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.
Cervical esophageal segment, T4, supraclavicular lymph node metastasis, or inability/refusal to undergo surgery due to personal reasons (refer to hospital below); ② Failure of neoadjuvant or conversion therapy; ③ Postoperative local recurrence, unresectable (target lesion present). C. No evidence of tumor recurrence or metastasis 2-3 weeks after radical treatment D. Ability to provide fresh tumor tissue samples (baseline) E. Normal major organ function F. Performance status (PS) score ≤ 1 G. Patients of childbearing potential must use contraception H. Voluntary participation with signed informed consent
None
Parallel
neoantigen-loaded dendritic cell vaccine (NeoDC-Vac)
Biological/VaccineExperimental 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.
2-year OS rate
Overall Survival (OS) is defined as the time from randomization (following radical treatment) to death from any caus
Progression-Free Survival (PFS)
The progression-free survival (PFS) is defined as the time from random assignment to the occurrence of the first event, which could be local failure, metastatic recurrence, disease progression, or death from any cause
Treatment-related adverse effects (TRAEs)
This study will collected any adverse medical events that occurred during the study drug treatment, and the treatment-related adverse events as assessed by CTCAE v5.0.
Biomarker analysis of tumor mutational burden (TMB)
Whole exome sequencing (WES) will be performed on tumor tissue samples collected prior to vaccine immunization to analyze the relationship between tumor mutational burden (TMB) and the efficacy of the vaccine therapy.
Biomarker analysis of tumor circulating tumor DNA (ctDNA)
The recurrence and metastasis of the tumor will be monitored through circulating tumor DNA (ctDNA) at four specific time points: at baseline, two weeks after the first cycle of vaccine immunization (i.e., 2.5 months post-treatment), during the vaccine boost phase (6 months post-treatment), and at the time of tumor progression.
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