Small Cell Lung Cancer
Conditions
Interventions
Early chest radiotherapy:Patients who achieved CR or PR with 2 cycles of immunotherapy combined with chemotherapy received chest radiotherapy
Sponsors
The Second Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: A) the subjects voluntarily joined the study and signed an informed consent form. B) male or female patients aged between 18 and 80. C) histologically confirmed as SCLC, imaging evaluation as stage IV (International Association for Lung Cancer Research and American Joint Committee on Cancer Classification 8th edition TNM lung cancer staging) without meningeal metastasis. D) according to the criteria for evaluating the efficacy of solid tumors (RECIST version 1.1), at least one imaging lesion can be measured. E) have not received systematic antineoplastic therapy before. F) ECOG score: 0-1. G) Life expectancy = 12 weeks. H) the function of the principal organs is normal, that is, the following criteria are met: 1) the standard of blood routine examination should be met (no blood transfusion and blood products in the previous 14 days, no correction with G-CSF and other hematopoietic stimulating factors): Hemoglobin (HB) = 90 g / L. Absolute neutrophil count (ANC) = 1.5 × 109 PG L (1500/m3). Platelet count (PLT) = 100x109 / L. 2) biochemical tests should meet the following standards: Total bilirubin (TBIL) = 1.5 ULN; for subjects with liver metastasis or evidence of / suspected Gilbert disease, TBIL = 3 ULN. "ALT and AST = 2.5" ULN, while for liver metastasis subjects, ALT and AST = 5 "ULN. Serum creatinine (Cr) = 1.5 ULN or endogenous creatinine clearance (CrCl) = 50 ml/min (Cockcroft-Gault formula: CrCL (mL/min) = [(140-age) * weight (kg) * F] / (SCr (mg/dL) * 72). Among them, male Fang 1, female Fang 0.85 SCr = serum creatinine). I) Doppler echocardiographic evaluation: left ventricular ejection fraction (LVEF) = normal lower limit (50%). J) Women of childbearing age must have taken reliable contraceptive measures or conducted pregnancy tests (serum or urine) within 7 days prior to enrollment, and the results were negative and were willing to use appropriate methods of contraception during the trial period and 8 weeks after the last administration of the trial drug. For men, it must be agreed to use appropriate methods of contraception or surgical sterilization during the trial period and 8 weeks after the last administration of the trial drug.
Exclusion criteria
Exclusion criteria: A) Pathology is non-small cell lung cancer (NSCLC) (including lung cancer with mixed SCLC and NSCLC). B) previously received antibodies or drugs targeting the immune checkpoint pathway, including, but not limited to, anti-PD-1, anti-PD-L1 or anti-cytotoxic T lymphocyte associated antigen 4 (anti-CTLA-4) antibodies. C) treatment with systemic immunomodulators (including, but not limited to, interferon, interleukin-2, tumor necrosis factor) within 4 weeks before enrollment or within 5 half-lives of the drug (whichever is the longer) (cancer vaccines are allowed in previous treatments). D) Imaging (CT or MRI) showed obvious cavitary tumor of the lung. E) Medical history and complications. Patients with symptomatic brain metastasis, carcinomatous meningitis, spinal cord compression, or diseases found in brain or leptomeninges by imaging CT or MRI examination during screening (patients with brain metastasis who have completed treatment 4 weeks before admission and whose symptoms are stable and have no progress can be enrolled). Patients are participating in other clinical studies (except non-intervention studies) or less than 4 weeks from the end of the previous clinical study. "there have been or are currently suffering from other malignant tumors in the past 2 years, except cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumor [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)]. She suffers from active, known or suspected autoimmune diseases, including a history of allogeneic organ transplantation, allogeneic hematopoietic stem cell transplantation, HIV positive history or acquired immunodeficiency syndrome (AIDS) history. Any disease that must be treated with corticosteroids (prednisone > 10 mg/ days or equivalent) or other immunosuppressive drugs within 14 days before enrollment. Note: patients who are or have used any of the following steroid regimens can be selected: Epinephrine replacement steroids (prednisone = 10 mg/ days or equivalent). Inhaled corticosteroids with very low absorption locally, in the eye, in the articular cavity, in the nose or in the whole body. Short course of treatment (= 7 days) prophylactic use of prescription corticosteroids (e.g. for contrast medium allergy) or for the treatment of non-autoimmune diseases (such as delayed allergic reactions caused by contact allergens). "patients with previous adverse reactions related to antineoplastic therapy (except alopecia) who have not recovered to NCI-CTCAE = 1. He suffers from severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade ?, poorly controlled arrhythmia, grade ? ~ ? cardiac insufficiency according to NYHA criteria, or left ventricular ejection fraction (LVEF) < 50% indicated by color Doppler ultrasound. She has a history of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease and so on. Uncontrollable moderate to massive serous effusions (including pleural effusion, ascites, pericardial effusion), aggravated chronic obstructive pulmonary disease and respiratory diseases in active pulmonary infection and / or acute bacterial or fungal infection requiring intravenous antibiotic treatment. A history of known severe hypersensitivity to other monoclonal antibodies. Known history of psychotropic substance abuse, alcohol abuse or drug use. Uncontrol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Overall Survival; | — |
Countries
China
Contacts
Public ContactAnwen Liu
The Second Affiliated Hospital of Nanchang University
Outcome results
None listed