non-small cell lung cancer
Conditions
Interventions
treatment group:Camrellizumab combined with stereotactic radiotherapy, apatinib mesylate and albumin-conjugated paclitaxel.
Sponsors
The 900th Hospital of The Joint Logistic Support Force of PLA
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 - 75 years,male or female. 2. Subjects with histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer 3. Patients with at least one evaluable or measurable lesions as per RECIST version 1.1. 4. Pathology clearly identifies no sensitive gene mutations (EGFR/ALK/ROS). 5. Patients who have not previously received chemotherapy for locally advanced or metastatic non-small cell lung cancer systems. Can also be enrolled if you have previously received Neoadjuvant or adjuvant therapy. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. Survival expectation >= 3 months. 8. Women of childbearing age must have a serum pregnancy study within 2 weeks prior to the first dose and the results are negative. Female subjects of childbearing age and partners who are women of childbearing age must be contraceptive during the study period and within 180 days after the last administration of the study drug. 9. The laboratory test value of the patient before medication should meet the following standards: 1)Routine blood WBC >= 3.0 x 10^9/L, ANC>= 1.5 x 10 ^9/L, PLT >= 90 x 10^9/L, HGB >= 9.0 g/dL; 2)Liver functionTBIL = 50 mL/min; 4)Blood coagulation function: INR <= 1.5, APTT<= 1.5 x ULN; 10. Subjects voluntarily joined the study, signed informed consent, good compliance, and followed up.
Exclusion criteria
Exclusion criteria: 1.Tumor histology or cytology confirmed the combination of small cell lung cancer. 2.Previously received any T cell costimulation or immunological checkpoint treatment, including but not limited to CTLA-4 inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors or other T cell-targeting drugs. 3.Interstitial lung disease, drug-induced pneumonia, radiation pneumonitis requiring steroid therapy or active pneumonia with clinical symptoms or severe pulmonary dysfunction. 4.Previous or current history of cancer other than NSCLC, except for non-melanoma skin cancer, in-situ cervical cancer or other cancers that have received curable treatment and have shown no signs of recurrence for at least 5 years. 5.High blood pressure that cannot be controlled by standard treatment (blood pressure is not stable below 150/90 mmHg). 6.Have a tendency to hereditary bleeding or coagulopathy. Clinically significant bleeding symptoms or clear bleeding tendency within 3 months prior to enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood++ and above. 7.Patients with clear or suspected brain metastases. Patients with a history of brain metastases (must be completed and patients who are no longer in need of corticosteroid therapy) can be enrolled; for patients with asymptomatic, lesions <= 3 and single less than 10 mm, who is determined by the investigator whether or not to enroll. 8.There are clinical symptoms or diseases of the heart that are not well controlled, such as: (1) heart failure of NYHA class 2 or higher; (2) unstable angina; (3) myocardial infarction within 24 weeks; (4) clinical need for treatment or Interventional supraventricular or ventricular arrhythmia. 9.There is a clinically uncontrollable third interstitial fluid (such as pleural effusion/pericardial effusion, patients who do not need drainage or stop drainage for 3 days without significant increase in effusion can be enrolled). 10.Imaging (CT or MRI) shows that the tumor invades the large blood vessels or the investigator judges that the tumor is highly likely to invade the important blood vessels during the follow-up study and cause fatal bleeding. 11.Have a history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency disease, or history of organ transplantation and bone marrow transplantation. 12.Active hepatitis B (positive detection of hepatitis B virus surface antigen [HBsAg] in the screening period, and detection of HBV-DNA detection value higher than the upper limit of the normal value of the laboratory in the research center) or hepatitis C (in the screening period, hepatitis C virus surface antibody [ HCsAb] positive, HCV-RNA positive). 13.Allergic reactions to test drugs for this application. 14.The investigator determined that the subject had other factors that might lead to the termination of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival;one-year survival rate;overall survival;Disease control rate;safety; | — |
Countries
China
Contacts
Public ContactYonghai Peng
The 900th Hospital of the Joint Logistic Support Force of PLA
Outcome results
None listed