Head and Neck Squamous Cell Carcinomas, Resectable Head and Neck Squamous-cell Carcinoma
Conditions
Brief summary
For resectable squamous cell carcinoma of the head and neck , novel therapeutic approaches are still needed to improve outcomes. Neoadjuvant immunochemotherapy is considered as a potentially effective strategy. The purpose of this study is to evaluate the safety and efficacy of neoadjuvant of tislelizumab combined with platinum doublet for resectable locally-advanced head and neck squamous-cell carcinoma .
Interventions
DRUGTislelizumab
Tislelizumab: 200mg,administered via Intravenous (IV) injection, day 1 of each 21-day cycle, neoadjuvant therapy : 2 cycles
DRUGNab-paclitaxel
260mg/m\^2, IV, day 1 of each 21-day cycle, neoadjuvant therapy : 2 cycles
DRUGCarboplatin
AUC 5 mg/mL/min by IV infusion once every 3 weeks,day 1 of each 21-day cycle,neoadjuvant therapy : 2 cycles
Sponsors
Xiang Lu
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients who voluntarily participate in the project and sign the informed consent. 2. Be 18 years of age on day of signing informed consent. 3. The performance status of the Eastern Cooperative Oncology Group (ECOG) is 0-1. 4. According to the 8th edition of the guidelines of the American Joint Committee on Cancer (AJCC), patients with stage III-IVA tumors confirmed by pathology as head and neck squamous cell carcinoma. 5. Resectable tumors were evaluated by head and neck surgeons before enrollment to exclude clinical evidence of distant metastasis. 6. Demonstrate adequate organ function.
Exclusion criteria
1. The patient has abnormal blood indicators, abnormal liver and kidney function. 2. The patient has received prior systemic anti-cancer therapy for head and neck squamous cell carcinoma including investigational agents within 3 months of first dose of study treatment. 3. The patient has previously suffered from other tumors , or has previously undergone anti-tumor treatments such as surgery, chemotherapy, and radiotherapy within the past 5 years. 4. The entire clinical research process cannot be completed due to personal, social and economic reasons. 5. Serious systemic diseases in the past and the diseases cannot be cured or controlled by drugs .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response (PCR) | From neoadjuvant therapy to surgical resection, up to 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Pathological Response (MPR) | From neoadjuvant therapy to surgical resection, up to 6 weeks | In the pathological examination of resected specimens, the proportion of residual tumor cells was less than 10%. |
| 3-year Disease-free survival (DFS) rate | 3-years after surgery | Time from randomization to disease recurrence or death of any cause |
| 3-year overall survival（OS）rate | 3-years after surgery | The proportion of all study cases in which no death from any cause occurred within 3 years after surgery |
Countries
China
Contacts
Primary ContactXiang Lu, professor
Outcome results
None listed