limited-stage small cell lung cancer
Conditions
Interventions
Test Group:adebrelimab maintenance therapy after hyperfractionated radiotherapy combined with chemotherapy
Sponsors
Beidahuang Group General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-80 years old, male or female; 2. Patients with limited-stage small cell Lung cancer confirmed by pathology (according to the Veterans Administration Lung Study Group, VALG staging); 3. Have not received any previous treatment; 4. Have measurable tumor target lesions (meet RECIST1.1 criteria); 5. Expected survival >3 months; 6.ECOGPS: 0-1 ; 7. Normal function of major organs; a) Blood routine examination (no blood transfusion within 14 days, no hematopoietic stimulating drugs to correct the state) : hemoglobin (Hb) =90g/L; Absolute neutrophil count (ANC) =1.5×109/L; Platelet (PLT) =100×109/L; White blood cell count (WBC) =3.0×109/L; b) Biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5×ULN (tumor liver metastasis, =5×ULN); Serum total bilirubin (TBIL) =1.5×ULN (Gilbert syndrome subjects, =3×ULN); Serum creatinine (Cr) =1.5×ULN or creatinine clearance =50ml/min; c) Coagulation function: activated partial thromboplastin time (APTT), International standardized ratio (INR), prothrombin time (PT) =1.5×ULN; d) Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) =50%; 8. Women of childbearing age must undergo a negative pregnancy test (ßHCG) before starting treatment, and women and men of childbearing age (who have sex with women of childbearing age) must agree to the uninterrupted use of effective contraception during treatment and for 6 months after the last therapeutic dose is administered; 9. The patients voluntarily joined the study and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Previous or concurrent malignancies within 5 years, except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, superficial or non-invasive bladder cancer; 2. Have active tuberculosis infection, or have a history of tuberculosis infection. 3. Patients with uncontrolled, symptomatic brain metastases or a history of uncontrollable mental illness or with severe intellectual or cognitive impairment; 4. Subjects with active, known, or suspected autoimmune disorders requiring hormone replacement therapy for hypothyroidism, skin disorders that do not require systemic treatment (such as vitiligo, psoriasis, or alopecia) may be enrolled; 5. Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage; 6. Subjects with any severe and/or uncontrolled medical condition, including: a) subjects with unsatisfactory blood pressure control (systolic blood pressure =150mmHg or diastolic blood pressure =100mmHg); b) have grade 2 myocardial ischemia or myocardial infarction, arrhythmias (including QTc=450ms in men, QTc=470ms in women, and grade 2 congestive heart failure (NYHA); 7. A history of psychotropic substance abuse, alcoholism or drug use; 8. Active hepatitis (Hepatitis B reference: HBsAg positive, and HBV DNA detection value exceeds the upper limit of normal value; Hepatitis C reference; HCV antibody positive, and HCV virus titer detection value exceeds the upper limit of normal value); 9. Positive for human immunodeficiency virus (HIV, HIV1/2 antibody); 10. Patients who cannot follow the trial protocol or cannot cooperate with follow-up; 11. Researchers consider it inappropriate to participate in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety;12-month progression-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease control rate;Progression-free Survival;Overall Survival; | — |
Countries
China
Contacts
Public ContactLiu Yongmin
Beidahuang Group General Hospital
Outcome results
None listed