Extensive small cell lung cancer
Conditions
Interventions
Radiotherapy group after two cycles of systemic treatment:Chemotherapy (cisplatin-etoposide) Q3W + Immunisation (Atezolizumab/Durvalumab/Serplulimab/Adebrelimab) total 2 cycles + Radiotherapy (30Gy/10
Radiotherapy group after four cycles of systemic treatment:Chemotherapy (cisplatin-etoposide) Q3W + Immunisation (Atezolizumab/Durvalumab/Serplulimab/Adebrelimab) total 4 cycles + Radiotherapy (30Gy/1
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) The patients voluntarily participate in this study, sign the informed consent form, have good compliance, and cooperate with the follow-up; (2) The age is greater than or equal to 18 years old, and both men and women are eligible; (3) The ECOG PS score is 0-2; (4) The small-cell lung cancer is confirmed by histology or cytology; (5) It is in the extensive stage according to the staging standards of the 8th edition of the AJCC/UICC, which is TxNxM1 or the VALG two-stage method; (6) It has not(6) No surgery, radiotherapy, chemotherapy, targeted or immunotherapy; (7) Vital organ function meets the following requirements (the use of any blood components and cell growth factors is not permitted 2 weeks prior to the commencement of the screening test): -Absolute Neutrophil Count (ANC) >= 1.0 × 10^9/L; Platelets >= 100 × 10^9/L; Hemoglobin >= 1.5 × 10^9/L; Blood pressure >= 1.5 × 10^9/L; andHemoglobin >= 8 g/dL; Serum albumin >= 2.8 g/dL; Total bilirubin = 60 mL/L.Serum creatinine = 60 mL/min (based on the Cockcroft-Gault formula); nternational Normalised Ratio (INR) and Activated Partial Thromboplastin Time (APTT) <= 1.5 × ULN (for those on stable doses of anticoagulant therapy e.g., low molecular weight heparin or warfarin and with an INR within the expected therapeutic range of the anticoagulant). (8) Female subjects of childbearing potential should have a negative urine or serum pregnancy test performed within 72 hours prior to the first dose of study drug and be willing to use an effective method of contraception for the duration of the trial up to 5 months after the last dose.For male subjects whose partner is a woman of childbearing potential, they should use an effective method of contraception during the trial and for 7 months after the last dose.
Exclusion criteria
Exclusion criteria: (1) Patients with a prior diagnosis of any other malignancy who have received surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy; and whose natural course or treatment is likely to interfere with the evaluation of the safety or efficacy of the investigational protocols for immunotherapy or radiotherapy; (2) Symptomatic central nervous system (CNS) metastases; (3) Bone metastases with a risk of paraplegia; (4) Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage operations; (5) Uncontrolled tumour-related pain; (6) Any active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonitis, uveitis, enterocolitis, hepatitis, pituitary gland inflammation, vasculitis, cardiomyopathies, nephritis, hyperthyroidism, hypothyroidism, etc.); autoimmune-mediated hypothyroidism treated with a stable dose of thyroid-replacing hormone; and autoimmune-mediated hypothyroidism treated with a stable dose of thyroid-replacing hormone. hypothyroidism and type I diabetes mellitus treated with stable doses of insulin may be enrolled; (7) Persons who have received an antineoplastic vaccine or who have received a live vaccine within 4 weeks prior to the first administration of study drug; (8) Persons who have a history of immunodeficiency, including a positive test for HIV, or who have other acquired, congenital immunodeficiency diseases, or who have a history of organ transplantation and a history of allogeneic bone marrow transplantation; (9) Persons who suffer from uncontrolled (9) Subjects with uncontrolled cardiac clinical conditions or diseases, such as (1) NYHA II or higher heart failure (2) unstable angina (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention; (10) Serious infections (CTCAE > Grade 2) within 4 weeks prior to first use of study drug, such as severe pneumonia requiring hospitalisation, bacteraemia, infectious co-morbidities, etc.; Baseline (11) History of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, or other uncontrolled acute lung disease; (12) Active tuberculosis infection detected by history or CT scan; or patients with a history of active tuberculosis infection within 1 year prior to enrollment, or patients with a history of active tuberculosis infection more than 1 year ago without regular treatment; (13) Known allergic reactions, hypersensitivity reactions, or contraindications to radiation therapy; (14) Pregnant or breastfeeding women; subjects of childbearing potential who are unwilling or unable to use effective contraception; (15) Subjects who have undergone In the judgement of the investigator, the subject has other factors that may cause him/her to be forced to terminate the study in the middle of the study, such as suffering from other serious illnesses (including psychiatric illnesses) that require comorbid treatment, recent comorbidities of other serious illnesses (e.g., cardiac infarction, cerebral vascular accidents) that have a high risk of recurrence under consideration, serious abnormalities of the laboratory test values, and family or social factors, which may affect the subject's safety or collection of experimental data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival ratio; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Overall Survival; | — |
Countries
China
Contacts
Public ContactYatian Liu
Jiangsu Cancer Hospital
Outcome results
None listed