SCLC
Conditions
Interventions
group 1:surufatinib+topotecan
Sponsors
Fuyang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old, gender unlimited, willing to participate in the study and sign informed consent; 2. Histopathological diagnosis of extensive small-cell lung cancer; 3. Previous treatment with at least etoposide combined with platinum regimen failed, but did not exceed 2-line systemic treatment. [definition: failure in the process of the treatment side effects, not tolerance, disease progression or relapse after treatment, not tolerance: the definition of hematology toxicity grade IV (a decrease in platelets level III and above), the hematology toxicity grade III or above reached] note: each line drugs refers to either single drug or drug combination, at least one cycle. 4.ECOG score: 0-1; 5. Have at least one measurable lesion on CT, according to RECIST 1.1; 6. Expect to survive for at least 3 months. 7. Major organ functions within 7 days before treatment meet the following criteria: (1) Hemoglobin (HB) >= 90 g/L; (2) Absolute value of neutrophil (ANC) >= 1.5×10^9/L; (3) Platelet (PLT) >= 100×10^9/L 8. Biochemical tests should meet the following standards: (1) Total bilirubin (TBIL) 60ml/min; 9. BMS must be asymptomatic or treated and stable with discontinuation of steroids and anticonvulsants at least 1 month prior to study treatment; 10. Patients of reproductive age (including female and female partners of male patients) must use effective birth control measures; 11. The subjects voluntarily participated in the study and signed the informed consent (ICF); 12. It is expected that patients with good compliance can follow up the efficacy and adverse reactions according to the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Small cell lung cancer complicated with other pathological types of tumors; 2. Prior use of surufatinib capsules; 3. Prior treatment with antiangiogenic drugs, including bevacizumab, sunitinib, sorafenib, anlotinib, apatinib, etc.; 4. Previous use of topoisomerase ? inhibitors, such as irinotecan and topotecan; 5. Patients with severe allergic history or allergic constitution; 6. Pregnant or lactating women; 7. Patients who have participated in other clinical trials in the past but have not terminated the trials; 8. Respiratory syndrome ( CTC-AE grade 2 dyspnea) with pleural effusion or ascites; 9. Patients who received chemotherapy, radiation, or other experimental anticancer therapy (other than bisphosphonates) within 4 weeks prior to initial dosing in this study. Patients who had previously received local radiation therapy were eligible if they met the following criteria: 4 weeks prior to the end of radiation therapy (2 weeks prior to the beginning of brain radiation therapy); In addition, the target lesions selected in this study are not in the radiotherapy region, or if the target lesions are in the radiotherapy region but have been confirmed to progress; 10. Patients with any severe and/or uncontrolled disease, including: (1) Patients with poor blood pressure control (systolic blood pressure>= 150 mmHg, diastolic blood pressure >= 100 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) Cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral therapy; (5) Renal failure requiring hemodialysis or peritoneal dialysis; (6) Have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; (7) Urine protein >=++ indicated by two consecutive urine routine tests, and the 24-hour urine protein level was confirmed > 1.0g; (8) Suffering from mental illness, including epilepsy, dementia, severe depression, mania, etc. 11. Major surgical treatment, open biopsy or obvious traumatic injury within 28 days before grouping (combined with clinical evaluation); 12. Patients whose imaging shows that the tumor has invaded the periphery of important blood vessels or who are judged by the investigator to be highly likely to invade important blood vessels and cause fatal massive bleeding 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 enrollment 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 thrombosis and pulmonary embolism; 15. Those who have a history of psychotropic drug abuse and cannot get rid of it or have mental disorders; 16. Subjects with difficulty swallowing or known drug absorption disorders. 17.There were other conditions that the researchers considered inappropriate for inclusion.=
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;overall survival;disease control rate;security; | — |
Contacts
Public ContactHesheng Qian
Fuyang Cancer Hospital
Outcome results
None listed