Health TrialsbyHealthPanel

Trifluridine/Tipiracil Plus Fruquintinib vs. Trifluridine/Tipiracil Plus Bevacizumab in Refractory Metastatic Colorectal Cancer: A Randomized, Controlled, Open-Label, Non-Inferiority Trial

ConditionRefractory Metastatic Colorectal Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

This study is an investigator-initiated, prospective, multicenter, randomized, controlled, open-label, non-inferiority trial designed to evaluate the efficacy and safety of trifluridine/tipiracil plus fruquintinib versus trifluridine/tipiracil plus bevacizumab in the treatment of refractory metastatic colorectal cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All study participants must sign the informed consent form before any study-related procedures are initiated.

Aged 18-75 years, both males and females.

Histologically confirmed unresectable colorectal cancer.

RAS status known (mutant or wild-type).

Disqualifiers

1.Prior treatment with trifluridine/tipiracil, fruquintinib, or any other VEGF-receptor tyrosine-kinase inhibitor (e.g., apatinib, regorafenib, anlotinib).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Trifluridine/tipiracil plus fruquintinib

    Drug

    Trifluridine/tipiracil 35 mg/m² orally twice daily on days 1-5 and 8-12, repeated every 4 weeks, plus fruquintinib 4 mg orally once daily for 3 weeks followed by 1 week off, repeated every 4 weeks.

  • trifluridine/tipiracil plus bevacizumab

    Drug

    Trifluridine/tipiracil 35 mg/m² orally twice daily on days 1-5 and 8-12, repeated every 4 weeks, plus bevacizumab 5 mg/kg intravenously on day 1 every 2 weeks.

Treatment groups

236 Participants
are divided into 2 treatment groups
Group A: Trifluridine/tipiracil plus fruquintinibExperimental treatment 1 intervention
Group B: Trifluridine/tipiracil plus bevacizumabActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

PFS

Progression-free Survival

Time frame
Time from the date of randomization to the first occurrence of disease progression (as assessed by the investigator according to RECIST v1.1) or death, whichever occurs first,up to 2 years

Secondary outcomes

1

OS

Overall Survival

Time frame
Time from the date of randomization to death from any cause up to 3 years
2

ORR

Objective Response Rate

Time frame
from randomization up to progressive disease or EOT due to any cause, up to 2 years
3

DCR

Disease Control Rate

Time frame
from randomization up to progressive disease or EOT due to any cause, up to 2 years
4

Safety and tolerance

Safety and tolerance evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0

Time frame
from first dose to within 30 days after the last dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: