Regorafenib Combined With Irinotecan Drug-Eluting Beads for Colorectal Cancer Liver Metastases
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSun Yat-sen University
About this trial
This study is a multicentre, prospective, randomised trial, aims to evaluate the efficacy and safety of Irinotecan Drug-Eluting Beads combined with regorafenib as the third-line treatment for a patient with colorectal cancer liver metastases. The study is planned to enrolled 126 patients failing first- and second-line standard chemotherapy treatment.
Eligibility criteria
Qualifiers
Patients over 18 years of age, of any race or sex, who have histologic or radiologic proof of colorectal cancer to the liver, who are able to give informed consent, will be eligible.
Patients failing first- and second-line standard systemic chemotherapy.
Patients with at least one measurable liver metastases, with size > 1cm response evaluation criteria in solid tumors (RECIST)
Patients with liver dominant disease defined as ≥80% tumor body burden confined to the liver
Disqualifiers
Prior treatment with TACE, regorafenib or fruquintinib
Patients with brain metastases
With serious heart, kidney, bone marrow, or lung, central nervous system diseases.
Patients suffered with other cancer.
Trial design
Treatments tested in this trial
- Regorafenib and DIBIRI
- Regorafenib
Treatment groups
126 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov