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

Conditions

• Adenocarcinoma Pancreas

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• PIPAC — DEVICE
  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-paclitaxel — DRUG
  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 Details

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.

Key Dates

Start date

Jan 11, 2026

Status verified

Jun 2026

Primary completion

Dec 30, 2027

Completion

Dec 30, 2027

Study Design

Enrollment

10 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Interventional Arm
  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.

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 ]

Central Contacts

• GI Trial Referral Team
  (516) 734-8900
  [email protected]

Locations (1)

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