KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer

This clinical trial will utilize a neoantigen nanovaccine constructed from the bacterial membranes of an engineered Lactococcus lactis strain (FOLactis). This platform, independently developed by our center, expresses KRAS antigenic peptides. The vaccine will be administered as adjuvant therapy to post-operative patients with colorectal or pancreatic cancer who carry KRAS mutations and are at high risk of recurrence. The study aims to assess the safety, immunogenicity, and preliminary efficacy of this neoantigen nanovaccine in a clinical setting.

NCT Number	NCT07353645
Lead Sponsor	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions	Colorectal Cancer, Pancreatic Cancer
Enrollment	49 participants
Start Date	2026-03-23
Primary Completion	2029-01-01 (estimated)
Study Completion	2031-01-01 (estimated)
Updated on ClinicalTrials.gov	2026-04-15