Actively Recruiting
To Evaluate the Feasibility and Safety of Combining Surgery (Pancreatectomy and Cytoreduction) With HIPEC for Treating Pancreatic Cancer With Peritoneal Involvement.
Led by Unidade Local de Saúde São João · Updated on 2026-03-25
20
Participants Needed
3
Research Sites
135 weeks
Total Duration
On this page
Sponsors
U
Unidade Local de Saúde São João
Lead Sponsor
U
Universitätsklinikum Hamburg-Eppendorf
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
To Evaluate the Feasibility and Safety of Combining Surgery (Pancreatectomy and Cytoreduction) With HIPEC for Treating Pancreatic Cancer With Peritoneal Involvement.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with pancreatic adenocarcinoma
- Histologically confirmed peritoneal metastasis
- No other metastases except possibly ovary
- Peritoneal Cancer Index (PCI) of 6 or less
- Age over 18 years
- ECOG performance status 0 or 1
- Able to give written informed consent
You will not qualify if you...
- Pregnant or breastfeeding
- Intestinal obstruction
- Kidney function with GFR less than 45 ml/min
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Zhongshan Hospital, Fudan University
Shanghai, shangaiShanghai Municipality, China, 200000
Not Yet Recruiting
2
Botton/Chamaplimaud Pancreatic cancer center
Lisbon, Lisbon District, Portugal, 1400-038
Not Yet Recruiting
3
ULS São João
Porto, Portugal, 4200-319
Actively Recruiting
Research Team
T
Tiago Bouça-Machado, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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