Head and neck squamous cell carcinoma
Conditions
Interventions
Platinum-tolerant group:Nimotuzumab 400 mg + TP regimen (albumin paclitaxel 260 mg/m2 + cisplatin/nedaplatin 80 mg/m2)+Toripalimab 240mg D1 Q3W for 2 cycles
Platinum-intolerant group:Nimotuzumab 400 mg+Toripalimab 240mg D1 Q3W for 2 cycles
Sponsors
Shandong Second Provincial General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18 ~ 75 years old; 2) Histopathologically or cytologically confirmed resectable stage III-IVB head and neck squamous cell carcinoma (oral, oropharyngeal, laryngeal, hypopharyngeal cancer); 3) ECOG PS score 0-1; 4) Platinum intolerance criteria: Age > 70 years old; ECOG PS score: > 2 points (if present, it does not refer to criteria 3); Renal dysfunction (creatinine clearance 1; Inability to receive intravenous hydration, such as due to cardiac dysfunction or other complications (investigator judgment); Patients refuse platinum chemotherapy; 5) Oropharyngeal cancer requires P16 histological examination (previous detection is not necessary). 6) Tumor tissue (from the center of the tumor tissue or resected tumor tissue) can be provided for PD-L1 testing (no additional testing is required if it has been previously tested). 7) According to RECIST 1.1 evaluation criteria, at least one measurable lesion; 8) expected survival time >= 6 months; 9) hematological parameters are basically normal: white blood cell count >= 4 × 10^9/L; absolute neutrophil count >= 1.5 × 10^9/L; platelets >= 100 × 10^9/L; hemoglobin >= 90 g/L; 10) renal function is basically normal: serum creatinine <= 1.5 × ULN or creatinine clearance (CrCl) = 60 mL/min (using the Cockcroft-Gault formula): female CrCl = (140-age) × body weight (kg) × 0.85/(72 × Scr mg/dl) male CrCl = (140-age) × body weight (kg) × 1.00/(72 × Scr mg/dl) 11) liver function is basically normal: serum total bilirubin <= 1.5 × ULN; aspartate aminotransferase (AST) <= 2.5 × ULN; alanine aminotransferase (ALT) <= 2.5 × ULN; 12) Female subjects must have a negative pregnancy test within two weeks before starting study drug and must be non-lactating patients; female subjects should agree to use effective contraception during the study and within 6 months after the last dose of study drug; male subjects should agree to use effective contraception during the study and within 6 months after the last dose of study drug; 13) subjects voluntarily join this study, signed written informed consent and able to comply with protocol-specified visits and related procedures.
Exclusion criteria
Exclusion criteria: 1) Receiving PD-1 inhibitors, EGFR monoclonal antibodies, EGFR-TKIs, anti-angiogenic drugs within 4 weeks before enrollment; 2) Participating in other interventional clinical trials within 30 days before screening; 3) Having a history of other malignant tumors (except cured cutaneous basal cell carcinoma); 4) Having a history of primary immunodeficiency; 5) Having poorly controlled concurrent diseases (such as heart failure, severe lung disease, severe liver disease, mental illness, etc.); 6) Known infection with HIV virus or active viral hepatitis or tuberculosis; 7) Major surgery or planned surgery within 90 days before the first dose of the test drug; 8) Allergic to the drugs or their components used in this protocol; 9) Pregnant (confirmed by blood or urine HCG test) or lactating women, or subjects of childbearing age are reluctant or unable to take effective contraceptive measures (applicable to both male and female subjects) until at least 6 months after the last test treatment; 10) Investigators believe that they are not suitable to participate in this study; 11) Unwilling to participate in this study or unable to sign informed consent; 12) vaccination with live vaccines within 30 days of administration;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate of tumors; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathologic complete response rate of primary tumor;Major pathologic response rate;2-year overall survival rate;2-year progression-free survival rate;2-year locoregional recurrence-free survival rate;2-year distant metastasis-free survival rate;Quality of life;Safety evaluation;Change in tumor related markers; | — |
Countries
China
Contacts
Public ContactYumei Wei; Zhenghua Lyu
Shandong Second Provincial General Hospital
Outcome results
None listed