LS-SCLC
Conditions
Interventions
Test group:Adebelizumab + etoposide + carboplatin
Control group:etoposide + carboplatin
Sponsors
Jinling Hospital, Nanjing University Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. age =18 years old, gender is not limited; 2. SCLC with a definitive diagnosis of limited stage by histology or cytology (T1-4N0-2M0, according to AJCC 8th edition staging); 3. no previous systemic systemic therapy; 4. measurable lesions as defined by RECIST v1.1 criteria; 5. ECOG physical status score of 0 or 1; 6. patients of childbearing age must agree to contraception; 7. have adequate organ and bone marrow function, defined as follows: hemoglobin = 9.0 g/dL; absolute neutrophil count = 1.5 × 109/L; platelet count = 100 × 109/L; INR = 1.5; total bilirubin (TBL) = 1.5 × upper limit of normal (ULN); AST and ALT = 2.5 × ULN; serum albumin = 3.0 g/ dL; serum creatinine = 1.5 × ULN or measured creatinine clearance > 60 mL/min or creatinine clearance > 60 mL/min calculated according to the Cockcroft-Gault formula (using actual body weight): males: creatinine clearance = (body weight × (140 - age))/(72 × serum creatinine) females: creatinine clearance = (body weight × (140 - age))/(72 × serum creatinine) females: creatinine clearance = (body weight × (140 - age))/(72 × serum creatinine) age))/(72 x serum creatinine) x 0.85 where CL = mL/min; serum creatinine = mg/dL; 8. patients with active HBV infection should should have received more than 2 weeks of antiviral therapy according to local antiviral treatment guidelines prior to enrollment and should have continued treatment for 6 months after study drug therapy; 9. expected survival = 12 weeks; 10. Voluntarily participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. patients with a history of HIV infection; 2. female patients whose pregnancy was detected within 24 hours prior to administration; 3. patients with a history of organ transplantation; 4. active or previously documented autoimmune-like or inflammatory diseases (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis (other than diverticulosis), systemic lupus erythematosus, tuberculosis syndrome, or Wegener's syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, pituitary gland inflammation, and uveitis, etc.]). The following are exceptions to this criterion: (a) patients with vitiligo or alopecia areata; (b) patients with hypothyroidism (e.g., after Hashimoto's syndrome) who are on stable hormone replacement therapy; (c) any chronic skin disease that does not require systemic therapy; (d) patients who have had no active disease in the last 5 years may be included, but only after consulting with the study physician; (e) patients with celiac disease that relies solely on dietary Patients with celiac disease that can be controlled; 5. active infection, including tuberculosis (clinical evaluation includes clinical history, physical examination, imaging findings, and tuberculosis screening consistent with local treatment principles); 6. uncontrolled comorbidities, including, but not limited to, persistent or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease, severe chronic gastrointestinal disease associated with diarrhea, or mental illness/social condition that limits compliance with study requirements, significantly increases the risk of AE, or impairs the patient's ability to provide written informed consent Mental illness/social condition that limits ability to provide written informed consent; 7. pre-existing abnormal thyroid function and failure to maintain thyroid function within the normal range despite medication; 8. current or prior use of immunosuppressive medications within 14 days prior to the first dose of adebenosumab. The following are exceptions to this criterion: (a) intranasal, inhaled, topical steroids, or locally injected steroids (e.g., intra-articular injections; (b) systemic glucocorticosteroids at no more than physiologic doses equivalent to 10 mg/day of prednisone or its equivalents; and (c) steroid hormones, as pre-treatment of hypersensitivity reactions (e.g., pre-treatment of CT scans); 9. persons with a history of psychotropic substance abuse that is not amenable to cessation or who have a psychotic disorder; 10. known history or evidence of interstitial lung disease or active non-infectious pneumonia; 11. live attenuated vaccination within 30 days prior to the first dose of study drug. Note: If enrolled, patients may not receive live vaccines during treatment with study drug and within 30 days of the last dose of study drug; 12. known to develop an allergic reaction or hypersensitivity to any study drug or any of its excipients; 13. concurrent enrollment in another clinical study, unless the study is an observational (non-interventional) clinical study or a follow-up period of an interventional study; 14. other circumstances judged by the investigator to be inappropriate for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of remission of major pathologies;R0 excision rate;Objective mitigation rate;Disease control rate; | — |
Countries
China
Contacts
Public ContactTangfeng Lv
Jinling Hospital, Nanjing University Medical College
Outcome results
None listed