Custom-Made vaccine aims to stop esophageal Cancer's return
NCT ID NCT05307835
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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27 people
The number who actually took part.
- Started
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Dec 2021
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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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.