Small cell lung cancer
Conditions
Interventions
Sponsors
Liaoning Cancer Hospital & institute
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patients voluntarily participated in the study, signed the informed consent, and were willing and able to comply with the treatment plan, test and follow-up, etc.; 2.Histologically or cytologically confirmed small cell lung cancer(SCLC) with punctable lesions; SCLC patients who received at least 2 lines standard chemotherapy that failed or were not tolerated;Have measurable lesions (according to RECIST 1.1); 3. Ages: 18-75 Years(concluding 18 and 75 Years); 4. ECOG PS 0-2; 5. Has life expectancy of greater than 3 months; 6. The main organ functions meet the following criteria: 1) (without blood transfusion or any blood component or cell growth factor within 14 days prior to enrollment): Absolute Neutrophil Count (ANC)=1.5×10^9/L Platelet Count of =80×10^9/L Hemoglobin=90g/L 2) Total Bilirubin (TBIL)=1.5 x ULN,If accompanied by liver metastasis, Total Bilirubin (TBIL)=2.5 x ULN ; ALT and AST=2.5 x ULN, If accompanied by liver metastasis, ALT and AST=5 x ULN Creatinine(Cr)=1.5×ULN (or creatinine clearance (CCr)= 50mL/min); (Cockcroft-Gault); 3) International standardized ratio (INR) or prothrombin time (PT) =1.5×ULN, partial prothrombin time (PTT or aPTT) =1.5×ULN (based on the normal value of clinical trial research center); 4) Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) = normal lower limit (50%); 7. Women of childbearing age should agree to use contraception (such as an intrauterine device, birth control pill or condom) during the study period and within 6 months after study treatment discontinuation; Negative serum or urine pregnancy test within 7 days prior to study enrollment and must be non-lactating; Men should agree to use contraception during the study and within 6 months after study treatment discontinuation.
Exclusion criteria
Exclusion criteria: 1. Patients who have previously received surufatinib 2. Previous treatment with VEGFR-TKI small molecule drugs, such as sunitinib, sorafenib; 3. Has had or is currently co-existing with other malignancies within 5 years, cured cervix carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basal membrane)]; 4. Prior chemotherapy, radiation, or other anticancer therapy within 4 weeks prior to the first dose of drug therapy (prior local radiation therapy was accepted if the following conditions were met: the end of radiation therapy was more than 4 weeks prior to the beginning of study therapy (brain radiation therapy was more than 2 weeks prior); The target lesions selected in this study are not in the radiotherapy region; or the target lesion is in the radiotherapy area, but has been confirmed to progress); 5. Factors affecting oral medication (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction); 6. Patients with cancerous meningitis; 7. Subjects with known CNS metastasis and/or spinal cord compression; Unless asymptomatic or treated and stable, no radiographic evidence of new or enlarged BMS has been found for at least 2 weeks after BMS treatment, and steroid or anticonvulsant therapy has been discontinued for at least 14 days prior to the start of study treatment; 8. Uncontrolled pleural effusion, pericardial effusion and peritoneal effusion requiring repeated drainage; 9. Unalleviated toxicity above CTCAE grade 1 due to any prior treatment, excluding hair loss; 10. Patients with any severe and/or uncontrolled disease, including: (1) Patients with poor blood pressure control (systolic blood pressure =140 mmHg, diastolic blood pressure =90 mmHg); (2) patients with grade I or higher myocardial ischemia or infarction, arrhythmias (including QTc =480ms) and grade 2 congestive heart failure (NYHA classification); (3) Active or uncontrolled severe infection (=CTC AE grade 2 infection); (4)Bleeding tendency or coagulation disorder or anticoagulation treatment; (5) Cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral therapy; (6) Renal failure requiring hemodialysis or peritoneal dialysis; (7) Have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; 8) Poor control of diabetes (FBG > 10mmol/L); 9) Patients with urinary protein =2+ as indicated by routine urine examination and 24-hour urine protein quantity > 1.0g; 10) Patients who have seizures and require treatment. 11. Major surgical treatment, open biopsy or obvious traumatic injury within 28 days prior to grouping; 12. Patients whose imaging shows that the tumor has invaded the vicinity of important blood vessels or whose tumor is highly likely to invade important blood vessels and cause fatal massive bleeding as determined by the investigator during the follow-up study; 13. Patients with any evidence or history of bleeding, regardless of severity; Patients with any bleeding or bleeding event =CTCAE grade 3 within 4 weeks prior to grouping had unhealed wounds, ulcers or fractures; 14.Patients who have experienced arteriovenous or venous thrombosis events within 6 months, such as cerebrovascular accident (including temporary ischemic attack), deep vein
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Disease control rate;safety and tolerance; | — |
Countries
China
Contacts
Public ContactLi XiaoLing
Liaoning Cancer Hospital & institute
Outcome results
None listed