NCT05794971 Regorafenib Combined With Irinotecan Drug-Eluting Beads for Colorectal Cancer Liver Metastases
| NCT ID | NCT05794971 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Sun Yat-sen University |
| Condition | Colorectal Cancer Liver Metastases |
| Study Type | INTERVENTIONAL |
| Enrollment | 126 participants |
| Start Date | 2023-06-10 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 126 participants in total. It began in 2023-06-10 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Bo Zhang, M.D
STUDY DIRECTOR
Sixth Affiliated Hospital, Sun Yat-sen University
Frequently Asked Questions
Who can join the NCT05794971 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Colorectal Cancer Liver Metastases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05794971 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 126 participants.
Is NCT05794971 currently recruiting?
Yes, NCT05794971 is actively recruiting participants. Contact the research team at zhangb28@mail.sysu.edu.cn for enrollment information.
Where is the NCT05794971 trial being conducted?
This trial is being conducted at Guangdong, China.
Who is sponsoring the NCT05794971 clinical trial?
NCT05794971 is sponsored by Sun Yat-sen University. The principal investigator is Bo Zhang, M.D at Sixth Affiliated Hospital, Sun Yat-sen University. The trial plans to enroll 126 participants.
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