Non-small cell lung cancer
Conditions
Interventions
experimental group:camrelizumab 200 mg/3w
docetaxel 75mg/ m2, D1, carboplatin AUC=5, D1, (squamous carcinoma
pemetrexed, 500mg/ m2 , D1, carboplatin AUC=5, D1, Non-squamous cell carcinomas
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Sign the written informed consent before joining the group; 2. Aged 18-70 years, both male and female; 3. Assess resectable patients before treatment: (1) Patients with resectable non-small cell lung cancer diagnosed by pathology and imaging (clinical stage IIIa, IASLC/UICC eighth edition TNM staging of lung cancer), (2) Subjects who are considered by the investigator to have hope for surgery after neoadjuvant therapy (clinical stage IIIb, IASLC/UICC eighth edition TNM staging of lung cancer), Note: lymph node staging by PET/CT, EBUS/EUS or mediastinoscopy ; 4. Gene detection EGFR(-), ALK(-), ROS(-); 5. With measurable lesions, (according to RECIST 1.1 criteria, the long diameter of CT scan of tumor lesions is >=10mm, and the short diameter of CT scan of lymph node lesions is >=15mm;); 6. ECOG PS score: 01; 7. The expected survival period is greater than 6 months; 8. The function of vital organs meets the following requirements (excluding any blood components and cell growth factors within 14 days): Blood routine: neutrophil>=1,500/mm3; platelet count >=100,000/mm3; hemoglobin >=5.6 mmol/L (9g/dL); Liver and kidney function: Serum creatinine (SCr) = 50 ml/min (Cockcroft-Gault formula); total bilirubin (TBIL) = 2+, 24-hour urine protein quantification must show protein <= 1g; 9. Normal coagulation function, no active bleeding and thrombotic disease: (1) International standardized ratio INR <= 1.5xULN; (2) Partial thromboplastin time APTT <= 1.5xULN; (3) Prothrombin time PT<=1.5ULN; 10. Non-surgical sterilization or female patients of childbearing age, need to use a medically approved contraceptive measure (such as an intrauterine device, contraceptives or condoms) during the study treatment period and within 3 months after the end of the study treatment period; non- Female patients of reproductive age with surgical sterilization must have a negative serum or urine HCG test within 7 days before study enrollment; and must be non-lactating; non-surgical sterilization or male patients of reproductive age, need to agree with their spouse during study treatment and research Use a medically approved contraceptive method for 3 months after the end of the treatment period; 11. The subjects voluntarily joined the study, with good compliance, and with safety and survival follow-up.
Exclusion criteria
Exclusion criteria: 1. Previously received radiotherapy, chemotherapy, hormone therapy, surgery or molecular targeted therapy; 2. Imaging confirmed patients with distant metastasis; 3. The subject has previously or concurrently suffered from other malignant tumors (except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); 4. Previous treatment with camrelizumab or other PD-1/PD-L1 therapy is not eligible; the subject is known to have previously treated macromolecular protein preparations, or known treatment of any camrelizumab, or Allergic to the chemotherapeutic components used during the neoadjuvant treatment of the subjects; 5. The subject has any active autoimmune disease or has a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis , nephritis, hyperthyroidism, hypothyroidism, those who have undergone thyroid surgery in the past cannot be included; subjects with vitiligo or complete remission of asthma in childhood, without any intervention in adulthood can be included; subjects need bronchial Asthma with medical intervention with dilators cannot be included); 6. The subject is using immunosuppressive, or systemic, or absorbable local hormone therapy to achieve the purpose of immunosuppression (dose > 10mg/day prednisone or other equivalent hormones), and within 2 weeks before enrollment is still in use; 7. Ascites or pleural effusion with clinical symptoms requires therapeutic puncture or drainage; 8. There are clinical symptoms or diseases of the heart that are not well controlled, such as: (1) Heart failure of NYHA grade 2 or above; (2) Unstable angina; (3) Myocardial infarction occurred within 1 year; (4) Patients with clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; 9. Abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg>2g/L), with bleeding tendency or receiving thrombolytic or anticoagulation therapy; 10. Previous or current severe bleeding (bleeding >30 ml within 3 months), hemoptysis (>5 ml fresh blood within 4 weeks), or thromboembolic events (including stroke events and/or transient cerebral insufficiency) within 12 months blood attack); 11. Subjects are still using traditional Chinese medicine immunomodulators within 2 weeks before enrollment; 12. Subjects with active infection or unexplained fever > 38.5 degrees during the screening period and before the first administration (subject to the investigator's judgment, the subjects with fever due to tumor can be enrolled); 13. Patients with past and current objective evidence of history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severely impaired lung function, etc.; 14. Subjects with congenital or acquired immunodeficiency, such as HIV infection, or active hepatitis (transaminase does not meet the inclusion criteria, hepatitis B reference: HBV DNA >= 10/ml; hepatitis C reference: HCV RNA >= 10^3/ml); chronic Hepatitis B virus carriers, HBV DNA < 2000 IU/ml (<10^4 copies/ml), must receive antiviral therapy at the sa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year progression-free survival (PFS) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate;Recurrence-free survival;Postoperative complication rate;Surgical resection rate;Overall survival; | — |
Countries
China
Contacts
Public ContactChen Jun
Tianjin Medical University General Hospital
Outcome results
None listed