TAS-102 and Bevacizumab as third line chemotherapy for colorectal cancer. Phase 2 trial

Phase 2

Recruiting

• Conditions: metastatic colorectal cancer

• Registration Number: JPRN-UMIN000030030
• Lead Sponsor: Department of Digestive Surgery,Nippon Medical School

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

1)contraindications for TAS-102 and Bevacizumab 2)previously received chemotherapy with TAS-102 3)severe drug allergy 4)pregnant woman or Possibility of the pregnant woman. male patient who hoping partner's pregnancy. 5)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.) 6)other active malignancies 7)have pleural effusion and ascitic fluid with the treatment 8)Comorbidity or history of heart failure 9)gastrointestinal ulcer or bleeding 10)previous hemoptysis 11)Clinical or radiological evidence of CNS metastases 12)Current or previous (within the last 6 months) history of GI perforation 13)Patient with interstitial pneumonia or lung fibrosis confirmed in imaging study 14)ongoing treatment with anticoagulant 15)Synchronous or metachronous multiple malignancy within the last 5 year disease free interval 16)Under continuous steroid administration 17)decision of unsuitable for this study by the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
progression free survival

Secondary Outcome Measures

Name	Time	Method
Response rate , overall survival, Safety, and incidence of Grade 3 neutropenia