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

NCT05307835 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-12-02

No results posted yet for this study

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

Interventions

BIOLOGICAL

iNeo-Vac-P01

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;

BIOLOGICAL

GM-CSF

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

Sponsors & Collaborators

  • Hangzhou Neoantigen Therapeutics Co., Ltd.

    collaborator INDUSTRY

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-02
Primary Completion
2026-06-30
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05307835 on ClinicalTrials.gov