Extensive-stage small cell lung cancer
Conditions
Interventions
experimental:adebrelimab+chemotherapy+liver radiotherapy
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1)The subjects voluntarily joined the study and signed the informed consent; (2) Aged 18-75 years old, male or female; (3) Patients with histopathologically confirmed extensive-stage small cell lung cancer; (4) Comfirmed with liver metastases; (5) According to RECIST 1.1, there was at least one single-diameter measurable lesion; (6) ECOG PS: 0-1; (7) Major organ function meets the following requirements (no blood components and cell growth factors are allowed 2 weeks before the start of study therapy) : a) Blood routine examination must meet: absolute neutrophil count (ANC) =1.5×109/L; Hemoglobin (HB) =9g/dL; Platelet (PLT) =100×109/L; Serum albumin (ALB) =2.8g/dL. b) Liver function: total bilirubin (TBIL) =1.5×ULN (total bilirubin =3.0 mg/dL for patients diagnosed with Gilbert syndrome); ALT, AST=5×UILN; c) Renal function: serum creatinine sCr=1.5×ULN or endogenous creatinine clearance =50ml/min (Cockcroft-Gault formula); d) Coagulation function: international normalized ratio (INR) =1.5 x ULN, activated partial thromboplastin time (APTT) =1.5 x ULN (only for patients who are not currently receiving anticoagulant therapy, patients who are currently receiving anticoagulant therapy should receive a steady dose of anticoagulant therapy); e) Others: Lipase =1.5 x ULN (Lipase >1.5 x ULN without clinical or imaging evidence of pancreatitis can be included in the group); Amylase =1.5 x ULN (if amylase >1.5 x ULN has no clinical or imaging evidence of pancreatitis, it can be included in the group); alkaline phosphatase (ALP) =5 x ULN; (8) Lung function test 1 second forced expiratory volume (FEV1) > 50% predicted normal expiratory volume and lung carbon monoxide dispersion (DLCO) or carbon monoxide dispersion factor (TLCO) > 40% predicted normal value; If subjects do not meet these criteria, they may be treated with inhaled steroids and bronchodilators if accompanied by clinical indications, and reevaluated for eligibility after 1-2 weeks; (9) Fertile female subjects should undergo a urine or serum pregnancy test that proves negative within 72 hours prior to receiving the initial study drug administration and be willing to use an effective method of contraception during the trial period up to 3 months after the last administration of adebrelimab; For male subjects whose partners are women of reproductive age, effective contraception should be used during the trial period and within 3 months after the last administration of adribalizumab; (10) The subjects had good compliance and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: (1) Histologically confirmed mixed SCLC or NSCLC; (2)Previously received systemic anti-tumor therapy for SCLC or anti-tumor therapy with immune checkpoint inhibitors; If previously received anti-tumor treatment with proprietary Chinese medicine, the interval between the end of Chinese medicine treatment and the first study drug could not less than 2 weeks; (3) Known allergy to the investigational drug or any excipients; Or have had a severe allergic reaction to other monoclonal antibodies; (4) Have any active autoimmune disease or history of autoimmune disease, such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after normal hormone replacement therapy); (5) Other malignant tumors within 5 years before the first dose, except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery; (6) HBsAg positive and HBV DNA test values exceeding the upper limit of normal (104 copies /mL or 2000IU/mL), or HCV positive (HCV RNA or HCV Ab test indicates acute or chronic infection), or a known history of HIV positive or known AIDS; (7) Subjects who are on systemic therapy with corticosteroids (> 10mg/ day at the therapeutic dose of prednisone) or other immunosuppressants within 14 days prior to their first dose of study drug; In the absence of active autoimmune disease, inhaled or topical steroid and adrenocortical hormone replacement at doses > 10mg/ day with prednisone efficacy doses are permitted; (8) Subjects who had a serious infection within 4 weeks prior to the first dose, including but not limited to infection complications requiring hospitalization, bacteremia, severe pneumonia, etc.; Exclude subjects with any active infection; (9) Patients with grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval =450 ms for men and =470 ms for women). According to NYHA standard ? ~ ? cardiac insufficiency or echocardiogram: subjects with LVEF (left ventricular ejection fraction) < 50% ; (10) Have undergone major surgery within 28 days prior to the first dose of study drug, or plan to undergo major surgery during the study period; (11) Use of live attenuated influenza vaccine within 28 days prior to the first administration, or anticipated use of such live attenuated influenza vaccine during the study period (patients are not allowed to receive live attenuated influenza vaccine 4 weeks prior to the first administration, during treatment, and 5 months after the last administration); (12) Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation; (13) Received any other investigational drug treatment or participated in another interventional clinical study within 4 weeks prior to signing the ICF; (14) Received systemic immunosuppressive drug therapy within 1 week before the first dose; (15) Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders; (16) In the investigator's judgment, the subject has other factors that may lead to the forced termination of the study, such as other serious medical conditions (including mental illness) requiring combined treatment, serious abnormalities in laboratory test values, or family or social factors that make long-term follow-up difficult; (1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival;12-month/24-month OS rate;6-month/12-month PFS rate;objective response rate;disease control rate;duration of response; | — |
Countries
China
Contacts
Public ContactLi Yan
West China Hospital, Sichuan University
Outcome results
None listed