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

NCT07353645 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2026-04-15

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

KRAS Neoantigen Nanovaccine

The 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.

Sponsors & Collaborators

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    lead OTHER

Principal Investigators

  • Baorui Liu · Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-23
Primary Completion
2029-01-01
Completion
2031-01-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07353645 on ClinicalTrials.gov