Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
NCT07353645

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

Led by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Updated on 2026-04-15

49

Participants Needed

1

Research Sites

249 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 75 years with an ECOG performance status of 0-1
  • Histologically confirmed colorectal or pancreatic adenocarcinoma after radical surgery (R0) and completion of at least 4 cycles of postoperative chemotherapy
  • Postoperative pathological stage IIIA, IIIB, or IIIC for colorectal cancer; stage I, II, or III for pancreatic cancer
  • Tumor must have at least one KRAS hotspot mutation: G12D, G12V, G12R, G12A, G12S, G12C, or G13D
  • No evidence of tumor recurrence or metastasis on imaging
  • Adequate blood counts: lymphocytes ≥0.5×10⁹/L, neutrophils ≥1.5×10⁹/L, white blood cells >2.5×10⁹/L, hemoglobin ≥90 g/L, platelets ≥90×10⁹/L
  • Adequate liver and kidney function: 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
  • Coagulation within normal limits: INR or PTT ≤1.5× ULN
  • Use of adequate contraception for patients of childbearing potential before and during the trial
  • Signed informed consent
  • Ability to follow study procedures and visits
Not Eligible

You will not qualify if you...

  • Colorectal cancer patients with microsatellite instability-high (MSI-H), deficient mismatch repair (dMMR), or BRAF mutations
  • Pancreatic cancer patients with neuroendocrine tumor components
  • History of other malignancies except certain treated cancers with at least 5 years disease-free
  • Prior treatments with anticancer vaccines or antibodies targeting T-cell co-regulatory proteins (e.g., anti-PD1, anti-PDL1, anti-CTLA4)
  • HIV, HCV, or HBV infection; uncontrolled coronary artery disease, asthma, cerebrovascular disease, or other investigator-defined exclusion conditions
  • Use of immunosuppressants or systemic corticosteroids (>10 mg/day prednisone or equivalent) within 2 weeks before enrollment
  • Significant cardiac symptoms or diseases including heart failure NYHA Class II or higher, unstable angina, recent myocardial infarction, significant arrhythmias, or prolonged QTc
  • Abnormal coagulation, bleeding disorders, or current thrombolytic/anticoagulant therapy (except low-dose aspirin or low molecular weight heparin)
  • Active infection, fever ≥38.5°C within 7 days before treatment, high white blood cell count, or chronic infections with non-healing wounds
  • Pregnant or breastfeeding women; women of childbearing potential must have a negative pregnancy test within 7 days before enrollment
  • Substance abuse or psychological/social factors affecting consent or study conduct
  • Known allergy to immunotherapy drugs
  • Inability to complete immunological or clinical assessments
  • History of allogeneic organ or hematopoietic stem cell transplantation
  • Concurrent participation in other interventional drug trials

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University

Nanjing, Jiangsu, China, 210008

Actively Recruiting

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Research Team

B

Baorui Liu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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