ES-SCLC
Conditions
Interventions
Experimental group:Surufatinib combined with Serplulimab and EP/EC
Sponsors
First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Fully understand and voluntarily sign the informed consent for this study; 2. Age =18 years old and =75 years old, male or female; 3. Extensive-stage small-cell lung cancer confirmed histologically or cytologically; At least one measurable lesion (RECIST 1.1) was required. 5. No previous systemic therapy, including chemotherapy, small molecule targeted therapy, immunosuppressive therapy, etc. If adjuvant therapy was given after surgery, patients were eligible for enrollment if they were more than 6 months after completion of adjuvant therapy (chemotherapy and/or radiotherapy). 6. Good liver/kidney function; 7. PS 0-2; 8. Expected survival =12 weeks; 9. Male or female patients of childbearing potential volunteered to use an effective contraceptive method, such as dual barrier methods, condoms, oral or injectable contraceptives, intrauterine devices, etc. during the study and for 6 months after the last study medication. "All female patients will be considered fertile unless they have undergone natural menopause, artificial menopause, or sterilization (e.g., hysterectomy, bilateral adnophorectomy, or radioactive ovarian irradiation).
Exclusion criteria
Exclusion criteria: 1. Medical contraindications to etoposide-platinum (carboplatin or cisplatin) -based chemotherapy; 2. Received approved or investigational systemic anti-tumor therapy in the past, including chemotherapy, radical radiotherapy, biological immunotherapy, targeted therapy, and traditional Chinese medicine therapy (traditional Chinese medicine therapy with clear indications for anti-tumor can also be enrolled after a one-week washout period); 3. Received any surgery or invasive treatment or operation within 4 weeks before enrollment (excluding venous catheterization, puncture drainage, puncture biopsy, etc.); 4. Presence of any of the following laboratory abnormalities: 1) absolute neutrophil count (ANC) 1.5 or activated partial prothrombin time (APTT) >1.5×ULN; 7. Electrolyte abnormalities judged by the investigator to be clinically significant; 8. Patients have drug-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 oral sorafenib; 10. Patients with active gastric and duodenal ulcer, ulcerative colitis and other gastrointestinal diseases, or unresected tumor with active bleeding, or other conditions that may cause gastrointestinal bleeding or perforation as judged by the investigator; 11. Patients with evidence or history of significant bleeding tendencies within 3 months before enrollment (bleeding >30 mL within 3 months, hematemesis, melena, hematochezia), hemoptysis (>5 mL of fresh blood within 4 weeks), or thromboembolic events (including stroke events and/or transient ischemic attack) within 12 months; 12.1 grade or above myocardial ischemia, myocardial infarction or severe arrhythmia (including QTc=450 ms(male), QTc= 470ms(female) and NYHA grade or above congestive heart failure; 13. Other malignant tumors in the past 5 years, excluding basal cell or squamous cell carcinoma of the skin after radical resection, or carcinoma in situ of the cervix; 14. Severe active or uncontrolled 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 (known hepatitis B virus (HBV) carriers must rule out active HBV infection, defined as HBV DNA positivity (>1×104 copies /mL or >2000 IU/ml); Known hepatitis C virus (HCV) infection with HCV RNA positive (>1×103 copies /mL), or other hepatitis, cirrhosis]; 16. Patients have current central nervous system (CNS) metastases or active brain or meningeal metastases. Subjects with treated brain metastases were eligible if they met the following criteria: asymptomatic; No radiographic progression =4 weeks after the end of treatment; Treatment was completed =14 days before the first d
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival;safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;Objective response rate;Disease control rates; | — |
Countries
China
Contacts
Public ContactJia Bin; Chang Zhiwei; Qin Yanru
First Affiliated Hospital of Zhengzhou University
Outcome results
None listed