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.
Age ≥18 years and ≤75 years, with an ECOG performance status of 0-1.
Patients with histologically confirmed colorectal adenocarcinoma or pancreatic adenocarcinoma who have undergone radical resection (R0) and completed at least 4 cycles of postoperative adjuvant chemotherapy.
Postoperative pathological stage for colorectal cancer is IIIA, IIIB, or IIIC. For pancreatic cancer, postoperative pathological stage is I, II, or III. The tumor must harbor at least one of the following KRAS hotspot mutations: G12D, G12V, G12R, G12A, G12S, G12C, or G13D.
No radiological evidence of tumor recurrence or metastasis.
Patients with colorectal cancer exhibiting microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) or harboring BRAF mutations.
Pancreatic cancer patients with neuroendocrine tumor components are excluded.
Patients with a history of other malignancies, except for carcinoma in situ of the cervix, treated squamous cell carcinoma or bladder epithelial tumors (Ta and TIS), or other malignancies that have been curatively treated (at least 5 years prior to enrollment).
Prior treatment with anticancer vaccines or any antibodies targeting T-cell co-regulatory proteins (e.g., anti-PD1, anti-PDL1, or anti-CTLA4).
Single group
KRAS Neoantigen Nanovaccine
DrugThe vaccine utilizes a neoantigen nanovaccine constructed from the bacterial membranes of engineered Lactococcus lactis, independently developed by the Cancer Center of Nanjing Drum Tower Hospital. It is administered via subcutaneous or intralymph node injection.
Dose-limiting toxicities (DLT)
Proportion of patients with a decrease in positive tumor markers (ctDNA and/or CEA/CA199)
Proportion of patients with clearance of positive tumor markers (ctDNA and/or CEA/CA199)
KRAS neoantigen specific T cells
From clinical trial enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to five years.
Recurrence-free survival (RFS)
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