The Safety and Effectiveness of Hyperthermic Intraperitoneal Chemotherapy Combined With Intravenous Chemotherapy for Peritoneal Metastatic Pancreatic Cancer, a Phase II Clinical Trial

Inclusion Criteria:

• Obtain signed informed consent from the patient or their legal representative, withadherence to the study protocol and follow-up procedures;

• Aged >=18 and <=80 years, regardless of gender;

• No contraindications to surgery, with an ECOG performance status of 0-1;

• Confirmed peritoneal metastasis by imaging or intraoperative detection, with rapidintraoperative histopathology indicating metastatic adenocarcinoma;

• No prior anti-tumor therapy before treatment, including systemic chemotherapy,interventional chemotherapy, high-intensity focused ultrasound (HIFU), radiotherapy,immunotherapy, molecular targeted therapy, or traditional Chinese medicineanti-tumor treatments;

• No severe hematological, cardiac, pulmonary dysfunction, or autoimmune deficiency (based on respective diagnostic criteria);

• Hematological criteria: White blood cells (WBC) >=3.0 × 10⁹/L; Absolute neutrophilcount (ANC) >=1.5 × 10⁹/L; Platelets (PLT) >=100 × 10⁹/L; Hemoglobin (Hgb) >=90 g/L.

• Blood biochemistry criteria: AST (SGOT) and ALT (SGPT) <=2.5 × upper limit of normal (ULN); Total bilirubin (TBIL) <=2 × ULN; Serum creatinine (CRE) <=1.5 × ULN.

• Coagulation function: Prothrombin time (PT) and international normalized ratio (INR) <=1.5 × ULN;

• Compliance with study visit schedules and other protocol requirements.

Exclusion Criteria:

• Presence of distant metastases to other organs (e.g., liver, bone, lung) withdefinitive evidence, except for ovarian metastases;

• History of other systemic malignancies within the past five years;

• Use of any non-anti-tumor investigational drugs within 4 weeks prior to treatment;

• Accompanied by massive ascites (extending from pelvic to upper abdominal cavity);

• History of upper gastrointestinal bleeding requiring repeated blood transfusionswithin the past three months;

• Pregnancy, autoimmune diseases, severe hyperthyroidism/hypothyroidism, centralnervous system disorders, psychiatric illnesses, unstable angina, congestive heartfailure, severe arrhythmias, or other uncontrolled serious medical conditions;

• History of hypersensitivity to the study drugs or medications with similar chemicalstructures;

• Patients requiring long-term warfarin anticoagulation therapy;

• Poor compliance, inability or unwillingness to provide signed informed consent;

• Patients likely to be lost to follow-up for ≥14 days during the treatment period.