advanced lung squamous cell carcinoma
Conditions
Interventions
Experimental group:recombinant human endostatin injection combined with afatinib dimaleate tablets and tegafur, gimeracil and oteracil potassium capsules
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. According to the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification 8th Edition TNM staging of lung cancer, patients with locally advanced (IIIB/IIIC), metastatic or recurrent (IV) lung squamous cell carcinoma who have histologically or cytologically proven inoperable and who cannot receive curative concurrent chemoradiotherapy, at least one measurable lesion according to RECIST 1.1 criteria; 2. Aged 18-75 years; 3. ECOG PS score: 0-2 points; the expected survival period is more than 3 months; 4. Previously received first-line antitumor therapy for advanced disease, and it was confirmed that the first-line therapy failed or could not be tolerated according to RECIST 1.1 criteria; 5. The function of major organs is normal, that is, the following criteria are met: (1) Good hematopoietic function, which is defined as absolute neutrophil count >=1.5x10^9/L and platelet count >=100x10^9/L; hemoglobin >=90g/L (no blood transfusion or erythropoietin (EPO) dependence within 7 days]; HB>=90g/L (no blood transfusion within 14 days); ANC >=1.5x10^9/L; PLT >=100x10^9 /L (2) Biochemical tests must meet the following criteria: BIL =60ml/min; 6. Good coagulation function, INR and PT <= 1.5 times ULN; if the subject is receiving anticoagulation therapy, as long as the PT is within the intended use range of the anticoagulant drug; 7. Females of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; negative serum or urine pregnancy test within 7 days prior to study enrollment, and must be non-lactating patients; men should agree to patients who must use contraception during the study period and for 6 months after the end of the study period. 8. The patients voluntarily joined the study, signed the informed consent, and had good compliance.
Exclusion criteria
Exclusion criteria: 1. Those with multiple factors that affect oral drugs (such as inability to swallow, after gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); 2. Known symptomatic brain metastases, spinal cord compression, cancerous meningitis, or diseases of the brain or leptomeninges found by CT or MRI at screening; 3. Central cavitary squamous cell carcinoma or patients with bleeding symptoms or bleeding tendency assessed by the investigator; 4. Patients with any severe and/uncontrolled disease such as: (1) Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months before randomization, severe uncontrolled arrhythmia; patients with unsatisfactory blood pressure control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); (2) Active or uncontrolled serious infection; (3) Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; (4) Poor control of diabetes (fasting blood glucose (FBG) > 10mmol/L); (5) Urine routine indicates urine protein >=++, and 24-hour urine protein quantification >1.0 g; (6) Active pulmonary tuberculosis, etc.; (7) Uncontrolled hypercalcemia (greater than 1.5 mmol/L calcium ion or calcium greater than 12 mg/dL or corrected serum calcium greater than ULN), or symptomatic hypercalcemia requiring continued bisphosphonate treatment; (8) Wounds or fractures that have not been healed for a long time; 5. Patients with bleeding tendency (such as active peptic ulcer) or treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogs; under the premise that the international normalized ratio (INR) of prothrombin time is less than or equal to 1.5, the use of low-dose warfarin (= grade 3) to Endo, Afatinib, and Sigirone; 10. The use of immunosuppressive drugs within 4 weeks before enrollment, excluding nasal spray, inhalation or other local glucocorticoids (ie no more than 10 mg/day prednisone or equivalent doses of other glucocorticoids ); 11. Have a history of immunodeficiency, including HIV test positive or other acquired and congenital immunodeficiency diseases; 12. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 13. There is a history of non-infectious pneumonia requiring glucocorticoid treatment or current interstitial lung disease within 1 year before enrollment; 14. Known or suspected active autoimmune disease (congenital or acquired), such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, thyroiditis, etc. (Vitiligo or asthma has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be enrolled); 15. Associated with other malignant tumors (except those that have been cured, such as cervical carcinom
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life;Objective response rate;Disease free control rate;Biomarker; | — |
Countries
China
Contacts
Public ContactChen Yang
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed