small cell lung cancer
Conditions
Interventions
LS-SCLC group:Anlotinib combined with concurrent chemoradiotherapy
ES-SCLC group:Anlotinib combined with concurrent chemoradiotherapy
Sponsors
Weihai Municipal Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up. 2. Aged >=18 years. 3. Limited-stage SCLC or extensive-stage SCLC confirmed by histology or cytology as inoperable. Limited stage was defined as: the disease was confined to one thoracic cavity and could be included in a single tolerable irradiation field; extensive stage was defined as: beyond the same thoracic cavity, = 90g/L, absolute neutrophil value (ANC) >= 1.5x10^9 /L, platelet (PLT) >= 80x10^9/L; (2) Biochemical tests should meet the following criteria: total bilirubin (TBIL) =60 mL/min (Cockcroft-Gault formula). 7. Females of childbearing age should agree to use contraception (such as an IUD, contraceptives, or condoms) during the study period and for 6 months after the end of the study; negative serum or urine pregnancy test within 1 week before study enrollment, and must be non-lactating patients; Men should agree that contraception must be used during the study period and for 6 months after the end of the study period.
Exclusion criteria
Exclusion criteria: 1. Histologically mixed SCLC and NSCLC components; 2. With multiple liver metastases; 3. There are central tumors invading local large blood vessels on imaging; or there are obvious cavitary or necrotic tumors in the lungs; 4. Participated in another clinical study of an experimental drug within the past 4 weeks; 5. Medical history: (1) Other active malignant tumors that require simultaneous treatment; (2) A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; (3) Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders; 6. Combined with any severe and/or uncontrolled disease: (1) Patients with unsatisfactory blood pressure control (systolic blood pressure >= 150 mmHg, diastolic blood pressure >= 100 mmHg); (2) Patients with grade I or above myocardial ischemia or myocardial infarction, arrhythmia (including male QTc >= 450ms (male), QTc >= 470ms (female)) and >= grade 2 congestive heart failure (New York Heart Association (NYHA) ) grade); or echocardiography showed that left ventricular ejection fraction (LVEF) was less than 50%; (3) Decompensated diabetes or other contraindications to high-dose glucocorticoid therapy; (4) Chronic obstructive pulmonary disease (COPD) exacerbation or other severe respiratory diseases requiring hospitalization; (5) Active or uncontrolled serious infection (>=CTC AE grade 2 infection); (6) Uncontrolled pleural effusion, pericardial effusion and ascites that require repeated drainage; (7) Liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis need to receive antiviral treatment; (8) Renal insufficiency: urine routine indicates urine protein >=++, and it is confirmed that the 24-hour urine protein quantification is greater than 1.0 g; 7. Imaging shows that the tumor has invaded around important blood vessels or the investigator judges that the tumor is very likely to invade important blood vessels and cause fatal hemorrhage during the follow-up study; 8. Patients who have undergone major surgery or have severe trauma have been eliminated for less than 2 weeks before enrollment; 9. Clinically significant hemoptysis (daily hemoptysis > 50mL) or clinically significant bleeding symptoms or a clear bleeding tendency within 3 months before enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood at baseline + + and above, or there are unhealed wounds, ulcers or fractures; 10. Arterial/venous thrombotic events, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism, have occurred within 6 months before enrollment; 11. Abnormal coagulation function (INR>1.5 or prothrombin time PT>ULN+4 seconds or APTT>1.5 ULN), with bleeding tendency or receiving thrombolytic or anticoagulation therapy. On the premise of prothrombin time international normalized ratio (INR) <= 1.5, low-dose heparin (daily dose of 60,000-12,000 U for adults) or low-dose aspirin (daily dose <= 100 mg) is allowed for prevention purposes; 12. In the judgment of the investigator, the patient cannot participate in the study if it is impossible for the patient to comply with the study procedures, restrictions and requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactYang Fujun
Weihai Municipal Hospital
Outcome results
None listed