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Neoantigen Vaccines in Esophageal Squamous Cell Carcinoma

NCT06675201 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2024-11-05

No results posted yet for this study

Summary

The aim of this clinical trial is to evaluate the efficacy and safety of consolidation therapy with a neoantigen-loaded dendritic cell vaccine (NeoDC-Vac) following radical chemoradiotherapy or chemoradiation-immunotherapy in patients with locally advanced, unresectable ESCC. The primary endpoint of the study is the OS rate. Secondary endpoints include OS, PFS, adverse events, CR rate, and quality of life (QoL) of patients. Exploratory endpoints involve the assessment of biomarkers such as TMB, PD-L1, and ctDNA.

The key questions this study aims to answer are:

-Can the combination of (ICIs and NeoDC-Vac as maintenance therapy improve OS and QoL in patients with locally advanced, unresectable ESCC following radical treatment? Can this novel approach provide an effective treatment option for these patients?

Participant Procedures:

1. Endoscopic examination at West China Hospital. Baseline fresh tumor tissue collection for NGS in neoantigen vaccine group.
2. Screening assessments, informed consent, and random assignment to experimental or control group.

Experimental Group\*\*: Neoantigen-loaded vaccine + standard ICIs as maintenance therapy.

Control Group\*\*: Standard ICIs as maintenance. One cycle per month for one year.
3. Tumor tissue NGS, ctDNA analysis, TIME evaluation, T cell response profiling. All costs covered by research funding.
4. After completing the full treatment regimen, participants will be monitored with regular follow-up visits by healthcare professionals to assess ongoing health outcomes and safety.

Conditions

  • Esophageal Squamous Cell Carcinoma (ESCC)
  • Neoantigen-loaded Dendritic Cell Vaccine
  • Immune Checkpoint Inhibitors (ICIs)

Interventions

BIOLOGICAL

neoantigen-loaded dendritic cell vaccine (NeoDC-Vac)

Experimental Group: Neoantigen Vaccine Combined with Immune Checkpoint Inhibitors (ICIs) Neoantigen Vaccine: Administered via subcutaneous injections at multiple sites, including bilateral axillary and bilateral inguinal regions. The initial phase consists of 5 injections during the first cycle, given at weeks 1, 2, 4, 6, and 8. Thereafter, the vaccine is administered once every 4 weeks, continuing for 1 year, or until disease progression, intolerable adverse events, or death from any cause. ICIs: Administered intravenously once a month, with a maintenance duration of 1 year, or until disease progression, intolerable adverse events, or death from any cause. Control Group: ICIs ICIs: Administered intravenously once a month, with a maintenance duration of 1 year, or until disease progression, intolerable adverse events, or death from any cause.

Sponsors & Collaborators

  • Sichuan University

    lead OTHER

Principal Investigators

  • zhenyu ding, MD · West China Hospital of Sichuan University, ChengDu, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2027-10-01
Completion
2027-10-01

Countries

  • China

Study Locations

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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 NCT06675201 on ClinicalTrials.gov