Oral Squamous Cell Carcinoma
Conditions
Interventions
Treatment group:Nimotuzumab injection 400mg, day 1, weekly for 6 cycles
Albumin-bound paclitaxel 260mg/m^2, day 1, every 3 weeks for 2 cycles
Cisplatin 75mg/m^2 (or carboplatin AUC=5), day 1, every 3 weeks for 2 cycles
Sponsors
The First Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. Histologically or cytologically confirmed, resectable stage III-IVb oral squamous cell carcinoma (including gingival carcinoma, tongue carcinoma, soft/hard palate carcinoma, floor-of-mouth carcinoma, lip carcinoma) according to the AJCC 8th Edition; 3. At least one measurable lesion as per RECIST version 1.1 criteria; 4. ECOG performance status of 0-1 or KPS score = 60; 5. Expected survival time = 6 months; 6. Adequate organ function; 7. Availability of tumor tissue (from the tumor core or resected tumor) for EGFR testing (not required if previously tested); 8. Female subjects must have a negative pregnancy test within two weeks prior to initiation of study treatment, must be non-lactating, and must agree to use effective contraception during the study and for 6 months after the last dose of the study drug. Male subjects must agree to use effective contraception during the study and for 6 months after the last dose of the study drug; 9. Subjects voluntarily participate in the study, sign a written informed consent form, and are able to comply with protocol-specified visits and related procedures.
Exclusion criteria
Exclusion criteria: 1. Patients who have previously received radiotherapy or chemotherapy; 2. Patients who have previously received treatment with PD-1 antibody or other immune therapy targeting PD-1/PD-L1; 3. Patients who have previously received targeted therapy such as EGFR monoclonal antibody or EGFR tyrosine kinase inhibitors; 4. Administration of systemic or local glucocorticoid therapy within 4 weeks prior to enrollment; 5. HIV-positive individuals; HBsAg-positive individuals with concurrent positive HBV DNA copy number (quantitative test = 10^3 cps/ml); or positive blood screening for chronic hepatitis C (HCV antibody positive) with concurrent positive HCV RNA; 6. Participation in other interventional clinical trials within 30 days prior to screening; 7. History of other malignancies (except for cured basal cell carcinoma of the skin); 8. History of primary immunodeficiency; 9. Presence of uncontrolled concurrent illnesses (e.g., heart failure, severe pulmonary disease, severe liver disease, psychiatric disorders, etc.); 10. Known hypersensitivity to the drugs used in this protocol or their components; 11. Pregnancy (confirmed by blood or urine HCG test) or lactation; or male or female subjects of childbearing potential who are unwilling or unable to use effective contraception until at least 6 months after the last dose of trial treatment; 12. Patients deemed unsuitable for participation in this study by the investigator; 13. Unwillingness to participate in the study or inability to sign the informed consent form; 14. Live vaccine administration within 30 days prior to study drug administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Pathological Response (MPR);Clinical Downstaging Rate (T or N downstage);Pathological Complete Response (pCR) Rate;2-Year Local Regional Control (LRC) Rate;2-Year Overall Survival (OS) Rate;2-Year Event-Free Survival (EFS) Rate;Safety Evaluation;Quality of Life (QoL);Tumor Markers; | — |
Countries
China
Contacts
Public ContactZhu Huiyong
The First Affiliated Hospital, Zhejiang University School of Medicine
Outcome results
None listed