Who may be eligible for this head and neck squamous cell carcinoma clinical trial?

Adults between 18 and 70 years old with locally advanced head and neck squamous carcinoma that can be surgically removed may be eligible. Participants must have no distant metastasis and a good physical health status. Please review eligibility criteria for more details.

Is there any cost to participate in this head and neck squamous cell carcinoma clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years - 70Years

All Genders

ID07010120

Immune-targeted Therapy Combined With Lysogenic HSV Virus for Neoadjuvant Treatment of Surgically Resectable Head and Neck Squamous Cell Carcinoma

Q: What is this trial studying for head and neck squamous cell carcinoma?

This trial is studying a combination of immune-targeted therapy and lysogenic herpes simplex virus virotherapy given before surgery to treat resectable head and neck squamous cell carcinoma. Researchers aim to evaluate the safety and tolerability of this combination and how it may improve surgery outcomes and reduce cancer recurrence.

Led by West China Hospital · Updated on 2025-06-13

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating a combination of immune-targeted therapy and lysogenic herpes simplex virus HSV virotherapy as a neoadjuvant treatment for patients with surgically resectable head and neck squamous cell carcinoma HNSCC. This study aims to improve surgical success and reduce the risk of recurrence and metastasis by using these therapies before surgery. The trial is a prospective, single-arm study focused on the safety and tolerability of this innovative approach for patients with locally advanced HNSCC without distant metastasis. Participants will receive tislelizumab on days 1 and 22, afatinib daily from days 1 to 42, and injections of lysogenic HSV virus into lymph nodes in two doses spaced two weeks apart. The virus dose will be adjusted based on lymph node size, with a dose-escalation phase followed by a dose-expansion phase using the most effective dose. After these treatments, patients will undergo standard surgery to remove the tumor. During the study, researchers will monitor participants for dose-limiting toxicities during surgery and evaluate responses such as major pathologic response and complete pathologic response. Additional assessments include adverse events up to 12 weeks, objective response rate up to 8 weeks, and one-year disease-free survival. Participants will attend scheduled visits for treatment administration, surgery, and follow-up to assess safety and treatment effects throughout the trial period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 70Years

All Genders

Eligibility Criteria

You may qualify if you...

Age 18 to 70 years, any gender
Pathologically confirmed head and neck squamous carcinoma without distant metastasis
Locally advanced HNSCC excluding nasopharyngeal, salivary gland, and thyroid cancers
Non-oropharyngeal HNSCC or HPV-negative oropharyngeal carcinoma at stages III, IVA, IVB; HPV-positive oropharyngeal carcinoma stages II and III
Eligible for surgical resection as evaluated by head and neck surgery
Definite lymph node metastasis with lymph node stage not N0 or Nx
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Adequate organ and bone marrow function
Able and willing to comply with study procedures and provide informed consent

You will not qualify if you...

Lymph node stage N0 or Nx
History of other malignancies except certain cured non-recurrent cancers
Active or history of autoimmune diseases including neurological and systemic autoimmune disorders
History of severe allergies to study drugs or components
Prior treatment with PD-1, PD-L1, CTLA-4, EGFR antibodies, EGFR-TKI, or anti-tumor vaccines
Use of active vaccines against infectious diseases within 4 weeks before study drug or planned during study
Major surgery or severe trauma within 4 weeks before study drug
Use of systemic corticosteroids or immunosuppressants within 14 days before study drug
Serious cardiac conditions or abnormal ECG posing risk
History or suspicion of interstitial pneumonia or pulmonary toxicity
Active or uncontrolled infections including tuberculosis, hepatitis B or C, HIV/AIDS
History of neurological or psychiatric disorders such as epilepsy or dementia
Recent substance or alcohol abuse within 3 months
Pregnant or breastfeeding women
Plans to have children or unwillingness to use contraception during and after study
Use of investigational drugs within 4 weeks prior or concurrent enrollment in other clinical trials
Other medical conditions judged by investigators to interfere with study participation

Research Team

Xingchen Peng

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