NCT05724329

Neoadjuvant Tislelizumab in Combination With Dasatinib and Quercetin in Resectable HNSCC (COIS-01)

Phase II Trial of Tislelizumab, an Anti-PD-1 Monoclonal Antibody, in Combination With Dasatinib and Quercetin, as a Novel Neoadjuvant Pre-Surgical Therapy for Head and Neck Squamous Cell Carcinoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2023-02-05
• Primary completion: 2024-04-05
• Completion: 2028-08-05
• First posted: 2023-02-13
• Last updated: 2024-09-19

Locations

1 site across 1 country: China