Neoantigen Vaccine in Esophagus Cancer Patients Following Neoadjuvant Therapy and Surgical Resection

Phase 1

Recruiting

• Conditions: Resectable Esophageal Cancer
• Interventions: Biological: iNeo-Vac-P01; Biological: GM-CSF

• Registration Number: NCT05307835
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief 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.

Detailed Description

It is known that cancer patients have mutations (changes in genetic material) that are specific to an individual patient and tumor. These mutations can cause the tumor cells to produce proteins that appear very different from the body's own cells. It is possible that these proteins used in a vaccine may induce strong immune responses, which may help the participant's body fight any tumor cells that could cause the cancer to come back in the future. The study will examine the safety of the vaccine when given at several different time points and will examine the participant's blood cells for signs that the vaccine induced an immune response.

Study Timeline

• Study Start: 2021-12-02
• Study First Submitted: 2022-03-23
• Study First Submitted QC: 2022-03-23
• Study First Posted: 2022-04-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-21
• Primary Completion: 2025-12-02
• Study Completion: 2025-12-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Personalized neoantigen vaccines	GM-CSF	iNeo-Vac-P01 (peptides)： 300 mcg per peptide
Personalized neoantigen vaccines	iNeo-Vac-P01	iNeo-Vac-P01 (peptides)： 300 mcg per peptide

Primary Outcome Measures

Name	Time	Method
AEs	1 year	To evaluate the number of patients with clinical or laboratory adverse events (AEs)
Relapse Free Survival Rate	1 year	Proportion of patients who have had surgery for less than 1 year before their first documented relapse

Secondary Outcome Measures

Name	Time	Method
Relapse Free Survival	3 years	The time between the patient's completion of surgery and the first recorded relapse
Overall Survival	3 years	From the time of the patient's surgery to the time of death
EORTC QLQ-C30 (version 3)	3 years	Quality of life questionnaire. All questionnaire responses were transformed linearly to scores from 0 to 100. For functional scores and global QOL, higher scores represent better function and QOL, whereas a higher score for the symptom scales represents more severe symptom.

Trial Locations

Locations (1)

The Second Affiliated Hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China