Actively Recruiting
Neoantigen Vaccines in Esophageal Squamous Cell Carcinoma
Led by Sichuan University · Updated on 2024-11-05
165
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Neoantigen Vaccines in Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Diagnosed with locally advanced unresectable esophageal squamous cell carcinoma after radical treatment
- Includes patients with cervical esophageal segment involvement, T4 stage, supraclavicular lymph node metastasis, or who cannot or refuse surgery
- No evidence of tumor recurrence or metastasis 2 to 3 weeks after radical treatment
- Ability to provide fresh tumor tissue samples at baseline
- Normal major organ function
- Performance status score of 1 or less
- Patients of childbearing potential must use contraception
- Voluntary participation with signed informed consent
You will not qualify if you...
- History of fistula caused by primary tumor invasion
- High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation
- Poor nutritional status
- Immune-related adverse events during prior radical treatment such as Grade 3 or higher pneumonitis or myocarditis
- Signs or symptoms of interstitial lung diseases
- Severe or uncontrolled medical conditions
- Presence of other cancers
- Other autoimmune diseases or prolonged use of immunosuppressants or steroids
- Difficulty communicating or inability to comply with long-term follow-up
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
West China Hospital of Sichuan University
Chengdu, Please Select, China, 610041
Actively Recruiting
Research Team
Z
zhenyu ding, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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