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NCT Number: NCT07493421

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

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.

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Key information

Conditions

Pancreatic Adenocarcinoma Abdominal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Peritoneal (Metastatic) Cancer Peritoneal Diseases Peritoneal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Hospital, Fudan University, Shanghai, shangaiShanghai Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pancreatectomy

Procedure

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

Other names: Total pancreatectomy, Radical Antegrade Modular Pancreatosplenectomy, RAMPS

Complete Cytoreduction

Procedure

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

Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Other

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

Primary outcomes

  1. Mortality

    Time frame: In-hospital or 90 days after surgery

    Measurement of postoperative mortality will be recorded

  2. 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

  1. 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

  2. Recurrence-Free Survival

    Time frame: 12 months from surgery

    Recurrence from surgery until cancer returns, or death from any cause

  3. Overall Survival

    Time frame: 12 months from surgery

    12 months OS

Study contacts

Contact information is provided by the study sponsor or research team.

Tiago Bouça-Machado, MD

CONTACT

[email protected]

+351 225 512 100

Sponsors and collaborators

Lead sponsor

Unidade Local de Saúde São João

Other Gov

Collaborators

  • Leiden University Medical Center
  • Shanghai Zhongshan Hospital
  • The Champalimaud Centre, Lisbon, Portugal
  • Universitätsklinikum Hamburg-Eppendorf

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 25, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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