Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Patients With Peritoneal Metastasis From Pancreatic Adenocarcinoma
Public ClinicalTrials.gov record NCT07253662. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase I Trial of Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Patients With Peritoneal Metastasis From Pancreatic Adenocarcinoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT07253662
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 10 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 10, 2026
- Primary completion
- Dec 29, 2027
- Completion
- Dec 29, 2027
- Last update posted
- Jun 2, 2026
2026 – 2027
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Zuckerberg Cancer Center | New Hyde Park | New York | 11040 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07253662, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 2, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07253662 live on ClinicalTrials.gov.