small cell lung cancer (SCLC)
Conditions
Interventions
Experimental group:Immune checkpoint inhibitors, antivascular drugs
Sponsors
Chinese Academy of Medical Sciences Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years; 2. Patients with extensive-stage SCLC confirmed by pathology or cytology; 3. Received 2 systemic chemotherapy in the past, including platinum-based chemotherapy regimen, recurrence or failure after treatment; 4. ECOG score: 0-2 points; 5. Expected survival time >= 3 months; 6. The investigator confirmed that there is at least one measurable lesion according to the RECIST1.1 standard, and its longest diameter measured by spiral CT is >= 10 mm; 7. The function of major organs is normal, and the test results at the time of screening must meet the following requirements: (1) The blood routine examination standards must be met (no blood transfusion and blood products within 14 days, no correction with G-CSF and other hematopoietic stimulating factors): hemoglobin (Hb) >= 90 g/L, neutrophil count (ANC) >= 1.5 x 10^9/L, platelet count (PLT) >= 100 x 10^9/L; (2) Biochemical tests should meet the following criteria: total bilirubin (TBIL) 45ml/min (Cockcroft-Gault formula), urine routine test results show urine protein (UPRO) < 2+ or 24-hour urine protein quantitative < 1g; 8. Men and women of gestational age must agree to take adequate contraceptive measures throughout the study period and within 6 months after the end of treatment; 9. Sign the written informed consent, and it is expected that the compliance with the research protocol will be good.
Exclusion criteria
Exclusion criteria: 1. There is a central tumor that invades local large blood vessels; there is obvious lung cavity or necrotic tumor; 2. Active central nervous system (CNS) tumor metastasis; 3. Known to be allergic to the study drug or any of its excipients, or to have severe allergic reactions to other monoclonal antibodies; 4. Receive a live attenuated vaccine within 4 weeks before the first dose or plan to receive it during the study; 5. The use of immunosuppressive drugs within 14 days before the first use of SHR-1316; 6. There is any active autoimmune disease or a history of autoimmune disease; 7. Suffering from myocardial ischemia or myocardial infarction of grade II or above, or poorly controlled arrhythmia; 8. Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders; 9. Received major surgical operation within 4 weeks before the first administration; 10. Other circumstances determined by the investigator to be inappropriate to participate in this research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Overall survival;Disease control rate;Duration of response; | — |
Countries
China
Contacts
Public ContactLiu Yutao
Chinese Academy of Medical Sciences Cancer Hospital
Outcome results
None listed