Lung cancer
Conditions
Interventions
Single arm clinical study:Apatinib?Albumin binding paclitaxel
Sponsors
Peking University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. 18 years old = 10 mm, and the length of CT scan of lymph node lesions >= 15 mm). Note: the only target focus should not be the focus that has received radiotherapy, unless there is clear evidence that the focus has progressed. 7. Patients with brain metastases receiving radiotherapy, radiotherapy must be completed at least 28 days before signing the information. After one month of radiotherapy, reexamination of the disease is stable, and all AES related to radiotherapy need to be restored to = 1.5 x 10^9/L 2) PLT >= 100 x 10^9/L 3) Hb >= 90g/L (no blood transfusion and blood products within 14 days, no correction with G-CSF and other hematopoietic stimulating factors). (2) Biochemical examination shall meet the following standards: 1) TBIL = 50ml / min (Cockcroft Gault formula). 9. Female subjects of childbearing age must carry out the serum pregnancy test within 3 days before the start of study medication, and the result is negative, and they are willing to carry out the serum pregnancy test during the study and after the last administration of study medication A medically recognized and highly effective contraceptive measure (e.g. IUD, contraceptive or condom) should be used within months; for male subjects whose partners are women of childbearing age, surgical sterilization should be used, or effective contraceptive methods should be adopted during the study period and within 3 months after the last study administration. 10. The subjects volunteered to join the study and signed the informed consent form, with good compliance, Cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Previously exposed to other anti angiogenic small molecule TKI drugs, such as enrotinib or anti angiogenic monoclonal antibodies, such as bevacizumab; or participated in clinical trials of other anti-tumor drugs within 4 weeks before the first administration; or previously received Taxus drug treatment; 2. Other antineoplastic drugs are being used within 4 weeks after the last systemic cytotoxic drug treatment or radiotherapy drug treatment or at present; 3. In the past 3 years, other malignant tumors, except for the curable ones: (1) Basal cell carcinoma and squamous cell carcinoma of skin; (2) Carcinoma in situ of cervix. 4. Patients with uncontrolled large amount of exudate (chest, pericardium, abdominal cavity). 5. Imaging (CT or MRI) shows that the tumor invades the large blood vessels or is indistinct with the blood vessel boundary; or imaging (CT or MRI) shows that there is any pulmonary cavity or necrotic lesions; 6. Uncontrolled hypertension (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg, despite the best medication); 7. Suffer from myocardial ischemia or myocardial infarction above grade II and poor control of arrhythmia (including QTc interval >= 450 ms for men and 470 MS for women). According to NYHA standard, grade III-IV cardiac insufficiency, or left ventricular ejection fraction indicated by color Doppler echocardiography (LVEF) 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5uln), with bleeding symptoms or undergoing thrombolysis or anticoagulation treatment; 10. It is known that there are hereditary or acquired bleeding and thrombotic tendencies, such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.; 11. There was obvious cough blood or hemoptysis of half teaspoon (2.5ml) or more per day within 2 months before entering the study; 12. Within 3 months before entering the study, there were significant clinical bleeding symptoms or clear bleeding tendency, such as gastrointestinal bleeding, peptic ulcer, occult blood in stool at baseline + + or above, or vasculitis, etc.; 13. Events of arteriovenous thrombosis (AVT) occurred within 6 months before the study, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc; 14. Long term anticoagulation with warfarin or heparin, or long-term antiplatelet therapy (aspirin >= 300 mg / day or clopidogrel >= 75 mg / day) is required; 15. Severe infection (such as intravenous drip of antibiotics, antifungal or antiviral drugs) occurred within 4 weeks before the first administration, or fever of unknown cause occu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;Clinical Benefit Rate;Overall survival;Duration of response;Quality of life assessment;afety; | — |
Countries
China
Contacts
Public ContactJun Zhao
Beijing University Cancer Hospital
Outcome results
None listed