[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"The First Affiliated Hospital of Henan University of Science and Technology\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":160},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,39,64,88,116,137],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100640971","phase-2-exploratory-clinical-study-of-camrelizumab-combined-with-concurrent-chemoradiotherapy-as-an-organ-preserving-strategy-for-locally-advanced-resectable-esophageal-squamous-cell-carcinoma-100640971",false,"NCT07622797","Exploratory Clinical Study of Camrelizumab Combined With Concurrent Chemoradiotherapy as an Organ-preserving Strategy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n* 1\\. Age ≥18 years old; 2. Histologically or cytologically confirmed esophageal squamous cell carcinoma (ESCC); 3. Patients with locally advanced resectable stage II\u002FIII\u002FIVa (cT1b-4aN0-3M0) ESCC; 4. Have not received chemotherapy, radiotherapy, or surgical treatment for esophageal cancer; 6. ECOG performance status: 0-1; 7. Expected survival ≥12 weeks; 8. Within 7 days prior to enrollment, the participant's blood routine and biochemical indicators meet the following criteria:\n\n  1. Hemoglobin ≥90 g\u002FL; absolute neutrophil count (ANC) ≥1.5 × 10\\^9\u002FL; platelets ≥100 × 10\\^9\u002FL (patients must not have received blood transfusion or growth factor support within 14 days before blood sampling);\n  2. ALT and AST ≤2.5 times the upper limit of normal (ULN); ALP ≤2.5 times ULN;\n  3. Total serum bilirubin \\\u003C1.5 times ULN (patients with Gilbert's syndrome may enroll if total bilirubin \\\u003C3 times ULN);\n  4. Serum creatinine \\\u003C1.5 times ULN or estimated glomerular filtration rate ≥60 ml\u002Fmin\u002F1.73 m²;\n  5. Serum albumin ≥30 g\u002FL;\n  6. International normalized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN, unless the patient is on anticoagulant therapy and PT value is within the expected therapeutic range;\n  7. Activated partial thromboplastin time (APTT) ≤1.5 times ULN. 9. Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%).\n\n     10\\. Women of childbearing potential must agree to use contraceptive measures (such as intrauterine device, contraceptive pills, or condoms) during the study and for 6 months after the study; must have a negative serum or urine pregnancy test within 7 days prior to study enrollment, and must not be breastfeeding; men must agree to use contraceptive measures during the study and for 6 months after the study.\n\n     11\\. No severe comorbidities that would result in a life expectancy of less than 5 years.\n\n     12\\. Subjects voluntarily participate in this study, sign the informed consent form, have good compliance, and cooperate with follow-up.\n\n     Exclusion Criteria:\n* 1\\. Individuals allergic to the treatment drugs; 2. History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation); 3. Active or uncontrolled severe infection (≥ CTCAE5.0 grade 2 infection), including but not limited to hospitalization due to infection complications, bacteremia, or severe pneumonia, or unexplained fever \\>38.5°C before the first administration; 4. Individuals with a history of mental drug abuse who cannot quit or have psychiatric disorders; 5. Subjects who have had or currently have other malignancies requiring active treatment within the past 5 years (fully treated cases with an expected 5-year survival \\>90%, such as basal cell or squamous cell skin cancer, cervical carcinoma in situ, or breast carcinoma in situ, are excluded from this restriction); 6. Uncorrectable coagulation disorders; 7. Clinically significant cardiovascular diseases, including but not limited to acute myocardial infarction, severe\u002Funstable angina, or coronary artery bypass surgery within 6 months prior to enrollment; congestive heart failure NYHA class ≥2; ventricular arrhythmias requiring drug treatment (including QTc interval ≥450 ms for men, ≥470 ms for women); left ventricular ejection fraction (LVEF) \\\u003C50%; 8. Severe liver disease (such as cirrhosis), kidney disease, respiratory system disease, uncontrolled diabetes, or other types of systemic diseases; 9. Patients whose imaging shows the tumor has invaded major blood vessels, or for whom the investigator judges that the tumor is highly likely to invade major blood vessels during the study period and cause fatal bleeding; 10. Presence of active autoimmune disease or immunodeficiency, or the following history, including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, hypophysitis, vasculitis, nephritis, etc. The following exceptions apply: patients with a history of autoimmune hypothyroidism who are receiving thyroid hormone replacement therapy may be enrolled. Patients with type 1 diabetes whose blood glucose is controlled after insulin therapy may participate in this study.\n\n  11\\. Patients who are using immunosuppressive agents or systemic corticosteroid therapy for immunosuppression purposes (dose \\>10 mg\u002Fday of prednisone or other equivalent steroids, and continued use within 2 weeks prior to enrollment); 14. Underwent surgery within 28 days before enrollment in this study (excluding biopsy) or whose surgical incision has not fully healed; 15. Received any other investigational drug treatment or participated in other interventional studies within 4 weeks prior to signing the informed consent; 16. Pregnant women (positive pregnancy test before taking the drug) or women who are breastfeeding; 17. Patients deemed unsuitable for enrollment based on the investigator's judgment.","ALL","18 Years",{"count":18,"type":19},164,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","This study is a prospective, exploratory clinical study aimed at evaluating the feasibility and safety of camrelizumab combined with synchronous chemoradiotherapy as an organ-preserving strategy for locally advanced resectable esophageal squamous cell carcinoma.\n\nThe study targets patients with locally advanced resectable stage II\u002FIII\u002FIVa (cT1b-4aN0-3M0) ESCC. A total of 164 subjects are expected to be enrolled.\n\nThe study is a randomized, non-controlled, open-label trial. Subjects meeting the inclusion criteria will be randomly assigned in a 1:1 ratio to receive either camrelizumab combined with radiotherapy, albumin-bound paclitaxel, and carboplatin treatment (Cohort 1) or camrelizumab combined with radiotherapy and capecitabine treatment (Cohort 2).\n\nThe screening period for the study is 28 days. After completing screening examinations and assessments, eligible subjects will be randomly assigned to the following treatment regimens.\n\nCohort 1:\n\n* Camrelizumab: 200 mg on Day 1, every 3 weeks\n* Radiotherapy: 50-50.4 Gy \u002F 25-28 fractions, Days 1-5, once a week\n* Albumin-bound paclitaxel: IV infusion, 60-80 mg\u002Fm², Day 1, weekly\n* Carboplatin: IV infusion, AUC=1-1.5, Day 1, weekly\n\nEach cycle lasts 3 weeks, with 2-4 cycles of medication.\n\nEfficacy evaluation (imaging and endoscopic examination) will be conducted within 6 weeks after the completion of treatment. If the efficacy evaluation indicates cCR, subjects will enter Group A1 and receive camrelizumab maintenance therapy (maximum 1 year). If the efficacy evaluation does not reach cCR, after consultation between the investigator and the subject, they will enter Group B1 to undergo radical surgery, followed by camrelizumab monotherapy maintenance treatment (maximum 1 year).\n\nCohort 2:\n\nCamrelizumab: ivgtt, 200 mg, D1, Q3W Radiotherapy: 50-50.4 Gy \u002F 25-28 fractions, D1-D5, QW Capecitabine: p.o. 625 mg\u002Fm², BID, D1-D14, Q3W; One cycle lasts 3 weeks, with 2-4 cycles of medication. Efficacy evaluation (imaging and endoscopy) will be conducted within 6 weeks after treatment completion. If the efficacy is assessed as cCR, the patient will enter Group A2: receive camrelizumab maintenance therapy (up to 1 year); if efficacy is not cCR, the patient will enter Group B2: undergo radical surgery, followed by camrelizumab monotherapy maintenance (up to 1 year).\n\nThis study will follow up subjects for disease recurrence and disease-free survival for at least 2 years. After all subjects complete the treatment\u002Ftermination visit, efficacy will be evaluated.",[25],"Late-stage Resectable Esophageal Squamous Carcinoma","RECRUITING","2026-06-02",{"date":29,"type":30},"2026-06-03","ACTUAL",{"date":32,"type":30},"2025-11-21",{"date":34,"type":19},"2030-12-31",{"name":36,"class":37},"The First Affiliated Hospital of Henan University of Science and Technology","OTHER",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":46,"enrollmentInfo":47,"targetDuration":4,"studyType":20,"phases":49,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":4},"100633947","phase-2-efficacy-and-safety-of-ql1706-combined-with-nab-paclitaxel-and-cisplatin-as-1st-line-therapy-for-advanced-or-metastatic-esophageal-squamous-cell-carcinoma-100633947","NCT07533305","Efficacy and Safety of QL1706 Combined With Nab-paclitaxel and Cisplatin as 1st Line Therapy for Advanced or Metastatic Esophageal Squamous Cell Carcinoma","A Single-arm Clinical Study of QL1706 (Anti PD-1 and CTLA-4 Antibody) in Combination With Nab-paclitaxel and Cisplatin as First-line Therapy in Patients With Advanced or Metastatic Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Subjects participate voluntarily and sign informed consent.\n* 18-75 years, male or female.\n* Histologically confirmed Unresectable Advanced or metastatic Esophageal Squamous Cell Carcinomas\n* No previous systemic anti-tumor treatment for unresectable locally advanced or metastatic esophageal squamous cell carcinoma has been received\n* At least 1 measurable target lesion and\u002For unmeasurable target lesion according to Response Evaluation in Solid Tumors (RECIST 1.1).\n* ECOG PS 0-1\n* Expected survival ≥ 12 weeks\n* Adequate organ function (without blood transfusion or growth factors within 14 days prior to first dose), including: ANC ≥ 1.5 × 10⁹\u002FL; Platelets ≥ 100 × 10⁹\u002FL; Hemoglobin ≥ 90 g\u002FL; Serum albumin ≥ 30 g\u002FL; Total bilirubin ≤ 1.5 × ULN; ALT\u002FAST ≤ 2.5 × ULN (≤ 5 × ULN if with liver or bone metastases); ALP ≤ 2.5 × ULN; Serum creatinine ≤ 1.5 × ULN; INR ≤ 1.5 (if not on anticoagulation);\n* Non-sterilized women of childbearing potential and male participants with such partners must agree to use medically approved contraception during and for 3 months after study drug administration. Women must test negative for serum or urine HCG within 7 days prior to first dose and not be breastfeeding\n\nExclusion Criteria:\n\n* Have received anti-PD-1 or anti-PD-L1 antibody therapy;\n* BMI \\\u003C 18.5 kg\u002Fm2 or weight loss ≥ 10% within 2 months before screening (at the same time, the effect of a large amount of pleural effusions and ascites on bogy weight should be considered);\n* Presence of any active autoimmune disease or history of autoimmune disease (such as: Autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, nephritis, hyperthyroidism)\n* Those who are taking immunosuppressants or systemic hormonal therapy for immunosuppressive purposes (dose\\> 10 mg\u002Fday prednisone or other equivalent cortiremonial hormones)\n* Severe allergic reaction to other monoclonal antibodies\n* Known history or evidence of interstitial lung disease or active non-infectious pneumonia\n* Known central nervous system metastases\n* History of other malignancies within the past 5 years or concurrent malignancies (except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix).\n* Uncontrolled cardiac clinical symptoms or diseases, such as: (1) NYHA class II or higher heart failure (2) unstable angina (3) myocardial infarction within the past year (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention (5) QTc \\> 450 ms (male); QTc \\> 470 ms (female)\n* Tumor invasion of major blood vessels, or based on imaging, the investigator determines a high likelihood of tumor invasion of major blood vessels during the study period, which may lead to fatal bleeding, such as imaging evidence of \\>90-degree encasement of major vessels or tumor cavitation\n* Patients with pleural effusion, ascites, or pericardial effusion requiring drainage; if the symptoms are stable after drainage as assessed by the investigator, enrollment is possible. Gastrointestinal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to the start of study treatment.\n* Major surgical procedures within 4 weeks prior to the start of study treatment (diagnostic procedures excluded) or anticipated need for major surgery during the study period.\n* Active infection, unexplained fever ≥38.5°C within 7 days prior to drug administration, or baseline white blood cell count \\>15×109\u002FL.\n* Congenital or acquired immunodeficiency (e.g., HIV infection); hepatitis B surface antigen (HBsAg) positive with hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥2000 IU\u002Fml, or positive for hepatitis C virus antibody.\n* Live vaccine administration within 4 weeks prior to study drug administration or during the study period.\n* As judged by the investigator, other factors that may affect study outcomes or lead to premature termination of the study, such as alcoholism, drug abuse, other serious diseases (including psychiatric disorders) requiring concurrent treatment, significant laboratory abnormalities, or family or social factors that may impact patient safety.","75 Years",{"count":48,"type":19},50,[22],"The purpose of this study is to assess the efficacy and safety of QL1706 combined with nab-paclitaxel and cisplatin in first-line therapy for patients with advanced or metastatic esophageal squamous cell carcinoma. QL1706 is a anti-PD-1 and anti-CTLA4 antibody.",[52,53,54],"QL1706","ESCC","First-line Therapy","NOT_YET_RECRUITING","2026-04-14",{"date":58,"type":30},"2026-04-16",{"date":60,"type":19},"2026-05-01",{"date":62,"type":19},"2029-06-30",{"name":36,"class":37},{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":20,"phases":75,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":38},"100619627","early-phase-1-a-single-center-open-label-single-ascending-dose-study-of-exenatide-circular-rna-lipid-nanoparticle-injection-cr059-in-chinese-subjects-with-type-2-diabetes-mellitus-100619627","NCT07347080","A Single-Center, Open-Label, Single Ascending Dose Study of Exenatide Circular RNA-Lipid Nanoparticle Injection (CR059) in Chinese Subjects With Type 2 Diabetes Mellitus","A Single-Center, Open-Label, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Exenatide Circular RNA-Lipid Nanoparticle Injection (CR059) in Chinese Subjects With Type 2 Diabetes Mellitus","CR059101","Inclusion Criteria:\n\n* Chinese male or female， 18≤age≤-65 years .\n* Diagnosed with T2DM for at least 3 months but less than 5 years, according to the Chinese Diabetes Society's \"Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2024 Edition)\" diagnostic criteria.\n* Patients who have failed treatment with diet and exercise alone, or metformin monotherapy, or a stable regimen for 12 weeks of metformin (dose ≥1500 mg\u002Fday or maximum tolerated dose ≥1000 mg\u002Fday) combined with one of the following oral antidiabetic drugs (or their fixed-dose combinations): sulfonylureas, glinides, alpha-glucosidase inhibitors, SGLT2 inhibitors, or thiazolidinediones (at ≥1\u002F2 the maximum approved dose, or the recommended minimum maintenance dose for SGLT2 inhibitors e.g., empagliflozin 10mg, canagliflozin 100mg). Fasting Plasma Glucose (FPG) must be \\\u003C13.0 mmol\u002FL, and 7.5%≤HbA1c ≤ 10.0%.\n* 18.5 kg\u002Fm²≤Body Mass Index (BMI) ≤40.0 kg\u002Fm² at screening and enrollment\n* Subjects have no pregnancy plan from screening until 3 months after the last dose and are willing to use at least one effective method of contraception during the entire trial period until 3 months after the last dose.\n* Able to understand and willing to sign the informed consent form, and fully understand the trial content, procedures, and potential adverse reactions.\n* Able to complete the trial according to the protocol requirements.\n\nExclusion Criteria:\n\n* Diagnosis of type 1 diabetes, diabetes due to pancreatic injury, or specific types of diabetes due to other diseases (e.g., acromegaly or Cushing's syndrome).\n* History of acute diabetic complications, such as ketoacidosis or hyperosmolar coma, within 6 months before screening.\n* Presence of severe chronic diabetic complications (e.g., proliferative diabetic retinopathy, severe diabetic neuropathy, diabetic foot, etc.) within 6 months before screening, deemed by the investigator as unsuitable for participation.\n* Allergic constitution (allergy to ≥2 types of drugs or foods) or keloid tendency, or clear history of drug allergy, or investigator suspects potential allergy to the investigational product or its components or similar drugs.\n* Fasting plasma glucose \\\u003C3.9 mmol\u002FL at screening or before enrollment, and\u002For history of ≥2 episodes of severe hypoglycemia or recurrent symptomatic hypoglycemia within 6 months before screening.\n* History or presence of Cushing's syndrome, polycystic ovary syndrome, or other hereditary endocrine diseases, or obesity secondary to factors such as hormones.\n* Use of weight-control medications or weight-loss surgery within 3 months before screening, or weight fluctuation exceeding 5% within 3 months.\n* Clinically significant abnormal TSH, FT3, or FT4 at screening, or previous diagnosis of thyroid dysfunction, deemed unsuitable by the investigator.\n* Personal or family history of multiple endocrine neoplasia type 2; personal or family history of medullary thyroid carcinoma; or thyroid nodules classified as C-TIRADS category 4 or higher on ultrasound.\n* History or presence of malignant tumors (except cured basal cell carcinoma or cervical carcinoma in situ).\n* History of thrombotic diseases (e.g., deep vein thrombosis, pulmonary embolism, stroke), known bleeding diathesis or coagulation dysfunction, major thrombotic event within 6 months, or any coagulation parameter ≥1.5x ULN, or clinically significant abnormal coagulation function deemed unsuitable by the investigator.\n* Long-term use (over 1 month) or current use of anticoagulants (e.g., warfarin, rivaroxaban, dabigatran) or antiplatelet drugs (e.g., aspirin, clopidogrel) before screening.\n* Diagnosis of significant cardiovascular or cerebrovascular disease within 6 months before screening, including but not limited to acute stroke, transient ischemic attack (TIA), acute coronary syndrome, coronary heart disease, heart failure, arrhythmia requiring treatment, etc.\n* History of gout or gout attack within 6 months before screening or before enrollment.\n* Untreated or poorly controlled hypertension (systolic BP \\>160 mmHg and\u002For diastolic BP \\>100 mmHg) at screening or before enrollment. Patients on antihypertensive therapy must have a stable regimen and dose for 1 month. If BP criteria are not met at screening\u002Fenrollment, one re-test is allowed. Exclusion if both readings fail.\n* Heart rate at rest (after at least 10 min) \\\u003C50 bpm or \\>100 bpm at screening or before enrollment. One re-test is allowed. Exclusion if both readings fail.\n* PR interval \\>210 ms and\u002For QRS complex duration \\>120 ms, and\u002For QTcF \\>450 ms at rest at screening or before enrollment. If criteria not met, repeat ECG twice on the same day; use the average of 3 measurements for judgment.\n* History of clinically significant chronic or acute exacerbating respiratory diseases, including but not limited to asthma, COPD (excluding obstructive sleep apnea).\n* History of severe gastrointestinal disease (e.g., active ulcer, gastroparesis, pyloric obstruction, inflammatory bowel disease) within 6 months before screening or before enrollment, or gastrointestinal surgery, or long-term use of drugs directly affecting GI motility due to chronic GI disease, deemed unsuitable by the investigator.\n* Severe renal disease or estimated Glomerular Filtration Rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73m² (CKD-EPI formula) at screening or before enrollment.\n* Serum amylase or lipase \\>3x Upper Limit of Normal (ULN) at screening or before enrollment, or history\u002Fknown chronic pancreatitis, acute pancreatitis, pancreatic injury.\n* History of cholelithiasis, acute or chronic cholecystitis (except those with no residual biliary stones post-treatment or post-cholecystectomy without sequelae, deemed eligible by the investigator).\n* Severe dyslipidemia, with LDL-C ≥4.40 mmol\u002FL or triglycerides (TG) ≥5.65 mmol\u002FL at screening or before enrollment. If on lipid-lowering therapy, regimen and dose must be stable for 1 month.\n* Clear history of psychiatric disorders (e.g., depression, schizophrenia, bipolar disorder) within 2 years before screening.\n* Major surgery within 1 month before screening, or presence of severe infection or active inflammation.\n* History of blood donation \\>400 mL, transfusion, or blood loss within 90 days before screening or before enrollment.\n* Any of the following laboratory abnormalities at screening or before enrollment: 1. ALT or AST \\>2x ULN; 2. Total Bilirubin \\>1.5x ULN; 3. Calcitonin ≥35 pg\u002FmL; 4. Hemoglobin \\\u003C110 g\u002FL (female) or \\\u003C120 g\u002FL (male); 5. Clinically significant abnormal platelet count; 6. Clinically significant abnormal white blood cell or neutrophil count;\n* Use of any approved or unapproved weight-affecting drugs or products within 3 months before screening, including but not limited to orlistat, phentermine-topiramate, naltrexone-bupropion, systemic corticosteroids, antidepressants (SSRIs, SNRIs, tricyclics, tetracyclics), antipsychotics\u002Fsedatives (e.g., imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid, lithium), etc.\n* Use of any DPP-4 inhibitor, or GLP-1, GIP, GCG receptor agonists, or FGF-21 within 6 months before screening.\n* History of bariatric surgery (except liposuction\u002Fabdominoplasty \\>1 year prior).\n* Participation in any drug or medical device clinical trial within 3 months before screening or before enrollment (except screen failures).\n* Positive serology for HBsAg, anti-HCV antibody, anti-TP antibody, or anti-HIV antibody at screening.\n* History of drug abuse and\u002For alcoholism (weekly alcohol intake \\>14 units) within 6 months before screening\n* Positive urine drug screen or alcohol breath test at screening.\n* Pregnant or lactating females, or subjects using oral contraceptives.\n* Intolerance to venipuncture or history of needle syncope, blood-injury syncope.\n* Any other physiological, psychological, or situational condition deemed by the investigator as unsuitable for trial participation.","65 Years",{"count":74,"type":19},9,[76],"EARLY_PHASE1","Primary Objectives:\n\n•To evaluate the safety and tolerability of a single dose of Exenatide Circular RNA-Lipid Nanoparticle Injection（CR059）in Chinese subjects with T2DM.\n\nSecondary Objectives:\n\n* To characterize the pharmacokinetic (PK) profile of a single dose of Exenatide Circular RNA-Lipid Nanoparticle Injection（CR059） in Chinese subjects with T2DM;\n* To characterize the pharmacodynamic (PD) profile of a single dose of Exenatide Circular RNA-Lipid Nanoparticle Injection（ CR059） in Chinese subjects with T2DM;\n* To evaluate the immunogenicity of a single dose of Exenatide Circular RNA-Lipid Nanoparticle Injection（ CR059） in Chinese subjects with T2DM;\n\nParticipants :\n\nDiagnosed with T2DM for at least 3 months but less than 5 years, according to the Chinese Diabetes Society's diagnostic criteria",[79],"T2DM","2026-03-31",{"date":82,"type":30},"2026-04-06",{"date":84,"type":30},"2026-01-20",{"date":86,"type":19},"2026-08-31",{"name":36,"class":37},{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":46,"enrollmentInfo":96,"targetDuration":4,"studyType":20,"phases":98,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},"100283653","chemoradiation-versus-esophagectomy-for-locally-advanced-esophageal-cancer-100283653","NCT02972372","Chemoradiation Versus Esophagectomy for Locally Advanced Esophageal Cancer","A Randomized, Open-label, Multicenter Trial of the Chemoradiation Versus Standard Esophagectomy for Locally Advanced Resectable Esophageal Squamous Cell Cancer in Chinese Patients","CELAEC","Inclusion Criteria:\n\n* Chinese\n* esophageal squamous cell cancer\n* mid or lower esophageal cancer\n* tumor is resectable disease\n* clinical stage: cT1bN+Mo, or cT2-4aN0-2M0\n\nExclusion Criteria:\n\n* who had distant metastasis to solid visceral organs or local invasion into trachea, descending aorta, or recurrent laryngeal nerve.\n* who had a serious premorbid condition or a poor physical status that compromised a thoracotomy.",{"count":97,"type":19},196,[99],"NA","The aim of this study is to compare outcomes in Chinese patients with locally advanced resectable esophageal squamous cell cancer who have received either surgery or definitive chemoradiation (CRT) by the randomized, open-label, multicenter trial.",[102],"Esophagus Cancer",[104,105,106],"esophageal cancer","chemoradiation","esophagectomy","2025-02-06",{"date":109,"type":30},"2025-02-10",{"date":111,"type":30},"2016-11",{"date":113,"type":19},"2027-12",{"name":36,"class":37},2,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":46,"enrollmentInfo":123,"targetDuration":4,"studyType":20,"phases":125,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":38},"100551786","phase-2-adebrelimab-in-combination-with-apatinib-and-chemotherapychemoradiotherapy-in-immuno-experienced-second-line-escc-100551786","NCT06464614","Adebrelimab in Combination With Apatinib and Chemotherapy\u002FChemoradiotherapy in Immuno-experienced Second-line ESCC.","A Double-arm, Non-randomized Controlled, Open-label Clinical Study of Adebrelimab in Combination With Apatinib and Chemotherapy\u002FChemoradiotherapy in Immuno-experienced Second-line Esophageal Squamous Cell Carcinoma.","Inclusion Criteria:\n\n* 1\\. Age 18-75 years old, male or female; 2. Esophageal squamous cell carcinoma confirmed by histology or cytology; 3. Patients who have progressed or are intolerant to first-line chemotherapy combined with immunotherapy (chemotherapy regimen can include platinum, purple shirt or fluorouracil as the basis, etc.) (progression of maintenance therapy after first-line chemotherapy combined with immunization can also be included).\n\n  4\\. Cohort A: Subjects who have at least one of the following two conditions will be treated with adebelimab combined with apatinib mesylate and chemoradiotherapy;\n  1. Symptomatic dysphagia, Mellow score ≥1 (Mellow score: 0 = able to eat all solid foods, 1 = only partially solid foods, 2 = able to eat soft foods, 3 = only able to drink liquids, 4 = complete dysphagia);\n  2. Hypometastatic disease: Oligometastatic disease is considered when there are ≤ 3 metastases in the liver, lungs, retroperitoneal lymph nodes, adrenal glands, soft tissues, bones, or brain. In addition, after receiving a median of 18 weeks of systemic therapy, metastatic lesions are considered to be oligometastatic lesions at the time of restaging if they do not progress or only progress in size. If the number of lesions increases when restaged after systemic therapy, it is not considered oligometastatic disease.\n\n     Cohort B: If the subjects do not have the above conditions, they will be treated with adebelimab in combination with apatinib mesylate and chemotherapy; 5. Have at least one measurable lesion according to the Efficacy Evaluation Criteria in Solid Tumors (RECIST 1.1); 6.ECOG：0～1； 7. Expected survival≥12 weeks; 8. The blood routine and biochemical indexes of the subjects within 7 days before enrollment meet the following criteria:\n\n     a. Hemoglobin ≥90g\u002FL, absolute neutrophil count (ANC) ≥ 1.5×109\u002FL, platelet ≥ 100×109\u002FL (patients must not have received blood transfusion or growth factor support within 14 days of blood sample collection); b. ALT, AST ≤ 2.5 times the upper limit of normal (ULN); ALP ≤ 2.5 times ULN; c. Serum total bilirubin \\\u003C 1.5 times ULN (patients with Gilbert syndrome can be enrolled if total bilirubin \\\u003C 3 times ULN); d. Serum creatinine \\\u003C 1.5 times ULN or estimated glomerular filtration rate ≥60ml\u002Fmin\u002F1.73m2; e. Serum albumin≥30g\u002FL; International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN, unless the patient is receiving anticoagulant therapy and the PT value is within the range of anticoagulant intended treatment; Activated partial thromboplastin time (APTT) ≤ 1.5 times ULN. 9. Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ low limit of normal (50%).\n\n  10\\. Females of childbearing potential should agree to use contraception (such as intrauterine device, contraceptive pills or condoms) during the study and for 6 months after the end of the study, have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be non-lactating patients, and males should agree to use contraception during the study and for 6 months after the end of the study period; 11. No serious concomitant disease that makes the survival time \\\u003C 5 years; 12. Subjects voluntarily joined this study, signed the informed consent form, had good compliance, and cooperated with follow-up.\n\nExclusion Criteria:\n\n* 1\\. Patients have any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; asthma that has been completely relieved in childhood and does not require any intervention in adulthood can be included; asthma patients requiring medical intervention with bronchodilators cannot be included); 2. The patient is using immunosuppressants, or systemic hormone therapy to achieve the goal of immunosuppression (dose\\> 10mg\u002Fday prednisone or other effective hormones), and continues to use it within 2 weeks before enrollment; 3. Patients with esophageal squamous cell carcinoma whose primary lesion is active hemorrhage; 4. Those with a variety of factors that affect oral medication (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); 5. Patients with brain metastases with symptoms or symptomatic control time of less than 3 months; 6. Patients with any severe\u002Funcontrolled disease, including: patients with unsatisfactory blood pressure control (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100 mmHg); Patients with grade I or grade myocardial ischemia or myocardial infarction, arrhythmias (including QT interval ≥480ms) and grade I cardiac insufficiency, active or uncontrolled serious infections, liver disease such as decompensated liver disease, active hepatitis B (HBV-DNA≥ 104 copies\u002Fml or 2000IU\u002F ml) or hepatitis C (positive for hepatitis C antibody and HCV-RNA above the lower limit of detection of the analytical method), urinalysis shows urine protein ≥++, and 24-hour urine protein quantification \\>1.0g; 7. Long-term unhealed wounds or fractures; 8. Pulmonary hemorrhage with NCI CTCAE grade \\>1 within 4 weeks prior to enrollment; bleeding from other sites with NCI CTCAE grade \\>2 within 4 weeks prior to enrollment; patients with bleeding tendencies (such as active peptic ulcers) or patients who are receiving thrombolytic or anticoagulant therapy such as warfarin, heparin, or their analogues; 9. Patients who have had arterior\u002Fvenous thrombotic events within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism; 10. Patients whose imaging shows that the tumor has invaded important blood vessels or who are judged by the investigator to have a high probability of invading important blood vessels during the follow-up study period, causing fatal hemorrhage; 11. Pregnant or lactating women; 12. Patients with other malignant tumors within 5 years (except for basal cell carcinoma of the skin and carcinoma in situ of the cervix that have been cured); 13. Patients with a history of psychotropic drug abuse who cannot be abstained from or patients with mental disorders; 14. Patients who have participated in clinical trials of other drugs within four weeks; 15. According to the judgment of the investigator, patients with concomitant diseases that seriously endanger the safety of patients or affect the completion of the study; 16. Those who, in the opinion of the investigator, are not suitable for inclusion.",{"count":124,"type":19},54,[22],"To assess the efficacy and safety of adebrelimab in combination with apatinib mesylate and chemoradiotherapy in immuno-experienced second-line esophageal squamous cell carcinoma (with symptomatic dysphagia or oligometastatic disease)，and to evaluate the efficacy and safety of adebrelimab in combination with apatinib mesylate and chemoradiotherapy in immuno-experienced second-line esophageal squamous cell carcinoma (without symptomatic dysphagia or oligometastatic disease).",[128],"Esophageal Cancer","2024-06-13",{"date":131,"type":30},"2024-06-18",{"date":133,"type":19},"2024-07-15",{"date":135,"type":19},"2026-08-01",{"name":36,"class":37},{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":144,"enrollmentInfo":145,"targetDuration":4,"studyType":20,"phases":147,"briefSummary":149,"conditions":150,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":4},"100548280","phase-3-clinical-study-on-the-effect-of-removal-of-porphyromonas-gingivalis-on-prognosis-of-esophageal-cancer-after-radical-surgery-100548280","NCT06418945","Clinical Study on the Effect of Removal of Porphyromonas Gingivalis on Prognosis of Esophageal Cancer After Radical Surgery","Porphyromonas Gingivalis Elimination From Oral Improves Esophageal Cancer Patients Survival After Radical Operation","Inclusion Criteria:\n\n1. Age 18-85 years old\n2. Histologically confirmed esophageal cancer\n3. Patients undergoing radical resection for esophageal cancer who do not require or are not eligible for radiotherapy，T1-T4N0-3M0\n4. ECOG：0～1\n5. Expected survival ≥12 weeks\n6. Radical surgery was performed within 28 days and met R0 criteria\n7. The patient did not receive neoadjuvant radiotherapy\u002Fneoadjuvant concurrent chemoradiotherapy before surgery and no longer received adjuvant radiotherapy\u002Fadjuvant chemoradiotherapy\n8. If the major organs function normally, the following criteria are met: HB≥90g\u002FL；b.ANC≥1.5×109\u002FL；c.PLT ≥80×109\u002FL；ALB≥30g\u002FL；b.ALT和AST≤2.5ULN\n9. Women of reproductive age should agree to use contraceptives (such as Iuds, contraceptives, or condoms) during the study period and for 6 months after the study ends; Have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be a non-lactating patient; Men should consent to patients who must use contraception during the study period and for 6 months after the end of the study period\n10. The subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up\n\nExclusion Criteria:\n\n1. Does not meet the above inclusion criteria\n2. Patients with distant visceral metastases\n3. Patients requiring adjuvant radiotherapy after neoadjuvant radiotherapy or radical surgery\n4. Allergic to tinidazole or metabolic disorder\n5. Patients in need of warfarin anticoagulation and those unable to abstain from alcohol\n6. Patients who do not tolerate ultrasonic dental cleaning\n7. Pregnant or lactating women\n8. Patients with other malignancies within 5 years (except cured basal cell carcinoma of the skin and cervical carcinoma in situ)\n9. Patients with a history of psychotropic substance abuse who are unable to abstain or have mental disorders\n10. Patients who have participated in clinical trials of other drugs within four weeks\n11. Patients with concomitant diseases that, in the investigator's judgment, seriously endanger patient safety or interfere with the patient's completion of the study\n12. Patients with recurrent mouth ulcers or other oral diseases that affect the oral flora\n13. Patients with chronic infectious diseases or autoimmune diseases requiring prolonged or repeated use of antimicrobials or glucocorticoids\n14. The researchers did not consider it suitable for inclusion","85 Years",{"count":146,"type":19},500,[148],"PHASE3","Esophagectomy is an important means of radical treatment of esophageal cancer, but due to local recurrence and metastasis, the 5-year survival rate of patients with esophageal cancer is only 20-30%. Studies have reported that about 50% of patients relapse within 1 year after surgery, and the short-term recurrence rate is high. Therefore, reducing the recurrence rate of esophageal cancer after operation is an important way to improve its prognosis. Porphyromonas gingivalis infection in ESCC tissues was significantly higher than that in paracancer tissues, and was significantly positively correlated with cancer cell differentiation, lymph node metastasis, TNM stage, and shortened survival of ESCC patients. In summary, porphyromonas gingivalis plays an important role in postoperative recurrence of esophageal cancer. Elimination of porphyromonas gingivalis can significantly reduce the recurrence rate of esophageal cancer after operation. Tinidazole is a class of nitroimidazole drugs. It has been pointed out that the pharmacological mechanism of Tinidazole is to inhibit the DNA synthesis of pathogenic bacteria, so as to eliminate bacteria in periodontal tissues and inhibit local inflammation. Based on this, we designed and fabricated a novel oral microneedle patch loaded with tinidazole. Tinidazole oral microneedle patch can effectively remove porphyromonas gingivalis and promote the repair of gingival tissue. In this study, based on the combination of mechanical removal and antibacterial treatment, a combination of ultrasonic dental cleaning and tinidazole oral composite microneedle patch was designed to completely remove porphyromonas gingivalis in oral cavity, and to evaluate the effect of removal of porphyromonas gingivalis in oral cavity on the prognosis of esophageal cancer after radical surgery.",[151],"Evaluate the DFS of Patients With Esophageal Cancer Who Underwent Radical Operation After Regular Removal of Porphyromonas Gingivalis","2024-05-13",{"date":154,"type":30},"2024-05-17",{"date":156,"type":19},"2024-08-01",{"date":158,"type":19},"2027-12-31",{"name":36,"class":37},""]