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

Launched by SHANGHAI ZHONGSHAN HOSPITAL · Apr 19, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for patients with peritoneal metastatic pancreatic cancer, which means the cancer has spread to the lining of the abdomen. The study is testing a combination of two types of chemotherapy: one delivered directly into the abdomen (hyperthermic intraperitoneal chemotherapy, or HIPEC) and another given through the vein (intravenous chemotherapy). The main goals of the trial are to see if this combined treatment can improve survival rates after one year and to evaluate how safe the treatment is for patients.

To participate in this trial, patients need to be between 18 and 80 years old, have confirmed peritoneal metastasis, and meet certain health criteria. They should not have received any previous cancer treatments or have serious health issues that could complicate the study. Participants will first undergo scans and surgery to confirm their condition, followed by two cycles of the HIPEC treatment, and then standard chemotherapy. Regular check-ups and imaging will help guide their treatment throughout the study. If you or someone you know might be interested in joining this trial, it’s a great opportunity to potentially access new treatment options while contributing to important cancer research.

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Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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;
• • 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.