Albumin-bound Paclitaxel (II) in Combination With Gemcitabine as First Line Therapy for Metastatic Pancreatic Cancer

Inclusion criteria

• 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.

Exclusion criteria

• 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.

4.Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy, defined as persistent signs/symptoms related to infection that have not improved despite appropriate antibiotics, antiviral therapy, and/or other treatments.

5.Known active HIV infection (i.e., HIV1/2 antibody positive); untreated active HBV infection (defined as HBsAg/HBcAg 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/or 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/L); gastrointestinal diseases of significant clinical importance, including gastrointestinal obstruction, gastrointestinal perforation, intra-abdominal abscess/infection, etc.; 7.Severe venous thromboembolic events, including deep vein thrombosis and pulmonary embolism, within 3 months prior to enrollment.

8.Uncontrolled pleural effusion, ascites, or pericardial effusion. 9.Peripheral sensory neuropathy or peripheral motor neuropathy of grade ≥2 (according to CTCAE V6.0).

10.Symptomatic brain metastases, leptomeningeal metastases, spinal cord tumor involvement, or spinal cord compression.

11.Pregnant or lactating women, and patients of childbearing potential who refuse to take appropriate contraceptive measures during the trial.

12.Patients judged by the investigator to be unsuitable for participation in this study.