Stage III unresectable non-small cell lung cancer
Conditions
Interventions
Experimental group:The dose of Endostar is 7.5 mg/m2, continuous intravenous infusion 5 days a week, starting 5 days before radiotherapy, one cycle every 2 weeks, a total of 4 cycles. Synchronous EP p
Control group:3 cycles of radiotherapy synchronous EP program. 14 days to 30 days after the end of radiotherapy, Envolimumab consolidation therapy was started, 400 mg each time, 28 days/time, until di
Sponsors
Jiamusi Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with stage III driver gene (EGFR19 or 21 mutation, ALK mutation) negative unresectable non-small cell lung cancer aged between 18 and 80 years old; 2. The clinical data of the enrolled patients should be complete, and all patients have undergone histopathological and genetic testing. According to the evaluation criteria for solid tumors (RECIST1.1), there is at least one lesion that can be measured by imaging; 3. No obvious history of infection, no use of immunosuppressive drugs and glucocorticoids in the past month (the dexamethasone used in the chemotherapy regimen for short-term antiemetic in small doses is negligible); 4. The function of each important organ is evaluated enough to tolerate the above-mentioned various treatment options, and the Karnofsky score of the general condition is at least 70 points; 5. No chest chemotherapy and radiotherapy, immunotherapy or biological therapy before receiving concurrent chemoradiotherapy; 6. Serum hemoglobin >= 100 g/L, platelet >= 10 x 10^9/L, absolute neutrophil count >= 1.5 x 10^9/L; 7. Serum creatinine = 60 mL/min; 8. Serum bilirubin 0.8 L; 10. The blood coagulation function is normal (the prolongation of PT does not exceed 3 s, and the prolongation of APTT does not exceed 10 s); 11. Patients sign a formal informed consent form to show that they understand that this study complies with the hospital's policy and ethical requirements.
Exclusion criteria
Exclusion criteria: 1. Stage III non-small cell lung cancer patients with positive driver gene mutations such as EGFR19 or 21, ALK, ROS1; 2. Whole lung exposure dose V20 in radiotherapy plan > 26%; 3. There is a history of serious basic diseases and chronic infectious diseases; 4. Asthma, lupus erythematosus, rheumatoid arthritis and other autoimmune diseases, immunodeficiency diseases and allergic diseases that may affect the detection of immune indicators; 5. Failure to complete the full course of treatment according to the scheduled plan due to the patient's personal reasons or physical intolerance; 6. Patients with any distant metastasis; 7. Severe allergic/allergic reactions to humanized antibodies or fusion proteins; 8. Known hypersensitivity to any component contained in the Endostar preparation; 9. Patients suffering from any other malignant tumors before or now (except non-melanoma of the skin or carcinoma in situ of the cervix); 10. Any other disease or condition that contraindicates chemotherapy and radiotherapy (such as active infection, within 6 months after myocardial infarction, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy ); 11. Unresolved toxic effects of grade 2 or higher (according to CTCAE, the Common Terminology Criteria for Adverse Events); 12. Received immunotherapy or research drugs within 4 weeks before receiving treatment (6 weeks for monoclonal antibodies); 13. Immune consolidation stage: grade 2 or higher pneumonia caused by radiotherapy and chemotherapy; 14. Pregnant or lactating women; 15. Women and men who may be pregnant but are unwilling to take appropriate contraceptive measures; 16. Evidence of hereditary bleeding constitution or coagulation disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Quality of survival;Safety; | — |
Countries
China
Contacts
Public ContactZhou Xiaohong
Jiamusi Cancer Hospital
Outcome results
None listed