Real-world Effectiveness and Safety of Trifluridine/Tipiracil plus bevacizumab in Metastatic Colorectal Cancer: A retrospective observational study using an administrative database

JRCT ID: jRCT1031220116

Registered date:04/06/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Colorectal cancer
• Date of first enrollment: 04/06/2022
• Target sample size: 11962
• Study type: Observational

Outcome(s)

• Primary Outcome: overall survival
• Secondary Outcome: time to treatment discontinuation, adverse events, post-treatment

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Patients with CRC aged over 20 years who were diagnosed between May 2014 and January 2021 by using the International Classification of Diseases, 10th revision (ICD-10) codes in the database.
-Patients who received FTD/TPI and/or regorafenib.

Exclude criteria

1) FTD/TPI- or regorafenib-treated patients with diseases other than CRC;
2) patients who received other chemotherapy except bevacizumab simultaneously with FTD/TPI
3) patients who received other chemotherapy simultaneously with regorafenib.

Related Information

• Primary Sponsor: Taiho Pharmaceutical Co., Ltd. Medical Affairs Division