Clinical Trial

To Evaluate the Feasibility and Safety of Combining Surgery (Pancreatectomy and Cytoreduction) With HIPEC for Treating Pancreatic Cancer With Peritoneal Involvement.

Recruiting
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Summary
The goal of this clinical trial is to evaluate the safety and feasibility of a combined surgical and chemotherapy approach (pancreatectomy with cytoreductive surgery and HIPEC) in patients aged 18 and older with pancreatic ductal adenocarcinoma and synchronous peritoneal metastases. The main questions it aims to answer are: Is the 90-day mortality rate for this intensive combined procedure lower than 5%? What are the postoperative morbidity and complication rates (as measured by the Clavien-Dindo classification) for these patients? How does this treatment impact the patient's quality of life 12 months after the procedure? Participants will: Complete at least 6 months of systemic chemotherapy to ensure the disease is stable or responding (biomarker CA19-9 must decline by \>20%). Undergo a major surgical procedure involving the removal of the pancreatic tumour (total Pancreatectomy or RAMPS) and any visible abdominal metastases (Cytoreductive Surgery). Receive Hyperthermic Intraperitoneal Chemotherapy (HIPEC), where heated Cisplatin and Paclitaxel are circulated in the abdominal cavity for 90 minutes during the operation. Participate in long-term follow-up to monitor recurrence-free and overall survival.
Trial Details
NCT Number NCT07493421
Lead Sponsor Unidade Local de Saúde São João
Collaborators: Universitätsklinikum Hamburg-Eppendorf, The Champalimaud Centre, Lisbon, Portugal, Leiden University Medical Center, Shanghai Zhongshan Hospital
Conditions Pancreatic Adenocarcinoma, Peritoneal (Metastatic) Cancer
Enrollment 20 participants
Start Date 2026-03-01
Primary Completion 2027-10-01 (estimated)
Study Completion 2028-10-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-25