Oral Squamous Cell Carcinoma (OSCC)
Conditions
Interventions
Study group:1. Targeted therapy: Nimotuzumab Injection 400 mg, day 1 (d1), every 3 weeks (q3w), for a total of 2 cycles.
2. Chemotherapy: Albumin-bound Paclitaxel 260 mg/m2 on day 1 (d1) plus Cisplati
Sponsors
The Third Affiliated Hospital of Air Force Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years and =6 months; 7. Adequate organ function: blood routine, liver and kidney function, and coagulation tests are basically within the normal reference range; 8. For female subjects: negative pregnancy test within 2 weeks before the start of study drug administration, and must be non-lactating; female subjects must agree to use effective contraceptive measures during the study period and within 6 months after the last administration of the study drug; male subjects must agree to use effective contraceptive measures during the study period and within 6 months after the last administration of the study drug; 9. Subjects voluntarily participate in this study, sign a written informed consent form, and can comply with the follow-up visits and related procedures specified in the protocol.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of prior radiotherapy or chemotherapy; 2. Patients who have previously received PD-1 antibody therapy or other immunotherapies targeting PD-1/PD-L1; 3. Patients who have previously received targeted therapies such as EGFR monoclonal antibodies or EGFR tyrosine kinase inhibitors; 4. Patients who received systemic or local glucocorticoid therapy within 4 weeks before enrollment; 5. HIV-positive patients; patients with positive HBsAg and positive HBV DNA copy number (quantitative detection >=1000 cps/ml); patients with positive chronic hepatitis C blood screening (positive HCV antibody) and positive HCV RNA; 6. Patients who participated in other interventional clinical trials within 30 days before screening; 7. Patients with a history of other malignant tumors (except for cured basal cell carcinoma of the skin); 8. History of primary immunodeficiency; 9. Presence of poorly controlled concurrent diseases (such as heart failure, severe lung disease, severe liver disease, mental illness, etc.); 10. Patients with allergies to the drugs used in this protocol or their components; 11. Pregnant women (confirmed by blood or urine HCG test) or lactating women, or childbearing-age subjects who are unwilling or unable to take effective contraceptive measures (applicable to both male and female subjects) until at least 6 months after the last trial treatment; 12. Patients who are deemed unsuitable to participate in this study by the investigator; 13. Patients who are unwilling to participate in this study or unable to sign the informed consent form; 14. Vaccination with live vaccines within 30 days before drug administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathologic Response (MPR) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);Pathological Complete Response (pCR) rate;2-year Overall Survival (OS) rate;2-year Event-Free Survival (EFS) rate;2-year Locoregional Control (LRC) rate;Safety assessment;Quality of Life (QoL); | — |
Countries
China
Contacts
Public ContactWei Jianhua
The Third Affiliated Hospital of Air Force Military Medical University
Outcome results
None listed