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.

Trial Details

NCT ID

NCT07353645

Phase

PHASE1 / PHASE2

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Status

RECRUITING

Cancer Type

Pancreatic Cancer

Interventions

KRAS Neoantigen Nanovaccine

Locations (sample)

Nanjing, Jiangsu, China|32.06167,118.77778

Key Eligibility Criteria

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 complet…
Postoperative pathological stage for colorectal cancer is IIIA, IIIB, or IIIC. For pancreatic cancer, postoperative pathological stage is I, II, or…
No radiological evidence of tumor recurrence or metastasis.

For full eligibility, visit ClinicalTrials.gov.

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