Actively Recruiting
Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Patients With Peritoneal Metastasis From Pancreatic Adenocarcinoma
Led by Northwell Health · Updated on 2026-04-06
10
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Patients With Peritoneal Metastasis From Pancreatic Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and sign informed consent form
- Age 18 years or older
- Histologically confirmed pancreatic adenocarcinoma with confirmed or strongly suspected peritoneal metastasis
- ECOG performance status of 2 or less
- Absolute neutrophil count greater than 1500/mm3
- Platelet count greater than 100,000/mm3
- Hemoglobin level greater than 9 g/dl
- Serum total bilirubin less than 1.5 times the upper limit of normal
- ALT and AST less than 2.5 times the upper limit of normal, or less than 5 times if chronic liver disease is present
- Creatinine clearance greater than 40 ml/min
- No contraindications for laparoscopy
- Peritoneal disease visible on imaging or laparoscopy
- For hepatitis B patients, undetectable viral load on therapy if applicable
- For hepatitis C patients, treated and cured or undetectable viral load if on treatment
- Women of childbearing potential and their partners must use effective contraception during and up to 6 months after treatment
- Laparoscopy findings confirming PIPAC access feasibility, room for aerosol therapy, no impending bowel obstruction, less than 5 liters of ascites, and not candidates for cytoreduction and HIPEC
You will not qualify if you...
- Presence of confirmed or suspected metastasis outside the peritoneum
- Bowel obstruction requiring nasogastric tube, PEG tube, or exclusive total parenteral nutrition
- Life expectancy less than 4 months
- Prior intra-abdominal aerosol chemotherapy
- Previous anaphylactic reaction to nab-paclitaxel
- Intra-abdominal ascites exceeding 5 liters
- Receiving other investigational agents
- Uncontrolled illnesses such as active infection, severe heart failure, recent heart attack, severe arrhythmias, severe kidney or liver impairment, or myelosuppression
- Immunocompromised status due to disease or medications
- New York Heart Association Class 3 or 4 heart disease, recent serious cardiac events, or COPD requiring recent hospitalization
- Exclusive total parenteral nutrition
- Pregnancy
- Psychiatric or social conditions limiting study compliance
AI-Screening
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Trial Site Locations
Total: 1 location
1
Zuckerberg Cancer Center
New Hyde Park, New York, United States, 11040
Actively Recruiting
Research Team
G
GI Trial Referral Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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