Small-cell lung cancer
Conditions
Interventions
Case group:None
Sponsors
Xi'an Jiaotong University First Affiliated Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age>=18 years old; 2. Small cell lung cancer confirmed by histopathology or cytology with measurable lesions (RECIST 1.1, see Appendix 2); 3. Failure of first-line chemotherapy; 4. The time interval between recurrence and the end of the last systemic chemotherapy is>=3 months; 5. An ECOG score of 0 or 1 (see Appendix 1); 6. Expected survival>=12 weeks; 7. At least one measurable lesion (RECIST 1.1 standard, see Appendix 2); 8. Main organs and bone marrow functions are basically normal: a) 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>=90 g/L; b) International Standardization Ratio (INR)=50%. 9. Fully understand this study, voluntarily participate, and sign an informed consent form. Male or female patients with fertility voluntarily use effective contraceptive methods such as dual barrier 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 they have undergone natural menopause, artificial menopause, or sterilization (such as hysterectomy, bilateral appendectomy, or radiation ovarian irradiation).
Exclusion criteria
Exclusion criteria: 1. Previously used sofatinib or other anti angiogenic drugs; 2. Have used anti PD-1, anti PD-L1, anti CTLA-4 antibodies, and any other antibodies or drugs that target T cell co stimulation or checkpoint pathways, such as ICOS or agonists (such as CD40, CD137, GITR, OX40, etc.); 3. Two or more platinum based chemotherapy failures (except for adjuvant chemotherapy, where the disease relapses or progresses within 6 months and has been considered as first-line treatment); 4. Imaging examination (CT or MRI) shows tumors with obvious lung vacuity or necrosis; 5. Patients with brain or central nervous system metastasis, including leptomeningeal disease, or CT/MRI examination indicating brain or leptomeningeal disease) (Within 28 days before the completion of randomized treatment and the symptoms of patients with brain metastasis are stable, they can be included in the group, but brain MRI examination is required, and CT or intravenous angiography confirms that there are no symptoms of cerebral hemorrhage); 6. The patient is participating in other clinical studies (excluding non-interventional studies) within 4 weeks after the completion of previous clinical studies 7. Patients who have received chemotherapy, radiotherapy, or other experimental anticancer treatment (excluding bisphosphonates) within 4 weeks before the first administration of this study. Patients who have previously received local radiotherapy are eligible for enrollment if they meet the following criteria: the end of radiotherapy is more than 4 weeks from the beginning of this study (brain radiotherapy is more than 2 weeks); In addition, the target lesion selected for this study is not in the radiotherapy area, or if the target lesion is within the radiotherapy area, but progress has been confirmed; 8.Having other types of malignant tumors within 8.5 years or up to now; 9. Patients with active, known, or suspected autoimmune diseases, including a history of allogeneic organ transplantation, allogeneic hematopoietic stem cell transplantation, HIV positive history, or a history of acquired immunodeficiency syndrome (AIDS); 10. Active or previously documented inflammatory bowel diseases (such as Crohn's disease, ulcerative colitis); 11. Non-remitting toxic reactions obtained from previous treatment, exceeding the level 1 of CTC AE (4.0), excluding hair loss; 12. Abnormal coagulation function (INR>1.5 or prothrombin time (PT)>ULN+4 seconds or APTT ULN>1.5), accompanied by bleeding tendency or receiving thrombolytic and anticoagulant treatment, Clinically significant hemoptysis (over half a tablespoon of hemoptysis per day; or clinically significant bleeding symptoms or bleeding tendencies within the first 4 weeks of grouping, such as gastrointestinal bleeding, hemorrhagic gastric ulcers (including gastrointestinal perforation and/or fistula, but gastrointestinal perforation or fistula has been manually removed, admission is allowed), baseline fecal occult blood+or above, unhealed wounds, ulcers, or fractures, etc; 13. Routine urinalysis showed that urinary protein>=++, or urinary protein volume within 24 hours>=1.0 g; 14. Uncontrolled hypertension (despite optimal drug treatment, SBP>=160 mmHg, DBP>=100 mmHg); 15. Patients with severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia; According to NYHA standards, Grade III to IV cardiac insufficiency or echocardiographic indications of left ventricular ejection fractio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progressive free survival, PFS;Disease control rate, DCR;Safety; | — |
Countries
China
Contacts
Public ContactYao Yu
Xi'an Jiaotong University First Affiliated Hospital
Outcome results
None listed