Limited stage Small Cell Lung Cancer
Conditions
Interventions
Adebrelimab Injection combined with Linperlisid Tablets test group:Adelbilizumab combined with linprixel for treatment
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age range from 18 to 75 years (including upper limit), regardless of gender; 2) LS-SCLC confirmed by pathology (histology or cytology) (AJCC 8th Edition Cancer staging stage I - III); 3) Prior to initial treatment, chest and upper abdominal CT, brain MR (or brain CT) examinations were conducted to demonstrate the absence of evidence of metastatic disease. Chest and upper abdominal CT can be replaced by PET/CT. If there are lower abdominal CT, pelvic CT, bone scan, EBUS, color ultrasound, pathological biopsy and other examinations, the examination results should be referred to; 4) Received radical synchronous radiotherapy and chemotherapy. The chemotherapy scheme must contain platinum and Etoposide, and the chemotherapy is 4-6 courses. Radiotherapy should be a 60 to 66 Gy QD (2 Gy/dose), 45 Gy BD (1.5 Gy/dose), or 45 Gy QD (3 Gy/dose) regimen. After radiotherapy and chemotherapy, the tumor did not progress; It is up to the researcher to decide whether to proceed with PCI, which should be completed within 56 days after the end of radiotherapy and chemotherapy. The first study medication should start within 1-56 days after the end of radiotherapy and chemotherapy; 5) The adverse reactions caused by radiotherapy and chemotherapy have returned to level 1 or below (excluding hair loss); 6) The ECOG physical fitness score evaluated within 7 days prior to the first study intervention was 0 or 1; 7) The expected life is at least 6 months; 8) Having sufficient PFT is defined as compensatory ventilation function (FEV1>50% predicted normal expiratory volume or FEV1>1.0L), and DLCO>40% predicted normal value. For subjects without DLCO measurement values, if the pulse blood oxygen saturation (O2 saturation) measured in indoor air without oxygen absorption is = 90%, it is considered to have sufficient oxygen transmission; 9) Having sufficient organ function, i.e. meeting the following criteria (no blood transfusion or blood products within 14 days, no correction using G-CSF or other hematopoietic stimulating factors): ?Blood routine: hemoglobin (HGB) = 90g/L; Platelet (PLT) = 100 × 109/L; Neutrophil count (ANC) = 1.5 × 109/L; White blood cell count (WBC) = 3.0 × 109/L; ? Blood biochemistry: Alanine transaminase, AST, Alkaline phosphatase = 1.5 × Upper limit of normal value (ULN); Total serum bilirubin (TBIL) = 1.5 × ULN; Albumin (ALB) = 3 g/dL; Serum creatinine = 1.5 × ULN or creatinine clearance rate (CrCl) = 60mL/minute (using Cockcroft/Fault formula); Coagulation function: International standardized ratio (INR) = 1.5, activated partial thromboplastin time (APTT) = 1.5 × ULN; ? Doppler ultrasound assessment: left ventricular Ejection fraction (LVEF) = 50%; ? Thyroid-stimulating hormone (TSH) = ULN (if abnormal, T3 and T4 levels should be investigated at the same time, if T3 and T4 levels are normal, they can be included in the group); 10) Men and women with Fertility must agree to use medically approved contraceptive measures during the study period and within 6 months after the last drug was used; 11) The subject (where applicable or their legal representative) provides written informed consent for the study.
Exclusion criteria
Exclusion criteria: If a subject meets any of the following criteria, they will not be eligible for admission to this study: 1) Mixed SCLC and NSCLC confirmed by histology or cytology; 2) Radiation and chemotherapy have caused = grade 2 pneumonia; 3) Previously received treatment with anti-tumor drugs targeting PI3K; 4) Have received anti PD-1, anti PD-L1 or anti PD-L2 inhibitors in the past or drug treatment targeting another stimulatory or co inhibitory T-cell receptor (such as CTLA-4, OX-40, CD137); 5) Received any other clinical study drug treatment or participated in another interventional clinical study within 4 weeks prior to the first use of the study drug; 6) Major organ surgery (excluding needle biopsy) or significant trauma occurred within 4 weeks before the first use of the study drug, or Elective surgery was required during the trial period; 7) Plan to receive or have received live attenuated vaccines within 4 weeks prior to the first use of the study drug; 8) Receive Corticosteroid hormone treatment (>10mg/day prednisone or Equivalent dose) or other immunotherapy within 2 weeks before the first use of the study drug; Inhalation or local use of steroid and epinephrine substitutes in the absence of active autoimmune diseases does not rule out the use of glucocorticoid at physiological dose (= 10mg/day prednisone or Equivalent dose); 9) Patients who have previously received tissue/organ transplantation or allogeneic hematopoietic stem cell transplantation; 10) Active, known or suspected autoimmune diseases (such as Vitiligo, type I diabetes, residual hypothyroidism due to autoimmune Thyroiditis that only needs Hormone replacement therapy, psoriasis that does not need systemic treatment, or will not recur without external trigger factors, can be admitted to the group); 11) Artery/vein thrombosis events (including cerebrovascular accident, Deep vein thrombosis and Pulmonary embolism) occurred within 6 months before screening; Receiving thrombolytic therapy, anticoagulant therapy, or antiplatelet therapy; 12) Clinical symptoms or diseases of the heart that cannot be well controlled, such as = grade 2 myocardial ischemia or myocardial infarction, uncontrollable arrhythmias (including male QTc = 450ms (male), QTc = 470ms (female)), = grade 2 congestive heart failure (New York Heart Association (NYHA) classification), unstable angina, myocardial infarction occurring within 6 months, clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention); 13) Patients highly suspected of being Interstitial lung disease, undergoing treatment or test that may lead to pulmonary toxicity, or suspected of having lung disease, undergoing targeted treatment or test, or other moderate and severe diseases that seriously affect lung function; 14) Active or uncontrolled severe infection (= CTC AE level 2 infection), including but not limited to hospitalization due to infection complications, Bloodstream infections or severe pneumonia, fever of unknown origin>38.5 ? before the first administration; 15) Subjects with active pulmonary tuberculosis or a history of active pulmonary tuberculosis infection within the 12 months prior to screening, regardless of treatment; 16) Active hepatitis B virus or hepatitis C virus infected persons (active hepatitis B reference: HBsAg positive, exceeding the upper limit of normal value [1000 copies/ml or 500 IU/ml] and HBV DNA quantitative>ULN; active hepatitis C reference: HCV antibody positive, and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence and severity of adverse events (AE and SAE);The incidence and severity of abnormal laboratory indicators;Recommended Dose for Phase II Trial (RP2D); | — |
Countries
China
Contacts
Public ContactMing Chen
Sun Yat-sen University Cancer Center
Outcome results
None listed