Combining Regorafenib with Irinotecan Drug-Eluting Beads for Liver Metastases from Colorectal Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Bo Zhang
  Guangdong, Guangzhou, China Recruiting

Study contacts

• Study coordinator: Bo Zhang, M.D
• Email: zhangb28@mail.sysu.edu.cn
• Phone: 86-13660397903

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.