Actively Recruiting
Tislelizumab Combined With Chemotherapy Followed by Surgery Versus Up-front Surgery in Resectable Head and Neck Squamous Cell Carcinoma (REDUCTION-I)
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2024-05-17
537
Participants Needed
3
Research Sites
413 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead Sponsor
Z
Zhongshan People's Hospital, Guangdong, China
Collaborating Sponsor
AI-Summary
What this Trial Is About
A prospective, randomized, open-label, multicenter Phase 3 trial designed to compare the safety and efficacy of Tislelizumab combined with chemotherapy followed by surgery versus up-front surgery in resectable head and neck squamous cell carcinoma.
CONDITIONS
Official Title
Tislelizumab Combined With Chemotherapy Followed by Surgery Versus Up-front Surgery in Resectable Head and Neck Squamous Cell Carcinoma (REDUCTION-I)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed head and neck squamous cell carcinoma planned for curative surgery, stage III or IVA
- Age 18 to less than 80 years at study entry
- ECOG performance status of 0 or 1
- Measurable disease as per RECIST 1.1 criteria
- No prior exposure to immune-mediated therapies such as anti-CTLA-4 or anti-PD-1/PD-L1 antibodies (except anticancer vaccines)
- Adequate liver, kidney, and bone marrow function based on specific laboratory tests
- Women of reproductive potential must have a negative pregnancy test within 21 days before enrollment and agree to use effective contraception for 23 weeks after last dose
- Men who are sexually active with women of reproductive potential must use contraception during the study and for 31 weeks after last dose unless azoospermic
- Ability to understand and sign informed consent
- Willingness and ability to comply with study procedures and follow-up
- Consent to use pre-treatment and post-operative tissue samples for research
You will not qualify if you...
- Participation in another investigational study within 4 weeks before treatment or unresolved adverse events from prior studies
- Another invasive cancer or related treatment within 5 years prior to study start
- Recent major surgery without adequate recovery
- Use of systemic corticosteroids (>10 mg prednisone daily) or immunosuppressive drugs within 14 days before study
- Active autoimmune disease requiring systemic steroids in past 3 months or severe autoimmune conditions
- Active, known or suspected autoimmune disease except certain stable conditions like vitiligo or psoriasis
- Evidence of interstitial lung disease or active non-infectious pneumonitis
- Active infection requiring systemic therapy
- Previous therapy with immune checkpoint inhibitors
- History of allergic reactions to similar drugs
- Conditions or lab abnormalities interfering with study participation or results
- Psychiatric or substance abuse disorders affecting cooperation
- Pregnant, breastfeeding, or planning pregnancy during study and follow-up
- 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: 3 locations
1
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guanzhou, Guangdong, China, 510000
Actively Recruiting
2
Zhong shan people's hospital
Zhongshan, Guangdong, China, 528400
Actively Recruiting
3
Huazhong University of Science and Technology Union Hospital (Nanshan Hospital)
Shenzhen, Nanshan, China
Actively Recruiting
Research Team
S
Song Fan, Doctor
CONTACT
B
Bin Wei, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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