Small cell lung cancer
Conditions
Interventions
Observation group:Sofantinib combined with chemotherapy
Sponsors
The Second Affiliated Hospital of Shandong First Medical University
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 and =75 years old, male or female; 3. Patients with extensive small cell lung cancer confirmed histologically or cytologically; 4. The patient must have at least one measurable lesion (RECIST 1.1); 5. The patient has not received treatment for advanced small cell lung cancer. Including radiotherapy, chemotherapy, immunotherapy and Chinese medicine therapy. Patients are allowed to have previously received adjuvant chemotherapy, but there must be at least 6 months between disease recurrence and completion of the final dose of chemotherapy. The end of radiotherapy must be 6 months before the first dose; Or have completed palliative radiation therapy before 7 days before the first dose (except for malignancies that have been radically cured and have not recurred or metastasized for 5 years or more); 6. Good liver/kidney function; 7.PS 0-1 score; 8. Expected survival =12 weeks; 9.Fertile male or female patients volunteered to use effective contraceptive methods, such as double barrier methods, condoms, oral or injectable contraceptives, and Iuds, during the study period and within 6 months of the last study medication. All female patients will be considered fertile unless the female patient has undergone natural menopause, artificial menopause or sterilization (such as hysterectomy, bilateral adnexectomy or radiation of the ovary).
Exclusion criteria
Exclusion criteria: 1. Received anti-angiogenesis small-molecule inhibitors or monoclonal antibodies before enrollment; 2. Received approved or under development systematic anti-tumor therapy within 4 weeks before enrollment, including chemotherapy, radical radiotherapy, biological immunotherapy, targeted therapy, and Chinese medicine therapy (Chinese medicine therapy with clear anti-tumor indications in the instructions can also be enrolled after 1 week washout period); 3. Participated in other domestic unapproved or unmarketed drug clinical trials and accepted the corresponding experimental drug treatment within 4 weeks before enrollment; 4. Received any surgery or invasive treatment or operation within 4 weeks before enrollment (excluding intravenous catheterization, puncture drainage, puncture biopsy, etc.); 5. Any of the following laboratory abnormalities occur: 1) Neutrophil absolute value (ANC) 1.5 or partially activated prothrombin time (APTT) >1.5×ULN; 8. The investigator identified clinically significant electrolyte abnormalities; 9. The patient currently has high blood pressure that is not controlled by drugs and is defined as: systolic blood pressure =140 mmHg and/or diastolic blood pressure =90 mmHg; 10. Unsatisfactory blood glucose control (FBG > 10 mmol/L); 11. The patient has any current disease or condition that affects the absorption of the drug, or the patient cannot take sofantinib orally; 12. The patient currently has gastrointestinal diseases such as active gastric and duodenal ulcers, ulcerative colitis, or active bleeding from unresectosed tumors, or other conditions determined by researchers that may cause gastrointestinal bleeding or perforation; 13. Patients with significant evidence or history of bleeding tendency within 3 months (bleeding >30 mL within 3 months, hematemesis, stool, and blood in the stool), hemoptysis (>5 mL of fresh blood within 4 weeks), or thromboembolic events (including stroke events and/or transient ischemic attacks) within 12 months before enlistment; Patients with grade 14.1 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 subtype); 15. Have had other malignancies within the past 5 years, except basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix; 16. Active or uncontrolled severe infection (=CTCAE v5.0 grade 2 infection); 17. Known human immunodeficiency virus (HIV) infection; A known history of clinically significant liver disease, including viral hepatitis [active HBV infection, i.e., positive HBV DNA (>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]; 18
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, OS;objective response rate, ORR; | — |
Countries
China
Contacts
Public ContactChang Jin
The Second Affiliated Hospital of Shandong First Medical University
Outcome results
None listed