advanced non-small cell lung cancer
Conditions
Interventions
Experimental group:camrelizumab combined with albumin Paclitaxe and carboplatin
control group:albumin Paclitaxe and carboplatin
Sponsors
The First people's Hospital of Yueyang
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Aged >=18 years; (2) Negative driving genes (EGFR, ALK, ROS1, RET, NTRK, BRAF, MET, HER-2) diagnosed by pathology, gene detection and imaging in patients with non-small cell lung cancer; (3) ECOG physical condition score: 0-1; (4) Predicted survival period (>=3 months); (5) No brain metastasis or brain metastasis but no symptoms; (6) Good main organ function, no severe hypertension, diabetes mellitus. And heart disease. That is to say, within the first 14 days of randomization, the relevant examination indicators meet the following requirements: a) blood routine examination: i. hemoglobin (> 90 g/L) (no blood transfusion within 14 days); ii. neutrophil count > 1.5 *10^9/L; iii. platelet count (> 100 *10^9/L); b) biochemical examination: i. total bilirubin (< 1.5 *ULN) (upper limit of normal value); ii. ALT or AST (< 2.5 *ULN); if there is any. For liver metastasis, ALT or AST were less than 5 *ULN; iii. Creatinine clearance rate was more than 60 ml/min (Cockcroft-Gault formula); c) Doppler echocardiography evaluation: left ventricular ejection fraction (LVEF) was more than 50%; d) blood glucose was controlled at fasting < 7.2 mmol/L, non-fasting < 10 mmol/L, and glycosylated hemoglobin < 7%. (7) Can tolerate chemotherapy and immunotherapy; (8) Sign informed consent; (9) Good compliance, family members agree to cooperate with survival follow-up.
Exclusion criteria
Exclusion criteria: (1) Participated in clinical trials of other drugs within four weeks; (2) Used antineoplastic drugs in the past, including chemotherapy, Kang Ai injection and Chinese patent medicines such as compound cantharidin; (3) Used immunotherapy patients in the past; (4) Had a history of psychotropic drug abuse and could not be withdrawn or had mental disorders; (5) Known major active infections, or Researchers identified major blood, kidney, metabolic, gastrointestinal, endocrine or metabolic disorders, or other serious uncontrolled concomitant diseases; (6) During acute and chronic tuberculosis infection (T-spot test positive, patients with suspected tuberculosis lesions on chest radiographs); (7) Those allergic to any research drug ingredients; (8) Disease history of epidemic defects, or other acquired, congenital immunodeficiency diseases, or organ transplantation history; (9) According to the judgement of researchers, there is a serious risk to patients'safety or accompanying diseases affecting patients to complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;DCR;PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;AEs; | — |
Countries
China
Contacts
Public ContactWeng Jie
The First people's Hospital of Yueyang
Outcome results
None listed