Esophageal Squamous Cell CarcinomaPhase 1NCT05317325
A Translational Study of Tumor Antigen-pulsed DC Vaccine for ESCC
A Phase 1 study testing OCDC vaccine; NeoDC vaccine in people with Esophageal Squamous Cell Carcinoma, 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-pulsed DC vaccine( OCDC and NeoDC) for postoperative adjuvant treatment of ESCC Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- OCDC vaccine; NeoDC vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 1 Apr 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed diagnosis of esophageal squamous cell carcinoma
- no preoperative adjuvant therapy
- Karnofsky performance status 0-2;
- The postoperative pathological stage is pT2-4 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.
China1 site
West China Hospital
Chengdu, Sichuan, 610000
Zhen-Yu Ding, Prof, 0086288542357, dignzhenyu@scu.edu.cn
About this study
Official title: A Translational Study of Tumor Antigen-pulsed Dendritic Cell Vaccine for Esophageal Squamous Cell Carcinoma
The aim of this single center, single arm and prospective study is to explore the safety and efficacy of tumor antigen-pulsed DC vaccine( OCDC and NeoDC) for postoperative adjuvant treatment of ESCC
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- OCDC vaccine; NeoDC vaccine
- Keywords
- esophageal cancer, tumour cell lysate, neoantigen, prime-boost, dendritic cell vaccine
- Medical subject headings
- Esophageal Squamous Cell Carcinoma, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCDC vaccine; NeoDC vaccineBiological
OCDC vaccine and NeoDC vaccine are administered in a prime-boost regimen by subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Autologous DCs pulsed with HOCl-oxidized autologous tumor lysate (OCDC) vaccine is administered in prime phase and personal neoantigen-sensitized DC(NeoDC) vaccine is administered in boost phase. Receives: Biological: OCDC vaccine; NeoDC vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of treatment-related adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: From the first administration of vaccine to 3 months after the last administration
Secondary outcomes (1)
Disease-free Survival
Number of participants with Disease-free Survival as assessed by RECIST1.1
Measured: from the study start to 1 year after the study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start1 Apr 2022 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell 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
- 20 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
- Zhen-Yu Ding, Prof, Principal investigator, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317325
- Sponsor's protocol ID
- HXDB-2203
- Status last verified
- Mar 2022
- First submitted
- 30 Mar 2022
- Last updated
- 7 Apr 2022
- 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 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Translational Study of Tumor Antigen-pulsed Dendritic Cell Vaccine for Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05317325
- Acronym / sponsor ID
- HXDB-2203
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- esophageal cancer, tumour cell lysate, neoantigen, prime-boost, dendritic cell vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 7 Apr 2022 (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-pulsed DC vaccine( OCDC and NeoDC) for postoperative adjuvant treatment of ESCC
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Biological: OCDC vaccine; NeoDC vaccineAutologous DCs pulsed with HOCl-oxidized autologous tumor lysate (OCDC) vaccine is administered in prime phase and personal neoantigen-sensitized DC(NeoDC) vaccine is administered in boost phase. |
Who may qualify
- Ages
- 18 to 80 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
- no preoperative adjuvant therapy
- Karnofsky performance status 0-2;
- The postoperative pathological stage is pT2-4 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 |
|---|---|---|
| OCDC vaccine; NeoDC vaccineOCDC vaccine and NeoDC vaccine are administered in a prime-boost regimen by subcutaneous injection. | Biological | Experimental Group |
Primary outcome
The number of treatment-related adverse events
Time frame: From the first administration of vaccine to 3 months after the last administration
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
1 secondary outcome
Disease-free Survival
Time frame: from the study start to 1 year after the study completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- 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 OCDC vaccine; NeoDC vaccine in people with Esophageal Squamous Cell Carcinoma, 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: status not confirmed, as of the sponsor's last update on 7 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhen-Yu Ding, Prof (0086288542357, dingzhenyu@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of treatment-related adverse events (time frame: From the first administration of vaccine to 3 months after the last administration). 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 7 Apr 2022.