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Custom-Made vaccine aims to stop esophageal Cancer's return

NCT ID NCT05307835

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial is testing a personalized vaccine made from a patient's own tumor proteins. The goal is to see if it's safe and can help prevent esophageal cancer from coming back after surgery and standard therapy. 27 patients who have completed initial treatments will receive the vaccine along with an immune booster.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Personalized neoantigen vaccine (iNeo-Vac-P01) plus immune adjuvant (GM-CSF)
What this could lead to
If it works, this could offer a new way to prevent esophageal cancer from coming back after surgery and standard treatments.
What could go wrong
This is a very early (Phase 1) and small study with only 27 people. The vaccine is personalized, so it's complex and may not work for everyone. Side effects are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

27 people

The number who actually took part.

Started

Dec 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Must freely sign informed consent; 2. Aged 18 to 80 years old; 3. Histologically or cytologically confirmed diagnosis of esophagus cancer; 4. ECOG score is 0 or 1; 5. completed Neoadjuvant combined with PD-1 therapy ;Completed surgical resection ;At the same time, standard postoperative treatment was performed 8 \~ 12 weeks of therapy; 6. Must provide all exons of tumor tissue sequencing data, transcriptome sequencing data and the peripheral blood of all exons sequencing data; 7. Completion of imaging records 1 week before personalized immunotherapy, including but not limited to full-body PET-CT and brain MRI, 8. 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; 9. 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; 10. Male patients are willing to take appropriate methods of contraception; 11. Good compliance, able to follow research protocols and follow-up procedures; Exclusion Criteria: 1. Diagnosed as other malignant tumor; 2. No neoantigen was found in the sequencing data; 3. Patients are unable to tolerate surgery and adjuvant therapy or patients with poor immune system status; 4. There have been bone marrow or stem cell transplants; 5. Received other systemic antitumor agents or systemic glucocorticoids with immunosuppressants; 6. Received other vaccine inoculation 4 weeks before treatment; 7. With HIV, HCV, HBV infection, severe asthma, autoimmune disease,immunodeficiency or treated with immunosuppressive drugs; 8. Uncontrolled complications include, but are not limited to, active infection, symptomatic congestive heart failure, unstable angina pectoris, and arrhythmias; 9. Infected with herpes virus (except those with scabs of more than 4 weeks); 10. Infected with respiratory virus (except those who have recovered for more than 4 weeks); 11. Have severe coronary or cerebrovascular disease, or other conditions considered ineligible by the investigator; 12. Drug abuse. Clinical, psychological or social factor result in affecting informed consent or research implementation; 13. Have a history of drug or vaccine allergies, or people who are allergic to other potential immunotherapies;

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • The Second Affiliated Hospital of Zhejiang University

    Hangzhou, Zhejiang, 310000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.