RecruitingNot ApplicableNCT07493421

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

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


Sponsor

Unidade Local de Saúde São João

Enrollment

20 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria3

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

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Interventions

PROCEDUREPancreatectomy

Total pancreatectomy for head tumours or radical antegrade modular pancreatosplenectomy (RAMPS) for distal tumours

PROCEDUREComplete 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

OTHERHyperthermic Intraperitoneal Chemotherapy (HIPEC)

HIPEC with Cisplatin (100 mg/m2) and Paclitaxel (175 mg/m2) is performed for 90 minutes in a closed fashion


Locations(3)

Zhongshan Hospital, Fudan University

Shanghai, shangaiShanghai Municipality, China

Botton/Chamaplimaud Pancreatic cancer center

Lisbon, Lisbon District, Portugal

ULS São João

Porto, Portugal

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NCT07493421


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