Combining Regorafenib with Irinotecan Drug-Eluting Beads for Liver Metastases from Colorectal Cancer
Regorafenib Combined With Irinotecan Drug-Eluting Beads as Third-line Treatment for Colorectal Cancer Liver Metastases: a Multicentre, Randomised Phase 3 Trial (RIDER)
This study is testing whether combining two treatments, regorafenib and irinotecan drug-eluting beads, can help people with liver cancer that has spread from colorectal cancer when other treatments haven't worked.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | fruquintinib, chemotherapy |
| Locations | 1 site (Guangdong, Guangzhou) |
| Trial ID | NCT05794971 on ClinicalTrials.gov |
What this trial studies
This multicenter, prospective, randomized trial evaluates the efficacy and safety of combining Irinotecan Drug-Eluting Beads with regorafenib as a third-line treatment for patients with colorectal cancer liver metastases. The study aims to enroll 126 patients who have not responded to first- and second-line chemotherapy treatments. Participants must have measurable liver metastases and meet specific health criteria to ensure safety and efficacy during the trial.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with confirmed colorectal cancer liver metastases who have failed prior chemotherapy and meet specific health criteria.
Not a fit: Patients with colorectal cancer liver metastases who have not undergone prior chemotherapy or have significant liver dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced colorectal cancer liver metastases who have exhausted standard therapies.
How similar studies have performed: Other studies have shown promise in using drug-eluting beads for localized treatment of liver metastases, suggesting potential success for this combined approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangdong, Guangzhou
- Bo Zhang — Guangdong, Guangzhou, China (Recruiting)
Study contacts
- Study coordinator: Bo Zhang, M.D
- Email: zhangb28@mail.sysu.edu.cn
- Phone: 86-13660397903
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.