Removal of the pancreas and visible abdominal tumors plus heated chemotherapy in the belly for pancreatic cancer that has spread to the peritoneum.
Cytoreductive Surgery and HIPEC for Pancreatic Cancer With Peritoneal Metastasis - IGNIS Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Unidade Local de Saúde São João Government |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Shanghai, shangaiShanghai Municipality and 2 other locations) |
| Trial ID | NCT07493421 on ClinicalTrials.gov |
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.
Who should consider this trial
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%.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shanghai, shangaiShanghai Municipality and 2 other locations
- Zhongshan Hospital, Fudan University — Shanghai, shangaiShanghai Municipality, China (Not_yet_recruiting)
- Botton/Chamaplimaud Pancreatic cancer center — Lisbon, Lisbon District, Portugal (Not_yet_recruiting)
- ULS São João — Porto, Portugal (Recruiting)
Study contacts
- Study coordinator: Tiago Bouça-Machado, MD
- Email: tiago.machado@chsj.min-saude.pt
- Phone: +351 225 512 100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.