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

Prior treatment

• Use of any non-anti-tumor investigational drugs within 4 weeks prior to treatment;
• Patients requiring long-term warfarin anticoagulation therapy;

Other illness

• History of other systemic malignancies within the past five years;
• History of upper gastrointestinal bleeding requiring repeated blood transfusions within the past three months;
• Pregnancy, autoimmune diseases, severe hyperthyroidism/hypothyroidism, central nervous system disorders, psychiatric illnesses, unstable angina, congestive heart failure, severe arrhythmias, or other uncontrolled serious medical conditions;
• History of hypersensitivity to the study drugs or medications with similar chemical structures;

Other

• Presence of distant metastases to other organs (e.g., liver, bone, lung) with definitive evidence, except for ovarian metastases;
• Accompanied by massive ascites (extending from pelvic to upper abdominal cavity);
• 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.

• Obtain signed informed consent from the patient or their legal representative, with adherence 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 rapid intraoperative 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 medicine anti-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 neutrophil count (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.