Non-small cell lung cancer
Conditions
Interventions
Case series:Endostatin+IO+chemotherapy
Sponsors
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-75 years; 2. Patients with ECoG grade 0-1; 3. Patients with squamous non-small cell lung cancer confirmed by histopathology or cytology; 4. It must be able to provide reports that EGFR, ALK and ros1 are all wild-type by tissue-based detection; 5. According to the TNM stage of lung cancer (8th Edition) issued by the International Association for lung cancer research and the Joint Committee of American Cancer classification, the patients in stage IV who can not undergo radical surgery or radical concurrent radiotherapy and chemotherapy are confirmed; 6. Patients who have not received any systemic treatment before; 7. According to RECIST v1.1, patients with at least one measurable tumor focus. In the baseline screening period, CT or MRI examination was used to confirm that the length and diameter of the focus >=10 mm (the short diameter of the lymph node focus >=15 mm), and according to RECIST v1.1, the focus was suitable for repeated and accurate measurement; 8. Tumor tissue samples must be provided: 10 unstained FFPE pathological sections archived or freshly obtained within 6 months before the first application. Osteopathy without soft tissue components or decalcified bone tumor samples is unacceptable; 9. 10ml of peripheral blood sample must be provided before the first application; 10. The results of laboratory examination in screening period indicated that the subjects had good organ function (no blood transfusion and no treatment with cell growth factor support within 2 weeks before screening), including: (1) Blood routine test: neutrophil (ANC) >=1.5x10^9/L; platelet count (PLT) >=100x10^9/L; hemoglobin (HB) >=90 g/L; (2) Blood biochemistry: TBIL =50ml / min; * * * TBIL <=3 ULN positive for liver metastasis subjects, ALT and AST <=5 ULN; (3) Coagulation function: INR <=1.5 ULN; APTT <=1.5 ULN; 11. Patients with expected survival of more than 3 months; 12. All patients must agree to take effective contraceptive measures during the study period and within 6 months after the treatment is stopped. The urine pregnancy test of female patients of childbearing age must be negative before treatment and administration; 13. Subjects (or their legal representatives / guardians) must sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with symptomatic central nervous system metastasis; 2. Patients with hypertension history or abnormal blood pressure at screening / baseline measurement (repeated measurement on the same day confirmed that systolic blood pressure > 140mmHg and / or diastolic blood pressure > 90mmHg); 3. Patients with active bleeding or pathological conditions with high bleeding risk, such as known bleeding disease, coagulation dysfunction or tumor involving large blood vessels, hereditary bleeding tendency or history of thrombosis or bleeding; 4. Patients with non healed wounds, active peptic ulcer or fracture, tracheoesophageal fistula, gastrointestinal perforation or gastrointestinal fistula and intra-abdominal abscess within 6 months; 5. Patients with local or systemic infection without adequate control, including active tuberculosis or patients with active tuberculosis infection within = 48 weeks before screening; 6. Patients with interstitial lung disease, drug-induced pneumonia, radiation pneumonia requiring steroid treatment or active pneumonia with clinical symptoms; 7. Patients with severe visceral organ dysfunction and myocardial infarction in the last 6 months; 8. Patients with clinically symptomatic serous effusion, such as pericardial effusion, pleural effusion and / or peritoneal effusion that cannot be controlled by pumping or other treatment; 9. Patients with active, known or suspected autoimmune diseases (such as uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism). Patients with vitiligo, type I diabetes, hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement therapy, or those who are not expected to recur in the absence of external stimulation can be included in the group; 10. Patients with a history of immunodeficiency, including HIV positive, or with other acquired or congenital immunodeficiency diseases, or with a history of organ transplantation; 11. Patients who continued to use corticosteroids (> 10mg / day prednisone or its equivalent) or other immunosuppressive agents for a long time = 14 days before entering the study. Allow inhaled or topical use of steroids and adrenal replacement steroids; . 12. Subjects who have been vaccinated or planned to be vaccinated with live vaccine within = 4 weeks before entering the study; 13. Patients with other malignancies less than or equal to 5 years before enrollment, but excluding fully treatable cervical carcinoma in situ, skin basal cell carcinoma or squamous cell carcinoma, local prostate cancer after radical surgery and breast ductal carcinoma in situ after radical surgery; 14. Patients with known mental illness, alcoholism, drug use or drug abuse affect the expression or observation of informed consent and / or adverse reactions; 15. HBsAg was positive and HBV DNA detection value exceeded the upper limit of normal value (1000 copies / ml or 500iu / ml), or HCV was positive (HCV RNA or HCV antibody detection indicated acute and chronic infection); 16. Patients who have known a history of allergy to the drug components of the program; 17. Female patients during pregnancy or lactation, and subjects of childbearing age who refuse to accept contraceptive measures; 18. The researchers judged the patients who were not suitable to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS;ORR; | — |
Countries
China
Contacts
Public ContactGuangyuan Hu
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology
Outcome results
None listed