Anlotinib Plus Platinum-etoposide in First-line of Extensive-stage Small-cell Lung Cancer

Exclusion Criteria

• •Having mixed small cell carcinoma and non-small cell carcinoma;
• •Having active central nervous system (CNS) metastases and/or cancerous meningitis or found to have active central nervous system (CNS) metastases and/or cancerous meningitis in examinations during the screening stage. Patients can be included in the study as long as they: (1) Have asymptomatic brain metastases (without progressive central nervous system symptoms induced by brain metastases, requiring no corticosteroids, and having the lesion size ≤ 1.5cm), provided that they should undergo regular brain imaging examinations for the diseased site; (2) Have been treated and are in stable status, have no imaging evidence for new or enlarged brain metastases at least 2 weeks after brain metastasis treatment, and have discontinued steroids or anticonvulsants at least 14 days before the therapy of the study starts.
• •Patients whose imaging findings showed invaded central great vessels or obvious pulmonary cavity or necrotizing tumor should be excluded.
• •Patients with hypertension who are taking two or more antihypertensive drugs should be excluded.
• •Patients having the following should be excluded: Cardiovascular diseases: Myocardial ischemia or myocardial infarction or grade II or above, uncontrolled arrhythmias, new functions of grade III to IV, or cardiac ejection fraction \< 50%;
• •Abnormal coagulation function (INR \> 1.5 or prothrombin time (PT) \> ULN+4 seconds, or APTT \> 1.5ULN), prone to bleeding or receiving thrombolytic or anticoagulant therapy;
• •Had significant cough blood or daily hemoptysis of 2.5ml or more in 2 months before the inclusion;
• •Having bleeding symptoms or definite bleeding tendency of significant clinical significance, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ or above at baseline, or vasculitis, in 3 months before the inclusion;
• •Having developed artery/venous thrombosis in 12 months before the inclusion;
• •With known hereditary or acquired bleeding and thrombosis tendency;
• •Having a wound or fracture that has cannot be healed for a long time;
• •Having received major surgery or had severe traumatic injury, fracture or ulcer in 4 weeks before the inclusion;
• •Subject to factors that significantly affect the absorption of oral medication;
• •Having developed abdominal fistula, gastrointestinal perforation or abdominal abscess in 6 months before the inclusion;
• •Having the urine routine result suggest urine protein ≥++, or confirmed the 24-hour urine protein amount ≥ 1.0g;
• •With serous membrane effusion that is with clinical symptoms and requires symptomatic treatment;
• •With active infections that require antimicrobial treatment;
• •Having a history of psychotropic drug abuse and unable to quit or with a mental disorder;
• •Having participated in other clinical trials on anti-tumor drugs 4 weeks before the inclusion;
• •Previously or currently having other incurable malignancies;
• •Having received over-potent CYP3A4 inhibitor treatment in 7 days before the inclusion, or have received over-potent CYP3A4 inducer treatment in 12 days before the inclusion.
• •Pregnant or lactating women who are fertile but are unwilling or unable to take effective contraception measures should be excluded.
• •Patients as determined by researchers to be subject to other conditions that may clinically affect the conduct or outcome of the study should be excluded.