Small cell lung cancer
Conditions
Interventions
One:Induction period: Subjects receIVed Adebrelimab (1200mg, iv, D1)+ etoposide (100 mg/m2, D1-3)+Capecitabine (AUC = 4-5, D1)/cisplatin (75 mg/m2, D1) (depending on the investigator)+apatinib (250mg,
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The age is 18-75 years old; 2. Pathological or cytological diagnosis of extensive small cell lung cancer; 3. Patients who have not received systemic treatment for extensive small cell lung cancer in the past (patients with limited SCLC who have received chemotherapy/radiotherapy in the past and have not received further treatment more than 6 months after the last chemotherapy/radiotherapy are eligible to participate in this study); 4. Life expectancy is at least 3 months; 5.ECOG score: 0-1; 6. There are lesions that can be evaluated by imaging. According to the criteria for evaluating the curative effect of solid tumors (RECIST 1.1), there is at least one measurable lesion, and its longest diameter is measured by spiral CT = 10 mm 7. For patients with brain metastasis, patients with asymptomatic brain metastasis or brain metastasis with stable symptoms can be included in the group; 8. The main organs function normally, that is, they meet the following standards: (1) The standard of routine blood examination should meet (blood transfusion and blood products have not been given within 14 days, and G-CSF and other hematopoietic stimulating factors have not been used for correction): A. hemoglobin (HB) = 90 g/l; B. Neutrophil count (ANC)= 1.5×109 /L; L; C. platelet count (PLT)= 100×109 /L; l; D white blood cell count (WBC) = 3.0× 109/l; (2) Biochemical examination shall meet the following standards: A. serum total bilirubin (TBIL) 50ml/min(Cockcroft-Gault formula); D activated partial thromboplastin time (APTT), international normalized ratio (INR) and prothrombin time (pt) = 1.5× uln; E. others: lipase =1.5 x ULN. If lipase > 1.5 x ULN has no clinical or imaging confirmation of pancreatitis, it can be included in the group; 9. Women of childbearing age must have taken reliable contraceptive measures or conducted pregnancy tests (serum or urine) within 7 days before entering the group, and the results are negative. Pregnant men and women must agree to take adequate contraceptive measures during the whole study period and within 6 months after the end of treatment; 10. The subjects volunteered to join the study and signed the informed consent form, which was good in compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. The subject has extensive meningeal metastasis or active brain metastasis with obvious symptoms; 2. Spinal cord compression has not been clearly treated by surgery and/or radiotherapy, or spinal cord compression diagnosed and treated before, and there is no evidence that the disease has been clinically stable for one week before joining the group; 3. Uncontrolled or symptomatic hypercalcemia; 4. Previous treatment with any T cell co-stimulation or immune checkpoint inhibitor, including but not limited to cytotoxic T lymphocyte associated antigen -4(CTLA-4) inhibitor, PD-1 inhibitor, PD-L1/2 inhibitor, CD137 agonist or other drugs targeting T cells; 5. Immunosuppressive drugs (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide and anti-tumor necrosis factor drugs) have been used within 14 days before the first use of adebelizumab, excluding nasal and inhaled corticosteroids or systemic steroid hormones with physiological dose (i.e., no more than 10 mg/ day of prednisolone or other corticosteroids with the same physiological dose); 6. Have active tuberculosis (TB) or have a history of active TB infection within 48 weeks before screening, regardless of whether they have received treatment; 7. Have been vaccinated or planned to be vaccinated with preventive vaccine or attenuated live vaccine within 4 weeks before the first administration; 8. Have a history of allogeneic bone marrow transplantation or solid organ transplantation; 9. Suffering from serious cardiovascular diseases: myocardial ischemia or myocardial infarction above grade II, and poorly controlled arrhythmia (including QTc interval = 450 ms for men and = 470 ms); for women); ? ~ ? cardiac insufficiency (according to NYHA classification of new york Heart Association, see Annex 3), or left ventricular ejection fraction (LVEF) less than 50% as indicated by color Doppler echocardiography; 10 with uncontrolled pleural effusion, pericardial effusion, or ascites that needs repeated drainage; 11. Any active autoimmune disease or history of autoimmune disease (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism and hypothyroidism) shall not be included; The following exceptions are made: patients with a history of autoimmune hypothyroidism but receiving thyroid hormone replacement therapy can be included in the study. Patients with type 1 diabetes whose blood sugar is controlled by insulin administration can participate in this study. 12. Abnormal coagulation function (INR>1.5 or prothrombin time (PT) > ULN+4 seconds or APTT >1.5 ULN), with bleeding tendency or undergoing thrombolytic or anticoagulant therapy; Note: On the premise that the international normalized ratio of prothrombin time (INR) is less than 1.5, it is allowed to use low-dose heparin (the daily dosage for adults is 0.6 ~ 12,000 U), low-dose aspirin (the daily dosage is less than 100 mg) or low-dose warfarin (1 mg orally once a day) for preventive purposes; 13. Have received major surgery or severe traumatic injury, fracture or ulcer within 4 weeks before joining the group, or plan to undergo major surgery during the study period; 14. Serious infection such as severe sepsis or septic shock shall not occur within 14 days before joining the group, including but not limited to hospitalization due to complications such as infection, bacteremia or severe pneumonia; 15. Clinically
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6 months PFS rate;Objective response rate;Disease Control Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactYang Meng
China-Japan Friendship Hospital
Outcome results
None listed