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Resectable Esophageal CancerPhase 1NCT05307835

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

A Phase 1 study testing iNeo-Vac-P01 and GM-CSF in people with Resectable Esophageal Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Resectable Esophageal Cancer
What is being tested?
iNeo-Vac-P01 and GM-CSF
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteChina
Study dates
2 Dec 2021to 31 Dec 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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;

Who cannot join

  • 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;
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  • 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;

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Second Affiliated Hospital of Zhejiang University

    Hangzhou, Zhejiang, 310000

Other trials in China

About this study

Official title: Clinical Study of a Personalized Neoantigen Vaccine in Esophagus Cancer Patients Who Have Completed Adjuvant Therapy Following Neoadjuvant Therapy and Surgical Resection

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.

Read the detailed 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.

Being tested
iNeo-Vac-P01, GM-CSF
Keywords
has received neoadjuvant therapy, At high risk of recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iNeo-Vac-P01Biological

    Also called Neoantigen peptides

    iNeo-Vac-P01 (peptides)： 4 x 300 mcg per peptide given on days 1, 4, 8, 15, 22, 52, and 82 for a total of 7 doses;

  • GM-CSFBiological

    Also called immune adjuvant, granulocyte-macrophage colony stimulating factor

    4 x 40 mcg (total dose 160 mcg) given on days 1, 4, 8, 15, 22, 52, and 82 for a total of 7 doses

Study groups in NCT05307835
Study groupRoleWhat they receive
Personalized neoantigen vaccinesExperimentaliNeo-Vac-P01 (peptides)： 300 mcg per peptide
Receives: Biological: iNeo-Vac-P01; Biological: GM-CSF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AEs

    To evaluate the number of patients with clinical or laboratory adverse events (AEs)

    Measured: 1 year

  2. Relapse Free Survival Rate

    Proportion of patients who have had surgery for less than 1 year before their first documented relapse

    Measured: 1 year

Secondary outcomes (3)

  1. Relapse Free Survival

    The time between the patient's completion of surgery and the first recorded relapse

    Measured: 3 years

  2. Overall Survival

    From the time of the patient's surgery to the time of death

    Measured: 3 years

  3. EORTC QLQ-C30 (version 3)

    Quality of life questionnaire. All questionnaire responses were transformed linearly to scores from 0 to 100. For functional scores and global QOL, higher scores represent better function and QOL, whereas a higher score for the symptom scales represents more severe symptom.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2022
  2. Study start2 Dec 2021
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05307835
Sponsor's protocol ID
INEO-P-006
Status last verified
Nov 2025
First submitted
23 Mar 2022
Last updated
2 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing iNeo-Vac-P01 and GM-CSF in people with Resectable Esophageal Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AEs (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05307835.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.

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