Neoantigen Vaccines in Esophageal Squamous Cell Carcinoma

NCT06675201 | Recruiting Phase 2 DMC

• 1 other identifier: CHANT-241 Study
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief 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:

1. 1.Endoscopic examination at West China Hospital. Baseline fresh tumor tissue collection for NGS in neoantigen vaccine group.
2. 2.Screening assessments, informed consent, and random assignment to experimental or control group.
3. 3.Tumor tissue NGS, ctDNA analysis, TIME evaluation, T cell response profiling. All costs covered by research funding.
4. 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)

Keywords

Esophageal Squamous Cell Carcinoma (ESCC); neoantigen tumor vaccine; immunotherapy

Outcome Measures

Primary Outcomes (1)

• 2-year OS rate

  Overall Survival (OS) is defined as the time from randomization (following radical treatment) to death from any caus

  24months

Secondary Outcomes (2)

• Progression-Free Survival (PFS)

  12months

• Treatment-related adverse effects (TRAEs)

  12months

Other Outcomes (2)

• Biomarker analysis of tumor mutational burden (TMB)

  12months

• Biomarker analysis of tumor circulating tumor DNA (ctDNA)

  12months

Study Arms (2)

NeoDC-Vac + ICIs

EXPERIMENTAL

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.

Biological: neoantigen-loaded dendritic cell vaccine (NeoDC-Vac)

ICIs

ACTIVE COMPARATOR

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.

Biological: neoantigen-loaded dendritic cell vaccine (NeoDC-Vac)

Interventions

neoantigen-loaded dendritic cell vaccine (NeoDC-Vac) BIOLOGICAL

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.

ICIs; NeoDC-Vac + ICIs

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sichuan University: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Please Select, 610041, China

RECRUITING

Related Publications (1)

• Chen 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 DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• zhenyu ding, MD

  West China Hospital of Sichuan University, ChengDu, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

zhenyu ding, MD

CONTACT

+86 028-854-22562; dingzhenyu@scu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: November 5, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)