Removal of the pancreas and visible abdominal tumors plus heated chemotherapy in the belly for pancreatic cancer that has spread to the peritoneum.
Official title: Cytoreductive Surgery and HIPEC for Pancreatic Cancer With Peritoneal Metastasis - IGNIS Trial
Run by Unidade Local de Saúde São João, Oporto · NCT07493421 · Data updated 2026-11-12
This trial will test whether removing the pancreas and visible abdominal tumors followed by heated intraperitoneal chemotherapy is safe and feasible for adults with pancreatic ductal adenocarcinoma who have limited peritoneal spread and have responded to at least six months of systemic chemotherapy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Unidade Local de Saúde São João, Oporto Government |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Shanghai, shangaiShanghai Municipality and 2 other locations) |
| Status | Recruiting |
| Started | March 1, 2026 |
| Main results expected | October 1, 2027 |
| Study ends | October 1, 2028 |
| Registry record updated | March 25, 2026 |
| Trial ID | NCT07493421 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with pancreatic ductal adenocarcinoma and confirmed peritoneal metastases, limited peritoneal tumor burden (PCI ≤ 6), no other distant metastases (except ovary), ECOG 0–1, and documented stability or response after at least six months of systemic chemotherapy with a CA19-9 drop >20%.
✕Probably not a fit
Patients with widespread metastatic disease (PCI > 6 or other distant metastases), poor performance status, intestinal obstruction, significant renal insufficiency, pregnancy, or who have not had an adequate systemic chemotherapy response are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional feasibility/safety protocol enrolls adults with histologically confirmed pancreatic ductal adenocarcinoma and synchronous peritoneal metastases who have completed at least six months of systemic chemotherapy with a CA19-9 decline of >20% and have limited disease burden (PCI ≤ 6) and ECOG 0–1. Eligible participants undergo a major operation (total pancreatectomy or RAMPS) combined with cytoreductive surgery to remove visible peritoneal tumor followed immediately by hyperthermic intraperitoneal chemotherapy (HIPEC). Primary outcomes include 90-day mortality, postoperative morbidity measured by the Clavien–Dindo classification, and quality of life at 12 months. Key exclusions include other distant metastases (except ovarian), intestinal obstruction, significant renal impairment (GFR <45 ml/min), and pregnancy.
Why it matters
Potential benefit: If safe and feasible, this combined approach could offer a curative-intent or life-prolonging option and improve quality of life for a small group of patients with limited peritoneal spread from pancreatic cancer.
How similar studies have gone: Cytoreductive surgery with HIPEC has shown benefit in selected peritoneal cancers such as appendiceal and ovarian disease, but its use in pancreatic cancer with peritoneal metastases is novel and currently supported by limited data.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
-
ULS São João
Porto, Portugal Recruiting -
Zhongshan Hospital, Fudan University
Shanghai, shangaiShanghai Municipality, China Not yet recruiting -
Botton/Chamaplimaud Pancreatic cancer center
Lisbon, Lisbon District, Portugal Not yet recruiting
Study contacts
- Study coordinator: Tiago Bouça-Machado, MD
- Email: tiago.machado@chsj.min-saude.pt
- Phone: +351 225 512 100
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.