Phase I/II Clinical Study of KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer With High Risk of Recurrence
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 must meet the following hematologic criteria: Lymphocyte count ≥0.5×10⁹/L, neutrophil count ≥1.5×10⁹/L, white blood cell count \>2.5×10⁹/L; Hemoglobin ≥90 g/L; Platelet count ≥90×10⁹/L.
• Patients must meet the following biochemical criteria: Total bilirubin ≤1.5 × upper limit of normal (ULN); AST and ALT ≤1.5 × ULN; Serum creatinine ≤1.5 × ULN or creatinine clearance ≥30 mL/min.
• Patients must meet the following coagulation criteria: INR or PTT ≤1.5 × ULN.
• Patients of childbearing potential must employ adequate contraception or other birth control methods before enrollment and throughout the trial.
• Signed informed consent form has been obtained.
• Ability to comply with the study protocol and follow-up procedures.