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

March 20, 2026 updated by: Tiago Bouça-Machado, Unidade Local de Saúde São João

Cytoreductive Surgery and HIPEC for Pancreatic Cancer With Peritoneal Metastasis - IGNIS Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • shangaiShanghai Municipality
      • Shanghai, shangaiShanghai Municipality, China, 200000
        • Not yet recruiting
        • Zhongshan Hospital, Fudan University
        • Contact:
        • Principal Investigator:
          • Liang Liu, Dr.
        • Sub-Investigator:
          • Yaolin Xu, Dr.
  • Portugal
    • Lisbon District
      • Lisbon, Lisbon District, Portugal, 1400-038
        • Not yet recruiting
        • Botton/Chamaplimaud Pancreatic cancer center
        • Contact:
        • Principal Investigator:
          • Gil Gonçalves, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Pregnancy
  • Intestinal obstruction
  • Renal insufficiency (GFR < 45 ml/min)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental arm
Pancreatectomy, combined with complete cytoreduction and HIPEC
Procedure: Pancreatectomy
Total pancreatectomy for head tumours or radical antegrade modular pancreatosplenectomy (RAMPS) for distal tumours
Other Names:
  • Total pancreatectomy
  • Radical Antegrade Modular Pancreatosplenectomy
  • RAMPS
Procedure: Complete Cytoreduction
Resection of all macroscopic peritoneal metastases, but also the greater and lesser omentum, the round ligament of the liver, the appendix and the ovaries, in case of female patients
Other Names:
  • CRS
Other: Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
HIPEC with Cisplatin (100 mg/m2) and Paclitaxel (175 mg/m2) is performed for 90 minutes in a closed fashion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: In-hospital or 90 days after surgery
Measurement of postoperative mortality will be recorded
In-hospital or 90 days after surgery
Morbidity
Time Frame: In-hospital or 90 days after surgery
Post-operative morbidity will be recorded and classified according to Clavien-Dindo classification
In-hospital or 90 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life after the Procedure
Time Frame: 12 months post-surgery
Assessed at 12 months post-surgery using the standardized EORTC QLQ-C30 questionnaire
12 months post-surgery
Recurrence-Free Survival
Time Frame: 12 months from surgery
Recurrence from surgery until cancer returns, or death from any cause
12 months from surgery
Overall Survival
Time Frame: 12 months from surgery
12 months OS
12 months from surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unidade Local de Saúde São João

Collaborators

Shanghai Zhongshan Hospital
Leiden University Medical Center
The Champalimaud Centre, Lisbon, Portugal
University Medical Center Hamburg-Eppendorf (UKE)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

March 14, 2026

First Submitted That Met QC Criteria

March 20, 2026

First Posted (Actual)

March 25, 2026

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE-67-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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