Small-cell lung cancer
Conditions
Interventions
Experimental group:Surufatinib+Tislelizumab
Sponsors
Fifth Medical Center of Chinese People's Liberation Army General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years; 2. Small cell lung cancer confirmed by histopathology or cytology, with measurable lesions (RECIST 1.1); 3. Patients with untreated extensive-stage small cell lung cancer; 4. ECOG score of 0 or 1 (see Appendix 1); 5. Expected survival >= 12 weeks; 6. Main organs and bone marrow function are basically normal: (1) Blood routine: white blood cells >= 4.0 x 10^9/L, neutrophils >= 1.5 x 10^9/L, platelets >= 100 x 10^9/L, hemoglobin >= 90g/L; (2) International normalized ratio (INR) = 50% detected by two-dimensional echocardiography; 7. Fully understand this research, participate voluntarily, and sign the informed consent; 8. Male or female patients with reproductive potential voluntarily use effective contraceptive methods during the study period and within 6 months of the last study medication, such as double-barrier contraceptive methods, condoms, oral or injectable contraceptives, intrauterine devices, etc. All female patients will be considered fertile unless the female patient has undergone natural menopause, artificial menopause, or sterilization (eg, hysterectomy, bilateral adnexectomy, or radioactive ovarian irradiation).
Exclusion criteria
Exclusion criteria: 1. Previous use of surufatinib or other anti-angiogenic drugs; 2. Have used tislelizumab or other anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies, and any other antibodies or drugs targeting T-cell co-stimulatory or checkpoint pathways, such as ICOS or agonists (such as CD40, CD137, GITR, OX40, etc.); 3. Patients with symptomatic brain metastases; 4. Imaging examination (CT or MRI) shows obvious lung empty or necrotic tumor; 5. Patients with brain or central nervous system metastasis, including leptomeningeal disease, or CT/MRI examinations suggest brain or leptomeningeal disease (Patients with brain metastases within 28 days before the completion of randomization and with stable symptoms can be enrolled, but brain MRI examination, CT or intravenous angiography are required to confirm no symptoms of cerebral hemorrhage); 6. The patient is participating in other clinical studies (except non-interventional studies) within 4 weeks after the end of the previous clinical study; 7. Patients who have received chemotherapy, radiotherapy or other experimental anticancer treatments (except bisphosphonates) within 4 weeks before the first dose of this study. Patients who had previously received local radiotherapy were eligible if they met the following criteria: the end of radiotherapy was more than 4 weeks after the start of the study (more than 2 weeks for brain radiotherapy); in addition, the target lesion selected for this study is not in the radiotherapy area, or if the target lesion is in the radiotherapy area, but has proven progression; 8. Suffering from other types of malignant tumors within 5 years or so far; 9. Patients with active, known or suspected autoimmune diseases, including allogeneic organ transplantation, history of allogeneic hematopoietic stem cell transplantation, history of HIV positive or acquired immunodeficiency syndrome (AIDS) history; 10. Active or previously documented inflammatory bowel disease (such as Crohn's disease, ulcerative colitis); 11. Obtained non-relieving toxicity from previous treatment, exceeding grade 1 of CTC AE (4.0), excluding alopecia; 12. Abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT ULN > 1.5), with bleeding tendency or receiving thrombolytic and anticoagulant therapy, clinically significant hemoptysis (more than half a tablespoon of hemoptysis per day) occurred within 3 months before enrollment; or clinically significant bleeding symptoms or bleeding tendency within 4 weeks before group assignment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer (including gastrointestinal perforation and/or fistula, but gastrointestinal perforation or fistula has been surgically removed and admission is allowed), baseline fecal occult blood ++ above, unhealed wounds, ulcers or fractures, etc.; 13. Urine routine shows urine protein >= + +, or urine protein amount >= 1.0 g within 24 hours; 14. Uncontrolled hypertension (SBP >= 160 mmHg, DBP >= 100 mmHg despite optimal medical therapy); 15. Patients with peripheral neuropathy of NCI-CTCAE grade II or above, except those caused by trauma; 16. Interstitial lung disease, uncontrolled moderate to massive serous effusion (including pleural effusion, ascites and pericardial effusion) after fluid aspiration, chronic obstructive pulmonary disease exacerbation, active pulmonary infection, and/or acute bacterial or fungal respiratory disease requiring intravenous antibiotic therapy within 28 days; 17.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactQin Haifeng
Fifth Medical Center of Chinese People's Liberation Army General Hospital
Outcome results
None listed