NCT05869097

Trifluridine/Tipiracil Plus Bevacizumab Versus Trifluridine/Tipiracil Monotherapy in Refractory Metastatic Colorectal Cancer

Efficacy and Safety of Trifluridine/Tipiracil Plus Bevacizumab Versus Trifluridine/Tipiracil Monotherapy for Refractory Metastatic Colorectal Cancer: a Retrospective Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 90 (actual)
• Sponsor: Hunan Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a retrospective study to compare the efficacy and safety between trifluridine/tipiracil (TAS-102) plus bevacizumab (BEV) with TAS-102 monotherapy in refractory metastatic colorectal cancer (mCRC) from November 2020 to October 2022 at the Hunan Cancer Hospital.

Detailed description

Our retrospective analysis was conducted to explore the efficacy and safety of patients treated with at least 1 cycle of TAS-102 with or without BEV in patients suffering refractory mCRC from November 2020 to October 2022 at the Hunan Cancer Hospital. Data from the electronic medical records were the sources. In TAS-102 monotherapy group, TAS-102 35 mg/m²orally twice a day on days 1-5 and 8-12, every 28 days were given to patients, while on days 1 and 15, every 28 days, patients received bevacizumab (5 mg /kg, intravenously) in TAS-102 plus BEV group. The median OS (mOS) was the primary end point.while mPFS, the ORR, the disease control rate(DCR) and the incidence of treatment-related adverse events (TRAEs) were the secondary end points.

Conditions

• Metastatic Colorectal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Trifluridine/Tipiracil	TAS-102 35 mg/m²orally twice a day on days 1-5 and 8-12, every 28 days
DRUG	Bevacizumab	Bevacizumab 5 mg /kg, intravenously on days 1,15,every 28 days

Timeline

• Start date: 2020-11-01
• Primary completion: 2022-10-31
• Completion: 2023-04-30
• First posted: 2023-05-22
• Last updated: 2023-05-22

Locations

1 site across 1 country: China