Pancreatic AdenocarcinomaNCT07493421
To Evaluate the Feasibility and Safety of Combining Surgery (Pancreatectomy and Cytoreduction) With HIPEC for Treating Pancreatic Cancer With Peritoneal Involvement.
A study testing Pancreatectomy, Complete Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in people with Pancreatic Adenocarcinoma and Peritoneal (Metastatic) Cancer, run by Unidade Local de Saúde São João, Oporto at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma, Peritoneal (Metastatic) Cancer
- What is being tested?
- Pancreatectomy, Complete Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Mar 2026to 1 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Intestinal obstruction
- Renal insufficiency (GFR < 45 ml/min)
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Portugal2 sites, 2 recruiting
- Not yet recruiting
Botton/Chamaplimaud Pancreatic cancer center
Lisbon, Lisbon District, 1400-038
Gil Gonçalves, MD, +351919362204, Gil.goncalves@fundacaochampalimaud.pt
Gil Gonçalves, MD
- Recruiting
ULS São João
Porto, 4200-319
Tiago Bouça-Machado, MD, +351 225 512 100, tiago.machado@chsj.min-saude.pt
tiago.machado@chsj.min-saude.pt
China1 site, 1 recruiting
- Not yet recruiting
Zhongshan Hospital, Fudan University
Shanghai, shangaiShanghai Municipality, 200000
Yaolin Xu, 8618817583729, xu.yaolin@zs-hospital.sh.cn
Liang Liu, Dr.
About this study
Official title: Cytoreductive Surgery and HIPEC for Pancreatic Cancer With Peritoneal Metastasis - IGNIS Trial
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?
Read more
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.
- Being tested
- Pancreatectomy, Complete Cytoreduction, Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
- Keywords
- Pancreatic Cancer, Cytoreduction Surgical Procedures, Hyperthermic Intraperitoneal Chemotherapy, Peritoneal Metastasis, Peritoneal Carcinomatosis
- Medical subject headings
- Neoplasm Metastasis, Neoplasms, Pancreatic Neoplasms, Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PancreatectomyProcedure or surgery
Also called Total pancreatectomy, Radical Antegrade Modular Pancreatosplenectomy, RAMPS
Total pancreatectomy for head tumours or radical antegrade modular pancreatosplenectomy (RAMPS) for distal tumours
Complete CytoreductionProcedure or surgery
Also called CRS
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
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Pancreatectomy, combined with complete cytoreduction and HIPEC Receives: Procedure: Pancreatectomy; Procedure: Complete Cytoreduction; Other: Hyperthermic Intraperitoneal Chemotherapy (HIPEC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measurement of postoperative mortality will be recorded
Measured: In-hospital or 90 days after surgery
Morbidity
Post-operative morbidity will be recorded and classified according to Clavien-Dindo classification
Measured: In-hospital or 90 days after surgery
Secondary outcomes (3)
Quality of Life after the Procedure
Assessed at 12 months post-surgery using the standardized EORTC QLQ-C30 questionnaire
Measured: 12 months post-surgery
Recurrence-Free Survival
Recurrence from surgery until cancer returns, or death from any cause
Measured: 12 months from surgery
Overall Survival
12 months OS
Measured: 12 months from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start1 Mar 2026
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, Single-Arm, Open-Label, Multicentre Feasibility Study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unidade Local de Saúde São João, Oporto
- Sponsor type
- Other government
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf, The Champalimaud Centre, Lisbon, Portugal, Leiden University Medical Center, Shanghai Zhongshan Hospital
- Responsible party
- Principal investigator, Tiago Bouça-Machado, Unidade Local de Saúde São João, Oporto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07493421
- Sponsor's protocol ID
- CE-67-2026
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytoreductive Surgery and HIPEC for Pancreatic Cancer With Peritoneal Metastasis - IGNIS Trial
- ClinicalTrials.gov ID
- NCT07493421
- Acronym / sponsor ID
- CE-67-2026
- Keywords
- Pancreatic Cancer, Cytoreduction Surgical Procedures, Hyperthermic Intraperitoneal Chemotherapy, Peritoneal Metastasis, Peritoneal Carcinomatosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Unidade Local de Saúde São João, OportoOther government
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf, The Champalimaud Centre, Lisbon, Portugal, Leiden University Medical Center, Shanghai Zhongshan Hospital
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, Single-Arm, Open-Label, Multicentre Feasibility Study
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Procedure: Pancreatectomy, Procedure: Complete Cytoreduction, Other: Hyperthermic Intraperitoneal Chemotherapy (HIPEC)Pancreatectomy, combined with complete cytoreduction and HIPEC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pancreatic adenocarcinoma
- Histologically confirmed peritoneal metastasis
- Excluded other sites of metastasis (except ovary)
- PCI less than or equal to 6
- Age > 18 years
Key exclusion criteria (3 listed)
- Pregnancy
- Intestinal obstruction
- Renal insufficiency (GFR < 45 ml/min)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PancreatectomyAlso: Total pancreatectomy, Radical Antegrade Modular Pancreatosplenectomy, RAMPSTotal pancreatectomy for head tumours or radical antegrade modular pancreatosplenectomy (RAMPS) for distal tumours | Procedure or surgery | Experimental arm |
| Complete CytoreductionAlso: CRSResection 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 | Procedure or surgery | Experimental arm |
| Hyperthermic Intraperitoneal Chemotherapy (HIPEC)HIPEC with Cisplatin (100 mg/m2) and Paclitaxel (175 mg/m2) is performed for 90 minutes in a closed fashion | Other | Experimental arm |
Primary outcome
Mortality
Time frame: In-hospital or 90 days after surgery
Measurement of postoperative mortality will be recorded
Morbidity
Time frame: In-hospital or 90 days after surgery
Post-operative morbidity will be recorded and classified according to Clavien-Dindo classification
3 secondary outcomes
Quality of Life after the Procedure
Time frame: 12 months post-surgery
Recurrence-Free Survival
Time frame: 12 months from surgery
Overall Survival
Time frame: 12 months from surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pancreatectomy, Complete Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in people with Pancreatic Adenocarcinoma and Peritoneal (Metastatic) Cancer, run by Unidade Local de Saúde São João, Oporto at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Portugal, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tiago Bouça-Machado, MD (+351 225 512 100, tiago.machado@chsj.min-saude.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: In-hospital or 90 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.