Locally advanced laryngeal and hypopharyngeal cancer
Conditions
Interventions
Induction therapy group:Nimotuzumab combined with TPF induction therapy
Sponsors
Bejing Tongren Hospital, Capital Medical Uniersity
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-75 years old, including 18 and 75 years old; 2. After histopathological or cytological confirmation, MRI imaging diagnosis was resectable stage laryngeal carcinoma/hypopharyngeal carcinoma (T3-T4a, any N, M0); 3. Immunohistochemical examination of histopathology showed positive expression of EGFR; 4. ECOG score is 0-2; 5. Combined with RECIST 1.1, it has clinically assessable lesions; 6. Estimated survival time >= 6 months; 7. The functions of important organs meet the following requirements (excluding the use of any blood components and cell growth factors within 14 days): • Normal bone marrow reserve function, white blood cell (WBC) >= 3.0 × 10^9/L; Neutrophil count (NEUT) >= one point five × 10^9/L, platelet count (PLT) >= 100 × 10^9/L, hemoglobin (Hb) >= 100 g/L• Normal renal function or serum creatinine (SCr) = 50 ml/min (Cockcroft-Gault formula) • Normal liver function or total bilirubin (TBIL) <= 1.5 times the upper limit of normal value (ULN) AST or ALT level <= 2.5 times the upper limit of normal value (ULN); 8. Able and willing to follow the research and follow-up process; 9. Men and women of gestational age must agree to take adequate contraceptive measures during the whole study period and within 6 months after the end of treatment; 10. The patient volunteered to participate in the clinical study and signed the informed consent form. The patient has good compliance and can cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Those who received EGFR monoclonal antibody, EGFR-TKI and anti-angiogenic drugs within 4 weeks before enrollment; 2. Those who are intolerant to platinum drugs and may be potentially allergic or intolerant to other drugs and similar biological agents under study; 3. Those with a history of other malignant tumors (excluding the cured skin basal cell carcinoma); 4. Advanced patients who have symptoms, have spread to the viscera, and are at risk of life-threatening complications in the short term (including patients with uncontrollable large amounts of exudates [chest cavity, pericardium, abdominal cavity], pulmonary lymphangitis, and more than 30% liver involvement); 5. Any active autoimmune disease or history of autoimmune disease (Including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism subjects with vitiligo or asthma in childhood that has been completely relieved after adulthood without any intervention can be included subjects with asthma requiring bronchodilator for medical intervention can not be included); 6. Patients with myocardial ischemia or myocardial infarction above grade II and arrhythmia with poor control (including QTc interval >= 450ms for men and >= 470ms for women). According to NYHA standard, patients with grade III to IV cardiac insufficiency or left ventricular ejection fraction (LVEF)<50% according to cardiac color Doppler examination Myocardial infarction, heart failure of class II or above of the New York Heart Association, uncontrolled angina pectoris, uncontrolled severe ventricular arrhythmia, pericardial disease of clinical significance, or ECG indicating acute ischemia or abnormal active conduction system occurred within 6 months before enrollment; 7. Those who have a history of abuse of psychotropic substances and are unable to give up or have mental disorders; 8. Major surgical operation, or open wound or fracture within 4 weeks before the first administration; 9. Known to be infected with HIV or active viral hepatitis or tuberculosis; 10. Pregnant (confirmed by blood or urine HCG test) or lactating women, or subjects of childbearing age 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; 11. Those with a history of hereditary or acquired haemorrhagic disease or coagulation dysfunction (whether they can be selected is determined by the researcher); 12. Other conditions determined by the investigator to be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Laryngeal function preservation;pathologicalcompleteresponse;Progression-free survival;No local recurrence survival;R0 resection rate;Adverse events; | — |
Countries
China
Contacts
Public ContactJugao Fang
Bejing Tongren Hospital, Capital Medical Uniersity
Outcome results
None listed