OncoMatch/Clinical Trials/NCT07030283
Intraperitoneal Paclitaxel With NALIRIFOX for Pancreatic Ductal Adenocarcinoma With Peritoneal Carcinomatosis
Is NCT07030283 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Paclitaxel and NALIRIFOX for pancreatic ductal adenocarcinoma (pdac).
Treatment: Paclitaxel · NALIRIFOX — 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: * 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Pancreatic Cancer
Disease stage
Required: Stage RESECTABLE, BORDERLINE RESECTABLE, III (NCCN classification)
Excluded: Stage IV
Primary tumor that is resectable, borderline resectable, or locally advanced per NCCN classification
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: FOLFIRINOX or NALIRIFOX (FOLFIRINOX, modified FOLFIRINOX, NALIRIFOX)
Prior treatment for 0-4 months with FOLFIRINOX, modified FOLFIRINOX, or NALIRIFOX and able to receive additional treatment per investigator opinion
Cannot have received: surgery or investigational therapy for metastatic pancreatic cancer
Exception: biliary drainage, diagnostic laparoscopy/laparotomy, and duodenal stenting is allowed
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)
Cannot have received: chemotherapy
Known disease progression with any prior chemotherapy
Cannot have received: radiation therapy
Has ever received or is currently receiving radiation for pancreatic cancer treatment
Lab requirements
Blood counts
ANC ≥ 1,500/mm3 without the use of hematopoietic growth factors within 14 days prior to screening; Platelet count ≥ 75,000/mm3; Hemoglobin > 9 g/dL
Kidney function
serum creatinine <1.5 x ULN
Liver function
Serum total bilirubin ≤ 1.5x ULN (biliary drainage is allowed for biliary obstruction), and AST and ALT ≤ 3 x ULN
Adequate biological parameters as evidenced by all of the following blood counts: ANC ≥ 1,500/mm3 without the use of hematopoietic growth factors within 14 days prior to screening; Platelet count ≥ 75,000/mm3; 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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Colorado Cancer Center · Aurora, Colorado
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify