Estimating the global cancer incidence and mortality in 2018: GLOBOCAN sources and methods.
J Ferlay, M Colombet, I Soerjomataram...
https://pubmed.ncbi.nlm.nih.gov/30350310Actively 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
Led by West China Hospital · Updated on 2025-06-13
29
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Run-in Period
Duration - 6 weeks
Participants receive Tislelizumab and Afatinib along with Lysogenic HSV virus injections as neoadjuvant therapy before surgery.
Tislelizumab on days 1 and 22; Afatinib daily from days 1 to 42; 2 Lysogenic HSV virus injections separated by 2 weeks
Surgery and Immediate Post-operative Care
Duration - Up to 1 week
Participants undergo standard of care surgical resection of head and neck squamous cell carcinoma following neoadjuvant therapy.
1 surgical procedure and immediate post-operative care
Follow-up
Duration - Up to 1 year
Participants are monitored for safety, disease-free survival, and treatment response after surgery.
Visits for adverse event monitoring up to 12 weeks and disease-free survival assessment up to 1 year
Trial Site Locations
Total: 1 location
1
Department of Radiation Oncology
Chengdu, Sichuan, China, 610000
Actively Recruiting
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Research Team
X
Xingchen Peng
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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Published Research Related To This Trial
Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries.
Freddie Bray, Jacques Ferlay, Isabelle Soerjomataram...
https://pubmed.ncbi.nlm.nih.gov/30207593Changes in survival in head and neck cancers in the late 20th and early 21st century: a period analysis.
Dianne Pulte, Hermann Brenner
https://pubmed.ncbi.nlm.nih.gov/20798198Follow-up in Head and Neck Cancer: Do More Does It Mean Do Better? A Systematic Review and Our Proposal Based on Our Experience.
Nerina Denaro, Marco Carlo Merlano, Elvio Grazioso Russi
https://pubmed.ncbi.nlm.nih.gov/27337948Promising new advances in head and neck radiotherapy.
P M Harari
https://pubmed.ncbi.nlm.nih.gov/15987991Induction chemotherapy followed by concurrent chemoradiotherapy (sequential chemoradiotherapy) versus concurrent chemoradiotherapy alone in locally advanced head and neck cancer (PARADIGM): a randomised phase 3 trial.
Robert Haddad, Anne O'Neill, Guilherme Rabinowits...
https://pubmed.ncbi.nlm.nih.gov/23414589Afatinib versus methotrexate as second-line treatment in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck progressing on or after platinum-based therapy (LUX-Head & Neck 1): an open-label, randomised phase 3 trial.
Jean-Pascal H Machiels, Robert I Haddad, Jérôme Fayette...
https://pubmed.ncbi.nlm.nih.gov/25892145