CarcinomaPhase 1NCT05023928
Tumor Antigen-sensitized DC Vaccine As an Adjuvant Therapy for Esophagus Cancer
A Phase 1 study testing Tumor antigen-sensitized DC vaccine in people with Carcinoma and Esophagus Cancer, run by Sichuan University at 1 site in China.
Trial summary
The aim of this single center, single arm and prospective study is to explore the safety and efficacy of tumor antigen-sensitized DC vaccine in postoperative adjuvant treatment of esophageal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carcinoma, Esophagus Cancer
- What is being tested?
- Tumor antigen-sensitized DC vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 30 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed diagnosis of esophageal squamous cell carcinoma；
- Immunotherapy for preoperative；
- Karnofsky performance status 0-1;
- The postoperative pathological stage is (y) Pt + and / or N + M0 according to AJCC 8th
- Function of the main organs is normal;
- Edition Patient's written informed consent
Who cannot join
- Tumor emergencies;
- Abnormal coagulation function;
- Contagious diseases, such as HIV, HBV, HCV infection;
- Mental disorders;
- Concomitant tumors;
- Immunological co-morbidities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Research on the Transformation of Postoperative Adjuvant Therapy of Tumor Antigen-sensitized DC Vaccine Applied to Esophagus Cancer
The aim of this single center, single arm and prospective study is to explore the safety and efficacy of tumor antigen-sensitized DC vaccine in postoperative adjuvant treatment of esophageal cancer.
- Conditions
- Carcinoma, Esophagus Cancer
- Being tested
- Tumor antigen-sensitized DC vaccine
- Keywords
- esophagus cancer, tumor neo-antigen DC vaccine, safety, clinical efficacy
- Medical subject headings
- Carcinoma, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor antigen-sensitized DC vaccineBiological
subcutaneous administration
| Study group | Role | What they receive |
|---|---|---|
| Tumor antigen-sensitized DC vaccine | Experimental | Tumor antigen-sensitized vaccine is administrated, 1-week interval, totally 2 times.
2-week later, Neo-antigen DC vaccine is administrated, 2-week interval, totally 5 times. Receives: Biological: Tumor antigen-sensitized DC vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0
Measured: 3 months after the last administration of cells
Secondary outcomes (1)
Disease-free Survival
Number of participants with Disease-free Survival as assessed by RECIST1.1
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start1 Sep 2021
- Primary completion1 Oct 2023
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarcinomaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen-Yu Ding, Sichuan University
- Investigators
- Zhen-Yu Ding, Prof, Principal investigator, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023928
- Sponsor's protocol ID
- CHANT-211
- Status last verified
- Mar 2025
- First submitted
- 21 Aug 2021
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Transformation of Postoperative Adjuvant Therapy of Tumor Antigen-sensitized DC Vaccine Applied to Esophagus Cancer
- ClinicalTrials.gov ID
- NCT05023928
- Acronym / sponsor ID
- CHANT-211
- Conditions
- Carcinoma, Esophagus Cancer
- Keywords
- esophagus cancer, tumor neo-antigen DC vaccine, safety, clinical efficacy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 27 Aug 2021 (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 single center, single arm and prospective study is to explore the safety and efficacy of tumor antigen-sensitized DC vaccine in postoperative adjuvant treatment of esophageal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tumor antigen-sensitized DC vaccine | Experimental | Biological: Tumor antigen-sensitized DC vaccineTumor antigen-sensitized vaccine is administrated, 1-week interval, totally 2 times. 2-week later, Neo-antigen DC vaccine is administrated, 2-week interval, totally 5 times. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pathologically confirmed diagnosis of esophageal squamous cell carcinoma；
- Immunotherapy for preoperative；
- Karnofsky performance status 0-1;
- The postoperative pathological stage is (y) Pt + and / or N + M0 according to AJCC 8th
- Function of the main organs is normal;
Key exclusion criteria (6 listed)
- Tumor emergencies;
- Abnormal coagulation function;
- Contagious diseases, such as HIV, HBV, HCV infection;
- Mental disorders;
- Concomitant tumors;
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 |
|---|---|---|
| Tumor antigen-sensitized DC vaccinesubcutaneous administration | Biological | Tumor antigen-sensitized DC vaccine |
Primary outcome
Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0
Time frame: 3 months after the last administration of cells
Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0
1 secondary outcome
Disease-free Survival
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
Zhen-Yu Ding, Prof principal investigator
Sichuan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tumor antigen-sensitized DC vaccine in people with Carcinoma and Esophagus Cancer, 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 12 Mar 2025. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0 (time frame: 3 months after the last administration of cells). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2025.