SCLC
Conditions
Interventions
Experimental Group:Paclitaxel for Injection(Albumin Bound)+Anlotinib
Sponsors
Huzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) The subjects voluntarily joined the study, signed the informed consent form, with good compliance, and cooperated with follow-up. (2) male or female patients aged 18-75 years; (3) patients with extensive-stage small cell lung cancer who had received first-line platinum-based chemotherapy and had at least one measurable or evaluable lesion on imaging (CT or MRI) before second-line treatment according to RECIST1.1 criteria; Progression was defined as PD assessed by RECIST1.1 in solid tumors after first-line platinum-based doubled-agent chemotherapy. For subjects who have received concurrent chemoradiotherapy or adjuvant chemotherapy in the limited stage before, if recurrence/metastasis occurs within 6 months after the last treatment, the original treatment plan is defined as the first-line treatment plan for the subject. Allow prophylactic brain, chest, and abdominal irradiation. (4) Patients with asymptomatic brain metastases or treated and stable brain metastases could be enrolled; (5) Life expectancy of at least 3 months, ECOG score: 0-1; (6) normal function of major organs, that is, meeting the following criteria: 1) Blood routine examination criteria should be met (no blood transfusion and blood products within the first 14 days, no G-CSF and other hematopoietic stimulating factor correction) : Hemoglobin (HB) >=90 g/L; Absolute neutrophil count (ANC) >=1.5*109/L (1500/m3); Platelet count (PLT) >=100*109/L; 2) Biochemical tests should meet the following criteria: Total bilirubin (TBiL) =50 ml/min (Cockcroft-Gault formula: CrCL (mL/min) =[(140-age)* Body weight (kg)* F]/(SCr(mg/dL)*72. Male F=1, female F=0.85, SCr= serum creatinine). 3) Doppler ultrasound assessment: left ventricular ejection fraction (LVEF): the lower limit of normal (50%); (7) Patients of childbearing age (including female patients and female partners of male patients) must have effective birth control measures.
Exclusion criteria
Exclusion criteria: 1. Non-small cell lung cancer (including small cell lung cancer and non-small cell lung cancer mixed); 2. Patients with previous use of anlotinib hydrochloride capsules or other antiangiogenic drugs; 3. The distance between the tumor lesion and the major blood vessels was =140mmHg or diastolic blood pressure >=90mmHg, despite optimal medical therapy); 6. Grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmia (including QTc interval >=450ms in men and >=470ms in women); 7. Patients with NYHA class III-IV cardiac dysfunction or left ventricular ejection fraction (LVEF) 1.5 or prothrombin time (PT) > ULN+4 seconds or APTT > 1.5ULN), bleeding tendency or receiving thrombolytic or anticoagulant therapy; 9. Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; Note: Low-dose heparin (6 000 to 12 000 units per day for adults) or low-dose aspirin (= ++ or confirmed 24-hour urine protein >=1.0g. 16. Have a history of psychotropic drug abuse and cannot quit or have mental disorders; 17. Participated in other clinical trials of antineoplastic drugs within 4 weeks before screening; 18. Previous or concurrent history of other uncured malignant tumors, except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix and superficial bladder cancer; 19. Pregnant or lactating women; Patients of childbearing potential who are unwilling or unable to use effective contraception; 20. Patients with any constitutional signs or history of bleeding; 21. According to the investigator's judgment, patients may have other factors that may lead to the forced termination of the study, such as other serious diseases or serious laboratory abnormalities or other factors that may affect the safety of the subjects, or family or social factors such as experimental data and sample collection.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| OS, Overall Survival;Disease Control Rate;DCR;security indexes;Objective Response Rate;ORR; | — |
Primary
| Measure | Time frame |
|---|---|
| Progression-Free-Survival, PFS; | — |
Countries
China
Contacts
Public ContactBin Wang
Huzhou Central Hospital
Outcome results
None listed