Clareo Health | The Safety and Effectiveness of Hyperthermic Intraperitoneal Chemotherapy Combined With Intravenous Chemotherapy for Peritoneal Metastatic Pancreatic Cancer, a Phase II Clinical Trial
The Safety and Effectiveness of Hyperthermic Intraperitoneal Chemotherapy Combined With Intravenous Chemotherapy for Peritoneal Metastatic Pancreatic Cancer, a Phase II Clinical Trial
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);
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.
You may not be if
Presence of distant metastases to other organs (e.g., liver, bone, lung) with definitive 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 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;
