RecruitingPhase 1Phase 2NCT07010120

A Clinical Trial of Neoadjuvant Targeted Therapy, Immunotherapy, and Lysogenic HSV-Based Virotherapy in Resectable Head and Neck Squamous Cell Carcinoma

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

29 participants

Start Date

Jun 10, 2025

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 trial is testing a combination of targeted therapy, immunotherapy, and a specially engineered virus (oncolytic herpes virus) given before surgery in patients with locally advanced head and neck cancer — to try to shrink the tumor and improve surgical outcomes. **You may be eligible if...** - You are 18–70 years old - You have been newly diagnosed with locally advanced squamous cell carcinoma of the head and neck (not including nasopharynx, salivary glands, or thyroid) - Your cancer has not spread to distant organs - For oropharyngeal cancer, your tumor must be HPV-negative, or if HPV-positive, must be stage III–IVB **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have previously received treatment for head and neck cancer - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding 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

DRUGTislelizumab

200mg IV Q3W

DRUGAfatinib

30mg PO QD

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.


Locations(1)

Department of Radiation Oncology

Chengdu, Sichuan, China

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NCT07010120


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