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NCT07253662 · ClinicalTrials.gov registry record · Phase 1
Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Patients With Peritoneal Metastasis From Pancreatic Adenocarcinoma
A Phase 1 study, sponsored by Northwell Health.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT07253662 is a Phase 1 study that is actively recruiting participants, run by Northwell Health. The registered enrollment target is 10 participants.
The verdict
NCT07253662, a Phase 1 study, is actively recruiting participants, sponsored by Northwell Health.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study 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%. 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.
Interventions
- DRUG Nab-paclitaxel
- DEVICE PIPAC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2026-01-11 |
| Est. Completion | 2027-12-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07253662
The ClinicalTrials.gov registry entry for NCT07253662 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwell Health, which has 370 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Nab-paclitaxel is the first listed.
NCT07253662 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07253662 about?
NCT07253662 is a clinical study titled "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 d...
What is the current status of trial NCT07253662?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2026-01-11. Estimated completion is 2027-12-30.
What interventions are being tested in trial NCT07253662?
The interventions under investigation include: Nab-paclitaxel (DRUG), PIPAC (DEVICE).
Who is sponsoring clinical trial NCT07253662?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
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