New cocktail targets Stomach-Lining pancreatic cancer
NCT ID NCT07030283
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests whether adding chemotherapy directly into the abdomen (intraperitoneal paclitaxel) to standard IV chemotherapy (NALIRIFOX) is safe and effective for adults with pancreatic cancer that has spread to the lining of the belly. Ten participants will receive the combination every two weeks. Researchers will monitor side effects, tumor shrinkage, and survival, and some may become eligible for surgery if the cancer responds well.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Jul 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Provision to sign and date the consent form. 2. Stated willingness to comply with all study procedures and be available for the duration of the study. 3. Be age 18 years or older. 4. Histologically or cytologically confirmed pancreatic adenocarcinoma with histologically or cytologically proven seeding in the peritoneal cavity without metastasis to other organs. 5. Primary tumor that is resectable, borderline resectable, or locally advanced per NCCN classification. 6. PCI score ≤ 8. 7. ECOG performance status of 0 or 1 8. Prior treatment for 0-4 months with FOLFIRINOX, modified FOLFIRINOX, or NALIRIFOX and able to receive additional treatment per investigator opinion 9. 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 10. 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 11. Adequate renal function as evidenced by serum creatinine \<1.5 x ULN Exclusion Criteria: 1. 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). 2. Evident distant metastatic disease outside of the peritoneal cavity. 3. Extensive metastatic disease in peritoneal cavity (PCI\>8). 4. Known disease progression with any prior chemotherapy. 5. Known hypersensitivity to paclitaxel or other liposomal products. 6. Current use of strong CYP2C8 inhibitors or inducers, or presence of any other contraindications for paclitaxel. 7. Known UGT1A1 deficiency or DPD deficiency. 8. Neuropathy Grade 2 or higher 9. Known active COVID infection with symptoms. 10. Has ever received or is currently receiving radiation for pancreatic cancer treatment. 11. 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). 12. 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. 13. 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. 14. 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. 15. 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. 16. Histologies other than adenocarcinoma, such as neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma. 17. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Colorado Cancer Center
RECRUITINGAurora, Colorado, 80045, United States
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Other studies related to the condition(s) this trial covers.
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- AI takes aim at pancreatic cancer: can it forecast chemotherapy outcomes?
- Can a smart drug outsmart pancreatic cancer?