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NCT Number: NCT05794971

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

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.

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Regorafenib and DIBIRI

Drug

Drug: Regorafenib Regorafenib will be given 3 weeks on/1 week off (initial dose: 80 mg od po.)

Drug: Irinotecan it will be mixed in eluting-beads and injected in the tumor.

Procedure: TACE Transcatheter arterial chemoembolization(TACE)is a minimally invasive procedure performed to decrease the tumor's blood supply.

Device: drug eluting-bead The eluting-bead,loaded with irinotecan (DEBIRI) to treat patients with hepatic metastases from colorectal cancer.

Other names: Drug: Irinotecan, Procedure: TACE, Device: drug eluting-bead

regorafenib

Drug

Drug: Regorafenib Regorafenib will be given 3 weeks on/1 week off (initial dose: 80 mg od po.)

Primary outcomes

  1. Overall Survival (OS)

    Time frame: 24 months

    OS is defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.

Secondary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: 24 months

    The PFS is defined as the time from the start of treatment to the date of first documented PD or death as a result of any cause, whichever occurred first. When a patient was alive and without progression, PFS was censored at the date of the last disease assessment.

  2. Objective Response Rate (ORR)

    Time frame: 24 months

    The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR)

  3. Disease Control Rate (DCR)

    Time frame: 24 months

    DCR is defined as the percentage of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating)

  4. Duration of response (DOR)

    Time frame: 24 months

    It was defined as the time from the first judgment of complete remission (CR) or partial remission (PR) to the discovery of disease progression (PD) after treatment

  5. Adverse enents

    Time frame: 24 months

    Safety variables will be summarized using descriptive statistics based on adverse events collection

Study contacts

Contact information is provided by the study sponsor or research team.

Bo Zhang, M.D

CONTACT

[email protected]

86-13660397903

Bo Zhang, M.D

CONTACT

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Regorafenib Combined With Irinotecan Drug-Eluting Beads as Third-line Treatment for Colorectal Cancer Liver Metastases: a Multicentre, Randomised Phase 3 Trial (RIDER)

Acronym: RIDER

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Apr 3, 2023
Registry last updated
May 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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