This study is a prospective, open-label, multi-center phase III study; patients with untreated stage IIIA to stage IVB head and neck squamous cell carcinoma (including oral cavity cancer, oropharyngeal cancer, hypopharyngeal cancer, and laryngeal cancer) who meet the inclusion criteria are randomized 1:1 and given pembrolizumab 200 mg d1+ chemotherapy for 2 cycles (experimental group), 2 cycles of chemotherapy (control group), and then stratified according to the patient's condition. If the imaging evaluation after neoadjuvant treatment is (complete response, CR), adjuvant radiotherapy will be given; if the imaging evaluation is (partial response, PR) or (stable disease, SD), surgery (within 2 weeks) will be performed, followed by standard treatment. The main research hypothesis of this study: pembrolizumab combined with standard chemotherapy can significantly improve the rate of pathological complete response (pCR) compared with standard chemotherapy.
Patients with stage IIIA-IVB head and neck squamous cell carcinoma confirmed by histology and/or cytology;
Have not received immunotherapy in the past;
The researchers believe that he can safely receive pembrolizumab combined with chemotherapy or neoadjuvant chemotherapy;
Age ≥18 years;
Presence of distant metastasis;
Female subjects with a positive urine pregnancy test within 72 hours before the start of the study or within 24 hours after starting radiation therapy (with or without cisplatin);
received a live vaccine within 30 days before enrollment;
Diagnosed with immunodeficiency or receiving systemic steroid treatment or any other form of immunosuppressive treatment within 7 days before enrollment;
Parallel
Pembrolizumab
DrugPembrolizumab 200mg, IV, on day1 of Q3W, 2 cycle
Cisplatin
DrugCisplatin 75 mg/m\^2, IV, day 1 of Q3W
Carboplatin
DrugCarboplatin AUC (area under curve) 2, IV, day 1-3 of Q3W
Nedaplatin
DrugNedaplatin 80-100 mg/m\^2, IV, day 2-4 of Q3W
Nab paclitaxel
DrugNab paclitaxel 260 mg/m\^2, IV, day 1 of Q3W
Docetaxel
DrugDocetaxel 75 mg/m\^2, IV, day 1 of Q3W
Liposomal paclitaxel
DrugLiposomal paclitaxel 135-175 mg/m\^2, IV, day 1 of Q3W
Fluorouracil
DrugFluorouracil 750 mg/m\^2, IV, day 1-5 of Q3W
Pathological complete response rate (pCR) of pembrolizumab combined with standard chemotherapy neoadjuvant therapy in patients with locally advanced head and neck squamous cell carcinoma
pCR was defined as the absence of residual invasive squamous cell carcinoma within the primary tumor specimen on resection/needle biopsy
Pathological complete response rate (pCR) of standard chemotherapy neoadjuvant chemotherapy in patients with locally advanced head and neck squamous cell carcinoma
pCR was defined as the absence of residual invasive squamous cell carcinoma within the primary tumor specimen on resection/needle biopsy
The objective response rate (ORR) of neoadjuvant therapy with pembrolizumab combined with standard chemotherapy
ORR was defined as the percentage of participants in the analysis population who have a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1
The objective response rate (ORR) of neoadjuvant chemotherapy with standard chemotherapy
ORR was defined as the percentage of participants in the analysis population who have a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1
The 1-year and 2-year event-free survival rates (1y-EFS, 2y-EFS) after pembrolizumab combined with standard chemotherapy neoadjuvant therapy
EFS is defined as the time from randomization to any event, including disease progression, discontinuation of treatment for any reason, or death
The 1-year and 2-year event-free survival rate (1y-EFS, 2y-EFS) after neoadjuvant chemotherapy with standard chemotherapy
EFS is defined as the time from randomization to any event, including disease progression, discontinuation of treatment for any reason, or death
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