To Evaluate the Feasibility and Safety of Combining Surgery (Pancreatectomy and Cytoreduction) With HIPEC for Treating Pancreatic Cancer With Peritoneal Involvement.
Recruiting now · Not applicable
Conditions studied: Pancreatic Adenocarcinoma, Peritoneal (Metastatic) Cancer
In brief
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.
Key facts
- Study ID
- NCT07493421
- Run by
- Unidade Local de Saúde São João
- People needed
- 20
- Starts
- 2026-03-01
- Expected to finish
- 2028-10-01
- Last updated by the study team
- 2026-03-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Pancreatic adenocarcinoma
- Histologically confirmed peritoneal metastasis
- Excluded other sites of metastasis (except ovary)
- PCI less than or equal to 6
- Age > 18 years
- ECOG performance status 0-1
- Written informed consent
You may not qualify if…
- Pregnancy
- Intestinal obstruction
- Renal insufficiency (GFR < 45 ml/min)
Where it is running
- ULS São João — Porto, Portugal (enrolling)
- Zhongshan Hospital, Fudan University — Shanghai, shangaiShanghai Municipality, China
- Botton/Chamaplimaud Pancreatic cancer center — Lisbon, Lisbon District, Portugal
Full record on ClinicalTrials.gov
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