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.
None
None
Parallel
Tislelizumab（neoadjuvant）
DrugTislelizumab 200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
Cisplatin （neoadjuvant）
DrugCisplatin 75 mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
Nab-paclitaxel （neoadjuvant）
DrugNab-paclitaxel 260mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
Surgical resection
Procedure/SurgeryStandard of care
Cisplatin（adjuvant）
DrugCisplatin 100 mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
Tislelizumab（adjuvant）
DrugTislelizumab 200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
Radiation
RadiationRecommended, standard of care
Carboplatin (neoadjuvant）
DrugCarboplatin (IV), AUC=5，administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
Carboplatin (adjuvant）
DrugCarboplatin (IV), AUC=5，administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
Event-free Survival (EFS)
EFS is the time from the date of randomization to the date of first record of any of the following events: disease progression; local or distant recurrence as assessed with imaging or biopsy as indicated; or death due to any cause.
Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Adverse Events
High-grade adverse events were tabulated using worst grade per Common Terminology Criteria for Adverse Events, National Cancer Institute (NCI CTCAE) Version 5.0 criteria.
Pathological complete response (pCR) rate
pCR is defined as the absence of invasive squamous cell carcinoma within the resected primary tumor specimen and all the sampled regional lymph nodes.
Major Pathological Response (MPR) rate
MPR is defined as ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen and all the sampled regional lymph nodes.
Event-free Survival (EFS)
EFS is the time from the date of randomization to the date of first record of any of the following events: disease progression; local or distant recurrence as assessed with imaging or biopsy as indicated; or death due to any cause.
Percentage of Participants Experiencing An Adverse Event (AEs)
Percentage of adverse events that are possibly, probably or definitely related to study treatment per Criteria for Adverse Events version 5 (CTCAE v5.0).
Event-free Survival (EFS)
EFS is the time from the date of randomization to the date of first record of any of the following events: disease progression; local or distant recurrence as assessed with imaging or biopsy as indicated; or death due to any cause（Arm A versus Arm B）.
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead sponsor
Zhongshan People's Hospital, Guangdong, China
Collaborator
Shenzhen Sixth People's Hospital
Collaborator
