Extensive-stage Small Cell Lung Cancer
Conditions
Interventions
Intervention Group 1 :chemotherapy combined with PD-1/PD-L1 inhibitor sequential radiotherapy combined with PD-1/PD-L1 inhibitor
Sponsors
Department of Oncology, Affiliated Hospital of Southwest Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Extensive-stage SCLC patients who have not received anti-tumor therapy before, who have been confirmed by histology or cytology, chest enhanced CT, liver and adrenal CT, cranial magnetic resonance, PET-CT/whole body bone imaging, etc. Patients who have undergone radical treatment, but have disease recurrence or progression 6 months after completion of treatment; 2. Aged 18 to 75 years old, able to express informed consent and sign an informed consent form, and be able to comply with the research protocol and follow-up procedures; 3. Patients must have >= 3 measurable lesions (according to RECIST 1.0 criteria); 3. No contraindications to radiotherapy, life expectancy is more than 6 months; 4. The Eastern Cooperative Group (ECOG) scoring scale evaluates 0-2 points; 5. Sufficient lung function, requirements: forced expiratory volume in the first second (FEV1) >= 1.2 liters/second or >= 50% of the expected value, postoperative expected (FEV1) >= 30%; 6. No history of other pulmonary malignant tumors, no chemotherapy or radiotherapy for lung tumors. 7. Patients who received radiotherapy, chemotherapy and hormone therapy for more than 4 weeks, and all adverse events caused by previous treatment have recovered to = 9.0 g/dL (which can be maintained or exceeded by blood transfusion); - Red blood cell count >= 2.0x10^9/L - Absolute neutrophil count (ANC) >=1.0x10^9/L; - Platelet count >=100x10^9/L; -Total bilirubin within normal limits; - Alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase = 60 ml/min; - International normalized ratio of prothrombin time in patients who have not received anticoagulant therapy (INR) <= 1.5, partial thromboplastin time (APTT) <= 1.5 times the upper limit of normal. Patients receiving full-dose or parenteral anticoagulant therapy can enter clinical trials as long as the anticoagulant dose is stable for at least 2 weeks before entering the clinical study, and the results of the coagulation test are within the limits of local treatment; the remaining screening The laboratory inspection values ??made by the investigation must meet the relevant standards; 9. Women of childbearing age should test urine and serum HCG within 7 days before the start of treatment, and the results must be negative; male and female patients of appropriate age must use reliable methods of contraception before entering the trial, during the research process until 30 days after drug withdrawal. Reliable contraceptive methods will be adjudicated by the principal investigator or designee.
Exclusion criteria
Exclusion criteria: 1. Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina pectoris, angina pectoris that started within the last 3 months, congestive heart failure (>= New York Heart Association [NYHA]) ] Grade II), myocardial infarction (6 months before enrollment), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases; 2.2 patients with uncontrolled neuropathy (grade 2 or above) or mental illness; 2. Active, known or suspected autoimmune disease. Subjects with the following conditions can be included: vitiligo, type I diabetes, residual hypothyroidism caused by autoimmune thyroiditis only with hormone replacement therapy, or conditions that are not expected to recur without external stimulation; 3. Previous treatment 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 costimulation or checkpoint pathway); 4. According to chest X-ray examination, sputum examination and clinical physical examination, it is judged to have active pulmonary tuberculosis (TB) infection. Patients with a history of active pulmonary tuberculosis infection within the previous 1 year were excluded even if they had been treated. Patients with a history of active pulmonary tuberculosis infection more than 1 year ago should also be excluded unless it can be demonstrated that the previous anti-tuberculosis treatment was sufficiently effective; 5. Known positive medical history of human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS); 6. Complications requiring treatment with immunosuppressive drugs, or comorbidities requiring systemic or topical corticosteroids at doses with immunosuppressive effects; 7. Patients who have received radiotherapy at the same site in the past cannot receive this hypofractionated radiotherapy; 8. Lactating women; 9. Patients who have undergone major surgery or suffered severe trauma within 2 months before the first drug; 10. Allergic to the research drug; 11. Other researchers think that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival, OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival, PFS;Objective remission rate,ORR;Safety and tolerability;health-related quality of life,HRQoL; | — |
Countries
China
Contacts
Public ContactLin Sheng
Department of Oncology, Affiliated Hospital of Southwest Medical University
Outcome results
None listed