Personalized vaccine for esophagus cancer after surgery

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

This study is testing a new personalized cancer vaccine for patients with esophagus cancer who have had surgery, to see if it helps their immune system fight any leftover cancer cells.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT05307835 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates a new personalized neoantigen cancer vaccine for patients with resectable esophagus cancer who have completed neoadjuvant therapy and surgical resection. The study aims to assess the safety, tolerability, and partial efficacy of the vaccine, which targets unique mutations in tumor cells to potentially enhance the immune response against any remaining cancer cells. Participants will receive the vaccine at various time points, and their immune responses will be monitored through blood tests. This approach seeks to provide a novel personalized treatment strategy for high-risk patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with histologically confirmed resectable esophagus cancer who have completed neoadjuvant therapy and surgical resection.

Not a fit: Patients who have not undergone neoadjuvant therapy or those with non-resectable esophagus cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this vaccine could significantly reduce the risk of cancer recurrence in esophagus cancer patients.

How similar studies have performed: Other studies using personalized neoantigen vaccines have shown promise, indicating potential for success in this novel approach.

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;

Where this trial is running

Hangzhou, Zhejiang

• The Second Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Ming Wu, M.D.

Conditions Resectable Esophageal Cancer; has received neoadjuvant therapy; At high risk of recurrence