Squamous cell carcinoma of the head and neck
Conditions
Interventions
Experimental group:Operation was performed after cycles of Paprizumab 200mg D1 combined with cisplatin 75mg/m^2 D1 / carboplatin AUC 2 D1-D3, fluorouracil 1000mg/m^2 D1, Q21d *2 (within 2 weeks)
Sponsors
Beijing Tongren Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with untreated IVA-IVB stage head and neck squamous cell carcinoma (including oral, oropharyngeal, hypopharyngeal and laryngeal cancers) with a definite histological and/or cytological diagnosis; 2. Radical excision is impossible or difficult in direct operation; 3. Patients with non-distant metastasis; 4. Confirm the expression of CPS before treatment; 5. The p16 status of oropharyngeal cancer patients should be confirmed before treatment; 6. The researchers believed that it could safely accept neoadjuvant therapy with Pabolizumab combined with cisplatin/carboplatin and fluorouracil; 7. Aged 18-75 years; 8. ECOG 0-1; 9. Measurable diseases as defined by RECIST v1.1; 10. Normal organ function; 11. Female and male patients with reproductive potential must agree to use appropriate contraceptive methods throughout the study period and for 180 days after the last study treatment; 12. Male patients must refrain from donating sperm throughout the study period and for 180 days after the last study treatment.
Exclusion criteria
Exclusion criteria: 1. Oropharyngeal, laryngeal and hypopharyngeal or non-oral neoplasms, such as nasopharyngeal, sinuses, other paranasal, oesophageal cancers or other unknown primary head and neck cancer (HNSCC); 2. Female subjects with positive urine pregnancy tests (with or without cisplatin) within 72 hours before the start of the study or within 24 hours after the start of radiotherapy; 3. Received live vaccine within 30 days prior to enrollment; 4. Diagnosed with immunodeficiency or received systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to enrollment; Have had other malignancies in the past 3 years that are known to be progressing or require aggressive treatment other than basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (e.g. cervical or breast cancer in situ); 5. Have radiographic detectable (even if asymptomatic and/or previously treated) CNS metastatic and/or carcinomatous meningitis; 6. Hearing loss detection >= level 2 (According to the average hearing loss of 500, 1000, 2000 and 4000Hz, the hearing loss degree is divided into five levels: 26~40dB for mild, 41~55dB for moderate, 56~70dB for moderate severe, 71~90dB for severe, and more than 90dB for extremely severe.) ; 7. Mental illness grade >=2 (2 points for one or two of the five scores: self-care ability, family life function performance, care and responsibility for family, occupational labor ability, and social activity ability. According to normal or mild abnormal 0 points, have functional defects 1 points, serious functional defects 2 points); 8. Grade 3-4 hemorrhage due to potential malignancy; 9. Had undergone surgery or had not fully recovered from toxicities or complications due to the intervention before the study began; 10. Had a tissue/solid organ allograft; 11. Severe hypersensitivity (>= grade 3) to Pabolizumab or any of its excipients, radiotherapy, cisplatin, 5-FU or its analogues; 12. Have an active autoimmune disease requiring systemic therapy in the past 2 years; 13. A history of (non-infectious) pneumonia requiring steroid treatment; 14. Have an active infection requiring systemic treatment; 15. A history of human immunodeficiency virus (HIV) infection; 16. A history of hepatitis B or hepatitis B virus positive (defined as positive hepatitis B surface antigen [HBsAg] response) or active hepatitis C (defined as detection of hepatitis C virus [HCV] RNA); 17. Have any medical history that could confound the results of the study, interfere with participant participation throughout the study or is detrimental to the best interests of the participant, medical history of abnormalities in treatment or laboratory tests (e.g., Hashimoto's thyroiditis, etc.); 18. A known history of mental or substance abuse disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comprehensive positive score;Objective response rate; | — |
Countries
China
Contacts
Public ContactFang Jugao
Beijing Tongren Hospital, Capital Medical University
Outcome results
None listed