Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT05794971

PHASE3

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

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

126

Start Date

2023-06-10

Completion Date

2028-03-31

Last Updated

2023-05-15

Healthy Volunteers

Conditions

Colorectal Cancer Liver Metastases Regorafenib

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.)

Inclusion Criteria: * 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 * Less than 60% liver tumor replacement * Eastern Cooperative Oncology Group (ECOG) Performance Status score of \< 2 * Child-pugh's grade A or B * Life expectancy of \> 3 months * Non-pregnant with an acceptable contraception in premenopausal women. * Hematologic function: absolute neutrophil count (ANC) ≥ 1.5 x 109/L, white cell count (WBC) ≥ 3.0 x 109/L, platelets ≥75 x109/L, international normalized ratio (INR) ≤1.3. * Adequate hepatic and renal function: Alanine aminotransferase (ALT) or aspartate aminotransferase ≤2.5×above upper normal range, total bilirubin≤1.5×above upper normal range, Serum creatinine≤1.5×above upper normal range * Women of child bearing potential and fertile men are required to use effective contraception negative serum beta human chorionic gonadotropin (βHCG) * Signed, written informed consent Exclusion Criteria: * 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. * patients who were seriously ill and had history of chronic disease such as tuberculosis (TB) and human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS) were excluded from the study. * known or suspected history of allergy to any of the related drugs used in the study * Women who are pregnant or breast feeding * Patients with serious somatic or psychiatric illness regarded as contraindications or in need of treatment that would interfere with study participation.

Locations (1)

Bo Zhang

Guangdong, Guangzhou, China