lung cancer
Conditions
Interventions
Sponsors
The Fifth Affiliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for the study: 1. Volunteer to participate in clinical research and sign written informed consent. 2. Aged 18-75 years, male and female. 3. Progress after TKI combined with antiangiogenic drugs. 4. According to recist1.1, there is at least one tumor that can be measured repeatedly. 5. It can provide high-throughput tumor gene detection reports including EGFR mutation sites and mutation abundance, or provide tumor tissue samples for flux tumor gene detection. 6. EGFR mutation was confirmed by tissue or hematological gene test, and no T790M mutation was found; 7. The expected survival time is more than 3 months; 8. ECoG status score was 0-2; 9. Organ function level must meet the following requirements: Hematological indexes: neutrophil count >= 1.5x10^9 / L, platelet count >= 80x10^9 / L, hemoglobin >=90 g/L; Liver function: total bilirubin = 60ml / min; Blood coagulation function: INR, Pt and APTT <= 1.5 times the upper limit of normal value; The ECG was basically normal. 10. Women of childbearing age must have serum pregnancy test within 3 days before the first administration and the results are negative. If they have sex with non sterile male partners, they must take effective contraceptive methods from the beginning of screening to 120 days after the last administration; the samples of non sterile male subjects who have sex with their partners of childbearing age must be collected from the beginning of screening to 120 days after the last administration Take an acceptable and effective contraceptive method.
Exclusion criteria
Exclusion criteria: Subjects who met any of the following exclusion criteria were not eligible for this study: 1. The subjects had cancerous meningitis. 2. Subjects with active central nervous system (CNS) metastasis should be excluded. Subjects with CNS metastases can participate in the study if their CNS metastases can be adequately treated and their neurological symptoms can return to baseline levels at least 2 weeks before enrollment (except for residual signs or symptoms related to CNS treatment). In addition, the subjects had to be those who did not use corticosteroids or received prednisone (or equivalent) with a stable or gradually reduced dose of 10 mg prednisone / day) or other immunosuppressive drugs within 14 days before enrollment. Subjects who received inhaled or topical corticosteroids, and those who received corticosteroid replacement therapy with a dose equivalent to > 10 mg prednisone / day, could participate in the study if they did not have active autoimmune diseases. 5. Have received immunotherapeutic drugs such as immunosuppressive agents in the past. 6. Have coagulation dysfunction or bleeding tendency, or have a history of thrombosis or hemorrhagic diseases; 7. Those who are receiving anticoagulant or thrombolytic therapy; 8. There were unhealed wound ulcers or fractures; 9. Positive HBsAg or HCAB indicates acute or chronic infection. 10. According to the chest X-ray examination, sputum examination and clinical physical examination, the active tuberculosis (TB) infection was judged. Patients with a history of active tuberculosis infection in the previous year should be excluded even if they have been treated; patients with a history of active tuberculosis infection more than one year ago should also be excluded, unless it is proved that the course and type of anti tuberculosis treatment used before are appropriate. 11. Previously severe heart disease, including: congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina pectoris, myocardial infarction, severe valvular disease and intractable hypertension. 12. Known to be allergic to any study drug or its excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective remission rate;Overall Survival;Disease control rate; | — |
Countries
China
Contacts
Public ContactZhong Lin
The Fifth Affiliated Hospital of Sun Yat-Sen University
Outcome results
None listed