SCLC
Conditions
Interventions
Case series:Sintilimab combined with anlotinib
Sponsors
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with SCLC who were confirmed by histopathology and cannot be surgically removed or be metastically; 2. SCLC patients who have received one standard chemotherapy regimen and failed whom have not previously applied immune checkpoint inhibitors and targeted therapies; 3. ECOG score is 0 or 1, and life expectancy >=12 weeks; 4. All patients need to provide tumor tissue samples before the first-line treatment (at the time of diagnosis) and after the first-line treatment progress for the detection of tumor infiltrating immune cells and TMB. Note: Organizing specimens without any node will not be included in the group; 5. According to the RECIST 1.1 standard, there should be at least one measurable lesion; 6. The organ function level must meet the following requirements (7 days before the first use of second-line antitumor drugs): Absolute bone marrow neutrophil count (ANC) >=1.5x10^9/L, platelet (PLT) >=100x10^9/L, hemoglobin (HB) >=9g/dL (no blood transfusion or component blood received within 14 days before testing); Liver: serum total bilirubin (TBIL) =50mL/min (Cockcroft-Gault formula); urine protein 1+, 24-hour urine protein determination is required. The total amount should be <=1 g. Patients with well-controlled hypertension are allowed to enter the group. The heart function is normal, that is, the electrocardiogram is normal or abnormal and has no clinical significance. The left ventricular ejection fraction (LVEF) of the heart ultrasound shows more than 50%. Coagulation: international standardized ratio (INR), activated partial thromboplastin time (APTT) <=1.5 times the upper limit of normal value (only applicable to patients who have not received anticoagulation therapy; patients receiving anticoagulation therapy should keep anticoagulants in treatment Within the required range); Normal or abnormal FT3, FT4 and TSH have no clinical significance; 7. Women of childbearing age must have negative serum or urine pregnancy test results within 7 days before the first test drug administration; males of reproductive ability or females with a possibility of pregnancy must use highly effective contraceptive methods (such as oral contraception) throughout the test Medicine, intrauterine contraceptive device, sex control or barrier contraception combined with spermicide), and continue contraception for 12 months after the end of treatment; 8. Subjects joined the study voluntarily, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Have received any anti-PD-1, anti-PD-L1, anti-PD-L2 treatment, endostatin (such as Endo), anti-VEGFR treatment (such as sunitinib) in the past (including clinical trial drugs and marketed drugs) , Sorafenib, perzopanib, axitinib, anrotinib, bevacizumab, ramucirumab, nidanib, vandetanib, etc.); 2. Patients currently receiving anti-tumor treatment; 3. Patients who participated in or are participating in clinical trials of other drugs/therapies within 4 weeks before the second-line first medication; 4. Issue/received major surgical operation within 4 weeks before the second-line first medication or have not recovered from the side effects of this operation, live vaccination, immunotherapy, and radiotherapy within 2 weeks. 5. Previous malignant tumors (except non-melanoma skin cancer and the following carcinoma in situ: bladder carcinoma in situ, gastric carcinoma in situ, colon carcinoma in situ, endometrial carcinoma in situ, cervical carcinoma in situ/dysplasia, melanin Tumor in situ carcinoma or carcinoma in situ of the breast) should be excluded unless at least 2 years before enrollment in the study to achieve complete remission and did not proceed during the study period and do not require additional treatment; 6. Patients with brain metastasis or meningeal metastasis and whose symptoms have not been controlled; 7. HIV antibody or Treponema pallidum antibody test result is positive; 8. Patients with active hepatitis B or hepatitis C: If HBsAg or HBcAb is positive, add HBV DNA (the test result is higher than the upper limit of the normal range). If the HCV antibody test result is positive, add HCV RNA (the test result is higher than the upper limit of the normal range); 9. People who are known to be allergic to the PD-1 inhibitor Sindilimumab and the anti-angiogenic drug anrotinib and any of its accessories; 10. Active lung disease (interstitial pneumonia, pneumonia, obstructive pulmonary disease, asthma) or a history of active tuberculosis; 11. Have any uncontrollable clinical problems, including but not limited to: Persistent or active (severe) infection; Hypertension with poor drug control (blood pressure continuously greater than 150/90mmHg); poorly controlled diabetes; Heart disease (Class III/IV congestive heart failure or heart block as defined by the New York Heart Association); Have an active autoimmune disease that requires systemic treatment in the past 2 years, or have a history of autoimmune disease or a history of syndromes requiring systemic use of steroids/immunosuppressants, such as: pituitary inflammation, colitis, hepatitis, Nephritis, etc., replacement therapy (such as thyroxine, insulin, renal or pituitary insufficiency physiological corticosteroid replacement therapy) is not counted as systemic therapy; 12. The following situations occurred within 6 months before the first medication: Deep vein thrombosis or pulmonary embolism; Myocardial infarction; Severe or unstable arrhythmia or angina; Percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting; Cerebrovascular accident, transient ischemic attack, cerebral embolism. 13. The patient has any conditions that affect the subject's swallowing of the drug, and any conditions that affect the treatment process (absorption, distribution, metabolism, or excretion) of the test drug in the body, including any kind of gastrointestinal resection or history of surgery; 14. Has received stem cell transplantation or or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| establish a dynamic model of TILs before and after SCLC first-line treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;ORR; | — |
Countries
China
Contacts
Public ContactXingsheng Hu
National Cancer Center /Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed