Lung cancer
Conditions
Interventions
Case group:Nil
Sponsors
General Hospital of Eastern Theater Command
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years, regardless of gender; 2. Subjects with EGFR/ALK gene wild-type, non-squamous non-small cell lung cancer confirmed by histopathology or cytology; 3. A maximum of 5 metastases are allowed, and the number of metastases is less than = 3; 4. Subjects who have received up to 4 months of prior systemic systemic therapy for advanced/metastatic disease with good systemic control and partial LESIONS SD or progression; 5. The subject signed the informed consent and voluntarily joined the study; 6. The investigator determined that subjects could continue to receive carrelizumab therapy; 7. Subjects are allowed to have prior local treatment, such as whole-brain radiotherapy or bone metastasis radiotherapy; 8. According to the efficacy evaluation criteria for solid tumors (RECIST1.1), there should be at least one measurable lesion, which has not received local treatment such as radiotherapy (target lesion located in the area of the previous radiotherapy, if proven to progress and in compliance with RECIST1.1 criteria, can also be selected as target lesion); 9. ECOG: 0-2; 10. Expected survival >= 12 weeks; 11. The functions of vital organs meet the following requirements (It is not recommended to use any blood components and cell growth factors 2 weeks before the start of the study) : (1) Neutrophil absolute count (ANC) >= 1.5 x 10^9 /L; (2) Platelet >= 100 x 10^9 /L; (3) Hemoglobin >= 9g/dL; (4) Serum albumin >= 2.8g/dL; (5) Bilirubin = 50 mL/min (7) Activated partial thrombin time (APTT) and international standardized ratio (INR) <1.5 times of ULN (INR can be screened for the expected treatment range of anticoagulants using a stable dose of anticoagulant therapy such as low molecular weight heparin or warfarin); 12. Fertile female subjects should undergo a urine or serum pregnancy test that is negative within 72 hours prior to receiving the first dose and be willing to use an effective method of contraception between the trial period and 3 months after the last dose of carrelizumab. For male subjects whose partners are women of reproductive age, effective contraceptive methods should be used during the trial period and within 3 months after the last administration of carrelizumab.
Exclusion criteria
Exclusion criteria: 1. Other malignancies have been diagnosed within 5 years prior to the first use of the study drug, other than basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or cervical and/or breast cancer in situ that has been effectively resected; 2. The presence of uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage; 3. Have any active autoimmune disease or a history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included if hormone replacement therapy is normal); Subjects with asthma who had vitiligo or whose asthma had been in complete remission in childhood and did not require any intervention as adults were not included. Subjects with asthma who required medical intervention with bronchodilators were not included. 4. Patients with uncontrolled cardiac clinical symptoms or diseases, such as : (1) NYHA Grade II or above heart failure; (2) unstable angina pectoris; (3) previous myocardial infarction within 1 year; (4) clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention. 5. Severe infections (CTC AE > grade 2) occurred within 4 weeks prior to the first use of the study drug, such as severe pneumonia, bacteremia, infection complications, etc., requiring hospitalization; Baseline chest imaging examination suggests active pulmonary inflammation, signs, and symptoms of infection within 2 weeks prior to the first use of the study drug, or the need for oral or intravenous antibiotic treatment, except in the case of prophylactic antibiotic use; 6. A known history or evidence of interstitial lung disease or active non-infectious pneumonia; 7. Congenital or acquired immune deficiency (such as HIV infection), active hepatitis B: (HBV-DNA 2000 IU/mL or >= 10^4/mL) or hepatitis C (HCV antibody positive and HCV-RNA above the detection limit of the assay method); 8. Subjects who received systematic treatment with corticosteroid (> 10mg/ day equivalent dose) or other immunosuppressants within 14 days prior to the first use of the study drug; 9. Previous antitumor therapeutic toxicity does not recover to < CTCAE grade 1 (except for alopecia) or to the level specified by inclusion/exclusion criteria; 10. Pregnant or lactating women; 11. As judged by the Investigator, subjects have other factors that may cause them to be forced to terminate the study, such as other serious diseases (including mental illness) requiring combined treatment, serious abnormal laboratory test values, family or social factors that may affect the safety of subjects or the data collection of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Countries
china
Contacts
Public ContactLv Tangfeng
General Hospital of Eastern Theater Command
Outcome results
None listed