss Plan: Willing to undergo a structured weight-loss program.\n\nExclusion Criteria:\n\n* Participants who meet any of the following conditions will be excluded from the trial:\n\n  1. Infectious Diseases: History of HIV\u002FAIDS, active hepatitis B\u002FC, or active tuberculosis.\n  2. Malignancy: History of any malignancy.\n  3. Organ Dysfunction:Severe hepatic impairment.Chronic kidney disease.\n  4. Cardiovascular\u002FCerebrovascular Events: History of angina, myocardial infarction, or stroke within the past 6 months.\n  5. Gastrointestinal Conditions:Severe gastrointestinal diseases (e.g., inflammatory bowel disease).Gastrointestinal surgery within the past 12 months.\n  6. Endocrine Disorders:Cushing's syndrome, hypothyroidism, acromegaly, or hypothalamic obesity.\n  7. Medications: Use of drugs affecting weight\u002Fenergy balance (e.g., antipsychotics, weight-loss medications) within the past 6 months.\n  8. Pregnancy\u002FLactation: Currently pregnant, planning pregnancy, or breastfeeding.\n  9. Compliance Issues: Inability to complete the study (due to health, immigration, or other reasons).\n  10. Informed Consent: Unwilling or unable to provide informed consent.\n  11. Weight Stability: \\>5% change in body weight within the past 6 months.\n  12. Individuals unable to use or operate a smartphone","65 Years",{"count":75,"type":23},500,[26],"Weight regain after intentional short-term weight loss is a common challenge. It often undermines the long-term benefits of obesity treatment. This study is a multi-center 2-arm randomized controlled trial across six regions in China, specifically targeting overweight or obese adults who have recently achieved a short-term weight reduction (≥5% of body weight). The trial will evaluate whether a 10-hour daily Time-Restricted Eating (TRE) regimen can more effectively prevent weight regain compared to standard weight maintenance counseling alone. Both the intervention and control groups will receive the same frequency and intensity of nutritional counseling for weight maintenance; the only difference is that the TRE group will be instructed to confine their daily eating to a self-selected 10-hour window, while the control group has no eating window restriction. In addition to the primary outcome of weight regain, the study will explore potential mechanisms underlying the effects of TRE and assess secondary outcomes including changes in body composition, metabolic health, and quality of life.\n\nThis study recruits participants from six distinct regions across Eastern, Western, Southern, Northern, and Central China to enhance national representativeness. The study is divided into two phases: the first phase is a 2-month weight loss run-in phase (the screening phase), during which participants will receive standardized lifestyle and diet guidance from trained dietitians. Those who achieve at least a 5% loss of initial body weight by the end of this phase-and maintain a stable weight for approximately three weeks-will proceed to the second phase. In the second phase, participants will be randomly assigned to one of two arms for a 12-month weight maintenance intervention. The Control Arm will receive periodic weight-management nutritional counseling without any eating time restriction, while the TRE Intervention Arm will receive the same guidance plus instructions to follow a daily 10-hour time-restricted eating schedule. This design ensures both groups receive equivalent dietary and lifestyle support, with TRE as the key differential strategy. Following the 12-month intervention phase, participants will be followed for an additional 12 months (without active intervention) to observe longer-term weight outcomes.\n\nData will be collected at multiple time points: baseline (before the weight loss phase), 2 months (end of the weight loss phase and prior to the start of the maintenance phase), 5 months, 8 months, 14 months (end of the weight maintenance phase), as well as 20 months and 26 months (during the post-intervention follow-up). Key outcomes include changes in body weight (to assess weight regain or maintenance), body composition, metabolic health indicators (e.g. blood glucose, lipids), and quality of life measures. To monitor dietary behaviors, participants will be asked to upload meal photos via a designated mobile application with automatic time-stamping, which will be used to assess eating timing and adherence to the prescribed eating window. Body weight will be measured once weekly using Bluetooth-enabled smart scales. To explore potential mechanisms of action, biospecimens (blood and stool) will be collected at baseline, 2 months, 8 months, and 14 months for analysis. In addition, Continuous Glucose Monitoring (CGM) will be performed in a randomly selected subsample of 200 participants (100 from each group) using a standardized device for 14 consecutive days at months 2, 8, and 14. These data will be used to evaluate glycemic stability and adherence to the assigned eating window. Real-time CGM readings will not be disclosed to participants and will not be used to guide individual-level interventions.",[79],"Overweight or Obese Adults","2026-05-18",{"date":82,"type":34},"2026-05-19",{"date":84,"type":34},"2026-01-26",{"date":86,"type":23},"2028-07",{"name":40,"class":41},10,{"id":90,"slug":91,"hasResults":12,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":96,"targetDuration":4,"studyType":24,"phases":98,"briefSummary":99,"conditions":100,"keywords":104,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},"100636587","non-stenting-treatment-strategy-for-acute-myocardial-infarction-with-non-severe-stenosiserosion-iv-100636587","NCT07567625","Non-stenting Treatment Strategy for Acute Myocardial Infarction With Non-severe Stenosis(EROSION IV)","Non-stenting Treatment Strategy for Acute Myocardial Infarction With Non-severe Stenosis: a Prospective, Multicenter, Open-label, Non-inferiority, Randomised Controlled Trial(EROSION IV)","Inclusion Criteria:\n\n1. Male or female patients aged ≥18 years and ≤75 years;\n2. Diagnosis of type 1 AMI, including STEMI (onset \\\u003C24 hours or 7-14 days) or NSTEMI;\n3. After coronary angiography (CAG) ± thrombus aspiration, TIMI flow in the culprit vessel is restored to grade 3 and maintained for at least 5 minutes, with diameter stenosis (DS) \\\u003C70% at the culprit lesion (QCA);\n4. Reference diameter of the culprit lesion \\>2.5 mm and ≤4.0 mm;\n5. Patients or a legally authorized representative must provide written Informed Consent prior to any study related procedure.\n\nExclusion Criteria:\n\n1.Clinical exclusion criteria:\n\n1. Severe cardiac dysfunction (Killip\u002FNYHA class ≥ 3) or LVEF \\\u003C 30%;\n2. Cardiopulmonary resuscitation (CPR) performed at the onset of AMI;\n3. Persistent hemodynamic or cardiac electrical instability after TIMI flow restoration;\n4. Contraindication to antithrombotic drugs, or concurrent hemorrhagic diseases such as peptic ulcer or coagulation disorders;\n5. Contraindication to contrast;\n6. Severe renal dysfunction \\[defined as eGFR ≤30 ml\u002Fmin\u002F1.73m² or Scr ≥2.0 mg\u002FdL\\] without regular dialysis (patients with chronic renal insufficiency on regular dialysis may be considered for enrollment);\n7. Active liver disease, defined as known infectious, neoplastic, or metabolic liver lesions, with ALT and AST \\>3× upper limit of normal (ULN);\n8. Previous history of CABG or PCI for the culprit lesion;\n9. Patients with other concurrent severe diseases and an expected life expectancy of \\\u003C1 year;\n10. Pregnant or lactating women. Women of childbearing potential must use effective contraceptive measures during the study treatment period;\n11. Inability to comply with the study protocol or other conditions deemed unsuitable for study participation by the investigator.\n\n2.Imaging exclusion criteria:\n\n1. Non-culprit lesion with DS ≥70% or planned revascularization;\n2. Left main coronary artery lesion with DS ≥50%;\n3. Culprit lesion is a true bifurcation lesion requiring a two-stent strategy;\n4. Long lesion (planned stent length \\>60 mm);\n5. Culprit lesion with dissection, false lumen, or other conditions necessitating stent implantation;\n6. Target lesion has undergone pre-treatment (such as balloon dilation, rotational atherectomy, etc.).\n\n3.Functional sub study:\n\n1. Individuals who are allergic to adenosine triphosphate (ATP) or any component in its preparations;\n2. Second and third degree atrioventricular block, sick sinus syndrome (without artificial pacemaker protectors);\n3. Patients with bronchial asthma.",{"count":97,"type":23},2000,[26],"This study is a prospective, multicenter, open-label, non-inferiority, randomized controlled trial. A total of 2,000 patients with STEMI (\\\u003C24 hours or 7-14 days) or NSTEMI will be recruited from at least 20 centers in China. Eligible patients must have residual DS \\\u003C 70% at the culprit lesion assessed by QCA, with optional thrombus aspiration, and TIMI flow of grade 3. Patients will be randomly assigned in a 1:1 ratio to the experimental group or the control group. The planned enrollment period is 36 months, and all patients will be followed up for at least 12 months after randomization, with continued follow-up until the end of the study. The primary outcome is the first occurrence of TLF after randomization, defined as the composite of cardiovascular death, target vessel myocardial infarction, ischemia-driven target lesion revascularization. The study aims to verify whether guideline-recommended standard medical therapy is non-inferior to DES implantation combined with guideline-recommended standard medical therapy in AMI patients with non-severe coronary artery stenosis.\n\nA total of 120 participants (60 in the experimental group and 60 in the control group) enrolled at the Second Affiliated Hospital of Harbin Medical University were included in the functional substudy. Using Abbott Pressure Wire™X pressure wire test functional indicators, and explore the incidence of coronary microvascular dysfunction (CMD) as assessed by the index of microcirculatory resistance (IMR) in two groups, and its impact on the rate of the composite endpoint of all-cause death and heart failure readmission occurring for the first time within 12 months.",[101,102,103],"Acute Myocardial Infarction (AMI)","ST-Segment Elevation Myocardial Infarction(STEMI)","Non-ST-Segment Elevation Myocardial Infarction(NSTEMI)",[105,106,107,108,109],"AMI","DES","TLF","IMR","OCT","2026-04-30",{"date":112,"type":34},"2026-05-05",{"date":114,"type":23},"2026-04",{"date":116,"type":23},"2030-12",{"name":40,"class":41},47,{"id":120,"slug":121,"hasResults":12,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":24,"phases":128,"briefSummary":129,"conditions":130,"keywords":132,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},"100617502","heart-voice-starry-journey---a-digital-act-intervention-for-asd-caregivers-100617502","NCT07319455","Heart Voice: Starry Journey - A Digital ACT Intervention for ASD Caregivers","Heart Voice: Starry Journey - A Family-Centric and Acceptance and Commitment Therapy Based Digital Narrative Intervention, on Psychological Flexibility and Mental Health in Caregivers of Children With Autism Spectrum Disorder: A Randomized Controlled Trial","Inclusion Criteria:\n\nThe child being cared for has been professionally diagnosed with Autism Spectrum Disorder (ASD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).\n\nThe primary caregiver of the child with ASD (parent or legal guardian). If multiple primary caregivers exist in the family, the one with the longest caregiving time will be included.\n\nPossesses basic cognitive and literacy skills. Provides informed consent and voluntarily agrees to participate in the study.\n\nExclusion Criteria:\n\nThe child being cared for has comorbid serious organic diseases (e.g., epilepsy, congenital heart disease) or neurological damage.\n\nCurrently participating in other psychological intervention studies or having received structured psychological support services within the past 3 months.\n\nThe family has experienced a major negative life event (e.g., bereavement, severe financial crisis, natural disaster) within the past 6 months.",{"count":127,"type":23},52,[26],"The goal of this clinical trial is to evaluate the effectiveness of the \"Heart Voice: Starry Journey\" program, a family-centric and Acceptance and Commitment Therapy (ACT)-based digital narrative intervention, in improving psychological flexibility and mental health among primary caregivers of children with Autism Spectrum Disorder (ASD). The main questions it aims to answer are:\n\n1. Does the \"Heart Voice: Starry Journey\" intervention lead to a greater improvement in psychological flexibility among caregivers of children with ASD, compared to a control group?\n2. Does the \"Heart Voice: Starry Journey\" intervention lead to a greater reduction in symptoms of anxiety and depression among caregivers of children with ASD, compared to a control group? Researchers will compare the intervention group (using the \"Heart Voice: Starry Journey\" program) with a wait-list control group (receiving usual care and access to the intervention after the trial) to see if the digital intervention is more effective.\n\nParticipants in the intervention group will:\n\n* Use the \"Heart Voice: Starry Journey\" mobile application over a 6-week period, engaging with interactive stories and ACT-based exercises.\n* Complete a series of online questionnaires about their psychological flexibility, anxiety, depression, and caregiver burden at the beginning of the study, immediately after the 6-week intervention, and at a follow-up time point (1 months later).\n\nParticipants in the wait-list control group will:\n\n* Continue with their usual care routines during the study period.\n* Complete the same series of online questionnaires at the same time points as the intervention group.",[131],"Autism Spectrum Disorder",[133,134,135],"Acceptance and Commitment Therapy","mHealth","Digital Storytelling","2025-12-21",{"date":138,"type":34},"2026-01-06",{"date":140,"type":23},"2026-03",{"date":142,"type":23},"2026-09",{"name":40,"class":41},1,{"id":146,"slug":147,"hasResults":12,"nctId":148,"briefTitle":149,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":151,"targetDuration":4,"studyType":24,"phases":153,"briefSummary":154,"conditions":155,"keywords":157,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":4},"100610614","phase-2-a-phase-ii-clinical-study-of-aipalolitovorelizumab-ql1706-combined-with-fruquintinib-in-the-treatment-of-immunodominant-pmmrmss-metastatic-colorectal-cancer-that-has-failed-second-line-or-above-treatment-100610614","NCT07229872","A Phase II Clinical Study of Aipalolitovorelizumab (QL1706) Combined With Fruquintinib in the Treatment of Immunodominant pMMR\u002FMSS Metastatic Colorectal Cancer That Has Failed Second-line or Above Treatment","Inclusion Criteria:\n\n1. Have a full understanding of this study and voluntarily sign the informed consent form;\n2. Aged 18 - 75 years;\n3. Patients must be pathologically confirmed as advanced, metastatic or recurrent microsatellite stable (MSS) colorectal cancer (detected by immunohistochemistry, PCR or NGS according to the detection standards of each institutional testing center);\n4. The results of patients' genetic testing show no POLD1\u002FPOLE mutations;\n5. At least one immune marker is positive:\n\n   * PD-L1 CPS score ≥ 10 points, and positive for tumor-infiltrating CD8+ T cells;\n\n     * TMB ≥ 10 Muts\u002Fmb, and positive for tumor-infiltrating CD8+ T cells; ③ Functional mutations in epigenetic genes such as ARID1A, KMT2A\u002FB\u002FC\u002FD, TET1\u002F2\u002F3, etc., and positive for tumor-infiltrating CD8+ T cells; ④ Presence of positive tertiary lymphoid structures (TLS) in the tumor microenvironment;\n6. Patients have previously received two or more treatment regimens for advanced or metastatic colorectal cancer, at least one of which includes fluorouracil; or patients have previously received one treatment regimen for advanced or metastatic colorectal cancer and cannot tolerate the second-line standard chemotherapy regimen;\n7. ECOG performance status of 0 - 1, with no deterioration within 7 days;\n8. Expected survival ≥ 3 months;\n9. Organ function levels must meet the following requirements:\n\n   * Sufficient bone marrow reserve: absolute neutrophil count ≥ 1.5×10⁹\u002FL, platelet count ≥ 90×10⁹\u002FL, hemoglobin ≥ 9 g\u002FdL; no blood transfusion or use of blood products within 14 days;\n\n     * Liver: plasma albumin ≥ 2.8 g\u002FdL; bilirubin ≤ 1.5 times the upper limit of normal (ULN); ALT and AST ≤ 2.5×ULN, and if there is liver metastasis, ALT and AST ≤ 5×ULN; ③ Kidney: serum creatinine ≤ 1.5×ULN;\n\n       * Heart: left ventricular ejection fraction (LVEF) ≥ 50%; ⑤ Coagulation: prothrombin time (PT) ≤ 1.5×ULN, international normalized ratio (INR) ≤ 1.5×ULN, activated partial thromboplastin time (APTT) ≤ 1.5×ULN; ⑥ Thyroid-stimulating hormone (TSH) ≤ ULN (if abnormal, FT3 and FT4 levels should be examined simultaneously; if FT3 and FT4 levels are normal, patients can be enrolled);\n10. Women of childbearing age need to take effective contraceptive measures;\n11. Have good compliance and be cooperative with follow-up;\n12. Agree to provide sufficient previously stored tumor tissue samples for testing.\n\nExclusion Criteria:\n\n1. Unable to comply with the study protocol or research procedures;\n2. Pregnant or lactating women;\n3. Any factors affecting oral administration;\n4. Patients who have previously received immunotherapy and fruquintinib;\n5. Complicated with any of the following conditions: uncontrolled hypertension, coronary artery disease, arrhythmia, and heart failure;\n6. Patients who participated in clinical studies of other drugs within 4 weeks before enrollment;\n7. Alcohol or drug abuse within 4 weeks after the last clinical trial;\n8. Anti-infective treatment did not stop 14 days before the start of the study;\n9. Severe uncontrolled systemic diseases, such as severe active infections;\n10. Urinalysis shows urine protein \\> ++, and it is confirmed that 24-hour urine protein \\> 1.0 g;\n11. Active bleeding within 3 months; severe arterial\u002Fvenous thrombotic events within 6 months; hereditary or acquired bleeding (e.g., coagulation dysfunction); major surgery (except biopsy and electroresection of polyps) within 4 weeks before the study, incompletely healed surgical incisions, or major trauma; use of aspirin (\\> 325 mg\u002Fday) or current or recent use of dipyridamole, clopidogrel, and cilostazol (10 days before the study);\n12. Acute myocardial infarction, acute coronary syndrome, or coronary artery bypass grafting within 6 months before the first treatment;\n13. Use of systemic glucocorticoids or other systemic immunosuppressive drugs within 2 weeks before treatment. Immunosuppressive drugs have been started or are expected to be used during the trial. Physiological replacement doses are allowed for inhaled glucocorticoids;\n14. Fractures or long-term unhealed wounds;\n15. Inactivated vaccines 接种 within 4 weeks before enrollment;\n16. Having other malignant tumors within 5 years before enrollment, except for basal cell carcinoma or squamous cell carcinoma of the skin after radical resection, or carcinoma in situ of the cervix;\n17. Known to be infected with human immunodeficiency virus (HIV), or positive for syphilis test, or known to be HIV-positive patients;\n18. Previously received allogeneic bone marrow transplantation or organ transplantation;\n19. Subjects allergic to the study drug or any of its auxiliary preparations;\n20. Electrolyte abnormalities judged by the researcher to be clinically significant;\n21. Detectable untreated chronic hepatitis B, chronic hepatitis B virus (HBV) carriers (HBV DNA \\> 2000 IU\u002FmL), or HCV carriers with detectable HCV RNA. Note: Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B patients (HBV DNA \\\u003C 2000 IU\u002FmL) can be included in the study;\n22. Previous radiation pneumonitis or chest CT scan showing active pneumonia within 4 weeks before the study;\n23. The patient has an autoimmune disease requiring intervention;\n24. Accompanied by brain metastasis, or severe malignant pleural or peritoneal effusion;\n25. Any other diseases, clinically significant metabolic abnormalities, abnormal physical examination or laboratory test results, which, in the researcher's judgment, reasonably suggest that the patient has a disease or condition unsuitable for the use of the study drug (such as having epileptic seizures requiring treatment), or will affect the interpretation of study results, or put the patient at high risk;\n26. Patients deemed inappropriate for inclusion in this study by the researcher.",{"count":152,"type":23},18,[53],"The goal of this clinical trial is to explore the preliminary efficacy and tolerability of Aipalolitovorelizumab (QL1706) in combination with fruquintinib for the treatment of metastatic colorectal cancer patients with immunodominant pMMR\u002FMSS type who have failed second-line or above treatment. It is an open-label, single-arm, single-center phase II trial. The main questions it aims to answer are:\n\nWhat is the objective response rate (ORR) of this combination therapy? What are the outcomes in terms of progression-free survival (PFS), overall survival (OS), and disease control rate (DCR)? What are the safety profiles and tolerability of the treatment?\n\nParticipants will receive:\n\nAipalolitovorelizumab (QL1706) injection at a dose of 5mg\u002Fkg, administered intravenously on Day 1 of each 3-week treatment cycle.\n\nFruquintinib at a dose of 5mg per day, taken orally continuously for the first 2 weeks of each 3-week cycle, followed by 1 week of withdrawal.\n\nThe treatment will continue until disease progression as assessed by RECIST v1.1 criteria, occurrence of unacceptable toxicity, decision to withdraw by the doctor or patient, non-compliance, or discontinuation due to administrative reasons. Participants will be monitored throughout the trial period to evaluate the efficacy and safety of the treatment.",[156],"Colorectal Cancer",[158,159,160,161],"Colorectal cancer","Immunotherapy","Microsatellite stability","Immune advantage","2025-11-13",{"date":164,"type":34},"2025-11-17",{"date":166,"type":23},"2025-12",{"date":168,"type":23},"2027-12",{"name":40,"class":41},{"id":171,"slug":172,"hasResults":12,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":12,"sex":177,"minAge":19,"maxAge":178,"enrollmentInfo":179,"targetDuration":4,"studyType":24,"phases":181,"briefSummary":182,"conditions":183,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":4},"100607370","the-neoadjuvant-treatment-of-early-high-risk-triple-negative-breast-cancer-with-hrd-positive-with-iparomlimab-and-tuvonralimab-combined-with-olaparib-and-paclitaxel-100607370","NCT07187674","The Neoadjuvant Treatment of Early High-risk Triple Negative Breast Cancer With HRD Positive With Iparomlimab and Tuvonralimab Combined With Olaparib and Paclitaxel","Single Arm, Prospective, Small Sample, Exploratory Clinical Study on the Neoadjuvant Treatment of Early High-risk Triple Negative Breast Cancer With HRD Positive With Iparomlimab and Tuvonralimab(QL1706)Combined With Olaparib and Paclitaxel","Inclusion Criteria:\n\n1. Voluntarily join this study and sign an informed consent form;\n2. Women aged ≥ 18 years and ≤ 70 years with early breast cancer:According to the definition of the latest ASCO\u002FCAP guidelines, triple negative breast cancer patients with T1cN1-2 or T2-4N0-2 stage confirmed by histopathology;\n3. Subjects with HRD positive tumor tissue evaluation;\n4. According to RECIST 1.1, there must be at least one measurable lesion;\n5. ECOG score: 0 to 1;\n6. Tumor tissue specimens that can be used for biomarker detection;\n7. The function of important organs meets the following requirements (no blood components or cell growth factor drugs are allowed to be used within 14 days before the first medication):\n\n   Absolute neutrophil count ≥ 1.5 × 10\\^9\u002FL; Platelets ≥ 100 × 10\\^9\u002FL; Hemoglobin ≥ 90 g\u002FL; Serum albumin ≥ 30 g\u002FL; Thyroid stimulating hormone (TSH) ≤ 1 × ULN (if abnormal, FT3 and FT4 levels should be examined simultaneously. If FT3 and FT4 levels are normal, they can be included in the group); Serum total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN; AKP≤ 2.5×ULN； Serum creatinine ≤ 1.5 × ULN;\n8. Female patients with non-surgical sterilization or childbearing age need to use a medically approved contraceptive measure (such as intrauterine device, contraceptive pill or condom) during the study treatment period and within 3 months after the end of the study treatment period; ; And must be non lactation; For male patients whose partners are women of childbearing age, effective methods of contraception should be used during the trial and within 3 months after the last administration of trial drugs.\n\nExclusion Criteria:\n\n1. There is any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo or asthma in childhood have been completely relieved and do not need any intervention after adulthood can be included; asthma requiring medical intervention with bronchodilators cannot be included);\n2. Currently using immunosuppressants or systemic hormone therapy for immunosuppression (with a dosage of \\>10mg\u002Fday of prednisone or other equally effective hormones), and still continuing to use them within 2 weeks prior to enrollment;\n3. Severe allergic reaction to other monoclonal antibodies;\n4. Known history or evidence of interstitial lung disease or active non infectious pneumonia;\n5. Having other malignant tumors in the past 5 years or at the same time (except for cured skin basal cell carcinoma and cervical carcinoma in situ);\n6. Have hypertension and can not be well controlled after antihypertensive drug treatment; Had hypertension crisis or hypertensive encephalopathy in the past;\n7. There are cardiac clinical symptoms or diseases that are not well controlled, such as: (1) heart failure above NYHA grade 2 (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention (5) qtc\\>450ms (male); Qtc\\>470ms (female);\n8. The urine routine showed that the urine protein was ≥ + +, and the 24-hour urine protein volume was confirmed to be \\>1.0 g;\n9. Patients with active infection, unexplained fever ≥ 38.5 ℃ within 7 days before medication, or white blood cell count \\>15 × 10\\^9\u002Fl at baseline;\n10. Have congenital or acquired immune deficiency (such as HIV infected persons); Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥ 2000 iu\u002Fml, or hepatitis C virus antibody positive;\n11. Less than 4 weeks before the study medication or may be vaccinated with live vaccines during the study period;\n12. Bilateral breast cancer;\n13. According to the judgment of the investigator, the patient has other factors that may affect the results of the study or cause the forced termination of the study, such as alcohol abuse, drug abuse, other serious diseases (including mental illness) requiring combined treatment, serious laboratory abnormalities, accompanied by family or social factors, which will affect the safety of the patient.","FEMALE","70 Years",{"count":180,"type":23},20,[26],"Breast cancer is one of the most common malignant tumors in women, accounting for the first cancer-related death cause in women. In recent years, the incidence has gradually increased, and the trend is younger. In 2022, the estimated number of new cases of female breast cancer worldwide is 2.389 million, and the estimated number of deaths is 666000. Triple negative breast cancer (TNBC) refers to breast cancer that is negative for estrogen receptor, progesterone receptor and human epidermal growth factor receptor 2, accounting for about 10% - 20% of malignant breast tumors. . At present, chemotherapy is still the main means of clinical treatment of TNBC, but the heterogeneity of TNBC in molecular level, pathology and clinical characteristics leads to different sensitivity of patients to different chemotherapeutic drugs, especially the sensitivity of most elderly patients to chemotherapeutic drugs is not high, and the prognosis is poor.\n\nThe development of immunotherapy in the field of breast cancer has witnessed the continuous deepening of medical understanding of cancer treatment. In the past, breast cancer was often regarded as a \"cold tumor\" insensitive to immunotherapy, but with the deepening of research, immunotherapy gradually occupied an important position in the treatment of breast cancer. The ongoing research hopes to identify patients who may benefit more from immunotherapy according to their respective tumor immune microenvironment.\n\nIts mechanism of action mainly includes two aspects: one is to restore the normal recognition and attack ability of the immune system to tumor cells and break the immune escape mechanism of tumor cells; The second is to stimulate a lasting immune response, so that the immune system can continuously monitor and clear tumor cells.\n\nTherefore, this study intends to evaluate the efficacy and safety of Iparomlimab and tuvonralimab combined with olaparib and paclitaxel in the neoadjuvant treatment of early high-risk TNBC with HRD positive.\n\nIt is planned to enroll 20 subjects. After enrollment, the subjects will receive six cycles of combination therapy with olaparib and docetaxel. Take 3 weeks as a treatment cycle until the treatment termination event specified in the protocol occurs, and the subject will continue to conduct postoperative efficacy and safety visits after the end of treatment.\n\nAfter neoadjuvant treatment, according to the routine treatment process of breast cancer, the subject will receive breast cancer surgery; After surgical treatment, according to the residual breast lesions of the patient, the attending physician and the subject will agree on the subsequent treatment plan.",[184],"Triple Negative Breast Cancer (TNBC)","2025-09-22",{"date":187,"type":34},"2025-09-23",{"date":189,"type":23},"2025-12-30",{"date":191,"type":23},"2028-12-31",{"name":40,"class":41},{"id":194,"slug":195,"hasResults":12,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":201,"sex":18,"minAge":19,"maxAge":202,"enrollmentInfo":203,"targetDuration":4,"studyType":205,"phases":4,"briefSummary":206,"conditions":207,"keywords":209,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":221},"100553671","single-cell-multi-omics-analyses-of-oct-diagnosed-plaque-subtypes-in-coronary-artery-disease-moop-cad-100553671","NCT06489119","Single-cell Multi-omics Analyses of OCT-diagnosed Plaque Subtypes in Coronary Artery Disease (MOOP-CAD)","Single-cell Multi-omics Analyses of OCT-diagnosed Plaque Subtypes in Coronary Artery Disease - a Prospective, Observational Study","MOOP-CAD","Inclusion Criteria:\n\n1. Male or female, Age ≥ 18 years and ≤ 85 years.\n2. Ability to understand the requirements of the study and to provide informed consent.\n\nControl group:\n\nPatients with coronary angiographic diameter stenosis \\\u003C20%.\n\nStable plaque group:\n\n1. Have been clinically stable for at least 6 months.\n2. Presence of ≥1 lesion with angiographic diameter stenosis \\>50% with no TCFA lesions in the most severely narrowed native coronary artery (target vessel). TCFA was defined as a lipidic plaque with the thinnest FCT \\\u003C75 mm and maximum lipid arc \\>180°.\n3. Rule out elevation of troponin or myocardial enzymology.\n\nVulnerable plaque group:\n\n1. Have been clinically stable for at least 6 months.\n2. Presence of ≥1 lesion with angiographic diameter stenosis \\>50% with TCFA lesions in the most severely narrowed native coronary artery (target vessel).\n3. Rule out elevation of troponin or myocardial enzymology.\n\nPlaque rupture group:\n\n1. Persistent chest pain for 30 minutes, arrival at the hospital within 24 hours from symptom onset. ST-segment elevation of \\>0.1 mV in ≥2 contiguous leads or new-onset left bundle branch block, and high sensitive Troponin T or I or CK\u002FCK-MB above upper reference value.\n2. Exist clearly identified culprit lesion.\n3. Plaque rupture was defined by the presence of a discontinuity of the fibrous cap with a cavity formed inside the plaque.\n\nPlaque erosion group:\n\n1. Persistent chest pain for 30 minutes, arrival at the hospital within 24 hours from symptom onset. ST-segment elevation of \\>0.1 mV in ≥2 contiguous leads or new-onset left bundle branch block, and high sensitive Troponin T or I or CK\u002FCK-MB above upper reference value.\n2. Exist clearly identified culprit lesion.\n3. Plaque erosion was defined by the presence of the attached thrombus overlying the intact fibrous cap of the atherosclerotic plaque, luminal surface irregularity at the culprit lesion in the absence of thrombus, or attenuation of the underlying plaque by thrombus without superficial lipid or calcium at the site of the thrombus.\n\nExclusion Criteria:\n\n1. Cardiogenic shock or circulatory depression，life-threatening arrhythmia.\n2. Known systolic heart failure with LVEF ≤30%.\n3. Severe systemic diseases (end-stage renal disease, serious liver dysfunction, chronic active inflammatory diseases, active oncologic diseases, autoimmune diseases).\n4. Septicemia, acute inflammatory event with fever.\n5. Patients with organ transplants or patients on the waiting list for an organ transplant.\n6. Previous CABG treatment, PCI treatment of the target vessel, and PCI treatment of non-target vessels within 1 year.\n7. Thrombolysis before PCI.\n8. Stenosis of the left main artery ≥50%.\n9. Characteristics rendering high-quality OCT imaging unlikely such as chronic total occlusion, pronounced tortuosity, heavily calcified vessels.\n10. Infarcted vessel with a diameter \\>4mm or \\\u003C2.5mm.\n11. \"No-reflow\" (TIMI 0-1) after thrombus aspiration or predilatation.\n12. Other subjects deemed unsuitable for study by investigators.",true,"85 Years",{"count":204,"type":23},350,"OBSERVATIONAL","The MOOP-CAD study program characterizes, for the first time, the pathophysiological processes and molecular mechanisms of coronary atherosclerotic plaque progression by combining in vivo intravascular imaging techniques with circulating immune single-cell multi-omics analysis. In this study, the investigators evaluate the imaging characteristics of coronary plaques by optical coherence tomography (OCT) and invasive angiography, and study the correlation between plaque characteristics and the multi-omics immune characteristic profiles.",[208],"Coronary Artery Disease",[210,211,212],"Coronary atherosclerosis","Optical coherence tomography","Multi-omics","2025-09-09",{"date":215,"type":34},"2025-09-15",{"date":217,"type":34},"2024-07-07",{"date":219,"type":23},"2026-07-15",{"name":40,"class":41},2,{"id":223,"slug":224,"hasResults":12,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":12,"sex":177,"minAge":19,"maxAge":4,"enrollmentInfo":229,"targetDuration":4,"studyType":24,"phases":231,"briefSummary":233,"conditions":234,"keywords":236,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":240,"completionDateStruct":241,"leadSponsor":243,"locationsCount":4},"100605382","phase-1-camrelizumab-pirfenidone-and-chemotherapy-in-the-treatment-of-advanced-triple-negative-breast-cancer-100605382","NCT07161791","Camrelizumab, Pirfenidone, and Chemotherapy in the Treatment of Advanced Triple-Negative Breast Cancer","Exploratory Clinical Study of Camrelizumab Combined With Pirfenidone and Chemotherapy in the Treatment of Advanced Triple-Negative Breast Cancer","Inclusion Criteria:\n\n* Female, aged 18-70 years.\n* Histologically confirmed recurrent\u002Fmetastatic TNBC (ER-negative: IHC ER \\\u003C1%; PR-negative: IHC PR \\\u003C1%; HER2-negative: IHC -\u002F+, or IHC ++ but FISH\u002FCISH negative), with at least one measurable lesion per RECIST v1.1.\n* ECOG performance status 0-2.\n* Estimated life expectancy ≥3 months.\n* Received first-line chemotherapy + PD-1\u002FPD-L1 inhibitor for metastatic or locally advanced unresectable TNBC, with response of CR\u002FPR or stable disease lasting ≥3 months. For neoadjuvant\u002Fadjuvant therapy, disease progression during treatment or within 6 months after completion will be considered as first-line failure.\n* Adequate organ function (no transfusion, growth factor, or thrombopoietic agents within 2 weeks before screening):\n* Hematology: ANC ≥1.5×10⁹\u002FL; PLT ≥90×10⁹\u002FL; Hb ≥90 g\u002FL.\n* Serum chemistry: TBIL ≤1.5×ULN; ALT and AST ≤1.5×ULN; ALP ≤2.5×ULN; BUN and Cr ≤1.5×ULN with creatinine clearance ≥50 mL\u002Fmin (Cockcroft-Gault).\n* TSH ≤ULN (if abnormal, T3 and T4 must be assessed; enrollment allowed if T3\u002FT4 normal).\n* Cardiac: LVEF ≥50% by echocardiography; 18-lead ECG with QTcF \\\u003C480 ms (female).\n* Women of childbearing potential must have negative pregnancy test (serum or urine) within 7 days prior to enrollment and agree to use adequate contraception during treatment and for 4 months after last dose.\n* Voluntarily signed informed consent and good compliance.\n\nExclusion Criteria:\n\n* Concurrent participation in another interventional cancer trial.\n* Received other antitumor therapy within 14 days before first dose.\n* Prior treatment with pirfenidone.\n* Untreated active brain metastases or leptomeningeal disease.\n* Major non-breast cancer surgery within 4 weeks prior to enrollment or incomplete recovery from such surgery.\n* Active or history of autoimmune disease (except vitiligo, resolved childhood asthma without treatment in adulthood).\n* Severe cardiac disease (e.g., heart failure with LVEF \\\u003C50%, uncontrolled arrhythmias, angina requiring medication, significant valvular disease, recent myocardial infarction, poorly controlled hypertension \\>180\u002F100 mmHg).\n* Congenital or acquired immunodeficiency (e.g., HIV infection).\n* Live vaccination within 4 weeks before or during study.\n* Known allergy to study drugs or excipients.\n* Severe concomitant disease or condition that may interfere with study participation per investigator judgment",{"count":230,"type":23},12,[232,53],"PHASE1","This is a prospective, single-arm, exploratory clinical study, planned to enroll 12 patients with advanced triple-negative breast cancer who have received first-line systemic treatment with immune checkpoint inhibitors. The treatment regimen will continue until disease progression, intolerable toxicity, withdrawal of informed consent, or investigator's judgment that treatment must be terminated. Imaging assessment will be performed according to RECIST 1.1 criteria, with the research center's assessment results as the final outcome. Subjects who discontinue treatment will enter the follow-up period: 1) Safety follow-up until 30 days after the last dose; 2) Subjects who discontinue treatment for reasons other than progression disease (PD) or death will undergo efficacy follow-up until disease progression, initiation of other anti-tumor drugs, or death, whichever comes first; 3) All subjects will enter the trial period upon enrollment and receive camrelizumab combined with pirfenidone and chemotherapy.",[235,184],"Breast Cancer",[235,237,159],"TNBC","2025-09-04",{"date":213,"type":34},{"date":215,"type":23},{"date":242,"type":23},"2027-12-31",{"name":40,"class":41},{"id":245,"slug":246,"hasResults":12,"nctId":247,"briefTitle":248,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":12,"sex":18,"minAge":250,"maxAge":4,"enrollmentInfo":251,"targetDuration":4,"studyType":205,"phases":4,"briefSummary":253,"conditions":254,"keywords":256,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":144},"100595528","cardiovascular-risk-early-screening-and-warning-in-harbin--a-prospective-cohort-study-100595528","NCT07033624","Cardiovascular Risk Early Screening and Warning in Harbin : A Prospective Cohort Study","Inclusion Criteria:\n\n* 1.Residents of Harbin city, regardless of gender.\n* 2.Meets at least two of the following conditions: diabetes, hypertension, hyperlipidemia, or obesity.\n* 3.No history of cardiovascular or cerebrovascular diseases.\n* 4.Willing to participate in the study and sign the informed consent form\n\nExclusion Criteria:\n\n* 1.History of antibiotic or probiotic treatment within the past month.\n* 2\\. Pregnant women.\n* 3\\. History of autoimmune diseases or malignant tumors; severe heart, liver, or kidney dysfunction; or a history of severe cardiovascular or cerebrovascular diseases.\n* 4\\. Any unstable condition or situation that may jeopardize patient safety or compliance.\n* 5\\. Patients unable to provide informed consent due to physical reasons or unwilling to participate.","45 Years",{"count":252,"type":23},10000,"The aim of this prospective cohort study is to collect the multi-omics profile of cardiovascular disease (CVD) high-risk individuals in Harbin, and to discover novel biomarker signatures of major adverse cardiovascular events (MACE) during a minimum 2-year follow-up period.",[255],"Cardiovascular Diseases",[257],"Cardiovascular diseases, microbiome, genomics, metabolism, imaging, risk prediction","2025-06-13",{"date":260,"type":34},"2025-06-24",{"date":262,"type":23},"2025-07-01",{"date":264,"type":23},"2047-07-01",{"name":40,"class":41},{"id":267,"slug":268,"hasResults":12,"nctId":269,"briefTitle":270,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":12,"sex":18,"minAge":73,"maxAge":4,"enrollmentInfo":272,"targetDuration":4,"studyType":24,"phases":274,"briefSummary":275,"conditions":276,"keywords":278,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":144},"100593158","application-of-remimazolam-combined-with-esketamine-in-painless-gastroscopy-and-colonoscopy-in-elderly-patients-100593158","NCT07002801","Application of Remimazolam Combined With Esketamine in Painless Gastroscopy and Colonoscopy in Elderly Patients","Inclusion Criteria:\n\n1. Patients undergoing painless gastroenteroscopy in outpatient clinics;\n2. aged 65 years and above;\n3. American Society of Anesthesiologists (ASA) grades I - III.\n\nExclusion Criteria:\n\n1. Patients with abnormal liver or kidney function;\n2. known respiratory or endocrine diseases;\n3. Patients with uncontrolled hypertension and NYHA classification Ⅲ-Ⅳ;\n4. Taking monoamine oxidase inhibitors, sedatives, analgesics, hypnotics, antipsychotics, antiemetics or antidepressants;\n5. Addiction to tobacco and alcohol;\n6. Patients allergic to the investigational drug;\n7. expected difficult airway;\n8. Body mass index (BMI) \\>35kg\u002Fm\\^2;\n9. Have participated in other clinical trials within the past three months;\n10. Patients with psychosocial illness or cognitive dysfunction and inability to cooperate or communicate.",{"count":273,"type":23},280,[26],"The objective of this clinical trial is to assess the feasibility of the remimazolam combined with esketamine OFA (opioid-free anesthesia) protocol for painless gastroscopy and colonoscopy in elderly patients and to determine if it is non-inferior to the traditional OA (opioid-containing anesthesia) protocol. The main questions it aims to answer are:\n\n* Is the remimazolam combined with esketamine protocol feasible for painless gastroscopy and colonoscopy in elderly patients?\n* Is the OFA protocol superior to the OA protocol?\n\nParticipants will:\n\n* During anesthesia induction, the experimental group will receive remimazolam combined with esketamine for anesthesia, while the control group will receive remimazolam combined with remifentanil.\n* Record respiratory and circulatory indicators and adverse reaction times.",[277],"Gastrointestinal Disease",[279,280,281,282],"remimazolam","esketamine","painless gastroscopy and colonoscopy","success rate of calming down","2025-05-26",{"date":285,"type":34},"2025-06-04",{"date":287,"type":34},"2025-03-14",{"date":289,"type":23},"2028-01",{"name":40,"class":41},{"id":292,"slug":293,"hasResults":12,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":24,"phases":300,"briefSummary":301,"conditions":302,"keywords":303,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":144},"100542909","act-combined-yoga-for-parental-burnout-in-parents-with-autistic-children-100542909","NCT06348992","ACT Combined Yoga for Parental Burnout in Parents with Autistic Children","ACT (Acceptance Commitment Therapy) Combined with Yoga for Parental Burnout in Parents with Autistic Children: a Randomized Controlled Trial.","Inclusion Criteria:\n\n* Parents of children diagnosed with ASD based on DSM-5\n* Parental burnout exists in parents\n* Parents have normal speech, hearing and cognitive functioning\n* Is the primary caregiver for children\n* Informed consent and voluntary participation\n\nExclusion Criteria:\n\n* Untreated ongoing or severe psychiatric disorders such as anxiety disorders, depressive disorders, schizophrenia, etc.;\n* other more serious psychosomatic disorders that would interfere with the intervention.",{"count":299,"type":23},60,[26],"OBJECTIVE: To explore the intervention effect of ACT combined with a yoga intervention program on parenting burnout in parents with ASD.\n\nMETHODS: This study used a combination of qualitative research and quantitative analysis to examine the intervention effects of an ACT-centered intervention program on parenting burnout in parents of children with ASD, and to clarify the evaluations and perceptions of parents with ASD about the research program through qualitative research.\n\nRESULTS AND CONCLUSION: To clarify the intervention effect of ACT combined with yoga intervention program on parenting burnout of ASD parents.",[131],[304,305,306,307,308],"Autism spectrum disorder","Parental burnout","Acceptance commitment therapy","Yoga","Psychosomatic intervention","2025-02-11",{"date":311,"type":34},"2025-02-13",{"date":313,"type":34},"2023-09-01",{"date":315,"type":23},"2025-05-31",{"name":40,"class":41},{"id":318,"slug":319,"hasResults":12,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":205,"phases":4,"briefSummary":326,"conditions":327,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":144},"100517366","an-imaging-study-of-polyvascular-disease-100517366","NCT06016608","An Imaging Study of Polyvascular Disease","Early Screen, Systematic Evaluation and Risk Warning of Polyvascular Disease Based on Multi-modality Imaging","Inclusion Criteria:\n\nTask 1:\n\n1. Patients with coronary artery disease (≥50% stenosis in any coronary artery on coronary angiography)\n2. Age ≥18 years old\n3. Proposed OCT-IVUS integrated imaging system\n4. able to provide written informed consent prior to the start of any procedures related to the study.\n\nTask 2:\n\n1. patients with coronary artery disease (coronary angiography reveals ≥50% degree of stenosis in any coronary artery) and patients with stroke or TIA (confirmed by a neurologist)\n2. Age ≥ 18 years\n3. able to provide written informed consent prior to the start of any procedures related to the study.\n\nExclusion Criteria:\n\nTask 1:\n\n1. severely tortuous\u002Fcalcified coronary arteries with anticipated difficulty in completing the OCT-IVUS integrated imaging system\n2. uncontrolled congestive heart failure or acute left heart failure;plan\n3. claustrophobia;\n4. left main stem occlusion;\n5. proposed coronary artery bypass grafting (CABG);\n6. uncontrolled severe ventricular arrhythmia;\n7. active bleeding or severe bleeding tendency;\n8. acute stroke;\n9. patients with hemodynamic instability or unstable cardiac electrical activity (including shock) ;\n10. severe renal insufficiency and\u002For anuria, except in cases where dialysis treatment has been planned;\n11. contraindications to the application of contrast media;\n12. patients who are severely uncooperative due to psychiatric or serious systemic illness;\n13. Patients who, in the opinion of the investigator, are unsuitable for participation in the study.\n\nTask 2:\n\n1. patients who are unable to comply with the follow-up schedule;\n2. uncontrolled congestive heart failure or acute left heart failure;\n3. patients with a life expectancy of less than 6 months;\n4. left main stem occlusion;\n5. proposed coronary artery bypass grafting (CABG);\n6. uncontrolled severe ventricular arrhythmia;\n7. active bleeding or severe bleeding tendency;\n8. patients with hemodynamic instability or unstable cardiac electrical activity (including shock) ;\n9. severe renal insufficiency and\u002For anuria, except in cases where dialysis treatment has been planned;\n10. contraindications to the application of contrast media;\n11. patients who are severely uncooperative due to psychiatric or serious systemic illness;\n12. patients who, in the opinion of the investigator, are not suitable for participation in the study.",{"count":325,"type":23},1100,"1. Establish a multimodality imaging database for PVD, improve the one-stop screening process for early PVD based on artificial intelligence, build a full-cycle control information platform, and promote the construction and standardization of a multidisciplinary co-morbidity and co-management diagnosis and treatment model.\n2. Based on non-invasive, zero-contrast ocular OCTA combined with one-stop CTA imaging of the heart and brain, construct an integrated \"eye-heart-brain\" early warning model for PVD, and explore a potential non-invasive and convenient early warning system for PVD.\n3. Based on the multi-omics, investigate EVs-mediated intercellular communication network, elucidate the roles and regulatory mechanisms of EVs in the development of PVD, search for potential targets for intervention, and construct an artificial intelligence-based \"pan-vascular score\" risk assessment system based on the combination of multi-modality imaging and multi-omics biomarkers.",[328],"Polyvascular Disease","2024-12-22",{"date":331,"type":34},"2024-12-27",{"date":333,"type":34},"2023-10-18",{"date":335,"type":23},"2025-12-31",{"name":40,"class":41},{"id":338,"slug":339,"hasResults":12,"nctId":340,"briefTitle":341,"officialTitle":341,"acronym":4,"eligibilityCriteria":342,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":343,"targetDuration":345,"studyType":205,"phases":4,"briefSummary":346,"conditions":347,"keywords":352,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":4},"100572691","a-multicenter-real-world-clinical-study-on-the-efficacy-and-safety-of-ensartinib-as-neoadjuvant-treatment-for-anaplastic-lymphoma-kinase-alk-positive-non-small-cell-lung-cancer-nsclc-patients-100572691","NCT06736561","A Multicenter Real-world Clinical Study on the Efficacy and Safety of Ensartinib As Neoadjuvant Treatment for Anaplastic Lymphoma Kinase (ALK) Positive Non-small Cell Lung Cancer (NSCLC) Patients.","Inclusion Criteria:\n\n1. Cohort 1: Female or male aged \\>=18 years;\n2. Cohort 1: Received neoadjuvant treatment with Ensartinib before the project started;\n3. Cohort 1: Diagnosed with clinical stage II-III resectable or potentially resectable (T1-4 N2 M0) ALK-positive NSCLC before neoadjuvant treatment;\n4. Cohort 1: Confirmed ALK positive by immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), next-generation sequencing (NGS), or other non-specific sequencing methods before receiving ALK inhibitor therapy.\n5. Cohort 2: Female or male aged \\>=18 years;\n6. Cohort 2: Intended to receive Ensartinib monotherapy as neoadjuvant treatment for 6-12 weeks;\n7. Cohort 2: Diagnosed with clinical stage II-III resectable or potentially resectable (T1-4 N2 M0) ALK-positive NSCLC before neoadjuvant treatment;\n8. Cohort 2: Confirmed ALK positive by immunohistochemistry (IFL), fluorescence in situ hybridization (FISH), next-generation sequencing (NGS), or other non-specific sequencing methods before receiving ALK inhibitor therapy;\n9. Cohort 2: Signed informed consent form;\n10. Cohort 3: Female or male aged \\>=18 years;\n11. Cohort 3: Intended to receive neoadjuvant treatment including Ensartinib, but not meeting the inclusion criteria for Cohort 2;\n12. Cohort 3: Diagnosed with clinical stage II-III resectable or potentially resectable ALK-positive NSCLC before neoadjuvant treatment;\n13. Cohort 3: Confirmed ALK positive by immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), next-generation sequencing (NGS), or other non-specific sequencing methods before receiving ALK inhibitor therapy;\n14. Cohort 3: Signed informed consent form.\n\nExclusion Criteria:\n\n1. Cohort 1: Patients who have received treatment with Ensartinib after the project has started;\n2. Cohort 1: Patients who have received Ensartinib treatment but have not completed the objective efficacy evaluation according to the follow-up cycle specified by the clinical physician;\n3. Cohort 1: History of hypersensitivity reactions to active or inactive excipients of Ensartinib or to drugs with similar chemical structures or categories as Ensartinib;\n4. Cohort 1: Patients who are participating in other clinical studies outside of this research;\n5. Cohort 1: Other circumstances deemed unsuitable for enrollment by the researchers.\n6. Cohort 2: Patients who have received Ensartinib treatment before the study started;\n7. Cohort 2: Patients who have received other systemic treatments besides Ensartinib;\n8. Cohort 2: Neoadjuvant treatment cycles less than 6 weeks or more than 12 weeks;\n9. Cohort 2: Patients who have received Ensartinib monotherapy but have not completed the objective efficacy evaluation according to the follow-up cycle specified by the clinical physician;\n10. Cohort 2: History of hypersensitivity reactions to active or inactive excipients of Ensartinib or to drugs with similar chemical structures or categories as Ensartinib;\n11. Cohort 2: Patients who are participating in other clinical studies outside of this research;\n12. Cohort 2: Other circumstances deemed unsuitable for enrollment by the researchers.\n13. Cohort 3: Patients who have received neoadjuvant treatment containing Ensartinib but meet the enrollment criteria for Cohort 2;\n14. Cohort 3: Patients who have received treatment containing Ensartinib but have not completed the objective efficacy evaluation according to the follow-up cycle specified by the clinical physician;\n15. Cohort 3: History of hypersensitivity reactions to active or inactive excipients of Ensartinib or to drugs with similar chemical structures or categories as Ensartinib;\n16. Cohort 3: Patients who are participating in other clinical studies outside of this research;\n17. Cohort 3: Other circumstances deemed unsuitable for enrollment by the researchers.",{"count":344,"type":23},100,"2 Years","Explore the efficacy and safety of Ensartinib in neoadjuvant treatment for ALK-positive non-small cell lung cancer in the real world.This is a real-world study of patients receiving enshatinib-based neoadjuvant therapy with R0 resection, divided into retrospective cohort 1, prospective cohort 2, and prospective cohort 3. The dose, duration, and whether to combine or sequentially treat enshatinib were clinical decisions made by the investigator on a patient-specific basis.",[348,349,350,351],"ALK Positive","Ensartinib","NSCLC","Neoadjuvant Therapy",[348,349,350,353],"Neoadjuvant therapy","2024-12-12",{"date":356,"type":34},"2024-12-16",{"date":358,"type":23},"2025-01-01",{"date":360,"type":23},"2028-06-30",{"name":40,"class":41},{"id":363,"slug":364,"hasResults":12,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":4,"eligibilityCriteria":368,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":369,"targetDuration":4,"studyType":24,"phases":371,"briefSummary":372,"conditions":373,"keywords":375,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":144},"100565926","phase-2-adebrelimab-combined-with-irinotecan-liposomes-5-fu-cf--lenvatinib-as-first-line-treatment-for-advanced-icc-100565926","NCT06648525","Adebrelimab Combined with Irinotecan Liposomes, 5-FU, CF ± Lenvatinib As First-line Treatment for Advanced ICC","Adebrelimab Combined with Irinotecan Liposomes, 5-fluorouracil, Calcium Folinate ± Lenvatinib As First-line Treatment for Advanced Intrahepatic Cholangiocarcinoma: a Prospective Clinical Study","Inclusion Criteria:\n\n1. Age: 18 to 75 years old, male or female not limited;\n2. Histologically confirmed unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma with measurable tumor lesions (meeting RECIST 1.1 criteria);\n3. Have not received systemic anti-tumor treatment in the past;\n4. Patients who relapse more than 6 months after curative surgery or after completion of adjuvant therapy (chemotherapy and\u002For radiotherapy) meet the inclusion criteria;\n5. ECOG PS：0-1；\n6. Expected survival period ≥ 3 months;\n7. The main organ functions are normal, which meets the following criteria:\n\n1\\) Blood routine examination (without blood transfusion or correction with hematopoietic stimulating factor drugs within 14 days): Hemoglobin (Hb) ≥ 85 g\u002FL; Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL; Platelet count (PLT) ≥ 80 × 109\u002FL; 2) Biochemical examination: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × ULN; Serum total bilirubin (TBIL) ≤ 3 × ULN; Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance rate ≥ 50ml\u002Fmin; 3) Coagulation function: Activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5 × ULN; 4) Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF) ≥ 50%; 8. Women of childbearing age must undergo a negative pregnancy test (β HCG) before starting treatment, and women and men of childbearing age (who have sexual relations with women of childbearing age) must agree to continuously use effective contraceptive measures during the treatment period and for 6 months after the last treatment dose; 9. Patients with a history of hepatitis B and C can be included in the study, but active hepatitis B patients must start antiviral therapy before starting the study treatment; 10. Participants voluntarily join the study and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women, or those who have the ability to conceive but refuse to take contraceptive measures;\n2. History of other malignant tumors within the past 5 years, excluding cervical carcinoma in situ or squamous cell carcinoma of the skin that has been adequately treated, or basal cell carcinoma of the skin that has been largely controlled;\n3. Merge other serious uncontrolled diseases (such as individuals with a history of difficult to control mental illness or severe intellectual or cognitive impairment; severe heart failure, angina pectoris, myocardial infarction, arrhythmia, etc.);\n4. Pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, and severe impairment of lung function;\n5. Suffering from active, known or suspected autoimmune diseases. Subjects with hypothyroidism who only require hormone replacement therapy and those with skin diseases that do not require systemic treatment may be included;\n6. Easy to bleed, at risk of massive hemoptysis, and with a history of significant coagulation dysfunction;\n7. Suffering from hypertension and unable to achieve good control with antihypertensive medication (systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg);\n8. History of immunodeficiency, including HIV testing positive, having other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation and allogeneic bone marrow transplantation;\n9. Severe active infections requiring intravenous antibiotic treatment occur during the screening period;\n10. Individuals with multiple factors that affect oral medication (such as inability to swallow, post gastrointestinal resection, chronic diarrhea, and intestinal obstruction);\n11. Individuals who are allergic to the experimental drug;\n12. Patients who cannot comply with the trial protocol or cooperate with follow-up;\n13. The researchers believe that participants should not participate in this experiment.",{"count":370,"type":23},68,[53],"This is a multicenter, open label, randomized, two-arm clinical study to observe and evaluate the efficacy and safety of adebrelimab combined with irinotecan liposomes, 5-fluorouracil, calcium folinate ± lenvatinib as first-line treatment for advanced intrahepatic cholangiocarcinoma (ICC).",[374],"Intrahepatic Cholangiocarcinoma (Icc)",[376,377,378,379],"Adebrelimab","Irinotecan liposomes","Lenvatinib","Intrahepatic Cholangiocarcinoma","2024-10-16",{"date":382,"type":34},"2024-10-18",{"date":384,"type":23},"2024-10",{"date":386,"type":23},"2028-04",{"name":40,"class":41},{"id":389,"slug":390,"hasResults":12,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":4,"eligibilityCriteria":394,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":395,"targetDuration":4,"studyType":24,"phases":397,"briefSummary":398,"conditions":399,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":401,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":144},"100527948","study-on-the-improvement-of-myocardial-microcirculation-after-acute-anterior-myocardial-infarction-100527948","NCT06154395","Study on the Improvement of Myocardial Microcirculation After Acute Anterior Myocardial Infarction","A Comparative Study of 60 MHz HD-IVUS, OCT, and Conventional Angiography to Guide Reperfusion Therapy for Improving Myocardial Microcirculation Dysfunction After Acute Anterior Myocardial Infarction","Inclusion Criteria:\n\nClinical Inclusion Criteria:\n\n1. Subjects aged ≥18 years;\n2. Initial diagnosis of anterior wall ST-segment elevation myocardial infarction, with symptoms occurring within 6 hours, and undergoing primarypercutaneous coronary intervention (PCI);\n3. Subjects (or legal representatives) who understand the study requirements and treatment procedures and provide signed informed consent.\n\nImaging Inclusion Criteria (Visual Estimation):\n\n1. Target lesion is the culprit lesion, located in the native coronary artery, with a visually estimated reference vessel diameter (RVD) between 2.25 mm and 4.0 mm;\n2. Culprit segment of the infarct-related artery (IRA) is located between the origin of the left anterior descending (LAD) artery and the emergence of the second diagonal branch (D2);\n3. After pre-treatment , the degree of stenosis in the LAD is ≤90%, and TIMI flow is grade 3.\n\nExclusion Criteria:\n\nClinical Exclusion Criteria:\n\n1. History of coronary artery bypass grafting (CABG);\n2. Known history of myocardial infarction or PCI;\n3. Previous thrombolytic therapy before PCI;\n4. Severe liver or kidney dysfunction, severe valvular heart disease, chronic obstructive pulmonary disease, etc.;\n5. Contraindications to magnetic resonance imaging;\n6. Allergy to gadolinium contrast agents and\u002For accompanying medications for devices or procedures (e.g., any component of drug-eluting stents, all P2Y12 inhibitors, or aspirin);\n7. Expected lifespan of the subject less than 12 months;\n8. Pregnant or lactating females;\n9. Other subjects deemed unsuitable for participation in the study by the investigator.\n\nImaging Exclusion Criteria (Visual Estimation):\n\n1. Presence of lesions requiring intervention other than the target lesion at baseline surgery;\n2. No protected left main coronary artery disease (visual estimate of stenosis \\>50%);\n3. Diffuse severe calcification (\\>20 mm) or chronic total occlusion in the major coronary vessels (LCX, RCA);\n4. Severe coronary artery tortuosity (\\>45°) or calcification (\\>270°), or other conditions that may interfere with the use of intravascular imaging.",{"count":396,"type":23},90,[26],"This study is a prospective, single-center, randomized controlled clinical trial. Ninety patients with anterior wall ST-segment elevation myocardial infarction (STEMI) who are planned for primary percutaneous coronary intervention (PCI) within 6 hours of symptom onset will be screened. Patients with inclusion criteria and without exclusion criteria will be randomized into three groups in a 1:1:1 ratio: OCT-guided group, 60 MHz HD-IVUS-guided group, and angiography-guided group after signing the informed consent form.\n\nBased on the lesion characteristics detected by imaging in each group, coronary revascularization will be performed for the culprit vessels of myocardial infarction. The TIMI myocardial perfusion frame count (TMPFC) values of the culprit vessels will be recorded immediately after PCI, and secondary prevention medications for myocardial infarction will be administered. Three days after the procedure, a 3.0T cardiac magnetic resonance imaging (MRI) with gadolinium diethylenetriaminepentaacetic acid (Gd-DTPA) delayed enhancement (LEG) scan will be conducted to assess the microvascular obstruction (MVO) area.\n\nPatients will be followed in the outpatient clinic visit at 1 month (with a window period of XX days) after discharge, and a repeat cardiac MRI will be performed to determine the presence of MVO and the size of the myocardial infarction.",[400],"Intravascular Imaging and Microvascular Obstruction",{"date":382,"type":34},{"date":403,"type":34},"2023-12-20",{"date":405,"type":23},"2025-06-30",{"name":40,"class":41},{"id":408,"slug":409,"hasResults":12,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":413,"eligibilityCriteria":414,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":415,"targetDuration":4,"studyType":24,"phases":417,"briefSummary":418,"conditions":419,"keywords":423,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":432,"locationsCount":433},"100432546","cardioprotective-effect-of-dexmedetomidine-in-patients-with-st-segment-elevation-myocardial-infarction-100432546","NCT04912518","Cardioprotective Effect of Dexmedetomidine in Patients With ST-segment Elevation Myocardial Infarction","Cardioprotective Effect of Dexmedetomidine in Patients With ST-segment Elevation Myocardial Infarction: a Double-Blind, Multicenter, Randomized, Placebo-Controlled Clinical Trial","COOPERATION","Inclusion Criteria: the enrolled subjects must meet all of the following criteria:\n\n* Aged 18-75 years old (inclusive);\n* Diagnosed with anterior STEMI within 6h of symptom onset: (1) ischemic chest discomfort; (2) electrocardiogram (ECG) with ST elevation ≥0.2 mV in 2 or more contiguous precordial leads (one of which should be V2, V3, or V4);\n* Sign the informed consent form.\n\nExclusion Criteria: subjects who meet any one of the following criteria are excluded from the study:\n\n* Ventricular fibrillation, cardiogenic shock, Killip III-IV grade;\n* Sinus bradycardia (heart rate sustained \\\u003C60 beats\u002Fmin), PR interval\\> 240ms or II-III degree atrioventricular block;\n* Continuous systolic blood pressure \\\u003C120mmHg;\n* Severe breathing difficulties, aterial blood oxygen saturation \\\u003C92%;\n* Thrombolytic therapy has been performed before the first medical contact in the hospital;\n* Consciousness disorder or past cerebrovascular disease;\n* Previous history of myocardial infarction or PCI\u002FCABG treatment;\n* Known severe liver and kidney dysfunction;\n* Known allergy to dexmedetomidine;\n* CMR contraindications: such as claustrophobia, pacemaker or ICD implantation;\n* Pregnant or lactating women;\n* Malignant tumor or expected survival time \\\u003C1 year;\n* Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study (eg, poor compliance, inability of the patient to comply with study procedures and\u002For follow up);\n* Participate in other randomized controlled studies at the same time.",{"count":416,"type":23},250,[26],"This is a double-blind, multicenter, randomized, placebo-controlled clinical trial. It is planned to enroll patients admitted with anterior ST-segment elevation myocardial infarction (STEMI) within 6h of symptom onset and undergo primary percutaneous coronary intervention (pPCI). Patients who meet the inclusion criteria and without exclusion criteria were randomized 1:1 into the dexmedetomidine (DEX) group or the placebo (saline) group after signing the informed consent. In the DEX group, intravenous injection of DEX was started immediately after enrollment, covering the entire PCI operation, and the administration was stopped at the end of the pPCI. The administration of saline was the same as those in the DEX group. The primary endpoint was the myocardial infarct size (MIS) as assessed by cardiac magnetic resonance imaging (CMR) at 5±2 days post-STEMI. Based on a superiority design and assuming an 20.0% relative infarct size reduction (from 26.0% to 20.8% with a SD of 13.0%), 250 patients are required to be enrolled, accounting for 20% drop-out (α= 0.05 and power= 80%).",[420,421,422],"ST-segment Elevation Myocardial Infarction (STEMI)","Percutaneous Coronary Intervention","Cardioprotection",[420,424,425,422],"Percutaneous coronary intervention","Dexmedetomidine","2024-10-11",{"date":428,"type":34},"2024-10-15",{"date":430,"type":34},"2021-05-27",{"date":166,"type":23},{"name":40,"class":41},9,{"id":435,"slug":436,"hasResults":12,"nctId":437,"briefTitle":438,"officialTitle":438,"acronym":4,"eligibilityCriteria":439,"healthyVolunteers":12,"sex":18,"minAge":440,"maxAge":441,"enrollmentInfo":442,"targetDuration":4,"studyType":24,"phases":444,"briefSummary":445,"conditions":446,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":144},"100558616","effects-of-an-aerobic-exercise-intervention-on-core-symptoms-executive-functioning-and-quality-of-life-in-children-with-attention-deficit-hyperactivity-disorder-100558616","NCT06553430","Effects of an Aerobic Exercise Intervention on Core Symptoms, Executive Functioning, and Quality of Life in Children With Attention Deficit Hyperactivity Disorder","Inclusion Criteria:\n\n* Children clinically diagnosed with ADHD;\n* 7-14 years old;\n* Combined Raven's Test ≥ 80;\n* Not participating in any treatment other than drug therapy;\n* The body can participate in sports training;\n* The type of family intimacy is intimate or above;\n* Voluntarily participate and sign an informed consent form\n\nExclusion Criteria:\n\n* Children with a history of epileptic seizures;\n* Children with other mental or motor disorders;\n* Children with visual impairments;\n* Using other psychotropic drugs;\n* Have other comorbidities;\n* Merge other serious chronic diseases (such as severe heart, brain, kidney, lung, etc.), tumors, etc","7 Years","14 Years",{"count":443,"type":23},50,[26],"Selecting a maternal and child healthcare hospital in Shenzhen City, Guangdong Province, 50 cases of ADHD children as the study subjects, according to the inclusion and exclusion criteria to screen the eligible study subjects, introduction of the purpose and process of the study, informed consent to enrolment, the children were divided into the intervention group and the control group. The experimental group used aerobic exercise, while the control group was given daily physical activity, and general information questionnaires, Conners Parental Symptom Questionnaire, SNAP-IV scale, Stroop Colour Word Test, Rey Complex Graphics Test, Connection Test, Children's Depressive Disorder Self-assessment Scale, Children's Anxious Mood Disorder Screening Scale, Children's Quality of Life Universal Core Scale, and Children's Executive Functioning Questionnaire were assessed.",[447],"ADHD","2024-08-11",{"date":450,"type":34},"2024-08-14",{"date":452,"type":34},"2023-11-28",{"date":454,"type":23},"2024-11",{"name":40,"class":41},{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":4,"eligibilityCriteria":462,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":463,"targetDuration":4,"studyType":24,"phases":465,"briefSummary":466,"conditions":467,"keywords":469,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":473,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":4},"100555141","phase-2-adebrelimab-combined-with-albumin-paclitaxel-and-nedaplatin-as-neoadjuvant-therapy-for-locally-advanced-resectable-escc-100555141","NCT06508229","Adebrelimab Combined With Albumin Paclitaxel and Nedaplatin as Neoadjuvant Therapy for Locally Advanced Resectable ESCC","Adebrelimab Combined With Albumin Paclitaxel and Nedaplatin as Neoadjuvant Therapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma：a Prospective, Single Arm, Phase 2 Clinical Study","Inclusion Criteria:\n\n1. Age: 18 to 75 years old, no limit to male or female;\n2. Surgically resectable locally advanced esophageal squamous cell carcinoma confirmed by histology or cytology (clinical stage: stage IIa-IIIb);\n3. Have measurable lesions and meet RECIST v1.1) standards;\n4. Have not received any anti-tumor systemic treatment for esophageal cancer in the past;\n5. ECOG PS: 0-1 points;\n6. Expected survival ≥12 weeks;\n7. The functions of vital organs meet the following requirements:\n\n   1. Routine blood examination (no blood transfusion within 14 days, no correction with hematopoietic stimulating factor drugs):Hemoglobin (Hb) ≥90 g\u002FL; absolute neutrophil count (ANC) ≥1.5×109\u002FL; platelets (PLT) ≥100×109\u002FL; white blood cell count (WBC) ≥3.0×109\u002FL;\n   2. Biochemical examination: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN; serum total bilirubin (TBIL) ≤1.5×ULN (Gilbert syndrome subjects, ≤ 3×ULN); serum creatinine (Cr) ≤1.5 ×ULN or creatinine clearance ≥50ml\u002Fmin;\n   3. Coagulation function: Activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤1.5×ULN;\n   4. Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF) ≥50%;\n8. Non-surgical sterilization or female patients of childbearing age need to use a medically approved contraceptive method during the study treatment period and within 3 months after the end of the study treatment period; female patients of childbearing age who have non-surgical sterilization must use a medically approved contraceptive method before study enrollment. The serum or urine HCG test must be negative within 72 hours; and must be non-lactating; for males, they should be surgically sterilized, or agree to use appropriate contraceptive methods during the trial and within 3 months after the last administration of the trial drug;\n9. The patient voluntarily joined this study, signed the informed consent form (ICF), had good compliance, and cooperated with the follow-up.\n\nExclusion Criteria:\n\n1. Patients with locked lymph node metastasis;\n2. Have a history of other malignant tumors in the past 5 years, except for cervical carcinoma in situ or cutaneous squamous cell carcinoma that has been fully treated, or basal cell carcinoma of the skin that has been basically controlled;\n3. Suffering from bleeding disorders or a history of bleeding disorders;\n4. Have undergone major surgery or serious trauma within 4 weeks before taking the study drug for the first time;\n5. Those with uncontrolled, symptomatic brain metastases or a history of uncontrollable mental illness or severe intellectual or cognitive dysfunction;\n6. Have a history of interstitial lung disease and non-infectious pneumonia;\n7. Suffering from active autoimmune diseases or a history of autoimmune diseases, such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or reduced thyroid function after thyroid hormone replacement therapy can be included;\n8. Have a history of immunodeficiency, including testing positive for HIV, suffering from other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation;\n9. Subjects have cardiovascular clinical symptoms or diseases that cannot be well controlled, including but not limited to:\n\n1\\) NYHA class II or above heart failure; 2) Unstable angina; 3) Myocardial infarction within 1 year; 4) Clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention; 10. Severe active infection requiring intravenous antibiotic treatment occurs within 4 weeks before using the study drug; 11. Those who are allergic to experimental drugs; 12. Patients who cannot comply with the trial protocol or cannot cooperate with follow-up visits; 13. Those who the researcher believes are not suitable to participate in this trial.",{"count":464,"type":23},65,[53],"This is a multi-center, single-arm, phase II clinical study designed to observe and evaluate the effectiveness and safety of adebrelimab combined with albumin paclitaxel and nedaplatin as neoadjuvant therapy for locally advanced resectable esophageal squamous cell carcinoma.",[468],"Esophageal Squamous Cell Carcinoma",[376,470,471],"Chemotherapy","locally advanced ESCC","2024-07-17",{"date":474,"type":34},"2024-07-18",{"date":476,"type":23},"2024-07-30",{"date":478,"type":23},"2028-05-30",{"name":40,"class":41},{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":4,"eligibilityCriteria":486,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":487,"targetDuration":4,"studyType":24,"phases":489,"briefSummary":490,"conditions":491,"keywords":493,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":501,"locationsCount":4},"100555543","phase-1-irinotecan-liposomealbumin-paclitaxel-and-gemcitabine-first-line-treatment-for-pancreatic-cancer-100555543","NCT06513455","Irinotecan Liposome，Albumin Paclitaxel and Gemcitabine First-line Treatment for Pancreatic Cancer","Irinotecan Liposome Combined With Albumin Paclitaxel and Gemcitabine as First-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer","Inclusion Criteria:\n\n1. Age: 18 to 75 years old, male or female;\n2. Patients with pancreatic cancer diagnosed by histology or cytology;\n3. Not received anti-tumor system treatment (if received neoadjuvant or adjuvant therapy, need to ensure that the last time is more than 6 months)；\n4. With measurable tumor lesions (spiral CT scan ≥10mm, meet RECIST 1.1 standard);\n5. ECOG PS: 0-1 points;\n6. Expected survival time\\> 3 months;\n7. The functions of important organs meet the following requirements:\n\n   1. Absolute neutrophil count ≥1.5×109\u002FL, platelet ≥100×109\u002FL, hemoglobin ≥9g\u002FdL;\n   2. Bilirubin ≤ 1.5 times ULN (patients drained by retrograde technique may be included); ALT and AST ≤ 3 times ULN;\n   3. Creatinine ≤ 1.5 times, or MDRD creatinine clearance rate\\> 50 mL\u002Fmin;\n8. Women of childbearing age must undergo a negative pregnancy test (βHCG) before starting treatment. Women and men of childbearing age (sexual relationships with women of childbearing age) must agree to use them effectively during treatment and 6 months after the last dose of treatment Contraceptive measures;\n9. Signature of patient information and informed consent.\n\nExclusion Criteria:\n\n1. Previous allergy to irinotecan liposome, other liposome products, fluorouracil and other therapeutic drugs;\n2. previous or concurrent history of other malignant tumors, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;\n3. Participated in other drug clinical trials within 4 weeks before randomization;\n4. Severe gastrointestinal dysfunction;\n5. The presence of third space effusion (e.g., massive pleural effusion) in addition to ascites that could not reach a stable state within 2 weeks before randomization;\n6. Peripheral neuropathy (CTCAE≥ grade 3);\n7. Patients with a history of bleeding, with any bleeding event of CTCAE 5.0 grade 3 or higher within 4 weeks before screening; Gastrointestinal bleeding of CTCAE grade 3 or higher was reported within 6 months before randomization or within 1 month before randomization；\n8. Interstitial lung disease, except interstitial changes only on imaging;\n9. Screening patients with known or history of central nervous system metastases;\n10. Concomitant medication containing a strong inhibitor\u002Fstrong inducer of CYP3A4, CYP2C8, or a strong inhibitor of UGT1A1 within 2 weeks before randomization;\n11. Severe infection (CTCAE \\> grade 2) within 4 weeks before treatment; Signs and symptoms of infection requiring treatment with intravenous antibiotics within 2 weeks before the initiation of treatment (except for prophylactic antibiotics);\n12. Judging by the researchers, the participants have other factors that could lead to the forced midway termination of research, may affect the participants were given safety or test data collection, etc；\n13. Pregnant women or those who expect to become pregnant during the study treatment.",{"count":488,"type":23},132,[232,53],"This is a Phase I\u002FII , Open-label , Investigator-initiated Trail of liposomal irinotecan,nab-paclitaxel and gemcitabine as First-line Treatment in Advanced pancreatic cancer. The study was designed in two stages, the first stage was the tolerance observation stage, and the second stage was the curative effect expansion stage.\n\nThe first part of the study is the Dose-finding Phase designed to establish the safety of nab-paclitaxel，gemcitabine and liposomal irinotecan at different dose Levels(40 mg\u002Fm2, iv. q2w or 60 mg\u002Fm2, iv. q2w). The second part of the study is the Expansion Phase designed to generate additional clinical data at specified doses .\n\nThis study aims to evaluate the safety and efficacy of liposomal irinotecan，nab-paclitaxel and gemcitabine in the First-line treatment of advanced pancreatic cancer.",[492],"Pancreatic Cancer",[494],"Irinotecan Liposome","2024-07-16",{"date":497,"type":34},"2024-07-22",{"date":499,"type":23},"2024-09-01",{"date":242,"type":23},{"name":40,"class":41},{"id":503,"slug":504,"hasResults":12,"nctId":505,"briefTitle":506,"officialTitle":507,"acronym":4,"eligibilityCriteria":508,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":509,"enrollmentInfo":510,"targetDuration":4,"studyType":24,"phases":512,"briefSummary":513,"conditions":514,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":144},"100550607","restore-imaging-an-oct-ivus-imaging-substudy-of-restore-trial-100550607","NCT06449274","RESTORE Imaging: an OCT-IVUS Imaging Substudy of RESTORE Trial","Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque: an OCT-IVUS Imaging Substudy (RESTORE Imaging)","Inclusion Criteria:\n\n1. Subjects must be between 18 and 80 years of age\n2. Subject must present with acute myocardial infarction or unstable angina planned for PCI\n3. Successful stent implantation (i.e., residual stenosis less than 20%) must be done in culprit lesions and any lesions with ischemia evidence (e.g., QFR equal or less than 0.8)\n4. Subject must have at least one native non-culprit lesion with visually estimated stenosis of 40-80% and QFR \\>0.8\n5. Target lesion must have a visually estimated diameter of 2.0-4.0 mm and length of ≤ 50 mm\n6. Target lesion must have any two of the intravascular imaging criteria of PB \\>65%, MLA \\\u003C3.5 mm\\^2 (OCT) or 4.0mm\\^2 (IVUS), FCT \\\u003C75 μm, or maximal lipid arc \\>180°\n7. Subject must provide written informed consent before any study-related procedure\n\nExclusion Criteria:\n\n1. Subject has known hypersensitivity or contraindication to any of the study drugs (including all asprin, P2Y12 inhibitors, one or more components of the study devices, including paclitaxel, etc) that cannot be adequately pre-medicated\n2. Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.)\n3. Hypotension, shock, or need for mechanical support or intravenous vasopressors;\n4. Creatinine clearance ≤30 ml\u002Fmin\u002F1.73 m\\^2 (as calculated by MDRD formula for estimated GFR)\n5. Left ventricular ejection fraction\\\u003C30% by the most recent imaging test within 30 days before procedure (echo, MRI, contrast left ventriculography or others)\n6. Life expectancy \\\u003C2 years for any\n7. Subject is currently participating in another investigational drug or device clinical study that has not yet completed its primary endpoint\n8. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.\n9. The target lesion is located within 10 mm of the proximal or distal of stent\n10. The target lesion cannot be in the left main coronary artery\n11. The target lesion is located in a bifurcation lesion (i.e., the diameter of the branch vessels is \\>2 mm with \\>50% of stenosis)\n12. The target lesion is located in severe calcification or tortuosity of vessels\n13. The target lesion involved in the ostium of LAD, LCX or RCA (within 3 mm of the ostium)\n14. The target lesion is located within the bypass graft artery","80 Years",{"count":511,"type":23},180,[26],"The objective of this imaging substudy of RESTORE trial is to demonstrate the superiority of drug-coated balloon (DCB) treatment on non-flow limited vulnerable plaque as compared to guideline-directed medical therapy (GDMT) in improving plaque stabilization in patients with acute coronary syndrome.",[515],"Acute Coronary Syndrome (ACS)","2024-07-11",{"date":518,"type":34},"2024-07-15",{"date":520,"type":34},"2024-06-25",{"date":522,"type":23},"2026-06",{"name":40,"class":41},{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":4,"eligibilityCriteria":530,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":531,"targetDuration":4,"studyType":24,"phases":532,"briefSummary":533,"conditions":534,"keywords":537,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":520,"lastUpdatePostDateStruct":539,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":545,"locationsCount":144},"100531200","phase-2-ak104-in-combination-with-ak112-plus-chemotherapysoxxelox-as-first-line-treatment-for-advanced-ggej-cancer-100531200","NCT06196697","AK104 in Combination With AK112 Plus Chemotherapy(SOX\u002FXELOX) as First-line Treatment for Advanced G\u002FGEJ Cancer","A Phase II, Single Arm, Single Center Study of Cadonilimab(AK104) in Combination With Ivonescimab(AK112) Plus Chemotherapy(SOX\u002FXELOX) as First-line Treatment for Advanced Gastric (G) or Gastroesophageal Junction (GEJ) Cancer","Inclusion Criteria:\n\n1. Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent.\n2. Imaging examination confirmed unresectable locally advanced or metastatic gastric cancer (GC) or gastroesophageal binding cancer (GEJC), and histopathologically confirmed adenocarcinoma, with at least one measurable tumor lesion (spiral CT or MR scan ≥10mm, gonorrhea The short diameter of sling is ≥15mm, which meets the RECIST 1.1 standard); the lesion that has received radiotherapy is not selected as the target lesion, unless the radiotherapy lesion is the only measurable lesion and is clearly advanced according to imaging judgment, it can be considered as the target lesion;\n3. Subjects have not received prior systemic therapy for locally advanced or metastatic gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction. For subjects who have received prior neoadjuvant\u002Fadjuvant chemotherapy or chemoradiotherapy for curative intent, the time between disease progression and last treatment should be at least 6 months；\n4. HER2 is negative. HER2 negative is defined as: IHC 0\u002F1+, or IHC 2+ and FISH\u002FISH negative (HER2: CEP17 ratio \\\u003C2). FISH can be replaced by locally available and accepted ISH methods (such as DISH);\n5. The study allowed the inclusion of Subjects with gastric cancer with peritoneal metastasis (imaging results or ascites\u002Fabdominal lavage cytology test positive);\n6. Expected survival period \\> 3 months;\n7. ECOG score: 0-1;\n8. All acute toxic reactions caused by previous anti-tumor treatment or surgery are relieved to level 0-1 (according to NCI CTCAE version 5.0) or to the level specified in the group\u002Fexclusion standard. Except for other toxicicies that researchers such as hair loss, fatigue and hearing damage believe do not pose a safety risk to the subjects;\n9. Have good organ function (subsists are not allowed to receive blood transfusion or growth factor support treatment within 7 days before the first administration):\n\n1\\) Absolute count of neutrophils ≥1.5×109\u002FL; platelets ≥100×109\u002FL; hemoglobulin ≥90g\u002FL or 5.6mmol\u002FL; 2) Total bilirubin ≤ 1.5 times the upper limit of normal value (ULN); ALT and AST ≤2.5×ULN, for liver metastasis subjects, ALT and AST ≤5×ULN; albumin ≥3.0g\u002FdL (30g\u002FL); 3) serum creatinine ≤1.5 ×ULN or calculated serum creatinine clearance ≥50mL\u002Fmin (Cockcroft-Gault formula calculation).\n\n4\\) Normal urine routine, or urine protein \\\u003C2+; if urine protein ≥2+, the 24-hour urine protein quantity must be ≤1g; 5) Normal coagulation function, international standardization ratio (INR) ≤ 1.5×ULN, prothrombin time (PT) and activation partial thrombin time (APTT) ≤ 1.5×ULN; 10. Women of childbearing age must have a negative pregnancy test (βHCG) before starting treatment. Women of childbearing age and men (who have sex with women of childbearing age) must agree to use effective contraceptives continuously during treatment and 6 months after the last therapeutic dose; 11. Subjects signed the informed consent, and able to follow the planned visit, research treatment, laboratory examination and other experimental procedures.\n\nExclusion Criteria:\n\n1. known as squamous carcinoma, undifferentiated cancer or other tissue types of gastric cancer, or adenocarcinoma mixed with other tissue types of gastric cancer;\n2. HER2 positive stomach cancer patients: define IHC 3+, or IHC 2+ and FISH\u002FISH positive;\n3. Previously received immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.), immune checkpoint agonists (such as antibodies to ICOS, CD40, CD137, GITR, OX40 targets, etc.) , immune cell therapy and other treatment of any immune mechanism for tumors;\n4. In the first 14 days of randomization, there is still uncontrollable pleural hydration and ascites after puncture drainage and other treatments. Imaging shows that a small number of or medium chest and ascites patients can be selected for the study;\n5. Subjects have not received prior systemic therapy for locally advanced or metastatic gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction. For subjects who have received prior neoadjuvant\u002Fadjuvant chemotherapy or chemoradiotherapy for curative intent, the time between disease progression and last treatment should be at least 6 months;\n6. There are significant clinical bleeding symptoms or clear bleeding tendencies within 1 month before the first administration, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or vasculitis;\n7. There are clinically active hemoptysis, active diverticulitis, abdominal abscess, and gastrointestinal obstruction;\n8. Any other malignant tumors have been diagnosed within 5 years before entering the study, except for skin basal or squamous cell carcinoma, superficial bladder cancer, cervical insitus, intraductal cancer and thyroid papilloma cancer that can be treated locally and have been cured with clear medical records;\n9. Known active or untreated brain metastases, meningeal metastases, spinal cord compression, or leptomeningeal disease. However, subjects who meet the following requirements and have measurable lesions outside the central nervous system are allowed to enter the group: after treatment, the imaging is stable for at least 4 weeks before the start of the study treatment (if there is no new or expanded brain metastasis), and systemic glucocortic hormone and anticonvulsive drug treatment has been stopped at least 2 weeks;\n10. Interstitial lung disease, non-infectious pneumonia or uncontrollable systemic diseases (such as diabetes, hypertension, pulmonary fibrosis and acute pneumonia, etc.) are known, and a history of active tuberculosis is known;\n11. Subjects with active, known or suspected autoimmune disease. But Subjects who are in a stable state and do not require systematic immunosuppressive treatment are allowed, such as type 1 diabetes, hypothyroidism that only needs hormone replacement therapy, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis or hair loss);\n12. There are clinical symptoms or diseases of the heart that are not well controlled, such as: (1) NYHA level 2 and above cardiac insufficiency or cardiac ultrasound examination: LVEF (left ventricular ejection fraction) \\\u003C50%; (2) severe\u002Funstable angina pectoris; (3) randomized myocardial infarction within 6 months ; (4) Clinically significant supventricular or ventricular arrhythmia requires treatment or intervention; (5) Symptomatic congestive heart failure; (6) QTc\\>480 ms (QTc interval is calculated in the Fridericia formula; if QTc is abnormal, it can be separated by 2 minutes. The clock is detected 3 times in a row and takes its average value);\n13. Received the following treatments or drugs before the first administration:\n\n    1. Excessive surgery within the first 28 days (tissue biopsy required for diagnosis and peripheral vein puncture central venous catheterization \\[PICC\\] \u002F infusion port implantation are allowed);\n    2. Immunosuppressive drugs have been used within the first 14 days, excluding nasal spray and inhalation corticosteroids or systemic steroid hormones at physiological doses (i.e. no more than 10 mg\u002Fd prednisone or other corticosteroids of the same physiological dose of the drug);\n    3. Inoculated with live attenuated vaccine within the first 28 days or within 60 days after the study period and the end of the research drug treatment;\n    4. Receive local anti-tumor treatment within the first 28 days (such as radiotherapy or tumor embolization, etc.);\n    5. Received Chinese herbal medicine or Chinese medicine with anti-tumor indications in the first 2 weeks;\n14. Known allergies or intolerant to test drugs or their excipients; or a known history of severe hypersensitivity reactions to other monoclon antibodies;\n15. Unable to swallow, malabsorption syndrome, or uncontrollable nausea, vomiting, diarrhea or other gastrointestinal diseases that seriously affect drug use and absorption;\n16. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis (hepatitis B, defined as HBV-DNA≥500 IU\u002Fml; hepatitis C, defined as anti-HCV positive and HCV RNA higher than analysis The lower limit of detection of the method) or combined with hepatitis B and hepatitis C;\n17. Subjects who cannot comply with the test plan or cannot cooperate with the follow-up;\n18. Any conditions that, in the investigator's opinion, may put subjects treated with the study drug at risks, or interfere with the evaluation of study drug or subject safety, or the interpretation of results.",{"count":443,"type":23},[53],"The goal of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and anti-tumor activities of cadonilimab in combination with Ivonescimab plus chemotherapy as first-line therapy in adult subjects with HER2 negative、advanced or metastatic gastric (G) or gastroesophageal junction (GEJ) cancer.",[535,536],"Gastric Adenocarcinoma","Gastroesophageal Junction Adenocarcinoma",[538],"first-line treatment",{"date":540,"type":34},"2024-06-27",{"date":542,"type":34},"2024-04-10",{"date":544,"type":23},"2027-03",{"name":40,"class":41},{"id":547,"slug":548,"hasResults":12,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":4,"eligibilityCriteria":508,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":509,"enrollmentInfo":552,"targetDuration":4,"studyType":24,"phases":554,"briefSummary":555,"conditions":556,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":563,"locationsCount":152},"100544178","preventive-drug-coated-balloon-angioplasty-in-vulnerable-atherosclerotic-plaque-restore-trial-100544178","NCT06365502","Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque (RESTORE Trial)","A Multicenter, Prospective, Open-label, Controlled, Randomized Trial of Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque (RESTORE Trial)",{"count":553,"type":23},1860,[26],"The objective of this multicenter, prospective, open-label, controlled, randomized trial is to demonstrate the superiority of drug-coated balloon (DCB) treatment on non-flow limited vulnerable plaque as compared to guideline-directed medical therapy (GDMT) in improving clinical cardiovascular outcomes in patients with acute coronary syndrome.",[515],"2024-05-21",{"date":559,"type":34},"2024-05-22",{"date":561,"type":34},"2024-04-16",{"date":116,"type":23},{"name":40,"class":41},{"id":565,"slug":566,"hasResults":12,"nctId":567,"briefTitle":568,"officialTitle":569,"acronym":4,"eligibilityCriteria":570,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":571,"targetDuration":4,"studyType":24,"phases":573,"briefSummary":574,"conditions":575,"keywords":577,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":581,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":4},"100546020","phase-2-haicadebrelimablenvatinib-for-conversion-treatment-of-potentially-resectable-locally-advanced-biliary-tract-cancer-100546020","NCT06389500","HAIC+Adebrelimab+Lenvatinib for Conversion Treatment of Potentially Resectable, Locally Advanced Biliary Tract Cancer","Hepatic Arterial Infusion Chemotherapy Combined With Adebrelimab and Lenvatinib for Conversion Treatment of Potentially Resectable, Locally Advanced Biliary Tract Cancer: a Single-arm, Exploratory Clinical Study","Inclusion Criteria:\n\n1. Age: 18 to 75 years old, male or female;\n2. Biliary tract malignant tumors confirmed by histology or cytology, with measurable tumor lesions (spiral CT or MR scan ≥10mm, meeting RECIST 1.1 standards);\n3. Borderline resectable, locally advanced biliary malignant tumors, including gallbladder cancer, intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, and distal cholangiocarcinoma;\n4. Clinical stage: gallbladder cancer stage: IIIA-IVB; intrahepatic cholangiocarcinoma stage: IIA-IV; hilar cholangiocarcinoma stage: IIIB-IVB; distal cholangiocarcinoma stage: IIIA-IV;\n5. Expected survival \\> 3 months;\n6. ECOG PS score: 0-1 points;\n7. Liver function classification is Child-Pugh ≤7;\n8. Never received prior systemic treatment for biliary tract tumors;\n9. No peritoneal metastasis or other distant metastasis;\n10. Normal function of major organs;\n11. Women of childbearing age must have a negative pregnancy test (βHCG) before starting treatment, and women of childbearing potential and men (who have sexual active with women of childbearing potential) must agree to effective contraception uninterrupted for the duration of the treatment and for 6 months after the last therapeutic dose;\n12. Patients voluntarily enrolled in the study by signing an informed consent form.\n\nExclusion Criteria:\n\n1. Patients diagnosed with periampullary cancer;\n2. Previous or concurrent other malignant tumours within 5 years, except cervical carcinoma in situ, cutaneous squamous cell carcinoma or basal cell carcinoma of the skin that has been basically controlled;\n3. Those with uncontrolled, symptomatic brain metastases or a history of uncontrollable mental illness or severe intellectual or cognitive dysfunction;\n4. Pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia and severely impaired lung function;\n5. Suffering from active autoimmune diseases, history of autoimmune diseases, such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; Reduced thyroid function after thyroid hormone replacement therapy can be included;\n6. Have a history of immunodeficiency, including testing positive for HIV, suffering from other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation;\n7. Subjects have cardiovascular clinical symptoms or diseases that cannot be well controlled, including but not limited to: 1) NYHA class II or above heart failure; 2) Unstable angina; 3) Myocardial infarction within 1 year; 4) Clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention;\n8. Severe active infection requiring intravenous antibiotic treatment occurs during the screening period;\n9. Those who are allergic to experimental drugs;\n10. Patients who cannot comply with the trial protocol or cannot cooperate with follow-up visits;\n11. Those who the researcher believes are not suitable to participate in this trial.",{"count":572,"type":23},30,[53],"This is a single-arm, exploratory, phase II trial to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy combined with adebrelimab and lenvatinib for borderline resectable, locally advanced biliary tract cancer.",[576],"Biliary Tract Cancer",[376,578,378,579],"Hepatic Arterial Infusion Chemotherapy","Potentially Resectable Biliary Tract Cancer","2024-04-24",{"date":582,"type":34},"2024-04-29",{"date":584,"type":23},"2024-05-01",{"date":586,"type":23},"2028-05-01",{"name":40,"class":41},{"id":589,"slug":590,"hasResults":12,"nctId":591,"briefTitle":592,"officialTitle":593,"acronym":4,"eligibilityCriteria":594,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":595,"targetDuration":4,"studyType":24,"phases":597,"briefSummary":598,"conditions":599,"keywords":601,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":606,"lastUpdatePostDateStruct":607,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":613,"locationsCount":4},"100539492","phase-2-treatment-of-rectal-cancer-with-long-term-concurrent-chemoradiotherapy-combined-with-camrelizumab-100539492","NCT06304545","Treatment of Rectal Cancer With Long-term Concurrent Chemoradiotherapy Combined With Camrelizumab","Long-course Concurrent Chemoradiotherapy Combined With Camrelizumab in the Neoadjuvant Treatment of Locally Advanced\u002FLow Anus-preserving Rectal Cancer: a Phase II Single-arm Study.","Inclusion Criteria:\n\n1. Age: 18 to 75 years old, male or female,\n2. Histologically or cytologically confirmed rectal cancer with measurable tumour lesions (Spiral CT or MR scans ≥ 10 mm, meeting RECIST 1.1 criteria),\n3. Clinical stage: Rectal cancer cT3-4N0M0 or cT1-4N+M0 and low rectal cancer with need for anal preservation (\\\u003C5 cm from anal verge; T2N0M0),\n4. Expected survival \\> 3 months,\n5. ECOG PS score: 0-1,\n6. No peritoneal metastasis or other distant metastasis; Note: the presence of distant metastasis should be confirmed by CT or MR scan. If bone metastasis is suspected, a bone scan should be performed. If peritoneal metastasis is suspected, PET-CT should be performed or laparoscopy should be performed. If brain metastases are suspected, CT or MR should be performed,\n7. No previous radiotherapy or immune checkpoint inhibitor treatment for rectal cancer,\n8. Function of vital organs in accordance with the following requirements (excluding the use of any blood components and cell growth factors during screening):\n\n1)Absolute neutrophil count ≥ 1.5 x 10\\^9\u002FL; platelets ≥ 80 x 10\\^9\u002FL; hemoglobin ≥ 8.5 g\u002FdL, 2)Thyroid-stimulating hormone (TSH) ≤1 times ULN (if abnormal, T3 and T4 levels should be examined at the same time; if T3 and T4 levels are normal, they can be enrolled), 3)Bilirubin ≤1.5 times ULN; ALT and AST ≤2.5 times ULN, 4) Serum creatinine ≤1.5 times ULN, 9. Women of childbearing potential must undergo a negative pregnancy test (βHCG) prior to initiation of treatment, and women of childbearing potential and men who are sexually active with women of childbearing potential must agree to use effective contraception uninterruptedly for the duration of the treatment period and for 6 months after the administration of the last therapeutic dose, 10. Subjects voluntarily enrolled in the study and signed an informed consent form.\n\nExclusion Criteria:\n\n1. Previous pelvic or abdominal radiotherapy,\n2. Tumours that are expected to be unresectable after neoadjuvant therapy,\n3. Pregnant or lactating women, or those of childbearing potential who refuse to use contraception,\n4. History of other malignancies within the past 5 years, except adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or basal cell carcinoma of the skin that has been substantially controlled,\n5. Ineffectively controlled, symptomatic brain metastases or a history of psychosis that cannot be easily controlled or severe intellectual or cognitive dysfunction,\n6. Pulmonary fibrosis, interstitial pneumonitis, pneumoconiosis, radiation pneumonitis, drug-associated pneumonitis and severely impaired lung function,\n7. Subjects with active, known or suspected autoimmune disease, hypothyroidism requiring only hormone replacement therapy, skin disorders that do not require systemic therapy (e.g., vitiligo, psoriasis, or alopecia areata) may be eligible for enrolment,\n8. Congestive heart failure, difficult-to-control cardiac arrhythmia, myocardial infarction within 6 months, unstable angina, stroke or transient is chaemic attack, severe hypertension difficult to control with medication, or other patients who cannot tolerate the procedure,\n9. Severe active infections requiring intravenous antibiotic treatment occurring during the screening period,\n10. Allergy to the test drug,\n11. Have received or will receive a live vaccine within 30 days prior to camrelizumab administration,\n12. Known history of HIV infection or active hepatitis B or C,\n13. Patients who are unable to comply with the trial protocol or are unable to cooperate with follow-up visits,\n14. Those who in the opinion of the investigator are not suitable for participation in this trial.",{"count":596,"type":23},48,[53],"This is a single-arm, phase II clinical study aim to evaluate the efficacy and safety of long-term concurrent chemoradiotherapy combined with camrelizumab as a neoadjuvant therapy in the treatment of locally advanced\u002Flow rectal cancer requiring anus preservation.",[600],"Rectal Cancer",[602,603,604,605],"Camrelizumab","Long-term concurrent chemoradiotherapy","Neoadjuvant treatment","Locally advanced\u002Flow cancer requiring anus preservation","2024-03-10",{"date":608,"type":34},"2024-03-12",{"date":610,"type":23},"2024-03-15",{"date":612,"type":23},"2027-03-15",{"name":40,"class":41},""]