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Pancreatic Ductal Adenocarcinoma (PDAC)Phase 1NCT07030283

Intraperitoneal Paclitaxel With NALIRIFOX for Pancreatic Ductal Adenocarcinoma With Peritoneal Carcinomatosis

A Phase 1 study testing Paclitaxel and NALIRIFOX in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by University of Colorado, Denver at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This goal of this clinical trial is to learn whether the drug combination of intraperitoneal paclitaxel (chemotherapy given directly into the abdominal cavity) and intravenous NALIRIFOX (chemotherapy given into a vein, including fluorouracil, leucovorin, oxaliplatin, and liposomal irinotecan) is safe and works in… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Ductal Adenocarcinoma (PDAC)
What is being tested?
Paclitaxel and NALIRIFOX
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
31 Dec 2025to 1 Jul 2030
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provision to sign and date the consent form.
  • Stated willingness to comply with all study procedures and be available for the duration of the study.
  • Be age 18 years or older.
  • Histologically or cytologically confirmed pancreatic adenocarcinoma with histologically or cytologically proven seeding in the peritoneal cavity without metastasis to other organs.
  • Primary tumor that is resectable, borderline resectable, or locally advanced per NCCN classification.
  • PCI score ≤ 8.
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  • ECOG performance status of 0 or 1
  • Prior treatment for 0-64 months with FOLFIRINOX, modified FOLFIRINOX, or NALIRIFOX and able to receive additional platinum-based treatment per investigator opinion
  • Adequate biological parameters as evidenced by all of the following blood counts:
  • Absolute neutrophil count (ANC) >/= 1,500 per cubic millimeter without the use of hematopoietic growth factors within 14 days prior to screening
  • Platelet count >/= 75,000 per cubic millimeter
  • Hemoglobin > 9 g/dL
  • Adequate hepatic function as evidenced by:
  • Serum total bilirubin ≤ 1.5x ULN (biliary drainage is allowed for biliary obstruction), and
  • AST and ALT ≤ 3 x ULN
  • Adequate renal function as evidenced by serum creatinine <1.5 x ULN

Who cannot join

  • Prior treatment of pancreatic cancer in the metastatic setting with surgery or investigational therapy (Note: biliary drainage, diagnostic laparoscopy/laparotomy, and duodenal stenting is allowed).
  • Evident distant metastatic disease outside of the peritoneal cavity.
  • Extensive metastatic disease in peritoneal cavity (PCI>8).
  • Known disease progression with any prior chemotherapy.
  • Known hypersensitivity to paclitaxel or other liposomal products.
  • Current use of strong CYP2C8 inhibitors or inducers, or presence of any other contraindications for paclitaxel.
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  • Known UGT1A1 deficiency or DPD deficiency.
  • Neuropathy Grade 2 or higher
  • Known active COVID infection with symptoms.
  • Has ever received or is currently receiving radiation for pancreatic cancer treatment.
  • Receipt of live, attenuated vaccine within 30 days prior the first dose of Intraperitoneal paclitaxel. (Note: enrolled patients should not receive live vaccines during the study and up to 30 days after the last dose of intraperitoneal paclitaxel).
  • Known positive test results for human immunodeficiency (HIV) or patients with chronic or active hepatitis B or C. Patients who have a history of hepatitis B or C who have undetectable HBV DNA or HCV RNA after anti-viral therapy may be enrolled.
  • Active infection during screening visits or on the day of treatment, which in the investigator's opinion might compromise the patient's participation in the trial or affect the study outcome.
  • Any other medical or social condition deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
  • Pregnant or breast feeding; females of child-bearing potential must test negative for pregnancy within 7 days prior to C1D1. Both male and female patients of reproductive potential must agree to use a highly effective method of birth control during the study and for 9 months following the last dose of both IP PTX and IV NALIRIFOX.
  • Histologies other than adenocarcinoma, such as neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma.
  • Patients who, in the opinion of the investigator, have symptoms or signs suggestive of clinically unacceptable deterioration of the primary disease at the time of screening.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Puja Gupta Poddar contact

720-278-0236

puja.guptapoddar@cuanschutz.edu

United States1 site, 1 recruiting

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

    Puja Gupta Poddar, 720-278-0236, puja.guptapoddar@cuanschutz.edu

    Alexis Leal, MD

    Recruiting

Other trials in United States

About this study

Official title: Intraperitoneal Paclitaxel With Standard Systemic NALIRIFOX for Pancreatic Ductal Adenocarcinoma With Peritoneal Carcinomatosis: Prospective Pilot Trial

This goal of this clinical trial is to learn whether the drug combination of intraperitoneal paclitaxel (chemotherapy given directly into the abdominal cavity) and intravenous NALIRIFOX (chemotherapy given into a vein, including fluorouracil, leucovorin, oxaliplatin, and liposomal irinotecan) is safe and works in adults with pancreatic cancer that has spread to the peritoneum.

The main questions it aims to answer are:

Read more
  • Are people with pancreatic cancer able to tolerate the combination drug regimen?
  • How well does the combination drug regimen work to treat pancreatic cancer?

Participants will:

  • Obtain a port that goes into the abdomen to deliver intraperitoneal paclitaxel (called an intraperitoneal catheter)
  • Receive treatment with intravenous NALIRIFOX once every 2 weeks and intraperitoneal paclitaxel on days 1 and 8 of each 14-day cycle
  • Visit the clinic with each treatment for checkups and laboratory testing
  • Have imaging scans and blood lab testing to determine response to treatment
  • Have abdominal fluid lab testing that may help determine if the cancer is responding to treatment
  • Fill out questionnaires to see how the treatment affects how participants feel and function
  • Continue follow up after treatment ends to track survival

Some participants may be able to have surgery later if the cancer responds well. This is called conversion surgery. To be eligible for surgery, the cancer must have shrunk or stayed the same, peritoneal fluid (from the abdomen) must no longer show cancer cells, and a tumor marker called CA 19-9 must decrease or return to normal. The decision to do surgery will depend on the treating surgeon.

By testing this new treatment strategy, researchers hope to find a safer and more effective way to treat people with pancreatic cancer that has spread to the abdomen. If successful, this approach may lead to longer survival, better quality of life, and more people becoming eligible for surgery.

Being tested
Paclitaxel, NALIRIFOX
Keywords
Peritoneal Carcinomatosis, pancreatic adenocarcinoma, pancreatic ductal adenocarcinoma, PDAC, metastatic, NALIRIFOX, intraperitoneal chemotherapy, intraperitoneal paclitaxel, circulating tumor DNA (ctDNA), peritoneal cell-free DNA
Medical subject headings
Peritoneal Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PaclitaxelDrug

    Also called Taxol

    Paclitaxel is a chemotherapy medication that is FDA-approved to treat a number of cancer types. In this study, paclitaxel will be administered via the intraperitoneal port. Intraperitoneal paclitaxel is not FDA approved for pancreatic cancer.

  • NALIRIFOXDrug

    NALIRIFOX is a systemic chemotherapy treatment for metastatic pancreatic cancer that was approved by the FDA in February 2024. It's a combination of drugs that are already approved to treat pancreatic cancer: Liposomal irinotecan (Nal-IRI or Onivyde®), 5 fluorouracil (5-FU)/leucovorin, and Oxaliplatin.

Study groups in NCT07030283
Study groupRoleWhat they receive
Intraperitoneal Paclitaxel with Systemic NALIRIFOXExperimentalIntraperitoneal paclitaxel will be administered on days 1 and 8 via the intraperitoneal port, and systemic NALIRIFOX (Fluorouracil Continuous Infusion/Leucovorin/Liposomal Irinotecan/Oxaliplatin) will be administered on day 1 of each 14-day cycle. The maximum treatment duration is 12 cycles.
Receives: Drug: Paclitaxel; Drug: NALIRIFOX

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse event rate

    Measured: From enrollment through 30 days after last dose of treatment administered (approximately 7 months)

Secondary outcomes (5)

  1. 1-year survival rate

    Measured: From enrollment through 12 months after the last dose of treatment (approximately 18 months)

  2. Overall survival

    Measured: From enrollment through 24 months after the last dose of treatment (approximately 30 months)

  3. Progression-free survival

    Measured: From enrollment through end of treatment (approximately 6 months)

  4. Objective response rate

    Measured: From enrollment through end of treatment (approximately 6 months)

  5. Change in peritoneal carcinomatosis index

    The peritoneal carcinomatosis index is a score used to assess the amount of cancer in the peritoneal cavity. The score ranges from 0 to 39, with a higher score indicating a greater extent of cancer.

    Measured: From enrollment to 6 months after end of treatment (approximately 12 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2025
  2. Study start31 Dec 2025
  3. Primary completion1 Jul 2028 (estimated)
  4. Study completion1 Jul 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07030283
Sponsor's protocol ID
24-2111.cc
Status last verified
Jan 2026
First submitted
21 May 2025
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Paclitaxel and NALIRIFOX in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Puja Gupta Poddar (720-278-0236, puja.guptapoddar@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse event rate (time frame: From enrollment through 30 days after last dose of treatment administered (approximately 7 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07030283.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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