Low-dose Trifluridine/Tipiracil With Bevacizumab in mCRC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorRuijin Hospital
About this trial
This is a phase II, single-center, prospective trial aimed to investigate the efficacy and safety of a modified regimen of trifluridine/tipiracil plus bevacizumab in refractory metastatic colorectal cancer. Patients will be treated with trifluridine/tipiracil (17.5 mg/m2 dose orally twice daily, d1-10, every 14-days) plus bevacizumab (5mg/kg dose intravenously once at day 1, every 14-days). The study treatment will be administered until progression of disease, intolerable toxicity or withdraw of consent.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age over 60 years old, male and female
histologically confirmed adenocarcinoma of the colon or rectum
patients with metastatic or advanced unresectable diseases who had received two or more previous chemotherapy regimens or intolerance to last regimen
with or without measurable lesions
Disqualifiers
symptomatic metastases of central nervous system
other primary malignancies
uncontrollable comorbidities, such as hypertension, thrombotic diseases, chronic kidney disease
organ functions that cannot tolerate study treatment
Trial design
Design model
Single group
Treatments tested in this trial
Trifluridine/tipiracil (TAS-102) plus bevacizumab
DrugTrifluridine/tipiracil will be given at a 17.5 mg/m2 dose orally twice daily in a 14-day cycle consisting of 10 treatment days/4 rest days. Bevacizumab will be given at a 5mg/kg dose intravenously once at day 1 in a 14-day cycle. This is a single-arm study with all patients receiving these two drugs.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: ExperimentalExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
6-month progression-free survival rate
Defined as the proportion of patients who remain free from disease progression (as per RECIST criteria) or death for at least 6 months following initiation of study treatment.
Time frame
6 monthsSecondary outcomes
1
Adverse events
Time frame
through study completion, an average of 1 year2
Objective response rate
Time frame
up to 16 weeks3
Progression free survival
Time frame
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months4
Overall survival
Time frame
From date of enrollment until the date of death from any cause, assessed up to 100 monthsSponsors and contacts
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Source ClinicalTrials.gov