Recruiting nowPhase 2
What this trial is trying to do
The researchers are testing a vaccine made from engineered bacterial membranes carrying KRAS-mutant peptides. The idea is that this will train the immune system to recognise and attack remaining KRAS-mutant cancer cells after surgery in people at high risk of recurrence.
They hope an immune response against KRAS-mutant cells could reduce the chance of the cancer returning, but the trial has no comparison group and is mainly measuring whether the vaccine can be given safely, along with immune responses and early signs of benefit. An improvement would therefore first mean acceptable toxicity and evidence of an immune response; this trial is not designed to show longer survival.
Worth knowing: This is a small, non-randomised phase 2 trial whose main outcome is dose-limiting toxicity, so it cannot reliably establish whether the vaccine prevents recurrence or extends life.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT07353645 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | open label |
| Taking part | 49 people (planned) |
| Who can join | aged 18 Years to 75 Years |
| Run by | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug KRAS Neoantigen Nanovaccine
What it is measuring
Dose-limiting toxicities (DLT)
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
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.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- (K/N)RAS mutated
- G12C
- G12D
- G12V
- G13D
- Other codon
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion 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 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 foll…
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: China.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07353645, registered by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.