Clinical trial NCT05794971: Regorafenib Combined With Irinotecan Drug-Eluting Beads for Colorectal Cancer Liver Metastases
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Colorectal Cancer Liver Metastases
Regorafenib
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: 24 months
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: 24 months
measure: Objective Response Rate (ORR)
timeFrame: 24 months
measure: Disease Control Rate (DCR)
timeFrame: 24 months
measure: Duration of response (DOR)
timeFrame: 24 months
measure: Adverse enents
timeFrame: 24 months
Other outcomes:
Locations:
city: Guangdong
country: China
facility: Bo Zhang
state: Guangzhou
Study officials:
affiliation: Sixth Affiliated Hospital, Sun Yat-sen University
name: Bo Zhang, M.D
role: STUDY_DIRECTOR
References: