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

Sponsor
Hunan Cancer Hospital
Study ID
NCT05869097
Status
Completed

Conditions

  • Metastatic Colorectal Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
May 22, 2023
Start date
Nov 1, 2020
Status verified
May 2023
Primary completion
Oct 31, 2022
Completion
Apr 30, 2023

Study Design

Enrollment
90 participants (actual)

Arms

  • Arm: TAS-102 plus BEV group
    In TAS-102 plus BEV group, Patients received TAS-102 (35 mg/m²orally twice a day on days 1-5 and 8-12, every 28 days) and bevacizumab (5 mg /kg, intravenously, on days 1 and 15, every 28 days). Bevacizumab was approved to be a 30-minute intravenous infusion before TAS-102.
  • Arm: TAS-102 monotherapy group
    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.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Approximately 12 months ]

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