[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656586":3},{"organization":4,"outcomesModule":7,"designInfo":54,"detailedDescription":11,"studyPopulation":11,"armGroups":60,"interventions":78,"overallOfficials":11,"centralContacts":105,"locations":111,"responsibleParty":123,"collaborators":11,"id":125,"slug":126,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":11,"eligibilityCriteria":131,"healthyVolunteers":127,"sex":132,"minAge":133,"maxAge":134,"enrollmentInfo":135,"targetDuration":11,"studyType":138,"phases":139,"briefSummary":141,"conditions":142,"keywords":11,"overallStatus":144,"whyStopped":11,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},{"fullName":5,"class":6},"Tianjin Medical University Cancer Institute and Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":11},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Progression-Free Survival (PFS)",null,"Time from subject's first study drug administration to first documented disease progression (per RECIST v1.1) or death from any cause, whichever occurs first, assessed up to 5.5 months.",{"measure":14,"description":11,"timeFrame":15},"1-Year Event-Free Survival Rate (1y-EFS Rate)","12 months after signing informed consent, until first EFS event or loss to follow-up.",{"measure":17,"description":11,"timeFrame":18},"Recommended Phase 2 Dose (RP2D)","After all participants in each dose cohort complete the 21-day DLT observation period.",{"measure":20,"description":11,"timeFrame":21},"Disease-Free Survival (DFS)","From informed consent signature to tumor recurrence or all-cause death (whichever occurs first), assessed up to 20 months.",[23,26,29,32,35,38,41,43,46,49,51],{"measure":24,"description":11,"timeFrame":25},"Objective Response Rate (ORR)","Tumor response assessment every 8 weeks (±7 days) after first study drug administration until disease progression, death or end-of-follow-up, assessed up to 5.5 months.",{"measure":27,"description":11,"timeFrame":28},"Maximum Tolerated Dose (MTD)","After DLT observation completion and RP2D determination for all dose cohorts, assessed up to 1 months.",{"measure":30,"description":11,"timeFrame":31},"R0 Resection Rate","After neoadjuvant therapy completion, at pathological report of surgical specimen, assessed up to 7 months.",{"measure":33,"description":11,"timeFrame":34},"Incidence of Adverse Events","From the time of informed consent signature through 30 days after last study drug administration.",{"measure":36,"description":11,"timeFrame":37},"Disease Control Rate (DCR)","Tumor response assessment every 8 weeks (±7 days) after first study drug administration until disease progression, death or end-of-follow-up, assessed up to 5.5 months..",{"measure":39,"description":11,"timeFrame":40},"Overall Survival (OS)","Time from subject's first study drug administration to death from any cause, assessed up to 40 months.",{"measure":42,"description":11,"timeFrame":18},"Dose-Limiting Toxicity (DLT)",{"measure":44,"description":11,"timeFrame":45},"Event-Free Survival (EFS)","From informed consent signature to first local recurrence, distant metastasis, tumor progression, second malignancy or all-cause death (whichever occurs first), assessed up to 16 months.",{"measure":47,"description":11,"timeFrame":48},"Major Pathological Response (MPR) Rate","Upon completion of pathological diagnosis of resected surgical specimen, assessed up to 7 months.",{"measure":50,"description":11,"timeFrame":48},"Pathological Complete Response (pCR) Rate",{"measure":52,"description":11,"timeFrame":53},"Duration of Response (DOR)","Time from first documented CR or PR to subsequent disease progression or death from any cause, whichever occurs first, until end-of-follow-up, assessed up to 6 months.",{"allocation":55,"interventionModel":56,"interventionModelDescription":11,"primaryPurpose":57,"observationalModel":11,"timePerspective":11,"maskingInfo":58},"NON_RANDOMIZED","PARALLEL","TREATMENT",{"masking":59,"maskingDescription":11,"whoMasked":11},"NONE",[61,70,74],{"label":62,"type":63,"description":64,"interventionNames":65},"Chort 1","EXPERIMENTAL","Cisplatin + Albumin-bound Paclitaxel (Ⅱ) + Capecitabine + Gemcitabine, q2w, Treatment will continue until disease progression or intolerable toxicity.",[66,67,68,69],"Drug: Cisplatin","Drug: Albumin-bound Paclitaxel (Ⅱ)","Drug: Capecitabine","Drug: Gemcitabine",{"label":71,"type":63,"description":72,"interventionNames":73},"Chort 2","Cisplatin + Albumin-bound Paclitaxel (Ⅱ) + Capecitabine + Gemcitabine, q2w, with a maximum of 12 treatment cycles.",[66,67,68,69],{"label":75,"type":63,"description":76,"interventionNames":77},"Chort 3","Albumin-bound Paclitaxel (Ⅱ) + Capecitabine + Gemcitabine, q3w, for a total treatment duration of up to 6 months.",[67,68,69],[79,84,88,91,95,98,102],{"type":80,"name":81,"description":82,"armGroupLabels":83,"otherNames":11},"DRUG","Cisplatin","Cisplatin: 30 mg\u002Fm² , d1",[62,71],{"type":80,"name":85,"description":86,"armGroupLabels":87,"otherNames":11},"Albumin-bound Paclitaxel (Ⅱ)","Albumin-bound Paclitaxel (Ⅱ): 150 mg\u002Fm² , d1",[62,71],{"type":80,"name":85,"description":89,"armGroupLabels":90,"otherNames":11},"Albumin-bound Paclitaxel (Ⅱ): 100\u002F125 mg\u002Fm² , d1, d8",[75],{"type":80,"name":92,"description":93,"armGroupLabels":94,"otherNames":11},"Capecitabine","Capecitabine 625 mg\u002Fm²，po，bid, d1-14",[62,71],{"type":80,"name":92,"description":96,"armGroupLabels":97,"otherNames":11},"Capecitabine 1660 mg\u002F(m² • d), d1-14",[75],{"type":80,"name":99,"description":100,"armGroupLabels":101,"otherNames":11},"Gemcitabine","Gemcitabine 800 mg\u002Fm², d1",[62,71],{"type":80,"name":99,"description":103,"armGroupLabels":104,"otherNames":11},"Gemcitabine 1000 mg\u002Fm², d1, d8",[75],[106],{"name":107,"role":108,"phone":109,"phoneExt":11,"email":110},"Jihui Hao","CONTACT","022-2340123-3077","18622221120@163.com",[112],{"facility":113,"status":11,"city":114,"state":11,"zip":11,"country":115,"countryCode":116,"cosmosGeoPoint":117,"geoPoint":122,"contacts":11},"Tianjin Medical University Cancer Institute & Hospital","Tianjin","China","CN",{"type":118,"coordinates":119},"Point",[120,121],117.17667,39.14222,{"lat":121,"lon":120},{"type":124,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100656586","phase-2-albumin-bound-paclitaxel--combined-regimens-for-pancreatic-cancer-100656586",false,"NCT07828756","Albumin-bound Paclitaxel (Ⅱ)-Combined Regimens for Pancreatic Cancer","A Multi-cohort Exploratory Study to Evaluate the Efficacy and Safety of Albumin-bound Paclitaxel (Ⅱ)-Combined Regimens for Pancreatic Cancer","Inclusion Criteria:\n\n* Aged 18 to 75 years old.\n* Histopathologically confirmed pancreatic adenocarcinoma meeting any one of the following conditions: (1) Unresectable locally advanced or metastatic pancreatic cancer, with no prior systemic anti-tumor therapy for advanced disease. Prior neoadjuvant\u002Fadjuvant chemotherapy is permitted, provided the interval from completion of prior chemotherapy to study drug administration is more than 6 months. (2) High-risk resectable or borderline resectable pancreatic cancer assessed by a multidisciplinary team.(3) Curative resection (R0 or R1 resection) performed without prior neoadjuvant therapy, and adjuvant treatment can be initiated within 12 weeks postoperatively.\n* Presence of at least one measurable lesion per RECIST v1.1 (exclusive to participants in Cohort 3).\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n* Estimated survival time ≥ 3 months.\n* Adequate bone marrow function: absolute neutrophil count (ANC) ≥ 1.5×10⁹\u002FL, platelet count (PLT) ≥ 100×10⁹\u002FL, hemoglobin (Hb) ≥ 90 g\u002FL.\n* Adequate liver function: alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5×ULN (≤5×ULN allowed in patients with liver metastases); total bilirubin ≤ 1.5×ULN.\n* Adequate renal function: serum creatinine (Cr) ≤ 1.5×ULN, or creatinine clearance ≥ 60 mL\u002Fmin (calculated by Cockroft-Gault formula).\n* Adequate coagulation function: prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5×ULN.\n* Women of childbearing potential must have a negative serum\u002Furine pregnancy test within 14 days prior to enrollment, be non-lactating, and agree to use effective contraception throughout the study and for 6 months after the last study treatment. Male participants must agree to effective contraception during the study and for 6 months after study completion.\n* Able to understand the study information; participant or legal representative voluntarily provides written informed consent.\n\nExclusion Criteria:\n\n* History of other malignant tumors within the past 5 years\n* Known hypersensitivity or intolerance to any study drug or excipients.\n* Confirmed homozygous or compound heterozygous DPYD variants leading to complete dihydropyrimidine dehydrogenase (DPD) deficiency.\n* Presence of any of the following comorbidities: ① Severe or uncontrolled cardiovascular disease: New York Heart Association (NYHA) Class II or higher chronic heart failure, uncontrolled hypertension (systolic BP \\>150 mmHg and\u002For diastolic BP \\>90 mmHg despite stable medication), etc. ② Severe respiratory disorders: asthma requiring inhaled\u002Fsystemic glucocorticoids, active chronic obstructive pulmonary disease, etc. ③ Confirmed neurological diseases (epilepsy, dementia, etc.) or Grade ≥2 peripheral sensory\u002Fmotor neuropathy. ④ Uncontrolled diabetes mellitus (fasting blood glucose ≥10 mmol\u002FL under stable treatment). ⑤ Severe chronic or active infections requiring ≥1 consecutive week of systemic antibacterial, antifungal or antiviral therapy (including tuberculosis). ⑥ Active HIV infection (HIV antibody positive); untreated active HBV (HBsAg\u002FHBcAg positive with HBV-DNA above institutional upper limit of normal) or active HCV infection (HCV antibody positive with HCV-RNA above institutional upper limit of normal).\n* Untreated active brain metastases (including symptomatic brain or leptomeningeal metastases). Participants with brain metastases are eligible only if brain lesions are stable on imaging performed ≥4 weeks prior to first study dose, no new neurological symptoms or baseline symptom relapse, and no systemic steroid administration for ≥14 days before study treatment initiation, with no evidence of new or enlarged metastatic lesions.\n* Medical history as follows: ① Major abdominal\u002Fthoracic surgery within 28 days prior to first study dose, or planned major surgery during the study period (diagnostic puncture and infusion port implantation excluded). ② Severe cardiovascular\u002Fcerebrovascular events (myocardial infarction, unstable angina, cerebrovascular accident) within 6 months prior to enrollment; clinically silent lacunar infarcts are permitted.\n* History of deep vein thrombosis or pulmonary embolism within 3 months prior to enrollment.\n* Inability to swallow or untreated malabsorption syndrome.\n* Receipt of any investigational product within 1 month prior to enrollment.\n* Any other condition judged by the investigator to render the participant unsuitable for study participation.","ALL","18 Years","75 Years",{"count":136,"type":137},147,"ESTIMATED","INTERVENTIONAL",[140],"PHASE2","This is a prospective, multi-center, multi-cohort exploratory study. Cohort 1 enrolls 39 patients with unresectable locally advanced or metastatic pancreatic cancer, who will receive first-line treatment with cisplatin plus nab-paclitaxel (Ⅱ), capecitabine, and gemcitabine (PAXG).\n\nCohort 2 enrolls 27 patients with borderline-resectable or high-risk resectable pancreatic cancer, who will receive neoadjuvant therapy with the PAXG regimen.\n\nCohort 3 enrolls patients with pancreatic cancer who have undergone curative resection, who will receive adjuvant therapy with nab-paclitaxel (Ⅱ), capecitabine, and gemcitabine.\n\nObjectives of Study: To evaluate the efficacy and safety of nab-paclitaxel (Ⅱ)-based regimes for pancreatic cancer.",[143],"Pancreatic Cancer","NOT_YET_RECRUITING","2026-09-15",{"date":147,"type":148},"2026-09-18","ACTUAL",{"date":150,"type":137},"2026-09-30",{"date":152,"type":137},"2030-04-30",{"name":5,"class":6},1]