[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520076":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":41,"centralContacts":45,"locations":50,"responsibleParty":67,"collaborators":28,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":77,"sex":78,"minAge":79,"maxAge":28,"enrollmentInfo":80,"targetDuration":28,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":52,"whyStopped":28,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Trial group","EXPERIMENTAL","penpulimab in combination with anlotinib and AG regimen in the first-line treatment of advanced metastatic pancreatic cancer",[13,14,15,16],"Drug: Penpulimab","Drug: Anlotinib","Drug: Nab paclitaxel","Drug: Gemcitabine",{"label":18,"type":19,"description":20,"interventionNames":21},"Control group","ACTIVE_COMPARATOR","AG regimen in the first-line treatment of advanced metastatic pancreatic cancer",[15,16],[23,29,33,37],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Penpulimab","Penpulimab 200mg IV D1\n\n1 cycle every 21 days",[9],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Anlotinib","Anlotinib 12mg\u002F10mg P.O. QD D1-14 (12mg for body surface area ≥1.6m2, 10mg for body surface area ≤1.6m2)\n\n1 cycle every 21 days",[9],{"type":24,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"Nab paclitaxel","Nab-paclitaxel 125mg\u002Fm2 I.V. D1,8\n\n1 cycle every 21 days",[18,9],{"type":24,"name":38,"description":39,"armGroupLabels":40,"otherNames":28},"Gemcitabine","Gemcitabine 1.0g\u002Fm2 I.V. D1,8\n\n1 cycle every 21 days",[18,9],[42],{"name":43,"affiliation":5,"role":44},"Juan Du","PRINCIPAL_INVESTIGATOR",[46],{"name":43,"role":47,"phone":48,"phoneExt":28,"email":49},"CONTACT","+0086-13951826526","dujuanglyy@163.com",[51],{"facility":5,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"RECRUITING","Nanjing","Jiangsu","210008","China","CN",{"type":59,"coordinates":60},"Point",[61,62],118.77778,32.06167,{"lat":62,"lon":61},[65],{"name":66,"role":47,"phone":48,"phoneExt":28,"email":49},"Juan Du, PhD",{"type":68,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100520076","phase-2-penpulimab-combined-with-anlotinib-and-nab-paclitaxel-plus-gemcitabine-as-first-line-treatment-for-advanced-metastatic-pancreatic-cancer-100520076",false,"NCT06051851","Penpulimab Combined With Anlotinib and Nab-paclitaxel Plus Gemcitabine as First-line Treatment for Advanced Metastatic Pancreatic Cancer","Penpulimab Combined With Anlotinib and Nab-paclitaxel Plus Gemcitabine (PAAG) as First-line Treatment for Advanced Metastatic Pancreatic Cancer: a Prospective, Multicenter, Single-arm, Phase 2 Study","RCT-PAAG","Inclusion Criteria:\n\n* Ages ≥18 years，ECOG ≤ 2，Estimated survival time \\> 3 months\n* Histologically or Cytologically confirmed metastatic pancreatic adenocarcinoma\n* Based on Response Evaluation Criteria In Solid Tumors (RECIST1.1), there should be at least one measurable lesion\n* Patients have never received systematical anti-cancer therapy\n* Laboratory examination meets the following requirements:\n\nWhite blood cell (WBC) ≥3.0×109\u002FL; absolute neutrophil count (ANC) ≥1.5×109\u002FL; Hemoglobin (HB) ≥90g\u002FL; platelet count(PLT) ≥75×109\u002FL; Total bilirubin (TBIL) ≤1.5× normal upper limit (ULN); Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST)≤2.5×ULN, if accompanied by liver metastasis, ALT and AST≤5×ULN; Serum creatinine (Cr) ≤1×ULN or creatinine clearance (CCr)≥50ml\u002Fmin;\n\n* Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) \\> 50%\n* Patients of childbearing age should take appropriate protective measures before enrollment and during the trial\n* Volunteer to join the study, sign the informed consent, have good compliance, and cooperate with follow-up\n* Ability to follow the study protocol and follow-up procedures.\n\nExclusion Criteria:\n\n* Patients have ever received any systematical anti-cancer therapy in the past\n* Patients who participated in other clinical trials in the past 4 weeks\n* According to the investigator, patients who surgically available or potentially treatable(Patients who voluntarily give up surgical treatment can be enrolled after evaluation by the investigator)\n* Patients with moderate ascites requiring drainage\n* Patients with CNS metastases and\u002For carcinomatous meningitis\n* Patients with history of other primary malignancies except: 1) complete remission before enrollment for at least 2 years and requiring no additional treatment during the study period; 2) Adequately treated non-melanoma skin cancer or lentiform malignancy with no evidence of disease recurrence; 3) Adequately treated carcinoma in situ with no evidence of disease recurrence;\n* Patients with autoimmune disease or immune deficiency who are treated with immunosuppressive drugs\n* Patients with bleeding tendency.\n* Pregnant or lactating women.\n* Drug abuse, clinical or psychological or social factors that impact informed consent or the conduct of the study\n* Patients who may be allergic to PD-1 monoclonal antibody, anlotinib, albumin-bound paclitaxel and gemcitabine",true,"ALL","18 Years",{"count":81,"type":82},177,"ESTIMATED","INTERVENTIONAL",[85],"PHASE2","This is a multi-center, open-label， randomized controlled Phase II clinical study to observe and evaluate the efficacy and safety of Penpulimab combined with Anlotinib and Nab-paclitaxel plus Gemcitabine (PAAG ) versus AG first-line treatment in patients with metastatic pancreatic cancer.",[88],"Pancreatic Adenocarcinoma Metastatic",[90,91,92,93],"advanced metastatic pancreatic cancer","Chemotherapy","immunotherapy","Targeted Therapy","2023-09-18",{"date":96,"type":97},"2023-09-25","ACTUAL",{"date":99,"type":97},"2023-07-01",{"date":101,"type":82},"2026-07-01",{"name":5,"class":6},1]