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

NCT05307835 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: INEO-P-006
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Resectable Esophageal Cancer

Keywords

has received neoadjuvant therapy; At high risk of recurrence

Outcome Measures

Primary Outcomes (2)

• AEs

  To evaluate the number of patients with clinical or laboratory adverse events (AEs)

  1 year

• Relapse Free Survival Rate

  Proportion of patients who have had surgery for less than 1 year before their first documented relapse

  1 year

Secondary Outcomes (3)

• Relapse Free Survival

  3 years

• Overall Survival

  3 years

• EORTC QLQ-C30 (version 3)

  3 years

Study Arms (1)

Personalized neoantigen vaccines

EXPERIMENTAL

iNeo-Vac-P01 (peptides)： 300 mcg per peptide

Biological: iNeo-Vac-P01; Biological: GM-CSF

Interventions

iNeo-Vac-P01 BIOLOGICAL

iNeo-Vac-P01 (peptides)： 4 x 300 mcg per peptide given on days 1, 4, 8, 15, 22, 52, and 82 for a total of 7 doses;

Also known as: Neoantigen peptides

Personalized neoantigen vaccines

GM-CSF BIOLOGICAL

4 x 40 mcg (total dose 160 mcg) given on days 1, 4, 8, 15, 22, 52, and 82 for a total of 7 doses

Also known as: immune adjuvant, granulocyte-macrophage colony stimulating factor

Personalized neoantigen vaccines

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• 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；
• 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;
• Male patients are willing to take appropriate methods of contraception;
• Good compliance, able to follow research protocols and follow-up procedures;

You may not qualify if:

• 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;
• Infected with herpes virus (except those with scabs of more than 4 weeks);
• Infected with respiratory virus (except those who have recovered for more than 4 weeks);
• Have severe coronary or cerebrovascular disease, or other conditions considered ineligible by the investigator;
• Drug abuse. Clinical, psychological or social factor result in affecting informed consent or research implementation;
• Have a history of drug or vaccine allergies, or people who are allergic to other potential immunotherapies;

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Hangzhou Neoantigen Therapeutics Co., Ltd.: collaborator

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Interventions

Granulocyte-Macrophage Colony-Stimulating Factor; Adjuvants, Immunologic; Colony-Stimulating Factors

Intervention Hierarchy (Ancestors)

Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Immunologic Factors; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 1, 2022
• Study Start: December 2, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

CN (1)