Skip to main content
Clinical Trials/NCT07493421
NCT07493421RecruitingNot Applicable

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

Unidade Local de Saúde São João3 sites in 2 countries20 target enrollmentStarted: March 1, 2026Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
20
Locations
3
Primary Endpoint
Mortality

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Outcomes

Primary Outcomes

Mortality

Time Frame: In-hospital or 90 days after surgery

Measurement of postoperative mortality will be recorded

Morbidity

Time Frame: In-hospital or 90 days after surgery

Post-operative morbidity will be recorded and classified according to Clavien-Dindo classification

Secondary Outcomes

  • Quality of Life after the Procedure(12 months post-surgery)
  • Recurrence-Free Survival(12 months from surgery)
  • Overall Survival(12 months from surgery)

Investigators

Sponsor
Unidade Local de Saúde São João
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Tiago Bouça-Machado

MD

Unidade Local de Saúde São João

Study Sites (3)

Loading locations...

Similar Trials