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

Launched by SUN YAT-SEN UNIVERSITY · Mar 20, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for patients with colorectal cancer that has spread to the liver. The researchers want to see if combining two drugs, regorafenib and irinotecan drug-eluting beads, can help patients who have already tried other chemotherapy treatments without success. They plan to enroll 126 participants aged 18 and older who have measurable liver tumors and meet specific health criteria.

To be eligible, participants should have had at least two prior chemotherapy treatments and have liver cancer that mainly affects the liver. They also need to be in relatively good health with a life expectancy of more than three months. If you join this study, you'll receive the new treatment and be monitored closely for any effects. It's important to know that this trial cannot include individuals with certain serious health conditions or those who have already been treated with specific drugs related to the study. Overall, this research aims to find a potentially effective new option for patients facing difficult treatment situations.

Gender

ALL

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.