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

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


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.


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.

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


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

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

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.

Learn more

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

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note