Head and Neck CancerNCT05697926
Preclinical Research for Personalized TCR-T Therapy for Head and Neck Cancer
An observational study of Head and Neck Cancer, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
This study will obtain tumor samples from patients with head and neck cancers and aims to develop personalized TCR-T therapy for head and neck cancer by determining the reactive TCR clone sequences in head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Cancer
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 30 Jun 2026
- Phase
- Observational
- 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
Study population: Newly diagnosed patients with head and neck cancer without any treatment and willing to take part in this preclinical trial.
Who may be able to join
- Gender is not limited, age 18-75 years old;
- Estimated survival is greater than 3 months;
- Newly diagnosed patients with head and neck cancer without any treatment, or patients with refractory recurrent advanced head and neck cancer for which there is no available effective treatment;
- Patients with head and neck cancer whose tumor tissue can be surgically harvested;
- Volunteer to join the study and sign the informed consent.
Who cannot join
- Infected or had been infected with COVID-19;
- Active hepatitis B or C virus, HIV infection, or other uncured active infected persons;
- Patients with head and neck cancer who had received the following treatments:
- The patient had a history of using PD-1 and other immune checkpoint inhibitors 8 weeks before surgery; History of chemotherapy drug use 8 weeks before surgery; A history of hormone drug use within 4 weeks before surgery;
- Other situations that are not appropriate to be included in the clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, 200031
Jian Chen, phD, 008618917785406, chenjent@qq.com
About this study
This study will obtain tumor samples from patients with head and neck cancers and aims to develop personalized TCR-T therapy for head and neck cancer by determining the reactive TCR clone sequences in head and neck cancer.
- Conditions
- Head and Neck Cancer
- Being tested
- No intervention
- Keywords
- TCR-T therapy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is a preclinical study. No intervention will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Experiment | The excess tumor tissue from patients following surgical resection will be collected for further analysis. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical prognosis
Observation of the clinical prognosis including overall survival, progression-free survival, event-free survival, and recurrence-free survival.
Measured: 5 year postsurgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Mar 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697926
- Sponsor's protocol ID
- 2022105
- Status last verified
- Jan 2023
- First submitted
- 1 Jan 2023
- Last updated
- 26 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preclinical Research for Personalized TCR-T Therapy for Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT05697926
- Acronym / sponsor ID
- 2022105
- Conditions
- Head and Neck Cancer
- Keywords
- TCR-T therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 26 Jan 2023 (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.
This study will obtain tumor samples from patients with head and neck cancers and aims to develop personalized TCR-T therapy for head and neck cancer by determining the reactive TCR clone sequences in head and neck cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experiment | – | Other: No interventionThe excess tumor tissue from patients following surgical resection will be collected for further analysis. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed patients with head and neck cancer without any treatment and willing to take part in this preclinical trial.
Key inclusion criteria (5 listed)
- Gender is not limited, age 18-75 years old;
- Estimated survival is greater than 3 months;
- Newly diagnosed patients with head and neck cancer without any treatment, or patients with refractory recurrent advanced head and neck cancer for which there is no available effective treatment;
- Patients with head and neck cancer whose tumor tissue can be surgically harvested;
- Volunteer to join the study and sign the informed consent.
Key exclusion criteria (5 listed)
- Infected or had been infected with COVID-19;
- Active hepatitis B or C virus, HIV infection, or other uncured active infected persons;
- Patients with head and neck cancer who had received the following treatments:
- The patient had a history of using PD-1 and other immune checkpoint inhibitors 8 weeks before surgery; History of chemotherapy drug use 8 weeks before surgery; A history of hormone drug use within 4 weeks before surgery;
- Other situations that are not appropriate to be included in the clinical trial.
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 |
|---|---|---|
| No interventionThis is a preclinical study. No intervention will be performed. | Other | Experiment |
Primary outcome
Clinical prognosis
Time frame: 5 year postsurgery
Observation of the clinical prognosis including overall survival, progression-free survival, event-free survival, and recurrence-free survival.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by Eye & ENT Hospital of Fudan 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 5 inclusion and 5 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 26 Jan 2023. 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.
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 Jian Chen, Ph.D (+8621-64377134, chenjent@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical prognosis (time frame: 5 year postsurgery). 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 26 Jan 2023.