Phase III Study of Trifluridine/Tipiracil in Combination With Bevacizumab vs Trifluridine/Tipiracil Single Agent in Patients With Refractory Metastatic Colorectal Cancer

  • End date
    Dec 17, 2022
  • participants needed
  • sponsor
    Taiho Oncology, Inc.
Updated on 17 January 2022


This study is designed as an international, open-label, controlled two-arm, randomized phase III comparison study evaluating the efficacy and safety of trifluridine/tipiracil in combination with bevacizumab versus trifluridine/tipiracil monotherapy in patients with refractory mCRC.


This is an international, open-label, controlled two-arm, randomised phase III study evaluating the efficacy and safety of trifluridine/tipiracil in combination with bevacizumab versus trifluridine/tipiracil monotherapy in patients with refractory mCRC. The analysis will be done after 331 events are reported. In order to observe this number of events, 490 patients will be randomised (1:1) to receive trifluridine/tipiracil in combination with bevacizumab (experimental arm) or trifluridine/tipiracil monotherapy (control arm).

Condition Refractory Metastatic Colorectal Cancer
Treatment bevacizumab, Trifluridine/Tipiracil
Clinical Study IdentifierNCT04737187
SponsorTaiho Oncology, Inc.
Last Modified on17 January 2022


Yes No Not Sure

Inclusion Criteria

Has histologically confirmed unresectable adenocarcinoma of the colon or rectum (all other histological types are excluded)
RAS status must have been previously determined (mutant or wild-type) based on local assessment of tumor biopsy
Has received a maximum of 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer and had demonstrated progressive disease or intolerance to their last regimen
Has measurable or non-measurable disease as defined by RECIST version 1.1
Is able to swallow oral tablets
Estimated life expectancy ≥12 weeks
Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1

Exclusion Criteria

More than 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer
Pregnancy, lactating female or possibility of becoming pregnant during the study
Patients currently receiving or having received anticancer therapies within 4 weeks prior to randomization
Has not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy prior to randomization (excluding alopecia, and skin pigmentation)
Has symptomatic central nervous system metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease
Has severe or uncontrolled active acute or chronic infection
Has active or history of interstitial lung disease and/or pneumonitis, or pulmonary hypertension
Known Hepatitis B or Hepatitis C Virus infection
Known carriers of HIV antibodies
Confirmed uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 150 mm Hg and/or diastolic blood pressure ≥ 100 mm Hg) or uncontrolled or symptomatic arrhythmia
Deep arterial thromboembolic events including cerebrovascular accident or myocardial infarction within the last 6 months prior to randomization
Treatment with any of the following within the specified time frame prior to
major surgery within 4 weeks prior to randomisation (the surgical incision should be fully healed prior to study drug administration), or has not recovered from side effects of previous surgery, or patient that may require major surgery during the study
Prior radiotherapy if completed less than 4 weeks before randomisation, except if provided as a short course for symptoms palliation only
Drainage for ascites, pleural effusion or pericardial fluid within 4 weeks prior to randomization
Other clinically significant medical conditions
Other malignancies
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