OncoMatch/Clinical Trials/NCT07353645
KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer
Is NCT07353645 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies KRAS Neoantigen Nanovaccine for colorectal cancer.
Treatment: KRAS Neoantigen Nanovaccine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Pancreatic Cancer
Biomarker criteria
Required: KRAS G12D
KRAS hotspot mutations: G12D, G12V, G12R, G12A, G12S, G12C, or G13D
Required: KRAS G12V
KRAS hotspot mutations: G12D, G12V, G12R, G12A, G12S, G12C, or G13D
Required: KRAS G12R
KRAS hotspot mutations: G12D, G12V, G12R, G12A, G12S, G12C, or G13D
Required: KRAS G12A
KRAS hotspot mutations: G12D, G12V, G12R, G12A, G12S, G12C, or G13D
Required: KRAS G12S
KRAS hotspot mutations: G12D, G12V, G12R, G12A, G12S, G12C, or G13D
Required: KRAS G12C
KRAS hotspot mutations: G12D, G12V, G12R, G12A, G12S, G12C, or G13D
Required: KRAS G13D
KRAS hotspot mutations: G12D, G12V, G12R, G12A, G12S, G12C, or G13D
Required: BRAF mutation
colorectal cancer exhibiting...harboring BRAF mutations [excluded]
Disease stage
Required: Stage IIIA, IIIB, IIIC, I, II, III (postoperative pathological stage)
Postoperative pathological stage for colorectal cancer is IIIA, IIIB, or IIIC. For pancreatic cancer, postoperative pathological stage is I, II, or III.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: adjuvant chemotherapy — postoperative
completed at least 4 cycles of postoperative adjuvant chemotherapy
Must have received: surgery — radical resection (R0)
have undergone radical resection (R0)
Cannot have received: anticancer vaccine
Prior treatment with anticancer vaccines
Cannot have received: antibody targeting T-cell co-regulatory proteins (anti-PD1, anti-PDL1, anti-CTLA4)
any antibodies targeting T-cell co-regulatory proteins (e.g., anti-PD1, anti-PDL1, or anti-CTLA4)
Lab requirements
Blood counts
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
Kidney function
Serum creatinine ≤1.5 × ULN or creatinine clearance ≥30 mL/min
Liver function
Total bilirubin ≤1.5 × ULN; AST and ALT ≤1.5 × ULN
Cardiac function
Heart failure of NYHA Class II or higher; Unstable angina; Myocardial infarction within the past year; Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention; QTc >450 ms (males); QTc >470 ms (females)
Patients must meet the following hematologic criteria: ... biochemical criteria: ... coagulation criteria: ... Poorly controlled cardiac clinical symptoms or diseases, such as: Heart failure of NYHA Class II or higher; Unstable angina; Myocardial infarction within the past year; Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention; QTc >450 ms (males); QTc >470 ms (females).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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