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
Qualifiers
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
Treatments tested in this trial
- Trifluridine/tipiracil (TAS-102) plus bevacizumab
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov