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

Recruiting

• Conditions: Head and Neck Cancer
• Interventions: Other: No intervention

• Registration Number: NCT05697926
• Lead Sponsor: Eye & ENT Hospital of Fudan University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-01
• Study First Submitted QC: 2023-01-15
• Last Update Submitted: 2023-01-15
• Study First Posted: 2023-01-26
• Last Update Posted: 2023-01-26
• Study Start: 2023-03-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experiment	No intervention	The excess tumor tissue from patients following surgical resection will be collected for further analysis.

Primary Outcome Measures

Name	Time	Method
Clinical prognosis	5 year postsurgery	Observation of the clinical prognosis including overall survival, progression-free survival, event-free survival, and recurrence-free survival.

Trial Locations

Locations (1)

Eye & ENT Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China