NCT06675201 Neoantigen Vaccines in Esophageal Squamous Cell Carcinoma
| NCT ID | NCT06675201 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sichuan University |
| Condition | Esophageal Squamous Cell Carcinoma (ESCC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 165 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2027-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 165 participants in total. It began in 2024-10-01 with a primary completion date of 2027-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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: -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.
Eligibility Criteria
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
Contact & Investigator
zhenyu ding, MD
PRINCIPAL INVESTIGATOR
West China Hospital of Sichuan University, ChengDu, China
Frequently Asked Questions
Who can join the NCT06675201 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Esophageal Squamous Cell Carcinoma (ESCC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06675201 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06675201 currently recruiting?
Yes, NCT06675201 is actively recruiting participants. Contact the research team at dingzhenyu@scu.edu.cn for enrollment information.
Where is the NCT06675201 trial being conducted?
This trial is being conducted at Chengdu, China.
Who is sponsoring the NCT06675201 clinical trial?
NCT06675201 is sponsored by Sichuan University. The principal investigator is zhenyu ding, MD at West China Hospital of Sichuan University, ChengDu, China. The trial plans to enroll 165 participants.