non-small cell lung cancer
Conditions
Interventions
Case series:Apatinib+EGFR-TKI
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18~75 years; 2. Subjects with histologically confirmed non-small cell lung cancer (NSCLC), EGFR mutation in the positive, T790M was positive before entering the trail; 3. Patients with no anti vascular or other non EGFR-TKIs targeted therapies in previous treatmentincluding antiangiogenic drugs, rh-endostatinbevacizumab and single target or multi target targeted therapies in current clinical studies; 4. According to JACKMAN evaluation standard, patients with secondary resistance after EGFR-TKI treatment, according with definition of slow progress; 5. There is no restriction on smoking , including patients with nonsmoking, mild smoking and heavy smoking; 6. performance status (PS) of 0 to 2; 7. The main organ function is normal.;Inclusion criteria: 1. Aged 18~75 years; 2. Subjects with histologically confirmed non-small cell lung cancer (NSCLC), EGFR mutation in the positive, T790M was positive before entering the trail; 3. Patients with no anti vascular or other non EGFR-TKIs targeted therapies in previous treatmentincluding antiangiogenic drugs, rh-endostatinbevacizumab and single target or multi target targeted therapies in current clinical studies; 4. According to JACKMAN evaluation standard, patients with secondary resistance after EGFR-TKI treatment, according with definition of slow progress; 5. There is no restriction on smoking , including patients with nonsmoking, mild smoking and heavy smoking; 6. performance status (PS) of 0 to 2; 7. The main organ function is normal.;Inclusion criteria: 1. Aged 18~75 years; 2. Subjects with histologically confirmed non-small cell lung cancer (NSCLC), EGFR mutation in the positive, T790M was positive before entering the trail; 3. Patients with no anti vascular or other non EGFR-TKIs targeted therapies in previous treatmentincluding antiangiogenic drugs, rh-endostatinbevacizumab and single target or multi target targeted therapies in current clinical studies; 4. According to JACKMAN evaluation standard, patients with secondary resistance after EGFR-TKI treatment, according with definition of slow progress; 5. There is no restriction on smoking , including patients with nonsmoking, mild smoking and heavy smoking; 6. performance status (PS) of 0 to 2; 7. The main organ function is normal.;Inclusion criteria: 1. Aged 18~75 years; 2. Subjects with histologically confirmed non-small cell lung cancer (NSCLC), EGFR mutation in the positive, T790M was positive before entering the trail; 3. Patients with no anti vascular or other non EGFR-TKIs targeted therapies in previous treatmentincluding antiangiogenic drugs, rh-endostatinbevacizumab and single target or multi target targeted therapies in current clinical studies; 4. According to JACKMAN evaluation standard, patients with secondary resistance after EGFR-TKI treatment, according with definition of slow progress; 5. There is no restriction on smoking , including patients with nonsmoking, mild smoking and heavy smoking; 6. performance status (PS) of 0 to 2; 7. The main organ function is normal.;Inclusion criteria: 1. Aged 18~75 years; 2. Subjects with histologically confirmed non-small cell lung cancer (NSCLC), EGFR mutation in the positive, T790M was positive before entering the trail; 3. Patients with no anti vascular or other non EGFR-TKIs targeted therapies in previous treatmentincluding antiangiogenic drugs, rh-endostatinbevacizumab and single target or multi target targeted therapies in current clinical studies; 4. According to JACKMAN evaluation standard, patients with secondary resistance after EGFR-TKI treatment, according with definition of slow progress; 5. There is no restriction on smoking , including patients with nonsmoking, mild smoking and heavy smoking; 6. performance status (PS) of 0 to 2; 7. The main organ function is normal.
Exclusion criteria
Exclusion criteria: 1. Local recurrence after radical radiotherapy; 2. The activity of brain metastasis, cancer patients with meningitis, spinal cord compression, disease or screening imaging CT or MRI findings of brain or leptomeningeal (into the 21 day group had been completed before treatment and stable symptoms of patients with brain metastases were included, but by brain MRI, the evaluation of CT or venography confirmed no brain bleeding); 3. Imaging (CT or MRI) showed tumor lesions from large vessels less than 5 mm, or the presence of central local tumor invasion of great vessels; 4. Obvious cavity or necrosis formed in the tumor confirmed by Imageology(CT or MRI); 5. Patients with uncontrol hypertension (systolic blood pressure = 140 mmHg or diastolic blood pressure = 90 mmHg, despite optimal drug therapy); 6. Patients with grade II myocardial ischemia or myocardial infarction, poor control of arrhythmias (including QTc interval male = 450 ms, female =470 ms); 7. According to NYHA standard, III ~ IV cardiac insufficiency, or heart colour to exceed revealed left ventricular ejection fraction (LVEF) 1.5 or PT>ULN+4, or APTT>1.5 ULN), bleeding tendency or receiving coagulation therapy 9. Use of anticoagulants or vitamin K antagonists such as warfarin, heparin or similar drug treated patients; note: in the international normalized ratio of prothrombin time (INR) less than 1.5 of the premise, to prevent the use of allowing a small dose of heparin (adult daily dosage of 6 thousand ~1.2 000 U) or low-dose aspirin (daily dosage of less than 100 mg); 10. Before randomization within 2 months of active bleeding associated with hemoptysis (blood), or their daily hemoptysis amounted to half a teaspoon (2.5ml) or above; 11. Before randomization within 3 months had significant bleeding clinical significance or definite bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcer, baseline fecal occult blood and above, or suffering from vasculitis; 12. Arterial / venous thrombosis occurred within the first 12 months before randomization, such as cerebral vascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism; 13. Patients with bleeding tendency, inherited or acquired bleeding tendency and thrombus tendency known to be present (Such as hemophilia, coagulopathy, thrombocytopenia, hypersplenism etc.); 14. Unhealed bone fracture or wound for long time; 15. Received big surgery, had serious bone fracture or ulcer in 4 weeks before randomization; 16. There are several factors that affect oral medicine,such as unable to swallow, chronic diarrhea and intestinal obstruction; 17. History of abdominal fistula, gastrointestinal perforation or abdominal abscess within 6 month before randomization; 18. Urine protein=++, or urine protein in 24 hours=1.0g; 19. A serous cavity effusion (including hydrothorax, ascites, pericardial effusion) with local symptoms requiring local treatment; 20. Patients with active viral hepatitis B or C; 21. Active infections require antimicrobial treatment (for example, antimicrobial agents, antiviral agents, and antifungal agents); 22. Patients with a history of psychiatric drug abuse and can not be prevented or have mental disorders; 23. Participated in other cancer drug clinical trials within four weeks before randomization; 24. Have received prior treatment with VEGFR TKI before rando;Exclusion criteria: 1. Local recurrence after radical radiotherapy; 2. The activity of brain metastasis, cancer patients with meningitis, spinal cord compression, disease or screening imaging CT or MRI findings of brain or leptomeningeal (into the 21 day group had been completed before treatment and stable symptoms of patients with brain metastases were included, but by brain MRI, the evaluation of CT or venography confirmed no brain bleeding); 3. Imaging (CT or MRI) showed tumor lesions from large vessels less than 5 mm, or the presence of central local tumor invasion of great vessels; 4. Obvious cavity or necrosis formed in the tumor confirmed by Imageology(CT or MRI); 5. Patients with uncontrol hypertension (systolic blood pressure = 140 mmHg or diastolic blood pressure = 90 mmHg, despite optimal drug therapy); 6. Patients with grade II myocardial ischemia or myocardial infarction, poor control of arrhythmias (including QTc interval male = 450 ms, female =470 ms); 7. According to NYHA standard, III ~ IV cardiac insufficiency, or heart colour to exceed revealed left ventricular ejection fraction (LVEF) 1.5 or PT>ULN+4, or APTT>1.5 ULN), bleeding tendency or receiving coagulation therapy 9. Use of anticoagulants or vitamin K antagonists such as warfarin, heparin or similar drug treated patients; note: in the international normalized ratio of prothrombin time (INR) less than 1.5 of the premise, to prevent the use of allowing a small dose of heparin (adult daily dosage of 6 thousand ~1.2 000 U) or low-dose aspirin (daily dosage of less than 100 mg); 10. Before randomization within 2 months of active bleeding associated with hemoptysis (blood), or their daily hemoptysis amounted to half a teaspoon (2.5ml) or above; 11. Before randomization within 3 months had significant bleeding clinical significance or definite bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcer, baseline fecal occult blood and above, or suffering from vasculitis; 12. Arterial / venous thrombosis occurred within the first 12 months before randomization, such as cerebral vascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism; 13. Patients with bleeding tendency, inherited or acquired bleeding tendency and thrombus tendency known to be present (Such as hemophilia, coagulopathy, thrombocytopenia, hypersplenism etc.); 14. Unhealed bone fracture or wound for long time; 15. Received big surgery, had serious bone fracture or ulcer in 4 weeks before randomization; 16. There are several factors that affect oral medicine,such as unable to swallow, chronic diarrhea and intestinal obstruction; 17. History of abdominal fistula, gastrointestinal perforation or abdominal abscess within 6 month before randomization; 18. Urine protein=++, or urine protein in 24 hours=1.0g; 19. A serous cavity effusion (including hydrothorax, ascites, pericardial effusion) with local symptoms requiring local treatment; 20. Patients with active viral hepatitis B or C; 21. Active infections require antimicrobial treatment (for example, antimicrobial agents, antiviral agents, and antifungal agents); 22. Patients with a history of psychiatric drug abuse and can not be prevented or have mental disorders; 23. Participated in other cancer drug clinical trials within four weeks before randomization; 24. Have received prior treatment with VEGFR TKI before rando;Exclusion criteria: 1. Local recurrence after radical radiotherapy; 2. The activity of brain metastasis, cancer patients with meningitis, spinal cord compression, disease or screening imaging CT or MRI findings of brain or leptomeningeal (into the 21 day group had been completed before treatment and stable symptoms of patients with brain metastases were included, but by brain MRI, the evaluation of CT or venography confirmed no brain bleeding); 3. Imaging (CT or MRI) showed tumor lesions from large vessels less than 5 mm, or the presence of central local tumor invasion of great vessels; 4. Obvious cavity or necrosis formed in the tumor confirmed by Imageology(CT or MRI); 5. Patients with uncontrol hypertension (systolic blood pressure = 140 mmHg or diastolic blood pressure = 90 mmHg, despite optimal drug therapy); 6. Patients with grade II myocardial ischemia or myocardial infarction, poor control of arrhythmias (including QTc interval male = 450 ms, female =470 ms); 7. According to NYHA standard, III ~ IV cardiac insufficiency, or heart colour to exceed revealed left ventricular ejection fraction (LVEF) 1.5 or PT>ULN+4, or APTT>1.5 ULN), bleeding tendency or receiving coagulation therapy 9. Use of anticoagulants or vitamin K antagonists such as warfarin, heparin or similar drug treated patients; note: in the international normalized ratio of prothrombin time (INR) less than 1.5 of the premise, to prevent the use of allowing a small dose of heparin (adult daily dosage of 6 thousand ~1.2 000 U) or low-dose aspirin (daily dosage of less than 100 mg); 10. Before randomization within 2 months of active bleeding associated with hemoptysis (blood), or their daily hemoptysis amounted to half a teaspoon (2.5ml) or above; 11. Before randomization within 3 months had significant bleeding clinical significance or definite bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcer, baseline fecal occult blood and above, or suffering from vasculitis; 12. Arterial / venous thrombosis occurred within the first 12 months before randomization, such as cerebral vascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism; 13. Patients with bleeding tendency, inherited or acquired bleeding tendency and thrombus tendency known to be present (Such as hemophilia, coagulopathy, thrombocytopenia, hypersplenism etc.); 14. Unhealed bone fracture or wound for long time; 15. Received big surgery, had serious bone fracture or ulcer in 4 weeks before randomization; 16. There are several factors that affect oral medicine,such as unable to swallow, chronic diarrhea and intestinal obstruction; 17. History of abdominal fistula, gastrointestinal perforation or abdominal abscess within 6 month before randomization; 18. Urine protein=++, or urine protein in 24 hours=1.0g; 19. A serous cavity effusion (including hydrothorax, ascites, pericardial effusion) with local symptoms requiring local treatment; 20. Patients with active viral hepatitis B or C; 21. Active infections require antimicrobial treatment (for example, antimicrobial agents, antiviral agents, and antifungal agents); 22. Patients with a history of psychiatric drug abuse and can not be prevented or have mental disorders; 23. Participated in other cancer drug clinical trials within four weeks before randomization; 24. Have received prior treatment with VEGFR TKI before rando;Exclusion criteria: 1. Local recurrence after radical radiotherapy; 2. The activity of brain metastasis, cancer patients with meningitis, spinal cord compression, disease or screening imaging CT or MRI findings of brain or leptomeningeal (into the 21 day group had been completed before treatment and stable symptoms of patients with brain metastases were included, but by brain MRI, the evaluation of CT or venography confirmed no brain bleeding); 3. Imaging (CT or MRI) showed tumor lesions from large vessels less than 5 mm, or the presence of central local tumor invasion of great vessels; 4. Obvious cavity or necrosis formed in the tumor confirmed by Imageology(CT or MRI); 5. Patients with uncontrol hypertension (systolic blood pressure = 140 mmHg or diastolic blood pressure = 90 mmHg, despite optimal drug therapy); 6. Patients with grade II myocardial ischemia or myocardial infarction, poor control of arrhythmias (including QTc interval male = 450 ms, female =470 ms); 7. According to NYHA standard, III ~ IV cardiac insufficiency, or heart colour to exceed revealed left ventricular ejection fraction (LVEF) 1.5 or PT>ULN+4, or APTT>1.5 ULN), bleeding tendency or receiving coagulation therapy 9. Use of anticoagulants or vitamin K antagonists such as warfarin, heparin or similar drug treated patients; note: in the international normalized ratio of prothrombin time (INR) less than 1.5 of the premise, to prevent the use of allowing a small dose of heparin (adult daily dosage of 6 thousand ~1.2 000 U) or low-dose aspirin (daily dosage of less than 100 mg); 10. Before randomization within 2 months of active bleeding associated with hemoptysis (blood), or their daily hemoptysis amounted to half a teaspoon (2.5ml) or above; 11. Before randomization within 3 months had significant bleeding clinical significance or definite bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcer, baseline fecal occult blood and above, or suffering from vasculitis; 12. Arterial / venous thrombosis occurred within the first 12 months before randomization, such as cerebral vascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism; 13. Patients with bleeding tendency, inherited or acquired bleeding tendency and thrombus tendency known to be present (Such as hemophilia, coagulopathy, thrombocytopenia, hypersplenism etc.); 14. Unhealed bone fracture or wound for long time; 15. Received big surgery, had serious bone fracture or ulcer in 4 weeks before randomization; 16. There are several factors that affect oral medicine,such as unable to swallow, chronic diarrhea and intestinal obstruction; 17. History of abdominal fistula, gastrointestinal perforation or abdominal abscess within 6 month before randomization; 18. Urine protein=++, or urine protein in 24 hours=1.0g; 19. A serous cavity effusion (including hydrothorax, ascites, pericardial effusion) with local symptoms requiring local treatment; 20. Patients with active viral hepatitis B or C; 21. Active infections require antimicrobial treatment (for example, antimicrobial agents, antiviral agents, and antifungal agents); 22. Patients with a history of psychiatric drug abuse and can not be prevented or have mental disorders; 23. Participated in other cancer drug clinical trials within four weeks before randomization; 24. Have received prior treatment with VEGFR TKI before rando;Exclusion criteria: 1. Local recurrence after radical radiotherapy; 2. The activity of brain metastasis, cancer patients with meningitis, spinal cord compression, disease or screening imaging CT or MRI findings of brain or leptomeningeal (into the 21 day group had been completed before treatment and stable symptoms of patients with brain metastases were included, but by brain MRI, the evaluation of CT or venography confirmed no brain bleeding); 3. Imaging (CT or MRI) showed tumor lesions from large vessels less than 5 mm, or the presence of central local tumor invasion of great vessels; 4. Obvious cavity or necrosis formed in the tumor confirmed by Imageology(CT or MRI); 5. Patients with uncontrol hypertension (systolic blood pressure = 140 mmHg or diastolic blood pressure = 90 mmHg, despite optimal drug therapy); 6. Patients with grade II myocardial ischemia or myocardial infarction, poor control of arrhythmias (including QTc interval male = 450 ms, female =470 ms); 7. According to NYHA standard, III ~ IV cardiac insufficiency, or heart colour to exceed revealed left ventricular ejection fraction (LVEF) 1.5 or PT>ULN+4, or APTT>1.5 ULN), bleeding tendency or receiving coagulation therapy 9. Use of anticoagulants or vitamin K antagonists such as warfarin, heparin or similar drug treated patients; note: in the international normalized ratio of prothrombin time (INR) less than 1.5 of the premise, to prevent the use of allowing a small dose of heparin (adult daily dosage of 6 thousand ~1.2 000 U) or low-dose aspirin (daily dosage of less than 100 mg); 10. Before randomization within 2 months of active bleeding associated with hemoptysis (blood), or their daily hemoptysis amounted to half a teaspoon (2.5ml) or above; 11. Before randomization within 3 months had significant bleeding clinical significance or definite bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcer, baseline fecal occult blood and above, or suffering from vasculitis; 12. Arterial / venous thrombosis occurred within the first 12 months before randomization, such as cerebral vascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism; 13. Patients with bleeding tendency, inherited or acquired bleeding tendency and thrombus tendency known to be present (Such as hemophilia, coagulopathy, thrombocytopenia, hypersplenism etc.); 14. Unhealed bone fracture or wound for long time; 15. Received big surgery, had serious bone fracture or ulcer in 4 weeks before randomization; 16. There are several factors that affect oral medicine,such as unable to swallow, chronic diarrhea and intestinal obstruction; 17. History of abdominal fistula, gastrointestinal perforation or abdominal abscess within 6 month before randomization; 18. Urine protein=++, or urine protein in 24 hours=1.0g; 19. A serous cavity effusion (including hydrothorax, ascites, pericardial effusion) with local symptoms requiring local treatment; 20. Patients with active viral hepatitis B or C; 21. Active infections require antimicrobial treatment (for example, antimicrobial agents, antiviral agents, and antifungal agents); 22. Patients with a history of psychiatric drug abuse and can not be prevented or have mental disorders; 23. Participated in other cancer drug clinical trials within four weeks before randomization; 24. Have received prior treatment with VEGFR TKI before rando
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS;PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DOR;DCR;QoL; | — |
Countries
China
Contacts
Public ContactZhengbo Song;Zhengbo Song;Zhengbo Song;Zhengbo Song;Zhengbo Song ;;;;
Zhejiang Cancer Hospital;Zhejiang Cancer Hospital;Zhejiang Cancer Hospital;Zhejiang Cancer Hospital;Zhejiang Cancer Hospital
Outcome results
None listed