Esophageal Squamous Cell Carcinoma (ESCC)Phase 2NCT06675201
Neoantigen Vaccines in Esophageal Squamous Cell Carcinoma
A Phase 2 study testing neoantigen-loaded dendritic cell vaccine (NeoDC-Vac) in people with Esophageal Squamous Cell Carcinoma (ESCC) and Neoantigen-loaded Dendritic Cell Vaccine, run by Sichuan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma (ESCC), Neoantigen-loaded Dendritic Cell Vaccine, Immune Checkpoint Inhibitors (ICIs)
- What is being tested?
- neoantigen-loaded dendritic cell vaccine (NeoDC-Vac)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 1 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years
- 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
Who cannot join
- 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.
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Please Select, 610041
zhenyu ding, MD, 18980601957, 13027469041@163.com
About this study
Official title: 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
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:
Read more
-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:
- Endoscopic examination at West China Hospital. Baseline fresh tumor tissue collection for NGS in neoantigen vaccine group.
- 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.
- Tumor tissue NGS, ctDNA analysis, TIME evaluation, T cell response profiling. All costs covered by research funding.
- 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.
Read the detailed description
The objective of this clinical trial is to evaluate the efficacy and safety of neoantigen-loaded dendritic cell (DC) vaccines as consolidation therapy following definitive chemoradiotherapy or radiotherapy with immunotherapy in patients with locally advanced unresectable esophageal squamous cell carcinoma (ESCC). The primary endpoint is the 2-year overall survival (OS) rate. Secondary endpoints include OS, progression-free survival (PFS), adverse events, complete response (CR) rate, and patient quality of life. Exploratory endpoints focus on biomarker analysis, including tumor mutational burden (TMB), PD-L1 expression, and circulating tumor DNA (ctDNA).
The key questions this study aims to answer are whether maintenance therapy with immune checkpoint inhibitors (ICIs) combined with neoantigen vaccines can improve overall survival and quality of life in patients with locally advanced, unresectable ESCC following definitive treatment, ultimately providing a new therapeutic strategy for these patients.
Participants in the study will:
- Diagnostic Endoscopy at West China Hospital: Participants must undergo endoscopic examination at West China Hospital to confirm diagnosis. For patients in the neoantigen vaccine group, baseline fresh tissue samples will be obtained for next-generation sequencing (NGS) to screen for neoantigen peptides, which will be used to prepare individualized neoantigen vaccines.
- Enrollment and Consent: Participants will complete relevant examinations to determine eligibility. Upon confirmation of eligibility, they will provide informed consent and undergo randomization. Treatment Regimen:
- Experimental Group: Neoantigen tumor vaccine in combination with standard immune checkpoint inhibitors (ICIs) as maintenance therapy following definitive treatment.
- Control Group: Standard ICIs alone as maintenance therapy. The treatment cycle will consist of monthly administrations for a total duration of one year.
- Assessments During Treatment: Key assessments during treatment will include NGS sequencing of tumor tissue, ctDNA analysis from blood samples, evaluation of the tumor immune microenvironment (TIME), and T-cell response analysis. All of these assessments are essential for receiving the study treatment, and the associated costs will be covered by the research grant, ensuring that participants incur no additional financial burden.
- Conditions
- Esophageal Squamous Cell Carcinoma (ESCC), Neoantigen-loaded Dendritic Cell Vaccine, Immune Checkpoint Inhibitors (ICIs)
- Being tested
- neoantigen-loaded dendritic cell vaccine (NeoDC-Vac)
- Keywords
- Esophageal Squamous Cell Carcinoma (ESCC), neoantigen tumor vaccine, immunotherapy
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: neoantigen-loaded dendritic cell vaccine (NeoDC-Vac) |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year OS rate
Overall Survival (OS) is defined as the time from randomization (following radical treatment) to death from any caus
Measured: 24months
Secondary outcomes (2)
Progression-Free Survival (PFS)
The progression-free survival (PFS) is defined as the time from random assignment to the occurrence of the first event, which could be local failure, metastatic recurrence, disease progression, or death from any cause
Measured: 12months
Treatment-related adverse effects (TRAEs)
This study will collected any adverse medical events that occurred during the study drug treatment, and the treatment-related adverse events as assessed by CTCAE v5.0.
Measured: 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start1 Oct 2024
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal Squamous Cell Carcinoma (ESCC)Studies of the same condition, open and under way.
- More trials run by Sichuan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen-Yu Ding, Sichuan University
- Investigators
- zhenyu ding, MD, Principal investigator, West China Hospital of Sichuan University, ChengDu, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675201
- Sponsor's protocol ID
- CHANT-241 Study
- Status last verified
- Nov 2024
- First submitted
- 3 Nov 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41601631
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06675201
- Acronym / sponsor ID
- CHANT-241 Study
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Endoscopic examination at West China Hospital. Baseline fresh tumor tissue collection for NGS in neoantigen vaccine group.
- 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.
- Tumor tissue NGS, ctDNA analysis, TIME evaluation, T cell response profiling. All costs covered by research funding.
- 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.
Detailed description
The objective of this clinical trial is to evaluate the efficacy and safety of neoantigen-loaded dendritic cell (DC) vaccines as consolidation therapy following definitive chemoradiotherapy or radiotherapy with immunotherapy in patients with locally advanced unresectable esophageal squamous cell carcinoma (ESCC). The primary endpoint is the 2-year overall survival (OS) rate. Secondary endpoints include OS, progression-free survival (PFS), adverse events, complete response (CR) rate, and patient quality of life. Exploratory endpoints focus on biomarker analysis, including tumor mutational burden (TMB), PD-L1 expression, and circulating tumor DNA (ctDNA).
The key questions this study aims to answer are whether maintenance therapy with immune checkpoint inhibitors (ICIs) combined with neoantigen vaccines can improve overall survival and quality of life in patients with locally advanced, unresectable ESCC following definitive treatment, ultimately providing a new therapeutic strategy for these patients.
Participants in the study will:
- Diagnostic Endoscopy at West China Hospital: Participants must undergo endoscopic examination at West China Hospital to confirm diagnosis. For patients in the neoantigen vaccine group, baseline fresh tissue samples will be obtained for next-generation sequencing (NGS) to screen for neoantigen peptides, which will be used to prepare individualized neoantigen vaccines.
- Enrollment and Consent: Participants will complete relevant examinations to determine eligibility. Upon confirmation of eligibility, they will provide informed consent and undergo randomization. Treatment Regimen:
- Experimental Group: Neoantigen tumor vaccine in combination with standard immune checkpoint inhibitors (ICIs) as maintenance therapy following definitive treatment.
- Control Group: Standard ICIs alone as maintenance therapy. The treatment cycle will consist of monthly administrations for a total duration of one year.
- Assessments During Treatment: Key assessments during treatment will include NGS sequencing of tumor tissue, ctDNA analysis from blood samples, evaluation of the tumor immune microenvironment (TIME), and T-cell response analysis. All of these assessments are essential for receiving the study treatment, and the associated costs will be covered by the research grant, ensuring that participants incur no additional financial burden.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NeoDC-Vac + ICIs | Experimental | Biological: neoantigen-loaded dendritic cell vaccine (NeoDC-Vac)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. |
| ICIs | Active comparator | Biological: neoantigen-loaded dendritic cell vaccine (NeoDC-Vac)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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-80 years
- 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
Key exclusion criteria (2 listed)
- 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.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neoantigen-loaded dendritic cell vaccine (NeoDC-Vac)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. | Biological | ICIs, NeoDC-Vac + ICIs |
Primary outcome
2-year OS rate
Time frame: 24months
Overall Survival (OS) is defined as the time from randomization (following radical treatment) to death from any caus
2 secondary outcomes
Progression-Free Survival (PFS)
Time frame: 12months
Treatment-related adverse effects (TRAEs)
Time frame: 12months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Derived from this study: PubMed 41601631Chen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
zhenyu ding, MD principal investigator
West China Hospital of Sichuan University, ChengDu, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing neoantigen-loaded dendritic cell vaccine (NeoDC-Vac) in people with Esophageal Squamous Cell Carcinoma (ESCC) and Neoantigen-loaded Dendritic Cell Vaccine, run by Sichuan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact zhenyu ding, MD (+86 028-854-22562, dingzhenyu@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year OS rate (time frame: 24months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06675201, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.