TAS-102 plus Bevacizumab combination as salvage therapy in elderly patients with metastatic colorectal cancer, phase 2 trial
- Conditions
- metastatic colorectal cancer
- Registration Number
- JPRN-UMIN000021664
- Lead Sponsor
- Tokushima University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 25
Not provided
1) patient who had previously received chemotherapy with TAS-102 2) patient who has history of hemoptysis(>=25mL, fresh blood) 3) patient with other active malignancies 4) patient with symptomatic brain metastasis 5) patients with serious pleural effusion, ascites or pericardial effusion 6) patients with active infection 7) Patient with interstitial pneumonia or lung fibrosis confirmed in imaging study 8) patient who has important clinical complications(symptomatic unstable ischemic heart disease, arrhythmia, acute myocardial infarction within 6 months, liver cirrhosis, renal failure, active gastrointestinal ulcer, ileus, uncontrolled diabetes, uncontrolled hypertension, etc.) 9) patient with non-healing wound or traumatic bone fracture 10) patient with bleeding disorders or current use of anticoagulant 11) patient with severe drug allergy 12) male patient who hoping partner's pregnancy 13) patient who has at least either one of HIV antibody, HBs antigen, or HCV antibody 14) patient who given a dicision of unsuitable for this study by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method overall survival
- Secondary Outcome Measures
Name Time Method progression free survival, response rate , disease control rate, relative dose intensity, frequency and grade of adverse events