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

Sun Yat-sen University

Status and phase

Enrolling

Phase 3

Conditions

Regorafenib

Colorectal Cancer Liver Metastases

Treatments

Drug: Regorafenib and DIBIRI

Drug: Regorafenib

Study type

Interventional

Funder types

Other

Identifiers

NCT05794971

SYSU-IC-01

Details and patient eligibility

About

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.

Enrollment

126 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.