RecruitingPhase 3NCT05794971

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

Regorafenib Combined With Irinotecan Drug-Eluting Beads as Third-line Treatment for Colorectal Cancer Liver Metastases: a Multicentre, Randomised Phase 3 Trial (RIDER)


Sponsor

Sun Yat-sen University

Enrollment

126 participants

Start Date

Jun 10, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination treatment — an oral chemotherapy drug (regorafenib) plus beads filled with a chemotherapy drug (irinotecan) injected directly into liver tumors — for colorectal cancer that has spread to the liver. **You may be eligible if...** - You are 18 or older - You have colorectal cancer that has spread to the liver (confirmed by imaging or tissue) - You have already tried two lines of standard chemotherapy that did not work - You have at least one measurable liver tumor larger than 1 cm - At least 80% of your cancer burden is in the liver **You may NOT be eligible if...** - Your cancer has spread extensively outside the liver - You have not yet tried first- and second-line chemotherapy - Other health or organ-function concerns apply Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRegorafenib 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.

DRUGRegorafenib

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


Locations(1)

Bo Zhang

Guangdong, Guangzhou, China

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NCT05794971


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