small cell lung cancer
Conditions
Interventions
Anlotinib + Nivolumab combination therapy group:Nivolumab (3 mg/kg intravenously every 2 weeks). Anlotinib 12mg orally, once a day, continuous medication for 2 weeks and 1 week off, that is, a 3-week
Paclitaxel monotherapy group:Paclitaxel 175mg/m2 chemotherapy was given. Once every 3 weeks, follow up after 4-6 consecutive times.
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed small cell lung cancer with measurable lesions; 2. Using AJCC TNM 8th edition staging method combined with VALG staging method: AJCC stage IV (any T, any N, M1a/b/c), or T3-4 due to multiple lung nodules or tumors/nodules The volume is too large to be included in a tolerable radiotherapy plan; 3. 18-70 years old; ECOG PS score: 0-1 points; expected survival period of more than 3 months; 4. Progression within 6 months after the end of first-line etoposide + carboplatin/cisplatin therapy; 5. Major organ function within 7 days prior to initial treatment, meeting the following criteria: (1) Routine blood test standards (without blood transfusion within 14 days): 1) Hemoglobin (HB)>= 90g/L; 2) White blood cells (WBC) >= 3×10^9/L 3) Absolute neutrophil count (ANC)>= 1.5×10^9/L; 4) Platelet (PLT)>= 80×10^9/L (2) Biochemical tests are subject to the following criteria: 1) Albumin>= 30g/L; 2) Total bilirubin (TBIL) = 60ml/min; 6. Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >= lower limit of normal (50%); 7. Female patients of childbearing age who have a negative pregnancy test result at the time of enrollment, and who promise to take adequate and effective contraceptive measures or birth control from the start of the study to the end of the study and within 3 months after the last dose of the study drug can be enrolled. this research. Alternatively, the women enrolled in this study were women of infertility potential. 8. Good compliance with the program and willing to receive treatment and follow-up as required by the program.
Exclusion criteria
Exclusion criteria: 1. Extensive-stage small cell lung cancer receiving first-line non-etoposide + carboplatin/cisplatin therapy; 2. Conditions related to primary disease: (1) Cranial MRI/CT examination confirmed CNS metastases. (2) Received chest radiation therapy. (3) Uncontrolled pleural or pericardial effusion. 3. Other malignant tumors that have occurred or are currently concurrently present within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumor [Ta (non-invasive tumor), Tis (carcinoma in situ) ) and T1 (tumor-infiltrating basement membrane)]; 4. Patients with small cell lung cancer accompanied by hemoptysis (> 50 ml/day), or patients whose imaging shows that the tumor has invaded important blood vessels or that the investigator judges that the tumor is likely to invade important blood vessels and cause fatal bleeding during the follow-up study; 5. History of interstitial pneumonia requiring steroid treatment, or current interstitial pneumonia; 6. Has a history of gastrointestinal disease or surgery that the investigator believes may affect the absorption of the oral study drug; 7. Subjects who need to receive systemic corticosteroids (dose equivalent to >10 mg prednisone/day) or other immunosuppressive drugs within 14 days prior to enrollment or during the study period; enrollment is allowed under the following conditions: Subjects allowed Use topical or inhaled glucocorticoids; allow short-term (150 mmHg, diastolic blood pressure>90 mmHg); (2) Suffering from myocardial ischemia or myocardial infarction of grade I or above, arrhythmia (including QT interval >=440ms) and congestive heart failure of grade >=2 (New York Heart Association (NYHA) classification); (3) Active or uncontrolled serious infection (>= CTC AE grade 2 infection); (4) Liver cirrhosis, decompensated liver disease, active hepatitis; (5) Renal failure requiring hemodialysis or peritoneal dialysis; (6) A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; (10) Poor control of diabetes (fasting blood glucose (FBG)>10mmol/L); (11) Urine routine indicates urine protein >= ++, and 24-hour urine protein quantification >1.0 g; (12) Major surgical treatment or significant traumatic injury within 28 days; (13) Patients with any signs of bleeding or related medical history, regardless of severity; unhealed wounds, ulcers, or fractures; (14) Those who have experienced arterial/venous thrombotic events within 6 months, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism; (15) Those who have a history of psychotropic substance abuse and cannot quit or have mental disorders; (16) According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety;progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;objective response rate;disease control rate; | — |
Countries
China
Contacts
Public ContactRunbo Zhong
Shanghai Chest Hospital
Outcome results
None listed