lung cancer
Conditions
Interventions
Case series:PD-1 Inhibitor and Endostar
Sponsors
The Fifth Affiliated Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients who volunteer to participate in this study and sign the informed consent; 2. Age ranging from 18 to 75, both male and female; 3. Histologically proven stage IV (AJCC 8) non-small cell lung cancer patients who are not suitable for operation and radical concurrent chemoradiotherapy; 4. Patients who have received standardized first-line chemotherapy but failed, and who are assessed as disease progression and have at least one repeatably measurable tumor lesion according to RECIST 1.1 guidelines; 5. Patients who can provide their high-throughput tumor gene detection reports including PD-L1 expression, tumor mutation burden or tumor tissue samples for gene detection; 6. The estimated survival time is =3 months; 7. The ECOG score was 0-2; 8. The organ function must meet the following requirements: (1) neutrophils count =1.5×10^9/L, platelet count =80×10^9/L, hemoglobin = 90 g/L; (2) TBIL =1.5 ULN, ALT and AST =2.5 ULN, if liver metastases exist, ALT and AST =5 ULN; (3) Scr =1.25 ULN and Ccr =60ml/min (4) INRPT and APTT=1.5 ULN; (5) ECG is basically normal; 9. Childbearing age female subjects must have a negative result of serum pregnancy test within 3 days before the first administration; If sexual intercourse occurs with a non-sterilized male partner, acceptable and effective contraceptive methods must be adopted from the beginning of the screening to 120 days after the last administration; Non-sterilized male subjects who have sexual intercourse with female partners of childbearing age must adopt acceptable and effective contraceptive methods from the beginning of the screening to 120 days after the last administration.
Exclusion criteria
Exclusion criteria: 1. Subjects with cancerous meningitis; 2. Subjects with active CNS metastasis; But if after adequate treatment and the CNS symptoms have recovered to baseline at least two weeks before the enrollment (except the remaining signs and symptoms related to the treatment), the subjects can also join the study. In addition, subjects should not use corticosteroids, or receive prednisone (or equivalent) at a steady or decreasing dose of less than 10 mg/day; 3. Subjects with active known or suspected autoimmune diseases; 4. Subjects receiving systemic corticosteroids (equivalent to >10mg prednisone per day) or other immunosuppressive drugs within 14 days before treatment; 5. Subjects who have used anti-cancer vaccines or other immunostimulatory anti-cancer drugs before; 6. Subjects who have used PD-1 antibody, PD-L1 antibody, PD-L2 antibody, CD137 antibody or CTLA-4 antibody (including ipilimumab or any other antibodies or drugs specifically acting on T cell co-stimulation or checkpoint pathway) before; 7. Subjects who have previously received targeted therapy targeting VEGF or its receptor, such as bevacizumab, apatinib, etc; 8. Subjects who have coagulopathy or bleeding tendency, or have a history of thrombosis or hemorrhagic diseases; 9. Subjects who are receiving anticoagulant or thrombolytic therapy; 10. Subjects with unhealed wound ulcers or fractures; 11. HBsAg or HCAb positive; 12. Active pulmonary tuberculosis (TB) infection was diagnosed by chest X-ray, sputum examination and physical examination; 13. Subjects with EGFR mutation (regardless of mutation type); 14. Subjects with ALK translocation; 15. Subjects with severe heart disease, including congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina, myocardial infarction, severe valvular disease and intractable hypertension; 16. Subjects allergic to Endostar and PD-1 inhibitor or their supplementary materials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| progress free survival;ORR;DCR; | — |
Countries
China
Contacts
Public ContactLin Zhong
The Fifth Affiliated Hospital, Sun Yat-sen University
Outcome results
None listed