small cell lung cancer
Conditions
Interventions
Patients with extensive small cell lung cancer:After four cycles of adebelizumab+carboplatin+etoposide, adebelizumab was maintained until PD, adebelizumab+irinotecan+apatinib, and adebelizumab+apatini
Patients with extensive small cell lung cancer:After four cycles of adebelizumab+carboplatin+irinotecan, adebelizumab was maintained until PD, after four cycles of adebelizumab+etoposide+apatinib, ade
Sponsors
Shandong University Affiliated Provincial Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female, aged 18-75; 2. Histologically or cytologically confirmed ES-SCLC (according to the VALG staging system of the Veterans Administration); 3. ECOG performance status score 0-1; 4. There was no first-line systemic therapy or immune checkpoint inhibitor therapy for ES-SCLC. 5. Previous surgery and adjuvant therapy, such as radiotherapy and chemotherapy; There has been no treatment period for at least 6 months since the last chemotherapy, radiotherapy or radiotherapy and chemotherapy, and the diagnosis is extensive SCLC;; 6. Subjects with a history of asymptomatic central nervous system metastasis after treatment are eligible, provided that they meet all the following criteria: only supratentorial metastasis and cerebellar metastasis (that is, no metastasis to midbrain, pons, medulla or spinal cord); Central nervous system diseases do not need continuous corticosteroid treatment; There was no evidence of imaging progress from the end of CNS-guided treatment to random grouping. Subjects who find new asymptomatic central nervous system metastasis in screening imaging must receive radiotherapy and/or surgery for central nervous system metastasis. After treatment, if all other criteria are met, these subjects do not need to undergo additional brain scans before being randomly assigned; 7. Life expectancy =12 weeks; 8. Measurable lesions defined according to RECIST v1.1: previously irradiated lesions can only be considered as measurable diseases when there is a clear record of disease progress in this part, because radiation and previously irradiated lesions are not the only parts of the disease; 9. Women with reproductive potential must have a negative serum pregnancy test within 7 days before the first dose; 10. Before the first dose of study and treatment, the laboratory test values must meet the following conditions: (1) Hematology (no blood transfusion or correction with hematopoietic factors within 14 days before screening): White blood cell count (WBC)=3.0×109 /L; Absolute neutrophil count (ANC)=1.5×109 /L; Platelet (PLT)=100×10 9 /L; Hemoglobin (HGB) = 9.0g/dl; (2) Liver function: aspartate aminotransferase (AST)=2.5× in patients without liver metastasis. ULN, alanine aminotransferase (ALT)=2.5×ULN; ALT, AST=5×ULN in patients with liver metastasis; Serum total bilirubin (TBIL)=1.5×ULN (except Gilbert syndrome, total bilirubin = 3.0 mg/dl); (3) Renal function: serum creatinine =1.5×ULN or creatinine clearance rate (CrCl)=50. mL/min ; (4) Coagulation function: INR)=1.5×ULN or APTT)=1.5×ULN (only applicable to subjects who have not received anticoagulant therapy at present; Subjects currently receiving anticoagulant therapy should maintain a stable dose); (5) Others: lipase =1.5×ULN (if there is no clinical or imaging evidence of pancreatitis, subjects with lipase > 1.5×ULN can be included in the study); Amylase =1.5×ULN (if there is no clinical or imaging evidence of pancreatitis, subjects with amylase > 1.5×ULN can be included in the study); Alkaline phosphatase (ALP)=2.5×ULN, or ALP=5×ULN for liver or bone metastasis; 11. Subjects must participate voluntarily, sign informed consent form, have good compliance and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Active or untreated central nervous system metastasis, determined by computed tomography (CT) or MRI in screening and previous imaging evaluation; 2. Spinal cord compression has not been solved by surgery and/or radiotherapy, or previously diagnosed and treated spinal cord compression, and there is no evidence that the disease is clinically stable for more than 1 week before random grouping; 3. Meningeal diseases; 4. Clinically symptomatic effusion in the third space that requires repeated drainage, such as pericardial effusion, pleural effusion, and ascites that cannot be controlled by drainage or other methods; 5. Uncontrolled or symptomatic hypercalcemia; 6. The first dose is used to study malignant tumors other than SCLC within 5 years before treatment, except for the already treated cervical cancer in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection and ductal carcinoma in situ after radical resection (hormone therapy is allowed for non-metastatic prostate cancer or breast cancer); 7. Active, known or suspected autoimmune diseases (see Appendix 4), including but not limited to: myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis and inflammatory bowel disease. The following conditions are allowed: (1) patients with controlled type I diabetes treated with stable dose of insulin meet the conditions of this study; Subjects with a history of autoimmune thyroiditis-related hypothyroidism who only need hormone replacement therapy or whose condition is stable without external stimulation may meet the conditions of this study; Subjects with eczema, psoriasis, chronic lichen simplex or vitiligo (except those with psoriatic arthritis) can be included, provided that they meet the following conditions: the rash must cover less than 10% of the body surface area, the disease is well controlled at baseline, and only inefficient local steroid treatment is needed, and the basic diseases have not been aggravated in the past 12 months (psoralen and ultraviolet A [PUVA], methotrexate, vitamin A-like, biological agents). 8. Previous T cell co-stimulation or immune checkpoint therapy, including but not limited to cytotoxic T lymphocyte associated antigen 4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors or other drugs targeting T cells; 9. Have used corticosteroids (> 10 mg/ day prednisone or equivalent) or other immunosuppressants within 14 days before the first dose of study treatment. In the absence of active autoimmune diseases, inhaled or topical steroids and adrenal glands are allowed to replace steroids; 10. HBsAg positive and the number of copies of HBV DNA is greater than the normal upper limit of the laboratory in the research site (1000 copies /mL or 500 IU/mL), or HCV positive (HCV RNA or HCV Ab detection indicates acute and chronic infection); Known HIV-positive or acquired immunodeficiency syndrome (AIDS) history; 11. Have a history of idiopathic pulmonary fibrosis, tissue pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, radiation pneumonia requiring steroid treatment or active pneumonia with clinical symptoms; Or other moderate or severe lung diseases that seriously affect lung function (a history of radiation pneumonia (fibrosis) in the field of radioactivity is allowed); 12. Have active pulmonary tuberculosis (TB) or a history of active pulmonary tuberculosis infection within 48 weeks before screening, regardless of w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Disease control rate;Time of duration;Safety;Serious adverse event;Time to Progression; | — |
Countries
China
Contacts
Public ContactKainan Li
Shandong University Affiliated Provincial Third Hospital
Outcome results
None listed