A Phase 2 Study of NALIRIFOX Plus Radiation Therapy to Treat Pancreatic Cancer

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Full Title

Total Neoadjuvant NALIRIFOX Plus Ablative Dose Radiation Therapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma

Purpose

Researchers want to see if giving NALIRIFOX chemotherapy with high-dose radiation therapy and capecitabine before surgery helps people with pancreatic cancer. The people in this study have pancreatic cancer that involves major blood vessels but has not spread to other organs. The study includes people with pancreatic cancer that may or may not be removable (“borderline resectable” or “locally advanced”).

NALIRIFOX is similar to standard chemotherapy for operable pancreatic cancer. However, it has a different drug in it that may stay longer in the body and have fewer side effects. The radiation in this study, ablative dose radiation therapy, is given at a higher dose than standard radiation therapy. Capecitabine interferes with the growth of cancer cells and may help boost the effect of radiotherapy.

The medications used in this study are given intravenously (by vein), except for capecitabine. That drug is taken orally (by mouth). If your tumor responds to chemotherapy and chemoradiotherapy, you will have surgery to see if the tumor is removable.

Who Can Join

To join this study, there are a few conditions. You must:

  • Have pancreatic cancer that involves the blood vessels but has not spread to other organs (borderline resectable or locally advanced).
  • Have not had prior treatment for pancreatic cancer.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information and to see if you can join this study, please contact Dr. Alice Wei’s office at 212-639-5643.

Protocol

23-027

Phase

Phase II (phase 2)

Disease Status

Relapsed or Refractory

Investigator

ClinicalTrials.gov ID

NCT05851924