What is this clinical trial studying for head and neck squamous carcinoma?

This trial is studying a new treatment that combines immune-targeted therapy with a lysogenic herpes simplex virus to treat head and neck squamous carcinoma before surgery. Researchers aim to evaluate the safety and effects of this combination to improve surgery outcomes and reduce cancer recurrence. The study is sponsored by West China Hospital.

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

Adults aged 18 to 70 with confirmed surgically removable head and neck squamous carcinoma and lymph node metastasis may be eligible. Participants must have good overall health and no recent other cancers or active autoimmune diseases. Please review eligibility criteria for more details.

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

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

Actively Recruiting

Phase 1

Age: 18Years - 70Years

All Genders

ID06741982

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

Led by West China Hospital · Updated on 2024-12-19

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying a new treatment approach for patients with surgically removable head and neck squamous cell carcinoma HNSCC, a common and serious type of cancer in the head and neck region. The study evaluates the safety and tolerability of combining immune-targeted therapy with a lysogenic herpes simplex virus HSV as a neoadjuvant treatment to reduce tumor size before surgery. This innovative combination aims to improve surgery outcomes and lower the chances of cancer returning or spreading. Participants receive a combination of treatments including Tislelizumab given on days 1 and 22, and continuous daily Afatinib from days 1 to 42. They also receive injections of the lysogenic HSV virus directly into lymph nodes, with dosing based on lymph node size, given twice two weeks apart. After these treatments, patients undergo standard surgical removal of the tumor. The HSV virus injection includes an initial dose-escalation phase followed by a dose-expansion phase to find the most effective dose. During the study, patients are closely monitored for side effects and treatment tolerance, including checking for dose-limiting toxicities during surgery. Researchers will assess how well the tumor responds to treatment by examining major and complete pathological responses and overall tumor shrinkage up to eight weeks after treatment. They will also monitor adverse events for up to 12 weeks and follow disease-free survival for one year. The study duration and procedures are planned to provide detailed information on the safety and effects of this combined therapy.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 70Years

All Genders

Eligibility Criteria

You may qualify if you...

Age 18 to 70 years, any gender
Pathologically confirmed locally advanced head and neck squamous carcinoma (excluding nasopharyngeal, salivary gland, and thyroid cancers)
Stages III, IVA, or IVB for non-oropharyngeal and HPV-negative oropharyngeal carcinoma; stages II or III for HPV-positive oropharyngeal carcinoma
Treatable by surgical resection as assessed by head and neck surgeon
Definite lymph node metastasis with lymph node stage not N0 or Nx
ECOG physical status score of 0 or 1
Adequate organ and bone marrow function
Voluntary enrollment with signed informed consent and ability to comply with study visits and procedures

You will not qualify if you...

Lymph node staging of N0 or Nx
History of other malignancies except certain cured and non-recurrent skin, bladder, cervical, or gastrointestinal cancers
Active or history of autoimmune diseases including neurological or connective tissue disorders
History of severe drug allergy or known allergy to study drugs
Prior use of PD-1, PD-L1, CTLA-4, EGFR antibodies, or anti-tumor vaccines
Use of active vaccines within 4 weeks before first study dose or during study
Major surgery or severe trauma within 4 weeks before first study dose
Use of systemic corticosteroids or immunosuppressive agents within 14 days before study drug
Serious heart conditions or abnormal heart function
History or suspicion of interstitial pneumonia or active tuberculosis
Uncontrolled thyroid disease
Active infection, fever, or recent antibiotic use
Active hepatitis B or C, HIV infection
History of definitive neurological or psychiatric disorders
Recent substance or alcohol abuse
Pregnancy, breastfeeding, or unwillingness to use contraception
Recent investigational drug use or enrollment in another clinical study
Other factors that may prevent trial completion as judged by investigator

Research Team

Xingchen Peng

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