HNSCC
Conditions
Interventions
Experimental group:Pembrolizumab 200mg d1 combined with cisplatin 75mg/m2 d1/carboplatin AUC 2 d1-d3, albumin paclitaxel 260mg/m2 d1, q21d*2 cycles after surgery (within 2 weeks)
Sponsors
Beijing Tongren Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Untreated patients with stage IVA-IVB head and neck squamous cell carcinoma (including oral cancer, oropharyngeal cancer, hypopharyngeal cancer, and laryngeal cancer) who have been clearly diagnosed by histology and/or cytology; 2.Direct surgery cannot be radically removed or is difficult to remove; 3.Non-distant metastatic patients; 4.Confirm CPS expression before treatment; 5.Patients with oropharyngeal cancer must confirm their p16 status before treatment; 6.The investigator believes that it can safely receive pembrolizumab combined with cisplatin/carboplatin, albumin and paclitaxel neoadjuvant therapy; 7.Aged 18 to 65 years; 8.ECOG 0-1; 9.Measurable diseases defined by RECIST v1.1; 10.Organ function is normal; 11.Female and male participants with reproductive potential must agree to use appropriate contraceptive measures during the entire study period and within 180 days after the last study treatment; 12.Male participants must not donate sperm during the entire study period and within 180 days after the last study treatment.
Exclusion criteria
Exclusion criteria: 1.There is distant metastasis; 2.Suffer from oropharyngeal, throat and hypopharyngeal or oral tumors, such as nasopharyngeal, sinus, other paranasal, esophageal cancer or other unknown primary head and neck cancer (HNSCC); 3.Female subjects with a positive urine pregnancy test (with or without cisplatin) within 72 hours before the start of the study or within 24 hours after the start of radiotherapy; 4.Live vaccine was vaccinated within 30 days before enrollment; 5.Diagnosed with immunodeficiency or received systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before enrollment;vIn the past 3 years, there are other malignant tumors that are known to be progressing or require active treatment, except for skin basal cell carcinoma, skin squamous cell carcinoma or carcinoma in situ (such as cervical cancer in situ or breast cancer); 6.Have central nervous system metastases and/or cancerous meningitis detectable on imaging (even if asymptomatic and/or have been previously treated); 7.Hearing loss detection >= 2 (according to the average hearing loss of 500, 1000, 2000 and 4000Hz, the hearing loss is divided into 5 levels: 26~40dB is mild, 41~55dB is moderate, 56~70dB is moderate and severe, 71~90dB is severe, greater than 90dB is extremely severe.); 8.Mental illness level >=2 (one or two of the five scores are rated as 2 points, the five items are: personal life self-care ability, family life function performance, care and responsibility for family members, professional labor ability, social activities Ability. According to normal or mild abnormality, 0 points, 1 point for functional defects, and 2 points for severe functional defects); 9.Grade 3-4 bleeding due to potential malignant tumor; 10.Have undergone surgery before starting the research or failed to fully recover from toxicity or complications caused by intervention; 11.Have had allogeneic tissue/solid organ transplantation; 12.Severe hypersensitivity to Pembrolizumab or any of its excipients, radiotherapy, cisplatin, 5-FU or its analogues (>=Grade 3); 13.Suffering from active autoimmune disease and requiring systemic treatment in the past 2 years; 14.Have a history of (non-infectious) pneumonia requiring steroid therapy; 15.Suffering from active infection, requiring systemic treatment; 16.Have a history of human immunodeficiency virus (HIV) infection; 17.Having a history of hepatitis B or positive for hepatitis B virus (defined as positive for hepatitis B surface antigen [HBsAg]) or active hepatitis C (defined as detection of hepatitis C virus [HCV] ribonucleic acid). 18.Have any medical history that may confuse the research results, interfere with participants' participation during the entire study period, or be detrimental to the best interests of the participants, medical history of treatment or laboratory abnormalities (such as Hashimoto's thyroiditis, etc.); 19.Have a known history of mental illness or substance abuse disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comprehensive positive score; | — |
Countries
China
Contacts
Public ContactFang Jugao
Beijing Tongren Hospital, Capital Medical University
Outcome results
None listed