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

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

NCT ID: NCT05794971

Condition: Colorectal Cancer Liver Metastases
Regorafenib

Conditions: Official terms:
Colorectal Neoplasms
Neoplasm Metastasis
Liver Neoplasms
Irinotecan

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Regorafenib and DIBIRI
Description: 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.
Arm group label: Irinotecan Drug-Eluting Beads combined with regorafenib

Other name: Drug: Irinotecan

Other name: Procedure: TACE

Other name: Device: drug eluting-bead

Intervention type: Drug
Intervention name: Regorafenib
Description: Drug: Regorafenib Regorafenib will be given 3 weeks on/1 week off (initial dose: 80 mg od po.)
Arm group label: regorafenib

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Bo Zhang

Address:
City: Guangdong
Country: China

Status: Recruiting

Contact:
Last name: Bo Zhang, M.D

Phone: +8613660397903
Email: zhangb28@mail.sysu.edu.cn

Contact backup:
Last name: Bo Zhang

Start date: June 10, 2023

Completion date: March 31, 2028

Lead sponsor:
Agency: Sun Yat-sen University
Agency class: Other

Source: Sun Yat-sen University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05794971