Locally Advanced Head and Neck Squamous Cell Carcinoma
Conditions
Interventions
Single arm:Neoadjuvant Therapy with Nimotuzumab + Paclitaxel Liposome + Cisplatin
Sponsors
Department of Oncology, the Sixth Medical Center of PLA General Hospital, Beijing, China
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old and = 3 months; 7. Sufficient organ function; 8. Female subjects must have a negative pregnancy test within two weeks before the start of study drug administration and must be non-lactating; female subjects should agree to use effective contraceptive measures during the study and within 6 months after the last administration of the study drug; male subjects should agree to use effective contraceptive measures during the study 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 study visits and related procedures as specified in the protocol.
Exclusion criteria
Exclusion criteria: 1. Received PD-1 inhibitors, EGFR monoclonal antibodies, EGFR-TKIs, or anti-angiogenic drugs within 4 weeks prior to enrollment; 2. Participated in other interventional clinical trials within 30 days prior to screening; 3. History of other malignant tumors (except for curatively treated cutaneous basal cell carcinoma); 4. History of primary immunodeficiency disease; 5. Presence of poorly controlled comorbid diseases (such as heart failure, severe lung disease, severe liver disease, mental illness, etc.); 6. Known infection with HIV, active viral hepatitis, or tuberculosis; 7. Underwent major surgical procedures or had planned surgery within 90 days prior to the first administration of the study drug; 8. Allergy to the drugs used in this protocol, their components, and diagnosis and treatment-related drugs; 9. Pregnant women (confirmed by blood or urine HCG test), lactating women, or fertile subjects who are unwilling or unable to take effective contraceptive measures (applicable to both male and female subjects) for at least 6 months after the last study treatment; 10. Subjects deemed unsuitable for participation in this study by the investigator; 11. Subjects unwilling to participate in this study or unable to sign the informed consent form; 12. Administration of live vaccines within 30 days prior to drug administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathological Response,MPR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological Complete Response Rate(pCR);Objective Response Rate(ORR);Larynx Preservation Rate(LPR);R0 Resection Rate;2-Year Overall Survival Rate;2-Year Event-Free Survival Rate;2-Year Locoregional Control Rate;Quality of Life (EORTC QLQ-C30 (V3) and EORTC QLQ-H&N35)(QoL);Safety Evaluation(SE); | — |
Countries
China
Contacts
Public ContactGuan Gaowa
Department of Oncology, the Sixth Medical Center of PLA General Hospital, Beijing, China
Outcome results
None listed