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Clinical Trial NCT07493421 for Pancreatic Adenocarcinoma, Peritoneal (Metastatic) Cancer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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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. 20 Biomarker-Driven Long-Term Follow-up Overall Survival

Recruiting
Clinical Trial NCT07493421 is an interventional study for Pancreatic Adenocarcinoma, Peritoneal (Metastatic) Cancer that is recruiting. It started on 1 March 2026 with plans to enroll 20 participants. Led by Unidade Local de Saúde São João, it is expected to complete by 1 October 2028. The latest data from ClinicalTrials.gov was last updated on 25 March 2026.
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 th...

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Official Title

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

Conditions
Pancreatic AdenocarcinomaPeritoneal (Metastatic) Cancer
Other Study IDs
  • CE-67-2026
NCT ID Number
NCT07493421
Start Date (Actual)
2026-03-01
Last Update Posted
2026-03-25
Completion Date (Estimated)
2028-10-01
Enrollment (Estimated)
20
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Pancreatic Cancer
Cytoreduction Surgical Procedures
Hyperthermic Intraperitoneal Chemotherapy
Peritoneal Metastasis
Peritoneal Carcinomatosis
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalExperimental arm
Pancreatectomy, combined with complete cytoreduction and HIPEC
Pancreatectomy
Total pancreatectomy for head tumours or radical antegrade modular pancreatosplenectomy (RAMPS) for distal tumours
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
Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
HIPEC with Cisplatin (100 mg/m2) and Paclitaxel (175 mg/m2) is performed for 90 minutes in a closed fashion
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Mortality
Measurement of postoperative mortality will be recorded
In-hospital or 90 days after surgery
Morbidity
Post-operative morbidity will be recorded and classified according to Clavien-Dindo classification
In-hospital or 90 days after surgery
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Quality of Life after the Procedure
Assessed at 12 months post-surgery using the standardized EORTC QLQ-C30 questionnaire
12 months post-surgery
Recurrence-Free Survival
Recurrence from surgery until cancer returns, or death from any cause
12 months from surgery
Overall Survival
12 months OS
12 months from surgery
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • Pregnancy
  • Intestinal obstruction
  • Renal insufficiency (GFR < 45 ml/min)
Unidade Local de Saúde São João logoUnidade Local de Saúde São João
Study Responsible Party
Tiago Bouça-Machado, Principal Investigator, MD, Unidade Local de Saúde São João
Study Central Contact
Contact: Tiago Bouça-Machado, MD, +351 225 512 100, [email protected]
3 Study Locations in 2 Countries

shangaiShanghai Municipality

Zhongshan Hospital, Fudan University, Shanghai, shangaiShanghai Municipality, 200000, China
Yaolin Xu, Contact, 8618817583729, [email protected]
Liang Liu, Dr., Principal Investigator
Yaolin Xu, Dr., Sub-Investigator
Not yet recruiting

Lisbon District

Botton/Chamaplimaud Pancreatic cancer center, Lisbon, Lisbon District, 1400-038, Portugal
Gil Gonçalves, MD, Contact, +351919362204, [email protected]
Gil Gonçalves, MD, Principal Investigator
Not yet recruiting
ULS São João, Porto, 4200-319, Portugal
Tiago Bouça-Machado, MD, Contact, +351 225 512 100, [email protected]
Contact, [email protected]
Tiago Bouça-Machado, MD, Principal Investigator
Recruiting