Preclinical Research for Personalized TCR-T Therapy for Head and Neck Cancer

NCT05697926 | Recruiting

• 1 other identifier: 2022105
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Cancer

Keywords

TCR-T therapy

Outcome Measures

Primary Outcomes (1)

• Clinical prognosis

  Observation of the clinical prognosis including overall survival, progression-free survival, event-free survival, and recurrence-free survival.

  5 year postsurgery

Study Arms (1)

Experiment

The excess tumor tissue from patients following surgical resection will be collected for further analysis.

Other: No intervention

Interventions

No intervention OTHER

This is a preclinical study. No intervention will be performed.

Experiment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed patients with head and neck cancer without any treatment and willing to take part in this preclinical trial.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Eye & ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Central Study Contacts

Jian Chen, Ph.D

CONTACT

+8621-64377134; chenjent@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2023
• First Posted: January 26, 2023
• Study Start: March 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 26, 2023

Record last verified: 2023-01

Locations

CN (1)