squamous cell carcinoma of the head and neck
Conditions
Interventions
Experimental group:Nimotuzumab combined with Sintilimab
Sponsors
The Fifth Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent before any trial-related procedures are implemented; 2. Histologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx, hypopharynx, nasal cavity and paranasal sinuses), oropharyngeal cancer must be p16 negative (p16 >= 70% is positive), surgical evaluation is inoperable, patients who cannot tolerate surgery due to underlying diseases, patients who refuse surgery, or patients with local or regional recurrence after surgery; 3. Patients who have progressed or are intolerant to first-line systemic chemotherapy (which can include platinum, taxane, or fluorouracil-based) (progression on maintenance therapy after first-line chemotherapy can also be included). Concurrent chemoradiotherapy received for postoperative recurrence or metastasis is counted as first-line treatment; for radical concurrent chemoradiotherapy, neoadjuvant/adjuvant therapy (chemotherapy or chemoradiotherapy), if disease progression occurs during treatment or within 6 months after stopping treatment, it should be counted as first-line treatment failure; 4. PD-L1 expression is positive; 5. The tumor tissue samples were positive for EGFR immunohistochemistry or FISH; 6. Aged 18-75 years; 7. Expected survival period >= 3 months; 8. General performance status (PS) score of 0 or 1; 9. There are evaluable lesions according to RECIST 1.1 criteria; 10. Vital organ functions meet the following requirements: (1) Absolute neutrophil count >=1.5x10^9, platelets >=80x10^9, hemoglobin >=90g/L; (2) Total bilirubin level = 60 ml/min (Cockcroft-Gault formula); (4) Serum albumin >=28 g/L; 11. Patients in childbearing period should take effective contraceptive measures; 12. Those with good compliance can follow up the curative effect and adverse reactions according to the program requirements.
Exclusion criteria
Exclusion criteria: 1. The patient has poor physical fitness, cachexia, ECOG>3 points; 2. Currently participating in interventional clinical research treatment, or receiving other investigational drug treatment within 4 weeks before the first dose; 3. Received PD-1 inhibitor, EGFR monoclonal antibody, EGFR-TKI, anti-angiogenic drugs within half a year; 4. Those who are known to be allergic to the study drug in the program; 5. Those with a history of serious heart disease, including: documented history of congestive heart failure, high-risk uncontrolled arrhythmia, angina pectoris requiring drug treatment, clinically definite diagnosis of heart valve disease, history of severe myocardial infarction and resistant hypertension; 6. Those with chronic diarrheal disease (more than or equal to 4 watery stools per day) and renal insufficiency; 7. There is active infection or active infectious disease; 8. Pregnant or lactating patients; 9. There is a medical history, disease, treatment or abnormal laboratory results that may interfere with the test results, prevent the patients from participating in the research throughout the process, or the researcher believes that participating in the research is not in the best interests of the patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Median progression-free survival;Median overall survival;Median duration of remission;Safety and tolerability; | — |
Countries
China
Contacts
Public ContactShi Xingyuan
The Fifth Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed