Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-24 @ 10:40 PM
NCT ID:
NCT05307835
Eligibility Criteria:
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;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05307835
Study Brief:
Protocol Section:
NCT05307835