lung cancer
Conditions
Interventions
Case series:hypofractionated radiotherapy plus PD-1 blockade
Sponsors
Affiliated Hospital of Southwest Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Preoperative histology or cytology confirmed, chest enhanced CT, liver and adrenal CT, head magnetic resonance, PET-CT / whole body bone imaging and other well-staged patients with advanced lung cancer; multidisciplinary team (including at least one chest) The surgeon) to evaluate; 2. The patient is 18 to 80 years old and can express informed consent and sign an informed consent form, which can comply with the research plan and follow-up procedure; 3. Patients must have measurable lesions (according to RECIST 1.0); 4. no radiotherapy contraindications, life expectancy is greater than 6 months; 5. Eastern Cooperative Group (ECOG) rating scale evaluation 0-1 points; 6. Have sufficient lung function, requirement: 1st forced breathing volume (FEV1) >=1.2 liters / sec or >=50% predicted value, postoperative expectation (FEV1) >=30%; 7. There was no history of other malignant tumors in the lungs, and chemotherapy or radiotherapy for lung tumors was not performed; 8. From the previous radiotherapy, chemotherapy, hormone therapy and molecular targeted therapy for more than 4 weeks, all adverse events caused by previous treatment have been restored to =9.0 g/dL (can be maintained or exceeded by blood transfusion); (2) Red blood cell count >=2.0 x10^9/L; (3) absolute neutrophil count (ANC) >=1.0x10^9/L; (4) platelet count >=100x10^9/L; (5) total bilirubin is within normal limits; (6) alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase =60ml/min; (8) Patients who have not received anticoagulant therapy have an international normalized ratio of prothrombin time (INR) <=1.5 and partial thromboplastin time (APTT) <=1.5 times the upper limit of normal. Patients receiving total or parenteral anticoagulant therapy may be stable for at least 2 weeks before entering the clinical study, and the results of the coagulation test may be entered into clinical trials within the limits of local treatment; (9) Laboratory tests performed on the remaining screenings must comply with relevant standards: 10. Women of childbearing age test urine and serum HCG within 7 days before the start of treatment, the results need to be negative; male and female patients of the appropriate age must enter the test before the test, 30 days after the withdrawal of the drug must use a reliable method of contraception. A reliable method of contraception will be determined by the primary investigator or designated person.
Exclusion criteria
Exclusion criteria: 1. Any unstable systemic disease (including active infections, uncontrolled high blood pressure, unstable angina, angina pectoris that has started within the last 3 months, congestive heart failure (>=New York Heart Association [NYHA]] Grade II), cardiac infarction (6 months before enrollment), severe arrhythmia requiring medication, liver, kidney or metabolic disease; 2.2 patients with uncontrolled neuropathy (grade 2 or above) or mental illness; 2. Active, known or suspected of having autoimmune diseases. Subjects with the following conditions may be enrolled: vitiligo, type I diabetes, residual thyroid dysfunction caused by hormone replacement therapy, autoimmune thyroiditis, or no expected recurrence without external factors; 3. previously treated with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody acting on T cell co-stimulation or checkpoint pathway); 4. According to chest X-ray examination, sputum examination and clinical examination, it is determined that there is active tuberculosis (TB) infection. Patients with a history of active tuberculosis infection in the previous year should be excluded even if they have been treated. Patients with a history of active tuberculosis infection more than one year ago should also be excluded unless it can be demonstrated that the anti-tuberculosis treatment previously used is sufficiently effective; 5. A known history of immunodeficiency virus (HIV) is known or known to have acquired immunodeficiency syndrome (AIDS); 6. comorbidities requiring immunosuppressive drugs, or comorbidities requiring systemic or topical corticosteroids at doses with immunosuppressive effects; 7. Previously received radiotherapy at the same site, this large-scale radiotherapy could not be accepted; 8. pregnant or lactating women, as well as men and women who refuse to use appropriate contraceptive measures; 9. Patients who have undergone major surgery or severe trauma within 2 months prior to the first dose; 2.10 allergic to research drugs; 10. Investigators believe that anyone not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| local control rate, LCR;overall survival, OS;progression-free survival, PFS; | — |
Countries
China
Contacts
Public ContactSheng LIN
Department of Oncology, Affiliated Hospital of Southwest Medical University
Outcome results
None listed