Neoantigen Vaccine in Esophagus Cancer Patients Following Neoadjuvant Therapy and Surgical Resection (NCT05307835) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Neoantigen Vaccine in Esophagus Cancer Patients Following Neoadjuvant Therapy and Surgical Resection
China27 participantsStarted 2021-12-02
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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,
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
AEs
Timeframe: 1 year
2
Relapse Free Survival Rate
Timeframe: 1 year
Trial details
NCT IDNCT05307835
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
. 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；
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;