To explore the efficiency and safety of Tislelizumab combinated with carboplatin and polymeric micellar paclitaxel as a new neoadjuvant treatment regimen for resectable HNSCC patients with clinical positive lymph node metastasis
None
None
Single group
Carboplatin
DrugCarboplatin AUC 5 on weeks 1, 3, and 6
Tislelizumab
DrugTislelizumab 200 mg on weeks 3, 6, and 9;if adjuvant immunotherapy is omitted, Tislelizumab will be administered on weeks 1, 3, 6, 9, 12, 15 after surgery
Polymeric Micellar Paclitaxel
DrugPolymeric Micellar Paclitaxel 300mg/mg/m2 on weeks 1, 3 and 6
Surgical Resection of Primary +/- Neck Dissection
Procedure/SurgeryTwenty-eight days (+ 7 days) following the 3rd cycle of neoadjuvant therapy, patients will then undergo definitive surgical resection of the primary site +/- neck dissection(s).
Post-operative radiation therapy
RadiationPost-operative radiation therapy +/- radiosensitizing agent(s) will be administered per standard-of-care based on pathologic staging of the surgical specimen. If there is an excellent response to treatment with a high degree of downstaging the addition of adjuvant radiation may be omitted if NCCN guidelines are met. If the pathologic assesment following induction systemic therapy and surgery is ypT(pCR 或 MPR) and ypN(pCR) or ypT（ pCR 或 MPR）and ypN（ MPR）without the presence of Serious Adverse Event, adjuvant radiation will not be administered. Otherwise, patients will receive adjuvant RT-based treatment with standard radiation techniques.
Major pathological response (MPR) rate of metastatic lymph nodes
the proportion of cN+ patients with the percentage of residual viable tumor cells in the tumor bed of metastatic lymph nodes less than 10%
Major pathological response (MPR) rate of primary tumor
the proportion of cN+ patients with the percentage of residual viable tumor cells in the tumor bed of primary tumors less than 10%
Event-free survival (EFS)
In cancer, the length of time after primary treatment for a cancer ends that the patient remains free of certain complications or events that the treatment was intended to prevent or delay.
Overall survival（OS）
The time(years) from day 1 of study treatment until death from any cause.
Incidence of treatment-related adverse events
CTCAE 5.0
Correlation between ctDNA dynamic detection and 1-year and 2-year EFS and OS rate after Neoadjuvant immunochemotherapy
The ctDNA dynamic detection will contain NGS test including mutations(both somatic and germline), copy number variations, gene fusions along with genetic interpretation for each and every mutation identified in each test(both blood and tissue) during the whole therapeutic process
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