Abstract A122: Fecal microbiota transplantation in Pancreatic Cancer: Phase 0 Trial early results
Seyda Baydogan, Thais Bartelli, LE Li, Vidhi Chandra, Mostafa M. Hussein, Virginia Tahan, Sheryl S. Sabordo, Rebecca A. Snyder, Michael P. Kim, Naruhiko Ikoma, Ching-Wei David. Tzeng, Matthew Harold. Katz, Jennifer Wargo, Anirban Maitra, Yinghong Wang, Manoop Bhutani, Florencia McAllisterAbstract
BACKGROUND:
Pancreatic ductal adenocarcinoma (PDAC) is a highly lethal malignancy characterized by a profoundly immunosuppressive tumor microenvironment and limited therapeutic options. Emerging evidence suggests that the gut and tumor microbiome influence tumor progression and immune responses. Preclinical studies have demonstrated that fecal microbiota transplantation (FMT) can enhance antitumor immunity. We conducted the first clinical trial of FMT in patients with pancreatic cancer (NCT04975217) to evaluate its safety, feasibility, and biological impact.
METHODS:
This prospective, single-arm, window of opportunity study enrolled patients with resectable PDAC. The intervention was implemented between neoadjuvant therapy and surgical resection. Patients underwent microbiota depletion with antibiotics and bowel preparation, followed by FMT administered via colonoscopy and weekly oral FMT capsules for 2 weeks. The primary endpoint was safety and tolerability (CTCAE v5.0). Secondary endpoints included microbial, inflammatory and immune modulation.
RESULTS:
Eleven patients were enrolled; 2 were screen failures and 1 withdrew before treatment, resulting in 8 evaluable patients. FMT administration was feasible, and treatment was well tolerated. We didn’t observe any grade ≥3 adverse events related to FMT. All patients completed protocol-defined procedures. Microbial and immune modulation are currently being assessed.
CONCLUSION:
Overall, our findings show that FMT was safe and feasible, with no Grade ≥3 treatment-related toxicities. These findings support further investigation of microbiome modulation as a therapeutic strategy in pancreatic cancer.
Citation Format:
Seyda Baydogan, Thais Bartelli, LE Li, Vidhi Chandra, Mostafa M. Hussein, Virginia Tahan, Sheryl S. Sabordo, Rebecca A. Snyder, Michael P. Kim, Naruhiko Ikoma, Ching-Wei David. Tzeng, Matthew Harold. Katz, Jennifer Wargo, Anirban Maitra, Yinghong Wang, Manoop Bhutani, Florencia McAllister. Fecal microbiota transplantation in Pancreatic Cancer: Phase 0 Trial early results [abstract]. In: Proceedings of the AACR Conference on Pancreatic Cancer: New Frontiers in Biology and Therapeutic Development; 2026 Sep 25-28; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2026;86(18_Suppl_2):Abstract nr A122.