NCT06741982

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Head and Neck Squamous Cell Carcinoma (HNSCC) is one of the most common malignant tumors in the head and neck region. Globally, both its incidence and mortality rates have shown a significant upward trend, posing a serious threat to the life and health of patients. Although surgical resection is the main treatment approach for resectable HNSCC, a considerable number of patients still face a high risk of local recurrence and distant metastasis after surgery, which are the key factors contributing to poor prognosis. In recent years, immune-targeted therapy has emerged in the field of malignant tumor treatment and demonstrated unique treatment advantages and potential. It can specifically act on relevant targets of tumor cells, precisely regulate the body's immune system, and effectively enhance the body's immune response to tumor cells, thereby inhibiting the malignant biological behaviors of tumor cells such as growth, proliferation, and metastasis. Oncolytic herpes simplex virus (HSV) has the ability to specifically replicate within tumor cells and lyse them. Meanwhile, it can also induce a strong anti-tumor immune response in the body and has broad application prospects in tumor treatment. Based on the above situation, this study innovatively proposes to combine immune-targeted therapy with oncolytic HSV virus for the neoadjuvant treatment of resectable HNSCC. The aim is to fully utilize the synergistic effect of the two treatment modalities, minimize the tumor volume to the greatest extent, reduce the tumor stage, improve the surgical resection rate and radicality, decrease the risks of postoperative recurrence and metastasis, and ultimately improve the quality of life and prognosis of patients. By conducting this prospective, single-arm clinical study, it is expected to provide a more efficient, safe, and innovative treatment strategy and clinical practice basis for the treatment of resectable HNSCC.

Conditions

• HNSCC
• Lysogenic HSV Virus
• Neoadjuvant Therapy
• Immunotherapy
• Targeted Therapy

Interventions

Type	Name	Description
BIOLOGICAL	Lysogenic 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.
DRUG	Tislelizumab	200mg IV Q3W
DRUG	Afatinib	30mg PO QD

Timeline

• Start date: 2024-12-15
• Primary completion: 2026-12-15
• Completion: 2026-12-15
• First posted: 2024-12-19
• Last updated: 2024-12-19

Locations

1 site across 1 country: China