Squamous cell carcinoma of head and neck
Conditions
Interventions
Experimental group:pembrolizumab combined with PF induction chemotherapy in sequential surgery
Sponsors
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Patients with resectable stage III-IV (AJCC 8th Edition) head and neck cancer were initially diagnosed and pathologically diagnosed as squamous cell carcinoma; with histological and hematological samples for molecular marker detection; 2.At least one measurable solid tumor (efficacy evaluation criteria: RECIST 1.1); 3.Male or non pregnant female; 4.Aged 18 to 70 years; 5.Normal bone marrow function; 6.Normal liver function; 7.Normal renal function; 8.Karnofsky scale >= 70; 9.The patients voluntarily agreed to participate in the study and signed the informed consent form. They are willing to participate in and complete the study and follow-up.
Exclusion criteria
Exclusion criteria: 1.Have active or history of autoimmune diseases that may recur; 2.Anti tumor therapy has been performed, including chemotherapy, radiotherapy and surgery; 3.With other serious diseases which may bring greater risk or affect to the compliance of the test; 4.Known history of interstitial lung disease, non infectious pneumonia or highly suspected interstitial lung disease; 5.History of human immunodeficiency virus infection; 6.During screening, HBV or HCV tests meet any of the following criteria: (1)HBsAg positive and peripheral blood HBV DNA titer >= 104 copy number/ml or >= 2000 IU/ml; (2)HCV antibody is positive and HCV-RNA is higher than the detection limit of the analytical method; 7.Poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response, pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS);Objective response rate (ORR);Overall Survival (OS);Locoregional Recurrence Free Survival (LRFS); | — |
Countries
China
Contacts
Public ContactHan Ping
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Outcome results
None listed