RecruitingPhase 1NCT06741982

A Clinical Study on Neoadjuvant Treatment of Resectable Head and Neck Squamous Carcinoma With Immune-targeted Therapy and Lysogenic HSV Virus

A Prospective, Single-arm Clinical Study of Immune-targeted Therapy Combined With Lysogenic HSV Virus for the Neoadjuvant Treatment of Surgically Resectable Head and Neck Squamous Carcinoma


Sponsor

West China Hospital

Enrollment

21 participants

Start Date

Dec 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Evaluation of the safety and tolerability of immune-targeted therapy combined with neoadjuvant therapy with lysogenic HSV virus for patients with surgically resectable squamous carcinoma of the head and neck.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of immune checkpoint therapy and an oncolytic herpes simplex virus (a virus engineered to attack cancer cells) as neoadjuvant treatment — meaning treatment given before surgery — in patients with resectable (removable) head and neck squamous cell carcinoma. The goal is to shrink tumors before surgery and potentially improve long-term cure rates. **You may be eligible if...** - You are between 18 and 70 years old - You have been newly diagnosed with locally advanced head and neck squamous cell carcinoma (excluding nasopharyngeal, salivary gland, and thyroid cancers) with no distant spread - Your cancer is at stage III–IVB (for HPV-negative tumors) or stage II–III (for HPV-positive oropharyngeal cancer) - Your tumor is considered surgically removable **You may NOT be eligible if...** - Your cancer has spread to distant organs - Your cancer originated in the nasopharynx, salivary glands, or thyroid - You have already received treatment for this cancer - Your tumor is not surgically resectable Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALLysogenic HSV virus.

Lysosomal HSV virus injection (divided into a dose-escalation phase and a dose-expansion phase; in the dose-escalation phase, Group 1 took 106 pfu/mL and Group 2 took 108 pfu/mL, and in the dose-expansion phase the dose of lysosomal HSV virus with the highest MPR of the escalation phase was taken.) .. The dose of intralymph node injection of lysosomal HSV virus in patients was determined according to the size of metastatic lymph nodes, (diameter less than or equal to 1.5 cm, maximum 1 mL; diameter 1.5-2.5 cm, maximum 2 mL; diameter greater than 2.5 cm, maximum 4 mL). Two injections were given per patient, with each dose separated by 2 weeks.

DRUGTislelizumab

200mg IV Q3W

DRUGAfatinib

30mg PO QD


Locations(1)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

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NCT06741982


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