limited stage small cell lung cancer
Conditions
Interventions
Case series:SHR1210 q2w+Apatinib qd(4Dayson,3Daysoff)
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years, male and female; 2. LS-SCLC according to Veterans Administration Lung Study Group 3. PS 0~2; 4. Received first-line chemotherapy (regimen EP or EC) for 4 weeksthose who received it for more than 4 weeks are not accepted 5. Recieved first dose in 1-42 days after concurrent/sequential radiochemotherapy (including the 42nd day) 6. Total dose of radiotherapy treated with IMRT and 6MV-X ray is pCTV54-60Gy/28-30F 7. At least one target lesion that can be defined according to the solid tumor efficacy evaluation standard (RECIST 1.1); 8. The EP/EC first-line chemotherapy was effective and therapeutic evaluation after CT, RT was CR, PR or SD. 9. No brain metastases proved by imageology after the evaluation of CR/PR/SD; 10. Provide fresh tumor tissue sample or sample achieved 6 months before the first dose of experimental treatment.Sample should be sufficient to cut into 10 sections of 4~6µm thickness after formalin fixing and FFPE for staining and testing.Fine needle biopsy sample, smears collected from pleural effusion, bone tumor sample without soft tissue and decalcified bone or biopsy tissue drilled from the bone that's not sufficient for biomarker examination are not accepted. Submission can be delayed until or 4 weeks after the random; 11. Life expectancy of more than 12 week; 12. Existence of measurable lesion defined by RECIST v1.1,which can only be defined if it's not the only lesion and it makes obvious progress after radiotherapy; 13. Reproductive women must have a serum pregnancy study before the first dose and the results are negative. Reproductive women?subjects?and Male subjects whose companion?are reproductive women must agree to self-signed?informed consent form?and contraception within 24 weeks of the last study drug; 14. Except hearing loss, hair loss and fatigue, all toxicities caused by previous anti-tumor therapy must have recovered to =1 (according to CTCAE v4.03 of NCI) or baseline then can be enrolled; 15. The functions of vital organs and bone marrow meet the following requirements: 1) Routine blood: White blood cell = 3.0 × 109/L ,the absolute neutrophil count (ANC) =1.5 x 10^9/L , the platelet (PLT)= 100 x 10^9/L,hemoglobin (HGB)= 9 g/dL ;(note: this standard must be met without transfusion within 4 weeks prior to sample acquisition); 2) Liver function, serum total bilirubin (TBIL) acuities were 1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)=2.5 x ULN, if liver function is abnormal because of hepatocellular carcinoma (HCC) or cancer that has spread to the liver, AST and ALT= 5 times ULN, serum albumin (propagated) =2.8 g/dL; 3) Renal function, serum creatinine (Cr) =1.5 x ULN, or creatinine clearance = 40 ml/min; 4) International normalized ratio =1.5xULN, and activated partial thromboplastin time=1.5 xULN. 5) Others: lipase = 1.5xULN. If the lipase>1.5xULN,no clinical or imaging confirmed pancreatitis?can be enrolled.amylase =1.5xULN. If amylase >1.5xULN,no clinical or imaging findings?pancreatitis can be enrolled. Alkaline phosphatase (ALP) = 2.5 ULN.bone metastasis subjects, ALP = 5ULN. 16. Provide written, informed consent to participate in the study and follow the study procedures.
Exclusion criteria
Exclusion criteria: 1. Patients with any active autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatitis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephr itis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded. 2. Subjects are using immunosuppressive agents, or systemic, or absorptive, local hormone therapy to achieve immunosuppression.It is still in use within 2 weeks of the entry. 3. Had severe anaphylaxis to other monoclonal antibody before. 4. Imaging(CT or MRI) showed major vessel invaded by tumor and unclarity between vessels. 5. Imaging (CT or MRI) showed significant pulmonary vacuity or necrotic tumors,Borderline adenocarcinoma accompanied by a cavity can be considered after discussion with investigator. 6. Uncontrolled arterial hypertension greater than or equal to 140/90mmHg despite standard medical management. 7. Uncontrolled cardiac symptoms and diseases, such as (1) heart failure greater than NYHA II;(2)unstable pectoris; (3) myocardial infraction in a year; (4) supraventricular or ventricular arrhythmia in need of treatment or intervention. 8. Coagulant function abnormality(PT> 16s, APTT>43s, TT>21s, Fbg<2g/L)with bleeding tendency or is treated with thrombolysis and anticoagulation. 9. Routine urine p + + hint of urine protein, or confirm 24 hours urinary protein quantity acuity 1.0 g. 10. Patient should be after the last dose of chemotherapy, radiotherapy and surgery, less than 5 drug half-lives after taking targeting drug and less than 4 weeks before experimental treatment. Adversed effect (except hair loss) caused by previous treatment shout recover to =CTCAE I. 11. Patient with ascites or pleural effusion should be treated with puncture and drainage. 12. 2 months prior to random obvious coughing up blood, or daily haemoptysis quantity up to half a teaspoon (2.5 ml) or above. 13. Random before 3 months there have been significant clinical significance of bleeding symptoms or have definite bleeding tendency, such as gastrointestinal bleeding, bleeding ulcers, baseline period + + and above of defecate occult blood, or those with vasculitis, etc.. 14. Random before 6 months dynamic/enous thromboembolism events, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.. 15. The known inherited or acquired bleeding and thrombosis tendency (such as hemophilia, blood coagulation dysfunction, thrombocytopenia, the splenic function, etc.). 16. Patient with active infection or unexplained fever=38.5?. 17. Patient with pneumonia=2 grade cause by radiotherapy recovered to =1 grade in 14 days without systematic hormone therapy can be enrolled. 18. Patient with interstitial pneumonia should be screened out as researcher consider that previous pulmonary disease will interrupt the judgement of drug-related pulmonary toxicity. 19. Patient with pulmonary tuberculosis a year before the first dose of experimental drug or with active pulmonary tuberculosis over a year ago but no evidence of active pulmonary tuberculosis now determined by researcher can be enrolled. 20. Patient with congenital or acquired immunologic deficiency (such as HIV) or active hepatitis. 21. Patient to
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS;OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| DoR;QoL;TTDM;TMB; | — |
Countries
China
Contacts
Public ContactRui Meng
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed