[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571642":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":25,"centralContacts":29,"locations":36,"responsibleParty":52,"collaborators":11,"id":54,"slug":11,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":11,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":11,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":11,"overallStatus":38,"whyStopped":11,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Zhejiang Provincial People's Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Nimotuzumab+ AG","EXPERIMENTAL",null,[13,14],"Drug: Nimotuzumab","Drug: AG",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":11},"DRUG","Nimotuzumab","Nimotuzumab 400 mg on Day 1 and 15 of a 28-day cycle (6 cycles) ; Patients will receive Nimotuzumab 600 mg on days 1 and 8 of every 21-day cycle. Patients will receive six treatment cycles unless there is radiologic evidence of disease recurrence and unacceptable toxicity.",[9],{"type":17,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"AG","Patients will receive nab-paclitaxel 125 mg\u002Fm\\^2 followed by gemcitabine 1,000 mg\u002Fm\\^2 as one intravenous infusion over 30-40 minutes on days 1 and 8 of every 21-day cycle. Patients will receive six treatment cycles unless there is radiologic evidence of disease recurrence and unacceptable toxicity.",[9],[26],{"name":27,"affiliation":5,"role":28},"Yiping Mou, Dr","STUDY_CHAIR",[30,34],{"name":27,"role":31,"phone":32,"phoneExt":11,"email":33},"CONTACT","0086-057185893643","mouyiping@hmc.edu.cn",{"name":35,"role":31,"phone":11,"phoneExt":11,"email":11},"Tao Xia, Dr",[37],{"facility":5,"status":38,"city":39,"state":40,"zip":11,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Hangzhou","Zhejiang","China","CN",{"type":44,"coordinates":45},"Point",[46,47],120.16142,30.29365,{"lat":47,"lon":46},[50],{"name":51,"role":31,"phone":32,"phoneExt":11,"email":33},"Yiping Mou",{"type":53,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100571642",false,"NCT06722911","Study of Adjuvant Nimotuzumab Combined with Nab-paclitaxel+ Gemcitabine in EGFR-positive Pancreatic Cancer","Nimotuzumab Combined with Nab-paclitaxel+ Gemcitabine As Postoperative Adjuvant Therapy in Patients with EGFR-positive Pancreatic Cancer: a Prospective, Single-arm Study","Inclusion Criteria:\n\n* 1\\. Able and willing to provide a written informed consent.\n* 2\\. Age 18-75 years old, gender unlimited;\n* 3\\. Histologically or cytologically confirmed resected pancreatic ductal adenocarcinoma (PDAC), resectable evaluation is based on criteria of NCCN guidelines, no evidence of distant metastasis as demonstrated by imaging;\n* 4\\. Postoperative pathology suggested R0\u002FR1 resection;\n* 5\\. EGFR positive (by immunohistochemistry);\n* 6\\. KRAS gene and CDX-2 protein status must have been determined at baseline (only for post hoc analysis);\n* 7\\. Adequate organ and bone marrow function, defined as follows: absolute neutrophil count (ANC)≥1.5×10\\^9\u002FL; platelets≥80×10\\^9\u002FL; hemoglobin≥9.0 g\u002FdL; 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* 8\\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n* 9\\. Postoperative survival is expected to be ≥3 months;\n* 10\\. Fertile subjects are willing to take contraceptive measures during the study period.\n\nExclusion Criteria:\n\n* 1\\. Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma;\n* 2\\. History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);\n* 3\\. Accompanied by other serious diseases, including but not limited to: compensatory heart failure (NYHA grade III and IV), unstable angina, poorly controlled arrhythmias, uncontrolled hypertension (SBP\\>160mmHg or DBP\\>100mmHg); active infections; unmanageable diabetes mellitus; presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage; severe portal hypertension; gastric outlet obstruction; Respiratory insufficiency;\n* 4\\. Postoperative complications such as bleeding, pancreatic fistula, gastric obstruction, abdominal infection, and biliary fistula, which made the patient unable to receive adjuvant therapy within 12 weeks after surgery;\n* 5\\. CA199\\>180 U\u002Fml within 21d before adjuvant therapy;\n* 6\\. Known allergy to prescription or any component of the prescription used in this study;\n* 7\\. Known HIV, or syphilis infection, or active hepatitis (hepatitis B, hepatitis C);\n* 8 .Other reasons that are not suitable to participate in this study according to the researcher\\'s judgment.","ALL","18 Years","75 Years",{"count":64,"type":65},57,"ESTIMATED","INTERVENTIONAL",[68],"PHASE2","This is a prospective, single-arm trial. The main purpose of the study is to evaluate the efficacy and safety of Nimotuzumab combined with nab-paclitaxel+ gemcitabine (AG regimen) for postoperative adjuvant treatment of pancreatic cancer with EGFR-positive.",[71],"Pancreatic Cancer Resectable","2024-12-04",{"date":74,"type":75},"2024-12-09","ACTUAL",{"date":77,"type":75},"2024-11-15",{"date":79,"type":65},"2028-09-30",{"name":5,"class":6},1]