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Trial Title:
Preclinical Research for Personalized TCR-T Therapy for Head and Neck Cancer
NCT ID:
NCT05697926
Condition:
Head and Neck Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Conditions: Keywords:
TCR-T therapy
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
No intervention
Description:
This is a preclinical study. No intervention will be performed.
Arm group label:
Experiment
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.
Criteria for eligibility:
Study pop:
Newly diagnosed patients with head and neck cancer without any treatment and willing to
take part in this preclinical trial.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Gender is not limited, age 18-75 years old;
2. Estimated survival is greater than 3 months;
3. 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;
4. Patients with head and neck cancer whose tumor tissue can be surgically harvested;
5. Volunteer to join the study and sign the informed consent.
Exclusion Criteria:
1. Infected or had been infected with COVID-19;
2. Active hepatitis B or C virus, HIV infection, or other uncured active infected
persons;
3. 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;
4. Other situations that are not appropriate to be included in the clinical trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Eye & ENT Hospital of Fudan University
Address:
City:
Shanghai
Zip:
200031
Country:
China
Status:
Recruiting
Contact:
Last name:
Jian Chen, phD
Phone:
008618917785406
Email:
chenjent@qq.com
Start date:
March 1, 2023
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Eye & ENT Hospital of Fudan University
Agency class:
Other
Source:
Eye & ENT Hospital of Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05697926
