Small cell lung cancer
Conditions
Interventions
Extensive-stage small cell lung cancer with liver metastasis group:Local radiotherapy for liver metastases
Sponsors
Anhui Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Sign the informed consent form; at the time of signing the informed consent form, male or female subjects aged >= 18 years; 2.Able to comply with the study protocol; 3.Histologically or cytologically confirmed ES-SCLC; 4.Having at least one measurable liver metastasis lesion, with no previous radiotherapy targeting liver metastases; 5.ECOG performance status score of 0-2; 6.Expected survival period >= 3 months; 7.Except for hearing loss, alopecia, and fatigue, all toxicities caused by previous anti-tumor treatments must have recovered to = 1.5 × 10?/L; platelet count >= 100 × 10?/L; hemoglobin >= 90g/L;Liver function: total bilirubin = 60 mL/min (Cockcroft - Gault); urine routine results show urine protein = 2+ or 24-hour urine protein quantification < 1g;Coagulation function: international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; if the subject is receiving anticoagulant therapy, it is acceptable as long as PT is within the proposed range for the anticoagulant drug; 9.Female subjects of childbearing potential should be willing to use effective contraceptive measures during the trial period and within 6 months after the last dose, and have a negative pregnancy test before the start of treatment; 10.Male subjects are willing to take effective contraceptive measures during the trial period and within 6 months after the last dose.
Exclusion criteria
Exclusion criteria: 1.Histologically confirmed as mixed small-cell lung cancer; 2.Leptomeningeal metastasis or brain metastasis that progresses despite radiotherapy; 3.Poorly controlled pleural effusion, pericardial effusion, or ascites requiring repeated drainage procedures (once a month or more frequently); 4.Having grade >=3 pneumonia, active pneumonia, or pulmonary tuberculosis; 5.Having undergone major surgery within 4 weeks before the first administration of the study treatment or expecting to undergo major surgery during the study treatment period; 6.Suffering from active autoimmune diseases, or having a history of autoimmune diseases that may relapse; 7.Patients requiring long-term systemic use of corticosteroids. Patients who need intermittent use of bronchodilators, inhaled corticosteroids, or local injection of corticosteroids due to COPD or asthma can be enrolled; 8.Subjects with active chronic hepatitis B or active hepatitis C (those with positive HBsAg but HBV-DNA <= the upper limit of the normal value of the testing unit, and those with positive HCV-Ab but HCV-RNA <= the upper limit of the normal value of the testing unit can be enrolled); 9.Having received organ transplantation; 10.Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibodies); 11.Having any other malignant tumors within 2 years (except for clinically cured carcinoma in situ of the cervix, basal cell or squamous cell skin cancer); 12.Any clinically severe gastrointestinal dysfunction, with a history of inflammatory bowel disease or currently suffering from inflammatory bowel disease (such as Crohn's disease and ulcerative colitis); 13.Pregnant or lactating women; 14.The investigator determines that the subject has any clinical or laboratory test abnormalities or other reasons that make them unsuitable for participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Countries
China
Contacts
Public ContactHong Fu
Anhui Provincial Cancer Hospital
Outcome results
None listed