Adenocarcinoma PancreasPhase 1NCT07253662
Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Patients With Peritoneal Metastasis From Pancreatic Adenocarcinoma
A Phase 1 study testing PIPAC and Nab-paclitaxel in people with Adenocarcinoma Pancreas, run by Northwell Health at 1 site in United States.
Trial summary
Palliative systemic therapy is the standard treatment option for patients with pancreatic ductal adenocarcinoma (PDAC) and peritoneal metastasis (PM), who have a median overall survival of only 6-11 months and a serious adverse event (SAE) rate of >5%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma Pancreas
- What is being tested?
- PIPAC and Nab-paclitaxel
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2026to 30 Dec 2027
- Phase
- Phase 1
- 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
- Ability to understand and sign informed consent form
- Age ≥18 years
- Patient must have histologically confirmed pancreatic adenocarcinoma with either histologic confirmation or strong suspicion of peritoneal metastasis on cross sectional imaging
- ECOG performance status ≤ 2
- Pre-treatment Laboratory Parameters:
- Absolute neutrophil count (ANC) > 1500/mm3
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- Platelets > 100,000/mm3
- Hemoglobin > 9 g/dl
- Serum total bilirubin < 1.5 x upper limit of normal (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN, unless patient is known to have chronic liver disease (hepatitis) in which case AST and ALT must be ≤ 5 x ULN.
- Creatinine clearance (Ccr) > 40 ml/min
- No contraindications for a laparoscopy.
- The peritoneal disease does not have to be measurable by RECIST 1.1 but needs to visible on cross sectional imaging or diagnostic laparoscopy.
- For patients with a known history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Patients with a known history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
- Women of childbearing potential (WOCBP) and male patients with WOCBP partner must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 6 months after the PIPAC or last dose of chemotherapy in such a manner that the risk of pregnancy is minimized .-WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal. Post menopause is defined as:
- Amenorrhea ≥ 12 consecutive months without another cause or For women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered of childbearing potential.
- Laparoscopy findings must meet all of the below criteria in order to proceed to PIPAC:
- PIPAC access is feasible
- There is room for aerosol therapy
- There is no evidence of impending bowel obstruction
- < 5 L of ascites
- Not a candidate for cytoreduction and HIPEC
Who cannot join
- Confirmed or suspected extra-peritoneal metastasis
- Bowel obstruction requiring nasogastric tube, percutaneous endoscopic gastrostomy or exclusive total parenteral nutrition.
- Life expectancy of less than 4 months.
- Prior intra-abdominal aerosol chemotherapy
- Previous anaphylactic reaction to the nab-paclitaxel drug used.
- Intra-abdominal Ascites >5L
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- Patients may not be receiving any other investigational agents.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias, severe renal impairment, myelosuppression, or severe hepatic impairment.
- Immunocompromised patients such as those with an immunosuppressive medication or a known disease of the immune system.
- New York Heart Association (NYHA) Class 3 or 4; myocardial infarction, acute coronary syndrome, diabetes mellitus with ketoacidosis or chronic obstructive pulmonary disease (COPD) requiring hospitalization in the preceding 6 months.
- Exclusive total parenteral nutrition.
- Pregnancy. Patients with psychiatric illness/social situations that would limit compliance with study requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Zuckerberg Cancer Center
New Hyde Park, New York, 11040
About this study
Official title: Phase I Trial of Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Patients With Peritoneal Metastasis From Pancreatic Adenocarcinoma
Palliative systemic therapy is the standard treatment option for patients with pancreatic ductal adenocarcinoma (PDAC) and peritoneal metastasis (PM), who have a median overall survival of only 6-11 months and a serious adverse event (SAE) rate of >5%. Patients with peritoneal-only metastasis may demonstrate unique tumor biology with less potential for hematogenous and lymphatic spread, making them potential candidates for a regional approach directed at the peritoneum. PIPAC is a drug- delivery system that combines the pharmacokinetic advantages of low- dose intraperitoneal chemotherapy (high tumor tissue penetration with low systemic absorption/toxicity) with the principles of aerosolization (homogenous intraperitoneal distribution and deeper tissue penetration). PIPAC may offer a complimentary approach to maximize drug delivery to tumor implants, potentially improving quality of life and survival without significant additional morbidity. Several non-randomized studies have evaluated safety, feasibility, and efficacy of PIPAC with various intraperitoneal agents in a variety of tumor types. Very few patients with pancreatic cancer PM have been included in these studies and most have been treated with either PIPAC-oxaliplatin or doxorubicin/cisplatin. A recent phase 1 dose-escalation study included patients with ovarian, gastric, breast, and hepatopancreatobiliary malignancies. One patient with
pancreatic cancer was included in this study. The recommended phase 2 dose was 140 mg/m2, with guidance to decrease the dose to 112.5 mg/m2 in patients with hepatic impairment. Therefore, the dose utilized in this study is 112.5 mg/m2. This recommendation was based on concern for nab-paclitaxel hepatotoxicity, but there was no data presented to support this expert recommendation.
This study sets out to explore the role of PIPAC with nab-paclitaxel in combination with medical oncology choice standard of care therapy in this patient population.
- Conditions
- Adenocarcinoma Pancreas
- Being tested
- PIPAC, Nab-paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIPACDevice
Pressurized Intra Peritoneal Aerosol Chemotherapy (PIPAC) is a novel therapeutic approach that is minimally invasive, does not require cytoreduction (laparotomy) and can be frequently repeated. PIPAC entails accessing the abdominal cavity using standard laparoscopic techniques with the chemotherapeutics aerosolized via a high-pressure micro-injection pump (MIP) . PIPAC has not yet been investigated in the US and remains investigational in Europe. A MIP is utilized to aerosolize and deliver chemotherapeutic medications into the abdominal cavity during laparoscopy for treatment of primary and secondary peritoneal malignancy. The study device consists of a nebulizer, that when connected to a high-pressure injector, is inserted into the abdomen during a laparoscopic procedure. Pressurization of the liquid chemotherapy through the study device results in aerosolization of the chemotherapy intra-abdominally. The device is single use and not re-sterilized. It is removed at the conclusion
Nab-paclitaxelDrug
The dose for this intervention will be 112.5mg/m2, for which the rationale is provided in section 4.3: Justification of Dose. Nab-paclitaxel will be delivered during the PIPAC procedures via the device described above over 5 minutes and will remain in contact with the peritoneum for 30 minutes, after which the pneumoperitoneum will be evacuated, and the abdomen closed. Nab-paclitaxel is diluted in total volume of 200 ml NaCl 0.9%. The solution will be used within 4 hours of reconstitution per prescribing recommendation (if longer, a new solution will be reconstituted). This will be repeated twice, every six weeks, for a total of three PIPAC procedures.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Arm | Experimental | This study is a prospective single center, non-randomized phase I trial to confirm the safety of PIPAC with nab- paclitaxel in conjunction with standard of care systemic therapy in patients with peritoneal-only metastasis from PDAC. The efficacy signals noted in this trial will inform a potential phase II/III multicenter clinical trial.
Patients may receive up to 3 treatments whilst enrolled on the study, with a potential opportunity to extend outside of the trial for compassionate use. Receives: Device: PIPAC; Drug: Nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
To confirm the safety and tolerability of PIPAC with nab-paclitaxel in conjunction with medical oncologist choice standard of care therapy with CTCAE v5.0
DLTs are defined as any of the following events (based on CTCAE v5 and Clavien Dindo) during the first PIPAC cycle and attributable to PIPAC:
Any grade 3 or 4 non-hematologic toxicity, excluding:
Grade 3 nausea, vomiting, abdominal pain, or diarrhea that is adequately treated to grade 2 or lower within 48 hours.
Grade 3 fatigue that returns to grade 2 or less within 7 days.
Grade 3 laboratory/metabolic abnormalities that are not considered clinically significant or are easily correctable to grade 2 or lower within 72 hours.
Grade 3 infusion-related reaction (first occurrence and in the absence of steroid prophylaxis) that resolves within 6 hours with appropriate clinical management.
Grade 3 peripheral neuropathy
Surgical complication of Clavien-Dindo grade IIIB or greater
Measured: 2 years
To confirm the safety and tolerability of PIPAC with nab-paclitaxel in conjunction with medical oncologist choice standard of care therapy. Measurement of AEs according to NCI CTCAE version 5.0 during the first cycle, or throughout the 6 weeks following
Safety: DLTs during the safety evaluation period (6 weeks after initial PIPAC)
DLTs are defined as any of the following events (based of CTCAE v5 and Clavien Dindo) during the first PIPAC cycle and attributable to PIPAC:
Any Grade 3 laboratory/metabolic abnormality that requires medical intervention, irrespective of the duration of the event
Any grade 3 or 4 non-hematologic toxicity excluding:
Grade 3 treated nausea, vomiting, abdominal pain, or diarrhea that is adequately treated to grade 2 or lower within 48 hours.
Grade 3 fatigue that returns to grade 2 or less within 7 days.
Grade 3 laboratory/metabolic abnormalities that are not considered clinically significant or are easily correctable to grade 2 or lower within 72 hours.
Grade 3 infusion related reaction (first occurrence and in the absence of steroid prophylaxis) that resolves within 6 hours with appropriate clinical management.
Grade 3 peripheral neuropathy
Surgical complication of Clavien-Dindo grade IIIB
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start11 Jan 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma PancreasStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07253662
- Sponsor's protocol ID
- 25-0087
- Status last verified
- Jun 2026
- First submitted
- 26 Sep 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared outside the Northwell institution.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Patients With Peritoneal Metastasis From Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT07253662
- Acronym / sponsor ID
- 25-0087
- Conditions
- Adenocarcinoma Pancreas
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 11 Jan 2026 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 28 Nov 2025 (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.
Palliative systemic therapy is the standard treatment option for patients with pancreatic ductal adenocarcinoma (PDAC) and peritoneal metastasis (PM), who have a median overall survival of only 6-11 months and a serious adverse event (SAE) rate of >5%. Patients with peritoneal-only metastasis may demonstrate unique tumor biology with less potential for hematogenous and lymphatic spread, making them potential candidates for a regional approach directed at the peritoneum. PIPAC is a drug- delivery system that combines the pharmacokinetic advantages of low- dose intraperitoneal chemotherapy (high tumor tissue penetration with low systemic absorption/toxicity) with the principles of aerosolization (homogenous intraperitoneal distribution and deeper tissue penetration). PIPAC may offer a complimentary approach to maximize drug delivery to tumor implants, potentially improving quality of life and survival without significant additional morbidity. Several non-randomized studies have evaluated safety, feasibility, and efficacy of PIPAC with various intraperitoneal agents in a variety of tumor types. Very few patients with pancreatic cancer PM have been included in these studies and most have been treated with either PIPAC-oxaliplatin or doxorubicin/cisplatin. A recent phase 1 dose-escalation study included patients with ovarian, gastric, breast, and hepatopancreatobiliary malignancies. One patient with
pancreatic cancer was included in this study. The recommended phase 2 dose was 140 mg/m2, with guidance to decrease the dose to 112.5 mg/m2 in patients with hepatic impairment. Therefore, the dose utilized in this study is 112.5 mg/m2. This recommendation was based on concern for nab-paclitaxel hepatotoxicity, but there was no data presented to support this expert recommendation.
This study sets out to explore the role of PIPAC with nab-paclitaxel in combination with medical oncology choice standard of care therapy in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm | Experimental | Device: PIPAC, Drug: Nab-paclitaxelThis study is a prospective single center, non-randomized phase I trial to confirm the safety of PIPAC with nab- paclitaxel in conjunction with standard of care systemic therapy in patients with peritoneal-only metastasis from PDAC. The efficacy signals noted in this trial will inform a potential phase II/III multicenter clinical trial. Patients may receive up to 3 treatments whilst enrolled on the study, with a potential opportunity to extend outside of the trial for compassionate use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Ability to understand and sign informed consent form
- Age ≥18 years
- Patient must have histologically confirmed pancreatic adenocarcinoma with either histologic confirmation or strong suspicion of peritoneal metastasis on cross sectional imaging
- ECOG performance status ≤ 2
- Pre-treatment Laboratory Parameters:
Key exclusion criteria (12 listed)
- Confirmed or suspected extra-peritoneal metastasis
- Bowel obstruction requiring nasogastric tube, percutaneous endoscopic gastrostomy or exclusive total parenteral nutrition.
- Life expectancy of less than 4 months.
- Prior intra-abdominal aerosol chemotherapy
- Previous anaphylactic reaction to the nab-paclitaxel drug used.
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 |
|---|---|---|
| PIPACPressurized Intra Peritoneal Aerosol Chemotherapy (PIPAC) is a novel therapeutic approach that is minimally invasive, does not require cytoreduction (laparotomy) and can be frequently repeated. PIPAC entails accessing the abdominal cavity using standard laparoscopic techniques with the chemotherapeutics aerosolized via a high-pressure micro-injection pump (MIP) . PIPAC has not yet been investigated in the US and remains investigational in Europe. A MIP is utilized to aerosolize and deliver chemotherapeutic medications into the abdominal cavity during laparoscopy for treatment of primary and secondary peritoneal malignancy. The study device consists of a nebulizer, that when connected to a high-pressure injector, is inserted into the abdomen during a laparoscopic procedure. Pressurization of the liquid chemotherapy through the study device results in aerosolization of the chemotherapy intra-abdominally. The device is single use and not re-sterilized. It is removed at the conclusion | Device | Interventional Arm |
| Nab-paclitaxelThe dose for this intervention will be 112.5mg/m2, for which the rationale is provided in section 4.3: Justification of Dose. Nab-paclitaxel will be delivered during the PIPAC procedures via the device described above over 5 minutes and will remain in contact with the peritoneum for 30 minutes, after which the pneumoperitoneum will be evacuated, and the abdomen closed. Nab-paclitaxel is diluted in total volume of 200 ml NaCl 0.9%. The solution will be used within 4 hours of reconstitution per prescribing recommendation (if longer, a new solution will be reconstituted). This will be repeated twice, every six weeks, for a total of three PIPAC procedures. | Drug | Interventional Arm |
Primary outcome
To confirm the safety and tolerability of PIPAC with nab-paclitaxel in conjunction with medical oncologist choice standard of care therapy with CTCAE v5.0
Time frame: 2 years
DLTs are defined as any of the following events (based on CTCAE v5 and Clavien Dindo) during the first PIPAC cycle and attributable to PIPAC: Any grade 3 or 4 non-hematologic toxicity, excluding: Grade 3 nausea, vomiting, abdominal pain, or diarrhea that is adequately treated to grade 2 or lower within 48 hours. Grade 3 fatigue that returns to grade 2 or less within 7 days. Grade 3 laboratory/metabolic abnormalities that are not considered clinically significant or are easily correctable to grade 2 or lower within 72 hours. Grade 3 infusion-related reaction (first occurrence and in the absence of steroid prophylaxis) that resolves within 6 hours with appropriate clinical management. Grade 3 peripheral neuropathy Surgical complication of Clavien-Dindo grade IIIB or greater
To confirm the safety and tolerability of PIPAC with nab-paclitaxel in conjunction with medical oncologist choice standard of care therapy. Measurement of AEs according to NCI CTCAE version 5.0 during the first cycle, or throughout the 6 weeks following
Time frame: 2 years
Safety: DLTs during the safety evaluation period (6 weeks after initial PIPAC) DLTs are defined as any of the following events (based of CTCAE v5 and Clavien Dindo) during the first PIPAC cycle and attributable to PIPAC: Any Grade 3 laboratory/metabolic abnormality that requires medical intervention, irrespective of the duration of the event Any grade 3 or 4 non-hematologic toxicity excluding: Grade 3 treated nausea, vomiting, abdominal pain, or diarrhea that is adequately treated to grade 2 or lower within 48 hours. Grade 3 fatigue that returns to grade 2 or less within 7 days. Grade 3 laboratory/metabolic abnormalities that are not considered clinically significant or are easily correctable to grade 2 or lower within 72 hours. Grade 3 infusion related reaction (first occurrence and in the absence of steroid prophylaxis) that resolves within 6 hours with appropriate clinical management. Grade 3 peripheral neuropathy Surgical complication of Clavien-Dindo grade IIIB
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 3 Jun 2026.
- Individual participant dataSharing planned: No. Data will not be shared outside the Northwell institution.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PIPAC and Nab-paclitaxel in people with Adenocarcinoma Pancreas, run by Northwell Health at 1 site in United States.
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 23 inclusion and 12 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 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 GI Trial Referral Team ((516) 734-8900, gitrialreferral@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To confirm the safety and tolerability of PIPAC with nab-paclitaxel in conjunction with medical oncologist choice standard of care therapy with CTCAE v5.0 (time frame: 2 years). 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 3 Jun 2026.