Study

Intraperitoneal Paclitaxel with NALIRIFOX for Pancreatic Cancer That Has Spread to the Abdomen

The goal of this study is to find out if a combination of chemotherapy drugs is safe and works in adults with pancreatic cancer that has spread inside the abdomen. This study will test whether giving one drug, called paclitaxel, directly into the abdomen through a small tube (catheter) and giving another set of drugs, called NALIRIFOX, into a vein can help control the cancer.

Why this Research Matters

Pancreatic cancer that spreads to the peritoneum (the lining of the abdomen) can be hard to treat. This study is testing a new way to give chemotherapy directly to the area where cancer has spread. If you join this study, the study team will review your medical history, current medications, and past treatments to make sure it is safe for you to take part. You will also have a physical exam, blood tests, and scans. If you qualify, you will have a surgery to see if the tumor can be removed. If the tumor cannot be removed and the cancer has spread to the peritoneum, you will continue in the study. A small tube (catheter) will be placed into your abdomen to give the study drug directly to the area where the cancer has spread. After surgery, you will start two types of chemotherapy. One drug, called NALIRIFOX will be given through your vein every two weeks. Another drug called paclitaxel will be given through the catheter on days 1 and 8 of each 14-day cycle. You will have up to 12 treatment cycles. During the study, you will visit the clinic for checkups, lab tests, and scans to track your health, any side effects, and see how the cancer responds. Blood and abdominal fluid samples will be collected to learn how the treatment works. You will fill out questionnaires about your daily life and health. When treatment is done, the catheter will be removed. You will have follow-up visits or phone calls every 3 months for up to 2 years. Your treatment will last about 6 months, plus up to 2 years of follow-up.

Who can Participate

Adult

You may be able to join if you are 18 years or older, have pancreatic ductal adenocarcinoma that has spread to the peritoneum, and surgery shows it cannot be removed. Women who can become pregnant must have a negative pregnancy test before joining. Both men and women must use birth control during the study and for nine months after the last treatment. You must have the ability to come to in-person visits at CU Anschutz. To learn more, visit ClinicalTrials.gov.