NCT05794971RecruitingPhase 3
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)
Source: ClinicalTrials.gov · Last updated 15 May 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 126 (estimated)
- First submitted
- 20 Mar 2023
- Start date
- 10 Jun 2023
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Colorectal cancer
- NCT number
- NCT05794971
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 126
- From 10 Jun 2023 to the primary completion date, 31 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with TACE, regorafenib or fruquintinib
Other illness
- 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
- Patients with serious somatic or psychiatric illness regarded as contraindications or in need of treatment that would interfere with study participation.
Other
- Patients with brain metastases
- Women who are pregnant or breast feeding
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bo Zhang Coordinator of this site? Confirm its status | Guangdong | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.