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NCT07493421Recruiting

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

Source: ClinicalTrials.gov · Last updated 25 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
20 (estimated)
First submitted
14 Mar 2026
Start date
1 Mar 2026
Primary completion date
1 Oct 2027
Lead sponsor
Unidade Local de Saúde São João, Oporto
NCT number
NCT07493421

What you commit to

  • Study type: Interventional
  • Planned participants: 20
  • From 1 Mar 2026 to the primary completion date, 1 Oct 2027
  • 3 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

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

Other

  • Pregnancy
  • Intestinal obstruction

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Zhongshan Hospital,Fudan University
Coordinator of this site? Confirm its status
ShanghaiChinaNot yet recruiting
Botton/Chamaplimaud Pancreatic cancer center
Coordinator of this site? Confirm its status
LisbonPortugalNot yet recruiting
ULS São João
Coordinator of this site? Confirm its status
PortoPortugalRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.