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

NCT05794971 | Recruiting Phase 3 DMC

• 1 other identifier: SYSU-IC-01
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer Liver Metastases; Regorafenib

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  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.

  24 months

Secondary Outcomes (5)

• Progression-Free Survival (PFS)

  24 months

• Objective Response Rate (ORR)

  24 months

• Disease Control Rate (DCR)

  24 months

• Duration of response (DOR)

  24 months

• Adverse enents

  24 months

Study Arms (2)

Irinotecan Drug-Eluting Beads combined with regorafenib

EXPERIMENTAL

Drug: Regorafenib and DIBIRI

regorafenib

ACTIVE COMPARATOR

Drug: Regorafenib

Interventions

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.

Also known as: Drug: Irinotecan, Procedure: TACE, Device: drug eluting-bead

Irinotecan Drug-Eluting Beads combined with regorafenib

Regorafenib DRUG

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

regorafenib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Bo Zhang

Guangdong, Guangzhou, China

RECRUITING

MeSH Terms

Interventions

regorafenib; Irinotecan

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Bo Zhang, M.D

  Sixth Affiliated Hospital, Sun Yat-sen University

  STUDY DIRECTOR

Central Study Contacts

Bo Zhang, M.D

CONTACT

86-13660397903; zhangb28@mail.sysu.edu.cn

Bo Zhang, M.D

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Medical Oncology, Clinical Professor

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 3, 2023
• Study Start: June 10, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: May 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)