Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07493421

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding
  • Intestinal obstruction
  • Kidney function with GFR less than 45 ml/min

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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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

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