Malignant tumor of thymus
Conditions
Interventions
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18~75 years old; 2. Histologically proven thymic epithelial tumor (TET) patients(WHO); 3. ECOG(Eastern Cooperative Oncology Group) 0~2; 4. The Expected lifetime:=3 month; 5. Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function ). For example: HB=90 g/L, ANC>1.5×10^9/L; PLT>100×10^9/L, TBIL1.5×10^9/L; PLT>100×10^9/L, TBIL1.5×10^9/L; PLT>100×10^9/L, TBIL1.5×10^9/L; PLT>100×10^9/L, TBIL1.5×10^9/L; PLT>100×10^9/L, TBIL<1.5 times of upper limit of normal reference value, ALT and AST<2.5 times of upper limit of normal reference value(Liver metastasis <5×ULN), and CRE<1.2mg/dl 6. Patients will take contraceptive measures for the duration of the treatments and 8 weeks after the last treatment; 7. Signed the Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1. Indications for radical radiotherapy in local recurrence; 2. Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by CT or MRI (Patients with a history of CNS metastases or cord compression are eligible if they are clinically stable at least 21 days before randomization); 3. Imaging (CT or MRI) results indicate that the distance of tumour lessions and large vevessel less than 5mm,or existence of central tumors locally invading the large vessel could be detected 4. Imaging (CT or MRI) results indicate apparent pulmonary cavity or necrotizing tumors; 5. Patients with poor blood pressure control (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg ); 6. Patients with stage II myocardial ischemia or myocardial infarction, poor control of the arrhythmia (including QT interval male = 450 ms, female = 470 ms); 7. Grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF) 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT ULN > 1.5), with bleeding tendency or is treated with thrombolysis and anticoagulation; 9. Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or analogues; 10. Patients who had obvious hemoptysis within 2 months before screening, or experienced daily hemoptysis with a volume more than half a tea spoon (2.5ml) or above; 11. Patients who experienced bleeding symptoms of clinical significance , or with confirmed bleeding tendency such as hemorrhage of digestive tract, hemorrhagic gastric ulcer, baseline occult blood in stool ++ and above, or vasculitis, etc; 12. Patients who manifested arterial/venous thrombus events, e.g.cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism, etc., within 12 months before screening; 13. Patients with bleeding tendency (such as Hemophilia, coagulopathy, thrombocytopenia, hypersplenism etc); 14. Long untreated wound or fracture; 15. Patients who received major surgical operations or experienced severe traumatic injuries, bone fracture, or ulcers within 4 weeks before screening; 16. Have a variety of factors that affect oral medication (such as can not swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); 17. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before screening; 18. Patients whose routine urine tests indicate that urine protein = ++ or verifies that the 24-h urine protein quantitation = 1.0 g; 19. Serous effusion (including pleural effusion, ascites, pericardial effusion) with clinical symptoms and surgical treatment ; 20. Active severe infection or known chronic infection with hepatitis B virus, or hepatitis C virus; 21. Requiring antimicrobial treatment(such as antibiotics, antiviral drugs and antifungal drugs); 22. Having a history of psychiatric abuse and can not quit or have mental disorders; 23. Participated in other drug clinical researchers within four weeks; 24. Treated with VEGFR inhibitors before screening; 25. Past or concurrent with other malignancies, except for cured skin basal cell carcinoma and cervical in situ cancer; 26. Patients treated with potent CYP3A4 inhibitor 7 days before screening, or treated with po;Exclusion criteria: 1. Indications for radical radiotherapy in local recurrence; 2. Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by CT or MRI (Patients with a history of CNS metastases or cord compression are eligible if they are clinically stable at least 21 days before randomization); 3. Imaging (CT or MRI) results indicate that the distance of tumour lessions and large vevessel less than 5mm,or existence of central tumors locally invading the large vessel could be detected 4. Imaging (CT or MRI) results indicate apparent pulmonary cavity or necrotizing tumors; 5. Patients with poor blood pressure control (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg ); 6. Patients with stage II myocardial ischemia or myocardial infarction, poor control of the arrhythmia (including QT interval male = 450 ms, female = 470 ms); 7. Grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF) 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT ULN > 1.5), with bleeding tendency or is treated with thrombolysis and anticoagulation; 9. Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or analogues; 10. Patients who had obvious hemoptysis within 2 months before screening, or experienced daily hemoptysis with a volume more than half a tea spoon (2.5ml) or above; 11. Patients who experienced bleeding symptoms of clinical significance , or with confirmed bleeding tendency such as hemorrhage of digestive tract, hemorrhagic gastric ulcer, baseline occult blood in stool ++ and above, or vasculitis, etc; 12. Patients who manifested arterial/venous thrombus events, e.g.cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism, etc., within 12 months before screening; 13. Patients with bleeding tendency (such as Hemophilia, coagulopathy, thrombocytopenia, hypersplenism etc); 14. Long untreated wound or fracture; 15. Patients who received major surgical operations or experienced severe traumatic injuries, bone fracture, or ulcers within 4 weeks before screening; 16. Have a variety of factors that affect oral medication (such as can not swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); 17. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before screening; 18. Patients whose routine urine tests indicate that urine protein = ++ or verifies that the 24-h urine protein quantitation = 1.0 g; 19. Serous effusion (including pleural effusion, ascites, pericardial effusion) with clinical symptoms and surgical treatment ; 20. Active severe infection or known chronic infection with hepatitis B virus, or hepatitis C virus; 21. Requiring antimicrobial treatment(such as antibiotics, antiviral drugs and antifungal drugs); 22. Having a history of psychiatric abuse and can not quit or have mental disorders; 23. Participated in other drug clinical researchers within four weeks; 24. Treated with VEGFR inhibitors before screening; 25. Past or concurrent with other malignancies, except for cured skin basal cell carcinoma and cervical in situ cancer; 26. Patients treated with potent CYP3A4 inhibitor 7 days before screening, or treated with po;Exclusion criteria: 1. Indications for radical radiotherapy in local recurrence; 2. Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by CT or MRI (Patients with a history of CNS metastases or cord compression are eligible if they are clinically stable at least 21 days before randomization); 3. Imaging (CT or MRI) results indicate that the distance of tumour lessions and large vevessel less than 5mm,or existence of central tumors locally invading the large vessel could be detected 4. Imaging (CT or MRI) results indicate apparent pulmonary cavity or necrotizing tumors; 5. Patients with poor blood pressure control (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg ); 6. Patients with stage II myocardial ischemia or myocardial infarction, poor control of the arrhythmia (including QT interval male = 450 ms, female = 470 ms); 7. Grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF) 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT ULN > 1.5), with bleeding tendency or is treated with thrombolysis and anticoagulation; 9. Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or analogues; 10. Patients who had obvious hemoptysis within 2 months before screening, or experienced daily hemoptysis with a volume more than half a tea spoon (2.5ml) or above; 11. Patients who experienced bleeding symptoms of clinical significance , or with confirmed bleeding tendency such as hemorrhage of digestive tract, hemorrhagic gastric ulcer, baseline occult blood in stool ++ and above, or vasculitis, etc; 12. Patients who manifested arterial/venous thrombus events, e.g.cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism, etc., within 12 months before screening; 13. Patients with bleeding tendency (such as Hemophilia, coagulopathy, thrombocytopenia, hypersplenism etc); 14. Long untreated wound or fracture; 15. Patients who received major surgical operations or experienced severe traumatic injuries, bone fracture, or ulcers within 4 weeks before screening; 16. Have a variety of factors that affect oral medication (such as can not swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); 17. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before screening; 18. Patients whose routine urine tests indicate that urine protein = ++ or verifies that the 24-h urine protein quantitation = 1.0 g; 19. Serous effusion (including pleural effusion, ascites, pericardial effusion) with clinical symptoms and surgical treatment ; 20. Active severe infection or known chronic infection with hepatitis B virus, or hepatitis C virus; 21. Requiring antimicrobial treatment(such as antibiotics, antiviral drugs and antifungal drugs); 22. Having a history of psychiatric abuse and can not quit or have mental disorders; 23. Participated in other drug clinical researchers within four weeks; 24. Treated with VEGFR inhibitors before screening; 25. Past or concurrent with other malignancies, except for cured skin basal cell carcinoma and cervical in situ cancer; 26. Patients treated with potent CYP3A4 inhibitor 7 days before screening, or treated with po;Exclusion criteria: 1. Indications for radical radiotherapy in local recurrence; 2. Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by CT or MRI (Patients with a history of CNS metastases or cord compression are eligible if they are clinically stable at least 21 days before randomization); 3. Imaging (CT or MRI) results indicate that the distance of tumour lessions and large vevessel less than 5mm,or existence of central tumors locally invading the large vessel could be detected 4. Imaging (CT or MRI) results indicate apparent pulmonary cavity or necrotizing tumors; 5. Patients with poor blood pressure control (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg ); 6. Patients with stage II myocardial ischemia or myocardial infarction, poor control of the arrhythmia (including QT interval male = 450 ms, female = 470 ms); 7. Grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF) 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT ULN > 1.5), with bleeding tendency or is treated with thrombolysis and anticoagulation; 9. Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or analogues; 10. Patients who had obvious hemoptysis within 2 months before screening, or experienced daily hemoptysis with a volume more than half a tea spoon (2.5ml) or above; 11. Patients who experienced bleeding symptoms of clinical significance , or with confirmed bleeding tendency such as hemorrhage of digestive tract, hemorrhagic gastric ulcer, baseline occult blood in stool ++ and above, or vasculitis, etc; 12. Patients who manifested arterial/venous thrombus events, e.g.cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism, etc., within 12 months before screening; 13. Patients with bleeding tendency (such as Hemophilia, coagulopathy, thrombocytopenia, hypersplenism etc); 14. Long untreated wound or fracture; 15. Patients who received major surgical operations or experienced severe traumatic injuries, bone fracture, or ulcers within 4 weeks before screening; 16. Have a variety of factors that affect oral medication (such as can not swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); 17. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before screening; 18. Patients whose routine urine tests indicate that urine protein = ++ or verifies that the 24-h urine protein quantitation = 1.0 g; 19. Serous effusion (including pleural effusion, ascites, pericardial effusion) with clinical symptoms and surgical treatment ; 20. Active severe infection or known chronic infection with hepatitis B virus, or hepatitis C virus; 21. Requiring antimicrobial treatment(such as antibiotics, antiviral drugs and antifungal drugs); 22. Having a history of psychiatric abuse and can not quit or have mental disorders; 23. Participated in other drug clinical researchers within four weeks; 24. Treated with VEGFR inhibitors before screening; 25. Past or concurrent with other malignancies, except for cured skin basal cell carcinoma and cervical in situ cancer; 26. Patients treated with potent CYP3A4 inhibitor 7 days before screening, or treated with po;Exclusion criteria: 1. Indications for radical radiotherapy in local recurrence; 2. Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by CT or MRI (Patients with a history of CNS metastases or cord compression are eligible if they are clinically stable at least 21 days before randomization); 3. Imaging (CT or MRI) results indicate that the distance of tumour lessions and large vevessel less than 5mm,or existence of central tumors locally invading the large vessel could be detected 4. Imaging (CT or MRI) results indicate apparent pulmonary cavity or necrotizing tumors; 5. Patients with poor blood pressure control (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg ); 6. Patients with stage II myocardial ischemia or myocardial infarction, poor control of the arrhythmia (including QT interval male = 450 ms, female = 470 ms); 7. Grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF) 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT ULN > 1.5), with bleeding tendency or is treated with thrombolysis and anticoagulation; 9. Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or analogues; 10. Patients who had obvious hemoptysis within 2 months before screening, or experienced daily hemoptysis with a volume more than half a tea spoon (2.5ml) or above; 11. Patients who experienced bleeding symptoms of clinical significance , or with confirmed bleeding tendency such as hemorrhage of digestive tract, hemorrhagic gastric ulcer, baseline occult blood in stool ++ and above, or vasculitis, etc; 12. Patients who manifested arterial/venous thrombus events, e.g.cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism, etc., within 12 months before screening; 13. Patients with bleeding tendency (such as Hemophilia, coagulopathy, thrombocytopenia, hypersplenism etc); 14. Long untreated wound or fracture; 15. Patients who received major surgical operations or experienced severe traumatic injuries, bone fracture, or ulcers within 4 weeks before screening; 16. Have a variety of factors that affect oral medication (such as can not swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); 17. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before screening; 18. Patients whose routine urine tests indicate that urine protein = ++ or verifies that the 24-h urine protein quantitation = 1.0 g; 19. Serous effusion (including pleural effusion, ascites, pericardial effusion) with clinical symptoms and surgical treatment ; 20. Active severe infection or known chronic infection with hepatitis B virus, or hepatitis C virus; 21. Requiring antimicrobial treatment(such as antibiotics, antiviral drugs and antifungal drugs); 22. Having a history of psychiatric abuse and can not quit or have mental disorders; 23. Participated in other drug clinical researchers within four weeks; 24. Treated with VEGFR inhibitors before screening; 25. Past or concurrent with other malignancies, except for cured skin basal cell carcinoma and cervical in situ cancer; 26. Patients treated with potent CYP3A4 inhibitor 7 days before screening, or treated with po
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| QoL;OS;DCR;ORR;DOR; | — |
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