non-small cell lung cancer
Conditions
Interventions
experimental group:oral vinorelbine soft capsule rhythm chemotherapy combined with camrelizumab
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age: >= 75 years old; 2) Locally advanced or metastatic NSCLC diagnosed by histology or cytology pathology and not suitable for surgery or radiotherapy. Non-squamous NSCLC must be confirmed to be mutation negative by EGFR and ALK gene testing; patients with squamous cell carcinoma do not need to undergo EGFR and ALK gene testing; 3) With measurable lesions (according to the RECIST 1.1 standard, the CT scan length of the tumor lesion is >= 10mm, the short diameter of the CT scan of the lymph node lesion is >= 15mm, and the scan thickness is not greater than 5mm. The measurable lesion has not received radiotherapy, microwave or radiofrequency ablation, etc. Local treatment); 4) Sufficient hematological function, defined as absolute neutrophil count >= 1.5 x 10^9/L, platelet count >= 80 x 10^9/L, hemoglobin >= 90g/L (no blood transfusion or blood products within 14 days, no G-CSF And other hematopoietic stimulating factors); 5) Sufficient liver function, defined as total bilirubin (TBIL) = 45ml/min (Cockcroft-Gault formula); 7) The blood coagulation function is adequate, defined as the international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; if the subject is receiving anticoagulation therapy, as long as the INR/PT is within the proposed range of anticoagulation drugs can; 8) Volunteer to participate in this study and signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1) With EGFR gene mutation and/or ALK gene fusion mutation; 2) Have received the following therapies in the past: anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or CTLA-4 drugs; 3) With active autoimmune diseases that require systemic treatment (for example, use of disease-modifying drugs, corticosteroids, or immunosuppressive agents). Note: Alternative therapies (such as thyroxine, insulin, or physiological dose corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatments; inhaled corticosteroids can also be included in the group; 4) With interstitial pneumonia or pneumonia that requires systemic intravenous treatment or active tuberculosis; 5) Known to be allergic to vinca alkaloids or any ingredients in vinorelbine tartrate soft capsules; allergic to the active ingredients of PD-1 monoclonal antibody and or any excipients; 6) With a history of mental illness or drug abuse that may prevent the subject from participating in the research, or the researcher believes that participating in the research is not in the best interests of the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;DoR;DCR;QoL;AE;SAE; | — |
Countries
China
Contacts
Public ContactWencheng Zhao
Shanghai Pulmonary Hospital
Outcome results
None listed