A Phase 1 Study to Evaluate Safety and Efficacy of XER-001 (Amifostine for Nasoduodenal Delivery) in Combination With Sterotactic Body Radiotherapy for Treatment in Patients With Locally Advanced Pancreatic Cancer. (NCT07157033)

🧪 Interventions in This Study

• XER-001 (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Cytologic or biopsy confirmed adenocarcinoma of the pancreas
2. Disease deemed amenable to definitive treatment with SBRT by being:
3. Locally-advanced and/or technically unresectable, as determined by a specialist pancreaticobiliary surgeon and as part of a multidisciplinary team review including of multiphase cross-sectional imaging, demonstrating: i. Greater than 180-degree tumor involvement of the superior mesenteric artery (SMA) ii. Greater than 180-degree tumor involvement of the celiac axis including major branches of the celiac axis that would render the tumor unresectable (e.g. common hepatic artery) iii. Tumor involvement of the first branch of the SMA that is not surgically reconstructible iv. Long segment involvement of the superior mesenteric vein/portal vein/hepatic artery that is not amenable to surgical reconstructible.
4. Potentially resectable anatomically but deemed not a surgical candidate after multidisciplinary review (such as unresectable due to comorbid conditions that render. the risks of surgery prohibitive)
5. Potentially resectable but the patient elects to refuse surgery and prefers to pursue SBRT, and disease is deemed eligible for SBRT
6. Primary tumor involvement abutment of the bowel is allowed, however bowel infiltration or invasion (identified endoscopically or by contrast enhanced imaging) is not allowed.
7. No distant metastatic disease either prior to or following induction systemic therapy
8. Completion of medically indicated first line systemic therapy, which may include but is not limited to regimens such as FOLFIRNOX, gemcitabine/abraxane, and similar regimens
9. Patients must be able to understand and comply with any treatment related procedures for SBRT. including breath-hold techniques or tolerance of compression belt, or other motion management strategies for SBRT delivery.
10. Age 18 years or older
11. Eastern Cooperative Group (ECOG) performance status 0, 1, or 2
12. Adequate hematologic function as indicated by:

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (5 Sites)

• City of Hope — Duarte, California
• CIty of Hope — Irvine, California
• Karmanos Cancer Institute — Detroit, Michigan
• Christus St. Vincent Regional Cancer Center — Santa Fe, New Mexico
• Oncology Consultants, P.A. — Houston, Texas

📞 Contact the Study Coordinator

Phone: (214) 205-5746

Email: rfrnka@accelsobio.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Locally Advanced Pancreatic Adenocarcinoma

• PROACTIVE: Surgical Resection Outcomes in Locally Advanced and Unresectable Pancreatic Cancer After Neoadjuvant Chemotherapy — Los Angeles, California
• Acoustic Cluster Therapy (ACT) With Chemotherapy for the Treatment of Locally Advanced Pancreatic Cancer — Scottsdale, Arizona
• Pressure Enabled Intrapancreatic Delivery of SD-101 With Checkpoint Blockade for Locally Advanced Pancreatic Adenocarcinoma — Houston, Texas
• Testing the Addition of a New Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiotherapy in Patients With Locally Advanced Pancreatic Cancer — Duarte, California
• Studying Chemotherapy With or Without Panitumumab for Unresectable, Locally Advanced, or Metastatic Pancreatic Cancer Without KRAS Mutations — Anchorage, Alaska

Explore by condition: All Locally Advanced Pancreatic Adenocarcinoma clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.