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.
1.Age 18-75 years; 2.Histopathologically or cytologically confirmed metastatic pancreatic adenocarcinoma ; 3.No prior systemic anti-tumor therapy (neoadjuvant/adjuvant 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/L, platelet count (PLT) ≥ 100×10⁹/L, hemoglobin (Hb) ≥ 90 g/L; 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/min (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.
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.
Single group
Albumin-bound Paclitaxel (Ⅱ) + Gemcitabine
DrugAlbumin-bound Paclitaxel (Ⅱ) (125 mg/m², intravenous infusion, on days 1, 8, and 15) plus gemcitabine (1000 mg/m², 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.
Objective Response Rate(ORR)
Disease Control Rate (DCR)
Progression-Free Survival (PFS)
Overall Survival (OS)
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