Lung cancer
Conditions
Interventions
Experimental group:Camrelizumab and inhale hydrogen 6h/d
Sponsors
The Third Affiliated Hospital of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years; 2. Pathologically confirmed non-small cell lung cancer at initial treatment; 3. Patients with stage IIIb-IV advanced non-small cell lung cancer diagnosed; 4. No previous systemic anti-tumor treatment for advanced/metastatic disease; 5. The sensitive mutations of driving genes such as EGFR, ALK and ros-1 were negative; 6. ECOG score 0~1 points; 7. Life expectancy >= 3 months; 8. RECIST 1.1 criteria identified at least one measurable lesion; 9. The subject should not have received anti-PD-1 or PD-L1 or CTLA-4 or car-t immunotherapy; 10. Focus control after radiotherapy for asymptomatic brain metastasis or brain metastasis; 11. There was no significant abnormality in routine laboratory examination (blood routine, liver and kidney function, coagulation function, etc.): (1) Blood routine: ANC >= 1.5 x 10^9/L; PLT >= 80 x 10^9/L; (2) Biochemical examination shall meet the following standards: TBIL = 50 mL/min (CockcroftGault formula); 12. Sufficient tissue markers can be provided for PD-L1 detection or blood samples (1 week before treatment, 1 week after ablation, immune evaluation once every two months) for follow-up analysis; 13. Patients with potential fertility need to use a medically recognized contraceptive measure (such as IUD, contraceptive or condom) during the study treatment period and within 1 month after the end of the study treatment period; The serum or urine HCG test must be negative and must be non lactating within 72 hours before the study is enrolled; 14. The subjects volunteered to join the study and signed the informed consent form. They had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Other malignant tumors within five years; 2. Allergic to any component of Camrelizumab; 3. Have a history of interstitial lung disease (excluding radiation pneumonia without hormone treatment) and non infectious pneumonia; 4. The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, thyroid hyperfunction; patients suffering from vitiligo; asthma has been completely relieved in childhood, and can be included in adults without any intervention; patients with asthma that require bronchodilators for medical intervention cannot be included); 5. The subjects are using immunosuppressants, or systemic or absorbable local hormones to achieve the purpose of immunosuppression (dose > 10 mg/day, prednisone or other effective hormones) and continue to use them within 2 weeks before enrollment; 6. Severe infection (CTCAE > grade 2) occurred 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia and infection complications requiring hospitalization; baseline chest imaging revealed active pulmonary inflammation, symptoms and signs of infection within 2 weeks before the first use of the study drug, or the need for oral and intravenous antibiotics, except for the use of prophylactic antibiotics; 7. The subject had acute cardiovascular and cerebrovascular diseases such as acute cerebral infarction and acute coronary syndrome within 1 month, and the cardiovascular clinical symptoms or diseases were not well controlled; 8. According to NYHA standard, grade III ~ IV cardiac insufficiency, or left ventricular ejection fraction (LVEF) 1.5 x ULN, APTT > 1.5 x ULN) and bleeding tendency; 11. Long term untreated wounds or fractures; major surgery or severe traumatic injury, fracture or ulcer within 4 weeks; 12. Subjects with congenital or acquired immune deficiency (such as HIV infection) or active hepatitis (hepatitis B reference: HBV DNA detection value exceeds the upper limit of normal value; hepatitis C reference: HCV virus titer or RNA detection value exceeds the upper limit of normal value); 13. Those with a history of psychotropic substance abuse and who cannot be removed or have mental disorders; 14. According to the judgment of the investigator, patients with concomitant diseases that seriously endanger the safety of patients or affect the completion of the study; 15. The researchers believe that patient is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progress-free survival; | — |
Countries
China
Contacts
Public ContactLong Fei
The Third Affiliated Hospital of Shandong First Medical University
Outcome results
None listed