Neoadjuvant Tislelizumab in Combination With Dasatinib and Quercetin in Resectable HNSCC (COIS-01)
NCT05724329 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2024-09-19
Summary
The trial is being conducted to evaluate the efficacy and safety of Tislelizumab in combination with dasatinib and quercetin(combining immunotherapy and senolytics, COIS) in patients with head and neck squamous cell carcinoma who are about to undergo surgery.
Conditions
- Head and Neck Squamous Cell Carcinomas
Interventions
- DRUG
-
Tislelizumab + Dasatinib + Quercetin (neoadjuvant)
Patients receive Tislelizumab (IV) on day 1, dasatinib (PO) on day 1,2,3 and quercetin (PO) on day 1,2,3. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
- PROCEDURE
-
surgery
Standard of care
- DRUG
-
Tislelizumab + Dasatinib + Quercetin (adjuvant)
Tislelizumab (200 mg, day=1) Cycle=1-15cycle Dasatinib (100mg/day, day= 1,2,3) Cycle=1、2、3、8、9、10 Quercetin (1250mg/day, day= 1,2,3) Cycle=1、2、3、8、9、10
Sponsors & Collaborators
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-02-05
- Primary Completion
- 2024-04-05
- Completion
- 2028-08-05
Countries
- China
Study Locations
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