Lung Cancer
Conditions
Interventions
Case series:radiotherapy+PD-1
Sponsors
Linyi City People Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 79 Years
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years old on the day of signing the informed consent; 2. Pathologically confirmed as locally advanced or metastatic lung squamous cell carcinoma; 2.1 Among them, metastatic lung squamous cell carcinoma requires metastases =6 months; 7. Any other treatment for malignancies, including surgery, radiotherapy, chemotherapy, bio/targeting drugs, and immunologic drugs, must be terminated at least two weeks prior to enrollment and recovered from adverse effects from recent surgery, radiation, or chemotherapy; 8. The main organs function normally, that is, the following criteria are met: (1) Blood routine examination standards must be met (no blood transfusion and blood products within 14 days): ANC>=1.5x10^9/L; PLT>=100x10^9/L; Hemoglobin >=9g/dL; serum albumin >=3g/dL; Thyroid stimulating hormone (TSH) =60mL/min (using the standard Cockcroft-Gault formula); 9. Non-surgical sterilization or women of childbearing age, need to use a medically recognized contraceptive (such as intrauterine device, contraceptive or condom) during the study treatment period and within 3 months after the end of the study treatment period; Sexually ill women of childbearing age must have a negative serum or urine HCG test within 72 hours prior to study enrollment; and must be non-lactating; 10. Subjects voluntarily joined the study and signed informed consent, with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. The subject 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, hyperthyroidism, decreased thyroid function; subjects with vitiligo or complete remission in childhood asthma, can be included without any intervention in adults; subjects who require bronchodilators for medical intervention can not be included ); 2. Subjects are using immunosuppressive agents, or systemic, or absorbable local hormonal therapies for immunosuppression purposes (dose >10 mg/day of prednisone or other therapeutic hormones) and within 2 weeks prior to enrollment Still continuing to use; 3. Severe allergic reactions to other monoclonal antibodies; 4. Subjects have clinically symptomatic central nervous system metastases (eg.cerebral edema, need for hormonal intervention, or progression of brain metastases).Previously treated with brain or meningeal metastases, such as patients with clinically stable (MRI) who have been on hold for at least 1 month and who have stopped systemic hormonal therapy (dose > 10 mg/day of prednisone or other therapeutic hormones) for more than 2 weeks; 5. Suffering from high blood pressure, and can not be well controlled by antihypertensive drugs (systolic blood pressure =140mmHg or diastolic blood pressure >=90 mmHg); 6. There are clinical symptoms or diseases of the heart that are not well controlled, such as: (1) heart failure above nyha2 (2) unstable angina (3) myocardial infarction within 1 year (4) clinically significant supraventricular Or ventricular arrhythmia requires treatment or intervention; 7. The subject has an active infection or an unexplained fever >38.5 degrees during screening, prior to the first dose; 8. Subject with previous and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-associated pneumonia, severe lung function impairment, etc.; 9. Subjects with congenital or acquired immunodeficiency (such as HIV infection), or active hepatitis (hepatitis B reference: HBV DNA detection value exceeds the upper limit of normal; hepatitis C reference: HCV virus titer or RNA detection value exceeds the upper limit of normal); 10. Other known malignancies are developing or require active treatment. Exceptions include cutaneous basal cell carcinoma and cutaneous squamous cell carcinoma; 11.Had developed bone metastases had a palliative radiotherapy area > 5% of the bone marrow area within 4 weeks prior to participation in the study; 12. Subjects have previously received other pd-1 antibody therapy or other immunotherapy for pd-1/pd-l1; 14. Women during pregnancy or lactation; 15. The investigator judged that the subject had other factors that might lead to the termination of the study, such as other serious diseases (including mental illness) requiring combined treatment, severe laboratory abnormalities, and family or society. Factors such as the safety of the subject, or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free life (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Duration of response, DOR;Objective response rate, ORR;Disease Control Rate, DCR;quality of life;Safety indicators; | — |
Countries
China
Contacts
Public ContactZhongmin Zhang
Linyi City People Hospital
Outcome results
None listed