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PIPAC with nab-paclitaxel for Pancreatic Cancer with Peritoneal Metastasis

This study is looking at a new way to treat pancreatic cancer that has spread to the lining of the abdomen (peritoneal metastasis). It uses a treatment called Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) to deliver the drug nab-paclitaxel directly into the abdomen. This is done with a device that sprays the medicine. The main goal is to see how safe and tolerable this treatment is when given along with your doctor's usual care. They will be watching for any side effects for up to two years. This study plans to enroll 10 participants who are at least 18 years old and have pancreatic adenocarcinoma with peritoneal metastasis. The study status is currently unclear.

Study design
This is an interventional study with a planned enrollment of 10 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety and tolerability for up to 2 years after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07253662

Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Patients With Peritoneal Metastasis From Pancreatic Adenocarcinoma

Recruiting
PHASE1Ages 18+InterventionalTreatment
Northwell Health
~10 participants
Updated 2026-06-03 on ClinicalTrials.gov
What's tested:PIPACNab-paclitaxel

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over 2 years
+1 more outcome measured

Conditions

Adenocarcinoma Pancreas

Explore related trials

Pancreatic Adenocarcinoma

NCT07253662

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Zuckerberg Cancer Center

    New Hyde Park, New Yorkno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

GI Trial Referral Team
[email protected]
(516) 734-8900
Email the study team

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Eligibility criteria

Inclusion

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
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:
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

Exclusion

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
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.

What this trial measures

  • To confirm the safety and tolerability of PIPAC with nab-paclitaxel in conjunction with medical oncologist choice standard of care therapy with CTCAE v5.02 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 following2 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