Small cell lung cancer
Conditions
Interventions
Experimental group:Surufatinib in combination with EP/EC chemotherapy
Sponsors
Jingzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Have fully understood the study and voluntarily signed the informed consent; 2. Age =18 years old, male or female; 3. Patients with extensive small cell lung cancer confirmed by histology or cytology (no local symptoms); 4. Patients should have at least one measurable lesion (RECIST 1.1); 5. No previous systematic therapy, including chemotherapy, small molecule targeted therapy, immunosuppressive therapy, etc.; If adjuvant therapy was given after surgery, patients were eligible for inclusion >6 months after completion of adjuvant therapy (chemotherapy and/or radiotherapy). 6. Good liver/kidney function; 7.PS 0-2 points; 8. Expected survival =12 weeks; 9.Fertile male or female patients volunteered to use effective contraceptive methods, such as dual screen contraception, condoms, oral or injectable contraceptives, and intrauterine devices, during the study period and within 6 months of the last study medication. All female patients will be considered fertile unless the female has undergone natural menopause, artificial menopause or sterilization (e.g. hysterectomy, bilateral adnexectomy or irradiation of radioactive ovaries).
Exclusion criteria
Exclusion criteria: 1. Small cell lung cancer with other pathological types of tumors 2. Systemic chemotherapy was received before enrollment, and anti-angiogenesis small-molecule inhibitors or PD-1/PD-L1 inhibitors failed; 3. Received any surgery or invasive treatment or operation (excluding venous catheterization, puncture drainage, puncture biopsy, etc.) within 4 weeks before enrollment; 4. Any of the following laboratory test anomalies occur: 1) Neutrophil absolute value (ANC) 1.5 or partial activated prothrombin time (APTT) >1.5×ULN; 7. Electrolyte abnormalities of clinical significance were determined by the investigator; 8. The patient currently has medically uncontrolled hypertension, defined as: systolic blood pressure =140 mmHg and/or diastolic blood pressure =90 mmHg; 9. The patient has any current disease or condition that affects drug absorption, or the patient is unable to take sofantinib orally; 10. The patient currently has active gastric and duodenal ulcers, ulcerative colitis and other digestive diseases, or active bleeding from unexcised tumors, or other conditions determined by researchers that may cause gastrointestinal bleeding and perforation; 11. Patients with significant evidence or history of bleeding tendency within 3 months (bleeding >30 mL within 3 months, hematemesis, black feces, and blood in the stool), hemoptysis (fresh blood >5 mL within 4 weeks), or thromboembolic events (including stroke events and/or transient ischemic attack) within 12 months prior to inclusion; Patients with grade 12.1 or above myocardial ischemia, myocardial infarction, or severe arrhythmia (including QTc=450 ms(male), QTc= 470ms(female), and grade 1 or above congestive heart failure (NYHA classification); 13. Have had other malignant neoplasms within the past 5 years, other than basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix; 14. Active or uncontrolled severe infection (=CTCAE v5.0 grade 2 infection); 15. Known human immunodeficiency virus (HIV) infection; A known history of clinically significant liver disease, including viral hepatitis [active HBV infection, i.e., HBV DNA positive (>1×104 copies /mL or >2000 IU/ml) must be excluded for a known hepatitis B virus (HBV) carrier; Known hepatitis C virus infection (HCV) and HCV RNA positive (>1×103 copies /mL), or other hepatitis, cirrhosis]; 16. The patient currently has central nervous system (CNS) metastases or active BMS or meningeal metastases. Treated subjects with BMS were required to meet the following criteria to be enrolled: asymptomatic; No radiographic evidence of progress =4 weeks after treatment completion; Completion of treatment =14 days before the first dose of study drug; Systemic corticosteroid therapy (> 10mg/ day prednisone or equivalent) was not required =14 days pr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Overall Response Rate;disease control rate;safety; | — |
Countries
China
Contacts
Public ContactXi Tang
Jingzhou Central Hospital
Outcome results
None listed