Actively Recruiting
Tislelizumab Combined With Chemotherapy Followed by Surgery Versus Up-front Surgery in Resectable Clinically Node-negative Head and Neck Squamous Cell Carcinoma
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2024-05-17
154
Participants Needed
1
Research Sites
287 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A prospective, randomized, open-label, multicenter Phase 2 trial designed to compare the efficacy and safety of Tislelizumab combined with chemotherapy followed by surgery versus up-front surgery in resectable clinically node-negative head and neck squamous cell carcinoma.
CONDITIONS
Official Title
Tislelizumab Combined With Chemotherapy Followed by Surgery Versus Up-front Surgery in Resectable Clinically Node-negative Head and Neck Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed head and neck squamous cell carcinoma planned for curative surgical resection: stage III/IVA
- Age between 18 and less than 80 years
- ECOG performance status of 0 or 1 with measurable disease per RECIST 1.1
- No prior immune-mediated therapy including anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies
- Adequate liver and kidney function within 14 days before registration
- Adequate bone marrow function
- Women of reproductive potential must have a negative pregnancy test within 21 days before enrollment
- Women of reproductive potential must use highly effective contraception for 23 weeks after last study drug dose
- Men who are sexually active with women of reproductive potential must use effective contraception for 31 weeks after last study drug dose
- Ability to understand and sign informed consent
- Willingness and ability to follow study protocol and attend scheduled visits
- Consent to use remaining pre- and post-operative tissue for research
You will not qualify if you...
- Participation in another investigational agent study within 4 weeks before first treatment or unresolved adverse events from prior treatments
- History of another invasive cancer within 5 years or prior cancer treatments within 5 years before study day 0
- Incomplete recovery from major surgery unrelated to cancer before starting therapy
- Use of systemic corticosteroids (>10 mg prednisone daily) or immunosuppressants within 14 days before day -5
- Active autoimmune disease requiring systemic steroids within past 3 months or history of severe autoimmune disease
- Presence of active, known, or suspected autoimmune disease except certain specified conditions
- Evidence of interstitial lung disease or active non-infectious pneumonitis
- Active infection requiring systemic therapy
- Prior therapy targeting immune checkpoint pathways
- History of allergic reaction to study drugs or similar agents
- Any condition or abnormality that could interfere with study results or participation
- Psychiatric or substance abuse disorders interfering with cooperation
- Pregnancy, breastfeeding, or planning to conceive or father children during the study period through 23 weeks after last dose
- Known HIV infection
- Known active Hepatitis B or C or active tuberculosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Medical Ethics Committee of Sun Yat-sen Memorial Hospital
Guangzhou, Yuexiu, China, 510120
Actively Recruiting
Research Team
B
Bin Wei
CONTACT
Q
Qunxing Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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