Small cell lung cancer
Conditions
Interventions
Limited-stage small cell lung cancer (SCLC) concurrent or sequential chemoradiotherapy group:Thirty eligible subjects who meet the inclusion criteria will be selected from patients diagnosed with limi
Sponsors
Anhui Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Signing the informed consent form. When signing the informed consent form, male or female subjects aged >= 18 years old; 2.Able to comply with the study protocol; 3.Histologically or cytologically confirmed limited-stage small cell lung cancer; 4.No disease progression after 2-4 cycles of etoposide/carboplatin or etoposide/cisplatin; 5.ECOG performance status score of 0-2; 6.Expected survival period >= 6 months; 7.Except for hearing loss, alopecia, and fatigue, all toxicities caused by previous anti-tumor treatments must have recovered to= 1.5 × 10^9/L; platelet count >=100 × 10^9/L; hemoglobin >= 90g/L; (2)Liver function: Total bilirubin = 1.5 times the upper limit of normal, or prothrombin time (PT) = 1.5 times the upper limit of normal (ULN); if the subject is receiving anticoagulant therapy, it is acceptable as long as PT is within the intended 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 end of 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 end of the last dose.
Exclusion criteria
Exclusion criteria: 1.Histologically confirmed as mixed small-cell lung cancer; 2.Having grade >=3 pneumonia, active pneumonia, or pulmonary tuberculosis; 3.A history of chest radiotherapy; 4.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; 5.Suffering from active autoimmune diseases, or having a history of autoimmune diseases that may relapse; 6.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; 7.Subjects with active chronic hepatitis B or active hepatitis C (those with positive HBsAg but HBV-DNA <= the upper limit of the normal range of the testing unit, or positive HCV-Ab but HCV-RNA <= the upper limit of the normal range of the testing unit can be enrolled); 8.Having received organ transplantation; 9.Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibodies); 10.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); 11.Any clinically severe abnormal gastrointestinal function, a history of inflammatory bowel disease, or current inflammatory bowel disease (such as Crohn's disease and ulcerative colitis); 12.Pregnant or lactating women; 13.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; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective Response Rate;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactHong Fu
Anhui Provincial Cancer Hospital
Outcome results
None listed