[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614273":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":41,"locations":50,"responsibleParty":79,"collaborators":81,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":11,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":106,"whyStopped":11,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"The First Affiliated Hospital with Nanjing Medical University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Nimotuzumab+ AG","EXPERIMENTAL",null,[13,14],"Drug: Nimotuzumab","Drug: AG regimen",{"label":16,"type":17,"description":11,"interventionNames":18},"Placebo+ AG","PLACEBO_COMPARATOR",[14,19],"Drug: Placebo",[21,26,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":11},"DRUG","Nimotuzumab","Patients will receive 3 cycles of neoadjuvant treatment with Nimotuzumab (400 mg on days 1, 8, and 15 of a 21-day cycle), followed by surgery and 5 cycles of adjuvant Nimotuzumab (400 mg on days 1, 8, and 15 of a 21-day cycle).",[9],{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":11},"AG regimen","Patients will receive 3 cycles of AG (gemcitabine 1000 mg\u002Fm\\^2 and nab-paclitaxel 125 mg\u002Fm\\^2 on days 1 and 8 of a 21-day cycle), followed by surgery and 5 cycles of adjuvant AG (gemcitabine 1000 mg\u002Fm\\^2 and nab-paclitaxel 125 mg\u002Fm\\^2 on days 1 and 8 of a 21-day cycle).",[9,16],{"type":22,"name":31,"description":32,"armGroupLabels":33,"otherNames":11},"Placebo","Patients will receive 3 cycles of neoadjuvant treatment with placebo (400 mg on days 1, 8, and 15 of a 21-day cycle), followed by surgery and 5 cycles of adjuvant therapy (placebo 400 mg on days 1, 8, and 15 of a 21-day cycle).",[16],[35,38],{"name":36,"affiliation":5,"role":37},"Kuirong Jiang, MD","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":40,"role":37},"Chunyi Hao","Peking University Cancer Hospital & Institute",[42,46],{"name":36,"role":43,"phone":44,"phoneExt":11,"email":45},"CONTACT","+8615312995688","jiangkuirong@njmu.edu.cn",{"name":47,"role":43,"phone":48,"phoneExt":11,"email":49},"Chunyi Hao, MD","13911501185","haochunyi@bjmu.edu.cn",[51,67],{"facility":52,"status":11,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Kuirong Jiang","Nanjing","Jiangsu","210029","China","CN",{"type":59,"coordinates":60},"Point",[61,62],118.77778,32.06167,{"lat":62,"lon":61},[65],{"name":66,"role":43,"phone":11,"phoneExt":11,"email":11},"Min Tu, MD",{"facility":39,"status":11,"city":68,"state":11,"zip":69,"country":56,"countryCode":57,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Beijing","100000",{"type":59,"coordinates":71},[72,73],116.39723,39.9075,{"lat":73,"lon":72},[76,77],{"name":47,"role":43,"phone":11,"phoneExt":11,"email":11},{"name":78,"role":43,"phone":11,"phoneExt":11,"email":11},"Jianhui Wu, MD",{"type":80,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[82],{"name":40,"class":6},"100614273","phase-2-nimotuzumab-combined-with-nab-paclitaxelgemcitabine-in-the-perioperative-treatment-of-high-risk-resectableborderline-resectable-pancreatic-cancer-100614273",false,"NCT07277452","Nimotuzumab Combined With Nab-paclitaxel\u002FGemcitabine in the Perioperative Treatment of High-risk Resectable\u002FBorderline Resectable Pancreatic Cancer","Randomized Double-blind, Placebo-controlled, Multicenter Clinical Study of Nimotuzumab Combined With Nab-paclitaxel\u002FGemcitabine in the Perioperative Treatment of High-risk Resectable\u002FBorderline Resectable Pancreatic Cancer","NOTABLE-309","Inclusion Criteria:\n\n* 1\\. Age 18-75 years old, gender unlimited;\n* 2\\. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC);\n* 3\\. Confirmed as resectable\u002Fborderline resectable pancreatic cancer by CT\u002FMRI imaging (resectability assessment refers to NCCN guidelines). For resectable pancreatic cancer, at least one of the following high-risk factors must be met: 1) CA199 \\> 500 U\u002Fml; 2) the maximum diameter of the primary tumor \\> 3.0 cm; 3) Severe weight loss (BMI \\\u003C 18.5 kg\u002Fm² OR involuntary weight loss \\> 15% within 6 months); 4) Severe pain (Numeric Rating Scale \\[NRS\\]≥ 4); 5) Definite regional lymph node metastasis (N1 or N2) OR suspicious regional lymph node metastasis (short-axis diameter of lymph nodes ≥15 mm);\n* 4\\. Voluntarily agree to sample collection (for KRAS gene testing and post-hoc analysis);\n* 5\\. Adequate organ and bone marrow function, defined as follows: hemoglobin≥9.0 g\u002FdL; absolute neutrophil count (ANC)≥1.5×10\\^9\u002FL; platelets≥80×10\\^9\u002FL; serum total bilirubin (TBIL)≤1.5×ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (ULN); serum creatinine≤1.5×ULN or estimated creatinine clearance \\> 60 mL\u002Fmin;\n* 6\\. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2;\n* 7\\. Life expectancy of at least 3 months;\n* 8\\. Women of childbearing age should have a negative result of serum HCG or urine pregnancy tests within 72 hours prior to randomization (Postmenopausal women who have had amenorrhea for at least 12 months are considered sterile and women known to have had tubal ligation are not required to undergo pregnancy tests) ;\n* 9\\. Good compliance and signed informed consent.\n\nExclusion Criteria:\n\n* 1\\. Previous treatment for pancreatic cancer.\n* 2\\. Accompanied by other serious diseases, including but not limited to: active infections; unmanageable diabetes mellitus and uncontrolled hypertension (SBP\\>160mmHg or DBP\\>100mmHg); compensatory heart failure (NYHA grade III and IV), unstable angina or poorly controlled arrhythmias within 3 months prior to randomization; presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage; severe portal hypertension; digestive tract obstruction; respiratory insufficiency and severe lung disease; central nervous system disease or mental illness;\n* 3\\. Clinically diagnosed as local recurrence of pancreatic cancer, or there is evidence of peritoneal\u002Fother distant metastases;\n* 4.History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);\n* 5\\. Presence of bleeding or coagulation disorders;\n* 6\\. Known allergy to prescription or any component of the prescription used in this study;\n* 7\\. Known HIV infection, syphilis infection, or active hepatitis (hepatitis B or C);\n* 8\\. Women who are pregnant or are breastfeeding;\n* 9.Other reasons that are not suitable to participate in this study according to the researcher's judgment.","ALL","18 Years","75 Years",{"count":95,"type":96},156,"ESTIMATED","INTERVENTIONAL",[99],"PHASE2","This is a prospective, multicenter, randomized, double-blind, placebo-controlled study. Led by The First Affiliated Hospital with Nanjing Medical University and Peking University Cancer Hospital \\& Institute (as leading centers), its main purpose is to evaluate the clinical efficacy and safety of Nimotuzumab combined with nab-paclitaxel plus gemcitabine (AG) in the perioperative treatment of high-risk resectable\u002Fborderline resectable pancreatic cancer.",[102],"Pancreatic Cancer, Adult",[23,104,105],"resectable pancreatic cancer","borderline resectable pancreatic cancer","NOT_YET_RECRUITING","2025-11-30",{"date":109,"type":110},"2025-12-11","ACTUAL",{"date":112,"type":96},"2025-12-10",{"date":114,"type":96},"2029-12-10",{"name":5,"class":6},2]