Actively Recruiting
A Clinical Study on Neoadjuvant Treatment of Resectable Head and Neck Squamous Carcinoma With Immune-targeted Therapy and Lysogenic HSV Virus
Led by West China Hospital · Updated on 2024-12-19
21
Participants Needed
1
Research Sites
104 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 Study on Neoadjuvant Treatment of Resectable Head and Neck Squamous Carcinoma With Immune-targeted Therapy and Lysogenic HSV Virus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years, any gender
- Pathologically confirmed head and neck squamous carcinoma
- Locally advanced HNSCC without distant metastasis, excluding nasopharyngeal, salivary gland, and thyroid cancers
- Non-oropharyngeal HNSCC and HPV-negative oropharyngeal carcinoma stages III, IVA, IVB
- HPV-positive oropharyngeal cancers stages II and III, determined by p16 immunohistochemistry
- Suitable for surgical resection as evaluated by head and neck surgery
- Confirmed lymph node metastasis with lymph node stage not N0 or Nx
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Adequate organ and bone marrow function
- Voluntary participation 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
- Active or past autoimmune diseases including neurological and connective tissue disorders
- History of severe allergies or anaphylaxis to study drugs or components
- Prior treatment with PD-1, PD-L1, CTLA-4 antibodies, EGFR antibodies, EGFR-TKI, or anti-tumor vaccines
- Use of any active infectious disease vaccines within 4 weeks before first dose or during study
- Major surgery or severe trauma within 4 weeks prior to first dose
- Use of systemic corticosteroids or immunosuppressive agents within 14 days before dosing
- Serious cardiac conditions including abnormal function or arrhythmias
- History or suspicion of interstitial or non-infectious pneumonia
- Active tuberculosis or untreated prior tuberculosis
- Hyperthyroidism or organic thyroid disease; treated hypothyroidism allowed
- Active infection, fever of unknown origin, or recent antibiotic use
- Active hepatitis B or C or known HIV/AIDS infection
- Neurologic or psychiatric disorders such as epilepsy or dementia
- Substance or alcohol abuse within 3 months
- Pregnancy or breastfeeding; plans for pregnancy or inadequate contraception
- Recent participation in other investigational drug studies within 4 weeks
- Other factors judged by investigator to interfere with study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here