Neoantigen Vaccine in Esophagus Cancer Patients Following Neoadjuvant Therapy and Surgical Resection

  • STATUS
    Recruiting
  • End date
    Dec 3, 2025
  • participants needed
    40
  • sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
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Updated on 19 April 2022
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Summary

This research study is evaluating a new type of esophagus cancer vaccine called "Personalized Neoantigen Cancer Vaccine" as a possible treatment for esophagus cancer patients who have completed adjuvant therapy following neoadjuvant therapy and surgical resection. The purpose of the clinical study is evaluating the safety, tolerability and partial efficacy of the personalized neoantigen cancer vaccine in the treatment of resectable esophagus cancer, so as to provide a new personalized therapeutic strategy.

Description

It is known that cancer patients have mutations (changes in genetic material) that are specific to an individual patient and tumor. These mutations can cause the tumor cells to produce proteins that appear very different from the body's own cells. It is possible that these proteins used in a vaccine may induce strong immune responses, which may help the participant's body fight any tumor cells that could cause the cancer to come back in the future. The study will examine the safety of the vaccine when given at several different time points and will examine the participant's blood cells for signs that the vaccine induced an immune response.

Details
Condition Resectable Esophageal Cancer
Treatment GM-CSF, iNeo-Vac-P01
Clinical Study IdentifierNCT05307835
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Last Modified on19 April 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Must freely sign informed consent
Aged 18 to 80 years old
Histologically or cytologically confirmed diagnosis of esophagus cancer
ECOG score is 0 or 1
completed Neoadjuvant combined with PD-1 therapy ;Completed surgical resection ;At the same time, standard postoperative treatment was performed 8 ~ 12 weeks of therapy
Must provide all exons of tumor tissue sequencing data, transcriptome sequencing data and the peripheral blood of all exons sequencing data
Completion of imaging records 1 week before personalized immunotherapy, including but not limited to full-body PET-CT and brain MRI
Haematological index： White blood cells ≥ 3500 / MCL; Lymphocytes > 800/ MCL; neutrophils > 1500/ MCL; Platelets > 100000 / MCL; Hemoglobin >10.0g/dL; Total serum bilirubin <1.5× upper limit of normal value (ULN); AST/ALT<2.0 times the upper limit of normal; Serum creatinine <1.5 times the upper limit of normal；
Pregnant, lactating women and women of child-bearing age must have a negative pregnancy test within 7 days before entering the group, and short-term have no fertility plan, and are willing to take protective measures (contraception or other birth control methods) before and during the clinical trial
Male patients are willing to take appropriate methods of contraception
Good compliance, able to follow research protocols and follow-up procedures

Exclusion Criteria

Diagnosed as other malignant tumor
No neoantigen was found in the sequencing data
Patients are unable to tolerate surgery and adjuvant therapy or patients with poor immune system status
There have been bone marrow or stem cell transplants
Received other systemic antitumor agents or systemic glucocorticoids with immunosuppressants
Received other vaccine inoculation 4 weeks before treatment
With HIV, HCV, HBV infection, severe asthma, autoimmune disease,immunodeficiency or treated with immunosuppressive drugs
Uncontrolled complications include, but are not limited to, active infection, symptomatic congestive heart failure, unstable angina pectoris, and arrhythmias
Infected with herpes virus (except those with scabs of more than 4 weeks)
Infected with respiratory virus (except those who have recovered for more than 4 weeks)
Have severe coronary or cerebrovascular disease, or other conditions considered ineligible by the investigator
Drug abuse. Clinical, psychological or social factor result in affecting informed consent or research implementation
Have a history of drug or vaccine allergies, or people who are allergic to other potential immunotherapies
Clear my responses
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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