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Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

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Neoplasms, Squamous Cell

Head and Neck Neoplasms

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Tislelizumab

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Dasatinib

Quercetin

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Neoadjuvant treatment with Tislelizumab, dasatinib and quercetin for up to 3 cycles (cycle length: 21 days):

Tislelizumab (IV), dose= 200mg, day=1. Dasatinib (PO), dose=100mg/day, day= 1,2,3. Quercetin (PO), dose=1250mg/day, day= 1,2,3.

Following surgical resection, participants will receive adjuvant therapy:

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

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.

Tislelizumab + Dasatinib + Quercetin (neoadjuvant)

surgery

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

Tislelizumab + Dasatinib + Quercetin (adjuvant)

Bin Wei

Song Fan

Song Fan, Doctor

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.

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

MPR is defined as ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen and all the sampled regional lymph nodes.

Percentage of adverse events that are possibly, probably or definitely related to study treatment per Criteria for Adverse Events version 5 (CTCAE v5.0).

Overall survival will be defined as the time from treatment until death from any cause.

DFS is defined as the time from treatment until the date of the first relapse (local/regional recurrence or distant metastasis) or death (from any cause) whichever comes firsts and regardless of whether the patient withdraws from treatment or receives another anti-cancer therapy prior to disease relapse.

The rate of patients with complete remission (CR) or partial response (PR) evaluated by RECIST 1.1 criteria.

Rate of patients with an Unplanned Delay to Surgery defined as any change to scheduled surgery date considered to be at least possibly related to neoadjuvant treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neoadjuvant Tislelizumab in Combination With Dasatinib and Quercetin in Resectable HNSCC (COIS-01)	NCT05724329	Head and Neck S...	Tislelizumab + ... surgery Tislelizumab + ...	50 Years - 80 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Neoadjuvant Tislelizumab in Combination With Dasatinib and Quercetin in Resectable HNSCC (COIS-01)	NCT05724329	Head and Neck S...	Tislelizumab + ... surgery Tislelizumab + ...	50 Years - 80 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Neoadjuvant Tislelizumab in Combination With Dasatinib and Quercetin in Resectable HNSCC (COIS-01)	NCT05724329	Head and Neck S...	Tislelizumab + ... surgery Tislelizumab + ...	50 Years - 80 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Spots Global Cancer Trial Database for tislelizumab + dasatinib + quercetin (adjuvant)