squamous cell lung carcinoma
Conditions
Interventions
Group patients who had received at least one platinum-containing regimen and had advanced lung squamous cell carcinoma:Nimotuzumab + Seggio
Sponsors
Anhui Chest Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female aged 18 to 75 years when signing the informed consent; 2. The subjects voluntarily agreed to participate and signed the informed consent; 3. Locally advanced or metastatic lung squamous cell carcinoma confirmed by histology or cytology. For mixed lung squamous cell carcinoma subjects, if the squamous cell carcinoma component is more than 50%, the investigator will determine whether to join the group according to the specific situation; 4. All patients have received at least one platinum-containing chemotherapy and have disease progression. Before receiving Nimotuzumab combined with chemotherapy, all patients have not been treated with Nimotuzumab; 5. There is at least one measurable lesion that meets the RECIST 1.1 criteria, that is, according to CT cross-sectional images, the long diameter of non-lymph node lesions is >= 10 mm, or the short diameter of lymph node lesions is >= 15 mm; 6. ECOG score of 0 to 2 points; 7. The expected survival period is not less than 12 weeks; 8. Vital organs and bone marrow function meet the following requirements: (1) Blood routine: absolute neutrophil count (ANC) >=1.5x10^9/L, platelet (PLT) >=100x10^9/L, hemoglobin (HGB) >=9g/dL; (Note: required This criterion was met without blood transfusion within 4 weeks before the sample was obtained); (2) Liver function: serum total bilirubin (TBIL) = 2.8g/dL; (3) Renal function: serum creatinine (Cr) = 40 mL/min; 9. Women of childbearing age need to provide a pregnancy test report within 3 days before the start of treatment, and the result must be negative; 10. Females of childbearing potential must take high-efficiency contraception during the study period, and at least 120 days after the last "Nimotuzumab combined with Seggio" administration and at least 180 days after the last chemotherapy. Start contraceptive measures at least 3 months before administration; 11. Unsterilized males are required to take high-efficiency contraception for at least 180 days during the study period and after the last use of "Nimotuzumab combined with Seggio". Contraception is recommended to be initiated at least 3 months prior to the first dose of study treatment.
Exclusion criteria
Exclusion criteria: 1. Severe bone marrow suppression; 2. Patients who are receiving flucytosine and other fluorouracil antineoplastic drugs, solivudine and its structural analogs (brivudine); 3. Patients with severe liver and kidney dysfunction; 4. Known or suspected active autoimmune diseases (congenital or acquired), such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, thyroiditis, etc. (Vitiligo or in childhood Patients with complete remission of asthma in early stage and without any intervention after adulthood can be enrolled; patients with type 1 diabetes mellitus with good insulin control can also be enrolled); 5. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 6. Hypersensitivity to any of the ingredients of Nimotuzumab and Seggio; 7. Currently suffering from interstitial lung disease; 8. Suffering from other uncontrolled serious diseases, including but not limited to: (1) Serious infection in active stage or poorly controlled clinically; (2) HIV-infected persons (HIV antibody positive); (3) Acute or chronic active hepatitis B (HBsAg positive and HBVDNA>1*103/ml) or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA>15IU/ml); (4) Active tuberculosis, etc.; (5) Class III-IV congestive heart failure (New York Heart Association classification), poorly controlled and clinically significant arrhythmias; (6) Concomitant with other malignant tumors (except those that have been cured, such as cervical carcinoma in situ, non-melanoma skin cancer, etc.); (7) Other acute or chronic diseases, psychiatric disorders, or abnormal laboratory test values ??that may lead to increased risks associated with study participation or study drug administration, or interfere with the interpretation of study results, and which, at the investigator's discretion, will Patients listed as ineligible to participate in this study; 9. Pregnant or lactating women; 10. Inject anti-infective vaccines (such as influenza virus vaccine, human papilloma virus vaccine) within 4 weeks before treatment with study drug. During the treatment period, except for inactive vaccines, other vaccines are prohibited. 11. Major surgery has been performed within 4 weeks (28 days) before the administration of the study drug, except for diagnosis; 12. Any disease or condition that, in the opinion of the investigator, endangers patient safety or interferes with the evaluation of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival;overall surviva; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective remission rate;Disease Control Rate;life quality score; | — |
Countries
China
Contacts
Public ContactShi Qingming
Anhui Chest Hospital
Outcome results
None listed