[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561200":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":21,"responsibleParty":44,"collaborators":47,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":11,"officialTitle":55,"acronym":20,"eligibilityCriteria":56,"healthyVolunteers":53,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":20,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":20,"overallStatus":24,"whyStopped":20,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HRS-4642, Gemcitabine and Albumin-bound Paclitaxel","EXPERIMENTAL","HRS-4642 in Combination With AG for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer",[13],"Drug: HRS-4642+AG",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","HRS-4642+AG","HRS-4642 in Combination With Gemcitabine and Albumin-bound Paclitaxel will be administrated per dose level in which the patients are assigned.",[9],null,[22],{"facility":23,"status":24,"city":25,"state":26,"zip":27,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"Ruijin Hospital Shanghai Jiaotong University School of Medicine","RECRUITING","Shanghai","Shanghai Municipality","200025","China","CN",{"type":31,"coordinates":32},"Point",[33,34],121.45806,31.22222,{"lat":34,"lon":33},[37,42],{"name":38,"role":39,"phone":40,"phoneExt":20,"email":41},"Baiyong Shen, Ph.D&M.D","CONTACT","0086-021-64370045","shenby@shsmu.edu.cn",{"name":38,"role":43,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"type":43,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"BAIYONG SHEN","Professor",[48],{"name":49,"class":50},"Jiangsu HengRui Medicine Co., Ltd.","INDUSTRY","100561200","phase-2-hrs-4642-in-combination-with-ag-for-neoadjuvant-and-adjuvant-treatment-of-pancreatic-cancer-100561200",false,"NCT06587061","An Exploratory Clinical Study of HRS-4642 in Combination With Gemcitabine and Albumin-bound Paclitaxel for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer","Inclusion Criteria:\n\n1. Age: ≥18 and ≤80 years old, male or female;\n2. Pathologically or cytologically confirmed ductal adenocarcinoma of the pancreas; and subjects must have at least one measurable lesion as defined by RECIST v1.1;\n3. Imaging evaluation met the NCCN guidelines definition of resectable pancreatic cancer (including high-risk resectable) and borderline resectable pancreatic cancer.\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;\n5. Life expectancy ≥ 12 weeks;\n6. Adequate marrow and organ function;\n7. Female participants of childbearing age must undergo a pregnancy test within one week before the start of the study medication, and the result is negative. They are willing to use a medically recognized and efficient contraceptive method during the study period and within three months after the last administration of the study medication; For male participants whose partners are women of childbearing age, they should agree to use effective methods of contraception during the study period and within 6 months after the last study administration;\n8. Patients volunteered to participate in this study and signed informed consent;\n\nExclusion Criteria:\n\n1. Previously received any anti-tumor therapy;\n2. the presence of distant metastatic lesions diagnosed by imaging;\n3. Known hypersensitivity to the study drug or any of its components;\n4. previous or concurrent other malignant tumors;\n5. Participation in a clinical trial of any drug or medical device within 4 weeks prior to the first dose;\n6. Received live and attenuated vaccines within 4 weeks prior to the first dose of the investigational drug;\n7. previous allogeneic hematopoietic stem cell transplantation or organ transplantation;\n8. Patients with severe cardiovascular arterial thromboembolism (e.g., myocardial infarction, unstable angina, stroke), NYHA class 2 or greater cardiac insufficiency, and clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;\n9. with interstitial lung disease, non-infectious pneumonia or severe and uncontrolled medical illness, acute infections, recent history of major surgery (within 28 days or not yet recovered from side effects);\n10. with congenital or acquired immunodeficiencies such as human immunodeficiency virus (HIV) infection, active hepatitis B (positive hepatitis B virus surface antigen \\[HBsAg\\] test result at screening together with an HBVDNA test value of ≥10,000 copies\u002Fml \\[2000 IU\u002Fml\\]), active hepatitis C (hepatitis C virus antigen \\[HCV-antibodies\\] at screening), or active hepatitis C (hepatitis C virus antitoxin \\[HCV-antibodies\\] at screening).antibody \\[HCV-Ab\\] positive at screening and HCV-RNA positive at the same time), or co-infection with hepatitis B and hepatitis C;\n11. Presence of clinically significant acute or chronic pancreatitis; patients at high risk for pancreatitis, e.g., serum amylase and\u002For lipase concentrations ≥3 times ULN (except when the investigator determines that abnormally elevated amylase and\u002For lipase are associated with pancreatic cancer);\n12. Other situations that the researcher felt should not be included.","ALL","18 Years","80 Years",{"count":61,"type":62},30,"ESTIMATED","INTERVENTIONAL",[65],"PHASE2","To evaluate the safety and efficacy of HRS-4642 in Combination With AG for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer",[68],"Pancreatic Cancer","2026-05-22",{"date":71,"type":72},"2026-05-27","ACTUAL",{"date":74,"type":72},"2024-12-03",{"date":76,"type":62},"2027-12",{"name":5,"class":6},1]