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
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
21
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
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
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)
Treatment
Duration - Approximately 6 weeks
Participants receive immune-targeted therapy with Tislelizumab and Afatinib, combined with two injections of lysogenic HSV virus spaced two weeks apart as neoadjuvant treatment before surgery.
2 Tislelizumab infusions and continuous daily Afatinib administration for 42 days; 2 lysogenic HSV virus injections given 2 weeks apart
Surgery
Duration - 1 day
Participants undergo standard of care surgical resection following neoadjuvant treatment.
1 surgical procedure (in-person)
Follow-up
Duration - Up to 1 year
Participants are monitored for safety, disease recurrence, and survival outcomes after surgery.
Visits and assessments up to 1 year post-surgery
Trial Site Locations
Total: 1 location
1
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
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/23414589Phase III randomized trial of induction chemotherapy in patients with N2 or N3 locally advanced head and neck cancer.
Ezra E W Cohen, Theodore G Karrison, Masha Kocherginsky...
https://pubmed.ncbi.nlm.nih.gov/25049329Induction Chemotherapy Followed by Cetuximab Radiotherapy Is Not Superior to Concurrent Chemoradiotherapy for Head and Neck Carcinomas: Results of the GORTEC 2007-02 Phase III Randomized Trial.
Lionnel Geoffrois, Laurent Martin, Dominique De Raucourt...
https://pubmed.ncbi.nlm.nih.gov/30016178Afatinib 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/25892145Afatinib versus methotrexate as second-line treatment in Asian patients with recurrent or metastatic squamous cell carcinoma of the head and neck progressing on or after platinum-based therapy (LUX-Head & Neck 3): an open-label, randomised phase III trial.
Y Guo, M-J Ahn, A Chan...
https://pubmed.ncbi.nlm.nih.gov/31501887