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

NCT ID: NCT05794971

Last Updated: 2023-05-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-10
• Study Completion Date: 2028-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Irinotecan Drug-Eluting Beads combined with regorafenib

Group Type: EXPERIMENTAL

Regorafenib and DIBIRI

Intervention Type: 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.

regorafenib

Group Type: ACTIVE_COMPARATOR

Regorafenib

Intervention Type: DRUG

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

Interventions

Regorafenib and DIBIRI

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.

Intervention Type: DRUG

Regorafenib

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

Intervention Type: DRUG

Other Intervention Names

Drug: Irinotecan; Procedure: TACE; Device: drug eluting-bead

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Yanhong Deng

Director of Medical Oncology, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bo Zhang, M.D

Role: STUDY_DIRECTOR

Sixth Affiliated Hospital, Sun Yat-sen University

Locations

Bo Zhang

Guangdong, Guangzhou, China

Site Status: RECRUITING

Countries

China

Central Contacts

Bo Zhang, M.D

Role: CONTACT

zhangb28@mail.sysu.edu.cn

86-13660397903

Bo Zhang, M.D

Role: CONTACT

Facility Contacts

Bo Zhang, M.D

Role: primary

zhangb28@mail.sysu.edu.cn

+8613660397903

Bo Zhang

Role: backup

Other Identifiers

SYSU-IC-01

Identifier Type: -

Identifier Source: org_study_id