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Regorafenib Combined With Irinotecan Drug-Eluting Beads for Colorectal Cancer Liver Metastases

NCT05794971 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2023-05-15

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Regorafenib and DIBIRI

Drug: Regorafenib Regorafenib will be given 3 weeks on/1 week off (initial dose: 80 mg od po.) Drug: Irinotecan it will be mixed in eluting-beads and injected in the tumor. Procedure: TACE Transcatheter arterial chemoembolization（TACE）is a minimally invasive procedure performed to decrease the tumor's blood supply. Device: drug eluting-bead The eluting-bead,loaded with irinotecan (DEBIRI) to treat patients with hepatic metastases from colorectal cancer.

DRUG

Regorafenib

Drug: Regorafenib Regorafenib will be given 3 weeks on/1 week off (initial dose: 80 mg od po.)

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Bo Zhang, M.D · Sixth Affiliated Hospital, Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-10
Primary Completion
2027-03-31
Completion
2028-03-31

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05794971 on ClinicalTrials.gov