Clinical trial · Interventional
Neoantigen Vaccines in Esophageal Squamous Cell Carcinoma
Neoantigen Vaccines in Combination with Immune Checkpoint Inhibitors for Maintenance Therapy Following Definitive Treatment of Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma: an Open-Label, Randomized, Phase II Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Squamous Cell Carcinoma (ESCC) | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Immune Checkpoint Inhibitors (ICIs) | — | UNRESOLVED | — |
| Neoantigen-loaded Dendritic Cell Vaccine | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| neoantigen-loaded dendritic cell vaccine (NeoDC-Vac) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- NeoDC-Vac + ICIs
- description
- Experimental Group: NeoDC-Vac combined with ICIs NeoDC-Vac: 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.
- interventionNames
- Biological: neoantigen-loaded dendritic cell vaccine (NeoDC-Vac)
- type
- ACTIVE_COMPARATOR
- label
- ICIs
- description
- 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.
- interventionNames
- Biological: neoantigen-loaded dendritic cell vaccine (NeoDC-Vac)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: A. Age 18-80 years B. Locally advanced unresectable ESCC patients after radical treatment (radical chemoradiotherapy or chemoradiation); including: * 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 Exclusion Criteria: A. History of fistula caused by primary tumor invasion B. High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation C. Poor nutritional status D. Immune-related adverse events during prior radical treatment, such as Grade ≥3 pneumonitis, myocarditis, etc. E. Signs and symptoms of interstitial diseases F. Presence of any severe and/or uncontrolled medical conditions G. Presence of concurrent malignancies H. Presence of other autoimmune diseases, or prolonged use of immunosuppressants or steroids I. Difficulty in patient communication or inability to comply with long-term follow-up J. Other conditions deemed unsuitable by the investigator
References
Publications (1)
- DERIVEDChen Y, Zheng Y, Shi H, Yang W, Xu H, Li Y, Ding Z. Personalized neoantigen DC vaccine combined with camrelizumab following definitive therapy in locally advanced unresectable esophageal squamous cell carcinoma (CHANT-241): protocol for a randomized controlled trial. Front Immunol. 2026 Jan 12;16:1658670. doi: 10.3389/fimmu.2025.1658670. eCollection 2025. PMID 41601631