NCT06675201

Neoantigen Vaccines in Esophageal Squamous Cell Carcinoma

Recruiting now Phase 2 Last updated 5 November 2024

What this trial tests

Phase 2 trial testing neoantigen-loaded dendritic cell vaccine (NeoDC-Vac) in Esophageal Squamous Cell Carcinoma (ESCC) in 165 participants. Currently enrolling.

Timeline

1 October 2024

Primary endpoint
1 October 2027

1 October 2027

Quick facts

Lead sponsor	Sichuan University
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	165
Start date	1 October 2024
Primary completion	1 October 2027
Estimated completion	1 October 2027
Sites	1 location across China

Drugs / interventions tested

• neoantigen-loaded dendritic cell vaccine (NeoDC-Vac) — full drug profile →

Conditions studied

• Esophageal Squamous Cell Carcinoma (ESCC) — all drugs for Esophageal Squamous Cell Carcinoma (ESCC) →
• Neoantigen-loaded Dendritic Cell Vaccine — all drugs for Neoantigen-loaded Dendritic Cell Vaccine →
• Immune Checkpoint Inhibitors (ICIs) — all drugs for Immune Checkpoint Inhibitors (ICIs) →

Sponsor

Sichuan University

Who can join

Adults 18 to 80, any sex, with Esophageal Squamous Cell Carcinoma (ESCC) or Neoantigen-loaded Dendritic Cell Vaccine. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The role of neoantigens and tumor mutational burden in cancer immunotherapy: advances, mechanisms, and perspectives.
   Sun S, Liu L, Zhang J, Sun L, et al · · 2025 · cited 17× · PMID 40898324 · DOI 10.1186/s13045-025-01732-z
2. Immune biomarkers for head and neck cancer.
   Sobhani N, D'Angelo A, Kugeratski FG, Nguyen T, et al · · 2025 · cited 1× · PMID 41410866 · DOI 10.1007/s00262-025-04233-7
3. Advances and challenges in immunotherapy for advanced esophageal squamous cell carcinoma.
   Wang Y, Li H, Zhao P, Li Z, et al · · 2026 · PMID 42039176 · DOI 10.3389/fimmu.2026.1739762
4. Application of dendritic cell extracellular vesicles as a valid nanoparticle platform for cancer therapies: a narrative review.
   Nezamdoust FV, Nezhad-Mokhtari P, Mirzaahmadi B, Mazloumi Z, et al · · 2026 · PMID 42010708 · DOI 10.1186/s13287-026-05011-7
5. Advances in delivery technologies-powered cancer vaccines.
   Huang C, Wang H, Luo S, Yu C, et al · · 2026 · PMID 41756688 · DOI 10.1016/j.bioactmat.2026.02.014
6. 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.
   Chen Y, Zheng Y, Shi H, Yang W, et al · · 2025 · PMID 41601631 · DOI 10.3389/fimmu.2025.1658670
7. Immune Surveillance and Immune Escape in Cancer: Mechanisms and Immunotherapy.
   Peng Y, Zhan L, Shi J, Wang J, et al · · 2025 · PMID 41079643 · DOI 10.1002/mco2.70321
8. Comparison of Current Immunotherapy Approaches and Novel Anti-Cancer Vaccine Modalities for Clinical Application.
   Meade E, Garvey M. · · 2025 · PMID 40943226 · DOI 10.3390/ijms26178307