Non-small Cell Lung Cancer
Conditions
Interventions
Test group A :Camrelizumab+Recombinant human endostatin +chemotherapy
Test group B:Recombinant human endostatin +chemotherapy
Sponsors
Department of respiration, the Second Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participated in this study and signed the informed consent; 2. Age 18~70 years old, both male and female; 3. Advanced or metastatic (IIIB-IV) NSCLC confirmed by histology or cytology, no mutation in driver gene detection; 4. There is at least one measurable lesion as a target lesion (RECIST1.1), and a lesion that has received radiotherapy before cannot be regarded as a target lesion unless there is a clear progression of the lesion after radiotherapy; 5. Eastern Cooperative Oncology Group physical status score (ECOG PS) is 0-1 points; 6. Expected survival period >= 3 months; 7. Naive patients who have not received systemic anti-tumor therapy, including radiotherapy and chemotherapy, targeted and immunotherapy, or patients who have relapsed for more than 6 months after postoperative adjuvant chemotherapy; 8. Major organ function within 7 days before treatment, meeting the following criteria: (1) Blood routine examination standards (without blood transfusion within 14 days): hemoglobin (HB) >= 90g/L; absolute neutrophil value (ANC) >= 1.5x10^9/L; platelet (PLT) >= 80x 10^9/L; (2) Biochemical tests should meet the following criteria: total bilirubin (TBIL) ,= 1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase AST =60ml/min; serum albumin>=35g/L; (3) Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >= the lower limit of normal (50%).
Exclusion criteria
Exclusion criteria: 1. Severe allergic/anaphylactic reactions to humanized antibodies or fusion proteins; 2. Known to have hypersensitivity reactions to Endostat or any component contained in the antibody preparation; 3. Diagnosed as immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 14 days before the first dose of the study, allowing the use of physiological doses of glucocorticoids (=2000IU/ml or 104copies/ml), hepatitis C (positive hepatitis C antibody, and HCV-RNA higher than the detection limit of the analytical method); 7. According to chest X-ray examination, sputum examination and clinical physical examination, it is judged that there is active pulmonary tuberculosis (TB) infection. Patients with a history of active pulmonary tuberculosis infection within the previous 1 year, even if they have been treated, should be excluded; patients with a history of active pulmonary tuberculosis infection more than 1 year ago should also be excluded, unless it is proved that the course and type of anti-TB treatment previously used are appropriate; 8. Patients with brain metastases with symptoms or symptom control time less than 2 months; 9. Received major surgical treatment, incisional biopsy or obvious traumatic injury within 28 days before grouping; 10. Imaging shows that the tumor has invaded important blood vessels or the investigator judges that the tumor is very likely to invade important blood vessels and cause fatal bleeding during the follow-up study; 11. Regardless of the severity, patients with any signs of bleeding constitution or medical history; patients with any bleeding or bleeding events >= CTCAE grade 3 within 4 weeks before assignment, with unhealed wounds, ulcers or fractures; Those who have experienced arterial/venous thrombotic events within 12.6 months, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism; 13. According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;objective response rate;safety; | — |
Countries
China
Contacts
Public ContactYang Shuanying
The Second Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed