Squamous cell carcinoma of the head and neck
Conditions
Interventions
Experimental group:Paclitaxel-albumin+ Cisplatin+ Pabolizumab/Cetuximab
Sponsors
Hunan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Patients aged 18 to 70 years are male or female. 2.Local recurrence of squamous cell carcinoma, including primary and/or cervical lymph nodes, was confirmed by pathology. 3.The primary focus and lymph nodes can be surgically removed completely. 4.The primary and lymph nodes have the opportunity to be surgically removed completely (R1 excision), but the safety boundary is difficult to grasp (R0 excision). 5.Remote metastasis was ruled out by chest CT, head and abdomen imaging or PET-CT. 6.Vital organs function normally and can tolerate the prescribed treatment regimen(Absolute neutrophil count >= 1.8×10^9/L; Platelet count >= 100×10^9/L; Hemoglobin >= 9 g/dL; Serum albumin >= 3 g/dL; Bilirubin = 2000/µL; Serum creatinine <= 1.5 × ULN; Thyroid-stimulating hormone <= ULN.). 7.The performance status on the ECOG Performance scale is 0-1. 8.Women of childbearing age (15-49 years) who have tested negative for serum or urinary HCG within 7 days prior to treatment and have consented to use medically approved measures for contraception during treatment and for 120 days after the end of treatment. 9.Men who were not neutered were required to consent to a highly effective form of contraception during the study period and for at least 120 days after the last dose of PD-1 monoclonal antibody. 10.Sufficient tissue specimens are available for PD-L1 detection or exploratory studies. 11.Sign an informed consent form and voluntarily participate in the clinical trial research project.
Exclusion criteria
Exclusion criteria: 1.Patients with non-squamous cell carcinoma were pathologically confirmed. 2.Patients with distant metastases. 3.Local unresectable lesions Patients with unresectable lesions expected after 3 cycles of neoadjuvant therapy. 4.Have received EGFR-targeted therapy, and PD-1 or PD-L1 targeted therapy (if only one of these has been received, the other target drug may be used as neoadjuvant therapy and further screening may be possible). 5.Patients with active autoimmune disease or a history of autoimmune disease that may recur.Note: Patients with the following conditions are not excluded and may proceed to further screening: (1)Well-controlled type 1 diabetes mellitus (2) Hypothyroidism (if controlled with hormone replacement therapy only) (3) Well-controlled celiac disease (4)Dermatological conditions not requiring systemic therapy (e.g., vitiligo, psoriasis, alopecia) (5) Any other condition not expected to recur in the absence of an external trigger; 6.Any active malignancy within grade 1 potassium, sodium, or corrected calcium levels despite standard drug therapy or >= grade 3 hypoalbuminemia. 9.A history of interstitial lung disease, non-infectious pneumonia, or uncontrollable diseases, including pulmonary fibrosis and acute lung disease. 10.Severe chronic or active infections (including tuberculosis infections) requiring systemic antibiotic, antimicrobial, or antiviral treatment occurred within 14 days prior to the first administration of the study drug. 11.Known history of HIV infection. 12.Untreated patients with chronic hepatitis B or HBV carriers with chronic hepatitis B virus (HBV) DNA>=500 IU/mL or active hepatitis C virus carriers (HCV) should be excluded.Note: Inactive hepatitis B surface antigen (HBsAg) carriers, patients with treated and stable hepatitis B (HBV DNA < 500 IU/mL), and cured hepatitis C patients are eligible. 13.Any major surgery requiring general anesthesia was performed within <=28 days prior to treatment. 14.Previous stem cell allogeneic transplants or organ transplants. 15.Have any of the following cardiovascular risk factors.(1) Cardiac chest pain occurring within 28 days before treatment, defined as moderate pain limiting instrumental activities of daily living. (2) Symptomatic pulmonary embolism occurring within 28 days before treatment. (3) Acute myocardial infarction occurring within 6 months before treatment. (4) History of any heart failure meeting NYHA Class III or IV criteria within 6 months before treatment.(5) Ventricular arrhythmia of Grade =2 occur
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival at 2 years; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor pathological response rate;2-year recurrence free survival rate;R0/R1 resection rate after neoadjuvant therapy and surgery;Patient quality of life;2-year distant metastasis-free survival rate;Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactWenxiao Huang
Hunan Cancer Hospital
Outcome results
None listed