malignant tumor
Conditions
Interventions
Sponsors
Sir Run Run Shaw Hospital School of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with histologically-confirmed, advanced metastatic malignant tumor who have progressed on standard therapy; 2.At least one measurable lesions; 3. gastric cancer patients, always received second-line chemotherapy regimens, other cancer patients, always received standard treatment failure or recurrence, lack of a standard treatment at present; 4. Distance the last radiotherapy at least 4 weeks and recover from the acute toxicity of radiotherapy, except preventive brain radiotherapy or palliative bone metastatic lesions radiotherapy; 5. Males or females = 18 years; 6. Performance status of 02 on the ECOG criteria; 7. Expected survival is more than three months; 8. Adequate hepatic, renal, heart, and hematologic functions (without blood transfusion during 14 daysunused g-csf and other hematopoietic stimulating factor correct) Absolute Neutrophil Count(ANC) = 1.5×10^9/L, Platelet (PLT) = 100×10^9/L, Hemoglobin(HB) = 100 g/L; Aspartate transaminase(AST) and alanine transaminase (ALT)=2.5×ULN (hepatic metastasis ALT, AST < 5 x ULN) BUN and Cr=1×ULN, total bilirubin =1.5× ULNendogenous creatinine clearance =50 ml/min (Cockcroft - Gault formula); 9. during the test and the last 8 weeks after experimental patients must be used appropriate methods of contraception, or surgery sterilization; 10. Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
Exclusion criteria
Exclusion criteria: 1. Symptomatic brain metastases (Patients who have no symptoms and is not needed to receive therapy before 21 days may participate in this trial, but need to be confirmed by MRI\CT or venography that no hematencephalon symptom); 2. Imaging (CT or MRI) shows that the tumor lesion vessels = 5 mm, or into the center of the large vessels tumor;Or show obvious lung empty or necrotic tumor; 3. Uncontrolled hypertension(systolic pressure = 140 mmHg and/or diastolic pressure = 90 mm Hg) even though two or more than two hypotensive agents application; 4. Patients who suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male = 450 ms, female = 470 ms). Grade III-IV cardiac insufficiency according to New York Heart Association(NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF)1.5 o rPT>Upper Limit Of Normal(ULN)+4s or Activated Partial Thromboplastin Time (APTT) >1.5 Upper Limit Of Normal(ULN)), hemorrhagic tendency or receiving the therapy of thrombolysis or anticoagulation; 7. History of clinically significant haemoptysis =< 2 months (more than 2.5ml or half of one tea spoon of fresh blood per day) prior to registration; 8. History of clinically relevant major bleeding event =< 3 months; 9. Within 12 months before the first treatment occurs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack(TIA), hematencephalon, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.; 10. Known inherited and acquired hemorrhagic and thromboplastic possibility (such as hemophilia, coagulopathy, thrombocytopenia, hypersplenism, etc.); 11. Long-term untreated wounds or fractures; 12. Within 4 weeks of major surgery and/or injures, fractures, ulceration; 13. Significant factors that influence the ingestion and absorption of medicine (Such as unable to swallow, chronic diarrhea and intestinal obstruction); 14. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess = 6 months; 15. Urine protein=++, or 24h urine protein quantitation=1.0g; 16. Active infection need anti-microbial treatment (Antimicrobial, antiviral, antifungal drug treatment); 17. History of psychiatric drugs abuse and not be abstinent, or dysphrenia; 18. Less than 4 weeks from the last clinical trial; 19. History or concomitant other malignancy except cured basal cell skin cancer, or carcinoma in situ of the cervix, or superficial bladder cancer; 20. Pregnant or lactating women; Patients with fertility unwilling or unable to take effective contraceptive measures; 21. Other conditions regimented at investigators' discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Circulating tumor cells; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;ORR;DCR;safety; | — |
Countries
China
Contacts
Public ContactHaizhou Lou
Sir Run Run Shaw Hospital School of Medicine, Zhejiang University
Outcome results
None listed