Actively Recruiting
A Clinical Trial of Neoadjuvant Targeted Therapy, Immunotherapy, and Lysogenic HSV-Based Virotherapy in Resectable Head and Neck Squamous Cell Carcinoma
Led by West China Hospital · Updated on 2025-06-13
29
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years old, any gender
- Pathologically confirmed head and neck squamous carcinoma (excluding nasopharyngeal, salivary gland, and thyroid cancers)
- Locally advanced HNSCC without distant metastasis
- Non-oropharyngeal HNSCC or HPV-negative oropharyngeal carcinoma stages III, IVA, or IVB; HPV-positive oropharyngeal carcinoma stages II or III
- Evaluated as surgically treatable by head and neck surgery
- Definite lymph node metastasis with lymph node stage not N0 or Nx
- ECOG physical status score of 0 to 1
- Adequate organ and bone marrow function as defined in the protocol
- 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 cancers (e.g., basal cell carcinoma of skin, superficial bladder cancer)
- Active or history of autoimmune diseases including neurological and systemic autoimmune disorders
- History of anaphylaxis or severe drug allergy to study drugs or components
- Prior use of PD-1, PD-L1, CTLA-4 antibodies, EGFR antibodies, EGFR-TKI, or anti-tumor vaccines
- Use of active vaccines against infectious diseases within 4 weeks before first dose or planned during study
- Major surgery or severe trauma within 4 weeks prior to first study drug dose
- Use of systemic corticosteroids or immunosuppressive agents within 14 days prior to study drug
- Serious medical conditions such as abnormal cardiac function, ischemic heart disease, significant arrhythmias, or abnormal ECG posing risk
- History or suspicion of interstitial pneumonia or pulmonary toxicity
- Active or uncontrolled infections including tuberculosis, active hepatitis B or C, or HIV/AIDS
- Hyperthyroidism or organic thyroid disease; stable hypothyroidism allowed
- Active infection, fever of unknown origin, or recent systemic antibiotic use
- History of neurological or psychiatric disorders like epilepsy or dementia
- Substance or alcohol abuse within past 3 months
- Pregnant or breastfeeding women, or unwillingness to use contraception during and after study
- Participation in other investigational drug trials within 4 weeks prior to first dose unless observational or follow-up studies
- Any other factors judged by investigator that could prevent study completion or compliance
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of Radiation Oncology
Chengdu, Sichuan, China, 610000
Actively Recruiting
Research Team
X
Xingchen Peng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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