A phase II study of TFTD plus Bevacizumab in patients with unresectable advanced colorectal cancer
- Conditions
- unresectable advanced colorectal cancer
- Registration Number
- JPRN-UMIN000035638
- Lead Sponsor
- Department of Gastroenterological, Breast and Endocrine Surgery,Yamaguchi University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 45
Not provided
Patients who conflict with one of the following will not be included in this clinical study. 1. Patients with simultaneous active malignant disease. 2. Patients who had history of deep vein thrombosis, pulmonary embolism, or other significant thromboembolic disorder (thrombosis of the venous port or catheter or superficial venous thrombosis is not considered serious). 3. Patients with serious bleeding disorder, vasculitis, or serious gastrointestinal bleeding within 3 months before acquiring consent. 4. Patients with gastrointestinal perforation and / or history of fistula. 5. Patients with a history of pulmonary hemorrhage (hemoptysis). 6. Despite standard medical management, patients with uncontrollable arterial hypertension. 7. Patients with serious or unrecovered wounds, a history of peptic ulcer or fracture. 8. Patients with bowel obstruction, complication of inflammatory bowel disease or extensive intestinal resection, patients with Crohn's disease, ulcerative colon or chronic diarrhea. 9. Patients with serious drug allergy. 10. Patients with infection with fever over 38.0. 11. Patients with double active cancers which mean synchronous double cancers or metachronous double cancers with a disease-free period within 5 years. 12. Patients with brain metastasis. 13. Patients with severe complications such as the following. Patients with complications of infection during antibiotic administration. Patients with complications of treatment or poor control due to continued use of insulin. Patients of complication of hypertension with poor control. Patients with myocardial infarction that developed within 6 months. Patients with unstable angina. Patients in which liver cirrhosis was complicated. Patients in which interstitial pneumonia and pulmonary fibrosis are complicated. 14. Pregnant or nursing female. 15. Patient with mental illness. 16. Not appropriate for the study at the physician's assessment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to treatment failure
- Secondary Outcome Measures
Name Time Method Safety and efficacy