[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656941":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":11,"studyPopulation":11,"armGroups":28,"interventions":34,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":40,"collaborators":11,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":11,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":11,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":11,"overallStatus":66,"whyStopped":11,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":11},{"fullName":5,"class":6},"The First Affiliated Hospital with Nanjing Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Objective Response Rate(ORR)",null,"Every 8 weeks from time of first dose of study drug until completion of treatment for approximately 6 months.",[14,16,19],{"measure":15,"description":11,"timeFrame":12},"Disease Control Rate (DCR)",{"measure":17,"description":11,"timeFrame":18},"Progression-Free Survival (PFS)","The median time from first dose administration to tumor progression (per RECIST v1.1) or death in trial participants is expected to be 6 months.",{"measure":20,"description":11,"timeFrame":21},"Overall Survival (OS)","Overall survival (OS), defined as the time from first dose administration to death from any cause, is estimated to be 13 months in trial participants.",{"allocation":23,"interventionModel":24,"interventionModelDescription":11,"primaryPurpose":25,"observationalModel":11,"timePerspective":11,"maskingInfo":26},"NA","SINGLE_GROUP","TREATMENT",{"masking":27,"maskingDescription":11,"whoMasked":11},"NONE",[29],{"label":30,"type":31,"description":11,"interventionNames":32},"investigational arm","EXPERIMENTAL",[33],"Drug: Albumin-bound Paclitaxel (Ⅱ) + Gemcitabine",[35],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":11},"DRUG","Albumin-bound Paclitaxel (Ⅱ) + Gemcitabine","Albumin-bound Paclitaxel (Ⅱ) (125 mg\u002Fm², intravenous infusion, on days 1, 8, and 15) plus gemcitabine (1000 mg\u002Fm², intravenous infusion, on days 1, 8, and 15), every 4 weeks (Q4W). After 6 cycles, albumin-bound Paclitaxel (Ⅱ) (on days 1 and 15) plus gemcitabine (on days 1 and 15), every 4 weeks, until disease progression or unacceptable toxicity.",[30],{"type":41,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Kuirong Jiang","Professor","100656941","phase-2-albumin-bound-paclitaxel-ii-in-combination-with-gemcitabine-as-first-line-therapy-for-metastatic-pancreatic-cancer-100656941",false,"NCT07831330","Albumin-bound Paclitaxel (II) in Combination With Gemcitabine as First Line Therapy for Metastatic Pancreatic Cancer","Albumin-bound Paclitaxel (II) in Combination With Gemcitabine as First Line Therapy for Metastatic Pancreatic Cancer: A Multicenter, Single-Arm Study","Inclusion Criteria:\n\n* 1.Age 18-75 years; 2.Histopathologically or cytologically confirmed metastatic pancreatic adenocarcinoma ; 3.No prior systemic anti-tumor therapy (neoadjuvant\u002Fadjuvant chemotherapy is permitted, provided that the interval between completion of treatment and initiation of study treatment is \\>6 months); 4.At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; 5.ECOG performance status 0-2; 6.Expected survival time ≥ 3 months; 7.Bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5×10⁹\u002FL, platelet count (PLT) ≥ 100×10⁹\u002FL, hemoglobin (Hb) ≥ 90 g\u002FL; 8.Hepatic function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN (if liver metastases are present, ≤ 5×ULN is permitted); total bilirubin ≤ 1.5×ULN; 9.Renal function: Serum creatinine (Cr) ≤ 1.5×ULN or creatinine clearance ≥ 60 mL\u002Fmin (calculated by the Cockcroft-Gault formula); 10.Coagulation function: Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5×ULN; 11.Ability to understand the study, and voluntary participation with signed informed consent.\n\nExclusion Criteria:\n\n* 1.Participants with a history of other malignancies within the past 5 years (with the exception of cured basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or other cancers that have been adequately treated and considered cured); 2.Known allergy or intolerance to the study drug or its excipients; 3.Participation in any investigational drug or device therapy within 30 days prior to the first dose of study drug.\n\n  4.Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy, defined as persistent signs\u002Fsymptoms related to infection that have not improved despite appropriate antibiotics, antiviral therapy, and\u002For other treatments.\n\n  5.Known active HIV infection (i.e., HIV1\u002F2 antibody positive); untreated active HBV infection (defined as HBsAg\u002FHBcAg positive with HBV-DNA copy number above the upper limit of normal at the local laboratory) and HCV infection (HCV antibody positive with HCV-RNA level above the upper limit of normal); 6.There was uncontrolled systemic disease within 6 months before the first administration, including cardiovascular diseases such as unstable angina, myocardial infarction, chronic congestive heart failure of Class II or above (NYHA criteria), severe unstable ventricular arrhythmia, and history of severe pericardial disease; uncontrolled hypertension (defined as systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg despite standard antihypertensive therapy), or history of hypertensive crisis or hypertensive encephalopathy; uncontrolled diabetes mellitus (fasting blood glucose ≥10 mmol\u002FL); gastrointestinal diseases of significant clinical importance, including gastrointestinal obstruction, gastrointestinal perforation, intra-abdominal abscess\u002Finfection, etc.; 7.Severe venous thromboembolic events, including deep vein thrombosis and pulmonary embolism, within 3 months prior to enrollment.\n\n  8.Uncontrolled pleural effusion, ascites, or pericardial effusion. 9.Peripheral sensory neuropathy or peripheral motor neuropathy of grade ≥2 (according to CTCAE V6.0).\n\n  10.Symptomatic brain metastases, leptomeningeal metastases, spinal cord tumor involvement, or spinal cord compression.\n\n  11.Pregnant or lactating women, and patients of childbearing potential who refuse to take appropriate contraceptive measures during the trial.\n\n  12.Patients judged by the investigator to be unsuitable for participation in this study.","ALL","18 Years","75 Years",{"count":55,"type":56},59,"ESTIMATED","INTERVENTIONAL",[59],"PHASE2","This is a prospective, multicenter, open-label, single-arm study in participants with metastatic pancreatic adenocarcinoma who have not received any prior systemic anti-tumor therapy for advanced disease. To evaluate the efficacy and safety of albumin-bound paclitaxel (II) combined with gemcitabine for first-line treatment of metastatic pancreatic cancer.",[62,63,64,65],"Metastatic Pancreatic Adenocarcinoma","Albumin-bound Paclitaxel (II)","Gemcitabine","First-Line","NOT_YET_RECRUITING","2026-09-15",{"date":69,"type":70},"2026-09-21","ACTUAL",{"date":72,"type":56},"2026-09-05",{"date":74,"type":56},"2029-06-30",{"name":5,"class":6}]