small cell lung cancer
Conditions
Interventions
Queue A: The first-line regimen includes immune checkpoint inhibitor treatment group:Adelbolizumab: intravenous infusion, fixed dose 1200mg, infusion should be completed within 30-60 minutes, on the f
Irinotecan liposomes: intravenous infusion of 100 mg/m2, infusion time of 90 minutes, administered on the first day of each cycle, once every 3 weeks, until disease progression and/or intolerable toxi
Queue B: The first-line regimen does not include immune checkpoint inhibitor treatment group:Adelbolizumab: intravenous infusion, fixed dose 1200mg, infusion should be completed within 30-60 minutes,
Sponsors
The Fourth Hospital of Hebei Medical tniversity Hebei Tuor Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. All participants are required to sign an Informed Consent Form before starting the relevant procedures of the study, ICF) 2. = 18 years old and = 70 years old 3. SCLC confirmed by histology or cytology According to the Veterans Administration Lung Study Group, VALG staging is ES-SCLC 5. Previously received first-line treatment for ES-SCLC, and the first-line regimen must include etoposide and platinum chemotherapy, with objective imaging progress (judged according to RECIST 1.1 criteria). 6. ECOG PS 0-1 points 7. Estimated survival time = 12 weeks 8. = 28 days before the first dose of the investigational drug, CT or MRI scan with at least one target lesion that has not been previously treated with radiotherapy (RECIST v1.1) 9. Female subjects with fertility must undergo a blood pregnancy test within 72 hours before the first administration and the result is negative, and they are not breastfeeding. They must agree to use effective contraceptive measures during the trial period and within 2 months after the last administration of adelbilimumab or 6 months after the last administration of chemotherapy drugs (whichever is longer); For male subjects whose partners are fertile women, surgical sterilization or agreement to use effective contraception measures during the trial period and 2 months after the last dose of adelbizumab or 3 months after the last dose of chemotherapy drug (whichever is longer) should be considered. Sperm donation is not allowed during the study period Before the first dose of the investigational drug, the laboratory test values meet the following conditions: (1) Blood routine: White blood cell count, WBC = 3.5 × 109/L; Absolute neutrophil count, ANC) = 1.5 × 109/L; Platelets, PLT = 100 × 109/L; Hemoglobin content, HGB)=9.0 g/dL (2) Liver function: Aspartate transferase in subjects without liver metastasis, AST) Alanine aminotransferase, ALT)=2.5 x ULN, Alkaline phosphatase, ALP = 2.5 x ULN (upper limit of normal value, upper limit of normal); Liver metastasis subjects had ALT and AST1.5 x ULN and there is no clinical or imaging evidence of pancreatitis, it can be included in the study
Exclusion criteria
Exclusion criteria: 1. Mixed SCLC and NSCLC confirmed by histology or cytology 2. Primary drug-resistant patients are defined as those who have no response to first-line treatment or progress within 90 days after the end of treatment; 3. Clinical symptoms/untreated brain or meningeal metastases. Subjects with treated brain metastases need to meet the following conditions before they can be enrolled: Progress without MRI evidence = 4 weeks after treatment Complete treatment within = 28 days prior to the first dose of the investigational drug Treatment with systemic corticosteroids (>10mg/day prednisone or equivalent dose) is not required for = 14 days before the first dose of the investigational drug 4. Radiotherapy for the chest and whole brain should be completed less than 4 weeks before the first dose of the study drug (palliative radiotherapy for bone lesions should be completed before the first dose of the study drug and admission is allowed) 5. Third space effusion with clinical symptoms, such as pericardial effusion, pleural effusion, and abdominal effusion that cannot be controlled after pumping or other treatments 6. Received solid organ or blood system transplantation 7. Active, known or suspected autoimmune diseases. Allow vitiligo Type I diabetes, residual hypothyroidism due to autoimmune thyroiditis that only requires hormone replacement therapy, or the situation that it is expected not to recur in the absence of external stimuli can be included in the group 8. Use corticosteroids (>10 mg/day prednisone or equivalent dose) or other immunosuppressants within 14 days prior to the first study drug. Allowing inhalation or local use of steroids and adrenal replacement steroids in the absence of active autoimmune diseases 9. Subjects who have received or plan to receive live vaccines within = 4 weeks prior to the first study drug (note: it is allowed to receive inactivated viral vaccines for seasonal influenza within 30 days of the first administration; however, attenuated live vaccines for intranasal administration are not allowed) 10. Interstitial pneumonia, ILD disease, drug-induced pneumonia, radiation pneumonia requiring steroid treatment, or active pneumonia with clinical symptoms 11. Active pulmonary tuberculosis (tuberculosis), TB) or subjects with a history of active pulmonary tuberculosis infection within = 48 weeks prior to screening, regardless of treatment 12. Except for hair loss and fatigue, other toxicity caused by previous anti-tumor treatments needs to be restored to CTCAE 5.0 = 1 level before the first dose of study medication. Other toxicity caused by previous anti-tumor treatments that cannot be resolved within the expected timeframe and have long-term persistent sequelae, such as neurotoxicity caused by platinum based treatments, are allowed to be included in the study 13. Minor surgery (including catheterization) was performed within 48 hours prior to the first administration of the investigational drug 14. Current or recent (within 10 days prior to receiving the first study drug) use of aspirin (>325 mg/day) or other known nonsteroidal anti-inflammatory drugs that can inhibit platelet function 15. Current or recent (within 10 days prior to receiving the first dose of investigational medication) treatment with full dose oral or parenteral anticoagulants or thrombolytic agents. But preventive use of anticoagulants is allowed 16. There is a hereditary tendency for bleeding or coagulation dysfunction. Screening for clinically sign
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS;Progression free survival, PFS;Duration of response, DoR;Disease control rate, DCR;Six month survival rate;The incidence of adverse events and serious adverse events;ECG;Vital signs;Other safety indicators; | — |
Countries
China
Contacts
Public ContactWang Yvddong
The Fourth Hospital of Hebei Medical tniversity Hebei Tuor Hospital
Outcome results
None listed