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

Primary Purpose

Colorectal Cancer Liver Metastases, Regorafenib

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Regorafenib and DIBIRI
Regorafenib
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer Liver Metastases

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bo ZhangRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Irinotecan Drug-Eluting Beads combined with regorafenib

regorafenib

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Progression-Free Survival (PFS)
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.
Objective Response Rate (ORR)
The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR)
Disease Control Rate (DCR)
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)
Duration of response (DOR)
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
Adverse enents
Safety variables will be summarized using descriptive statistics based on adverse events collection

Full Information

First Posted
March 20, 2023
Last Updated
May 12, 2023
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05794971
Brief Title
Regorafenib Combined With Irinotecan Drug-Eluting Beads for Colorectal Cancer Liver Metastases
Acronym
RIDER
Official Title
Regorafenib Combined With Irinotecan Drug-Eluting Beads as Third-line Treatment for Colorectal Cancer Liver Metastases: a Multicentre, Randomised Phase 3 Trial (RIDER)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2023 (Anticipated)
Primary Completion Date
March 31, 2027 (Anticipated)
Study Completion Date
March 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Liver Metastases, Regorafenib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Irinotecan Drug-Eluting Beads combined with regorafenib
Arm Type
Experimental
Arm Title
regorafenib
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Regorafenib and DIBIRI
Other Intervention Name(s)
Drug: Irinotecan, Procedure: TACE, Device: drug eluting-bead
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Regorafenib
Intervention Description
Drug: Regorafenib Regorafenib will be given 3 weeks on/1 week off (initial dose: 80 mg od po.)
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
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.
Time Frame
24 months
Title
Objective Response Rate (ORR)
Description
The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR)
Time Frame
24 months
Title
Disease Control Rate (DCR)
Description
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)
Time Frame
24 months
Title
Duration of response (DOR)
Description
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
Time Frame
24 months
Title
Adverse enents
Description
Safety variables will be summarized using descriptive statistics based on adverse events collection
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bo Zhang, M.D
Phone
86-13660397903
Email
zhangb28@mail.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Bo Zhang, M.D
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Zhang, M.D
Organizational Affiliation
Sixth Affiliated Hospital, Sun Yat-sen University
Official's Role
Study Director
Facility Information:
Facility Name
Bo Zhang
City
Guangdong
State/Province
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bo Zhang, M.D
Phone
+8613660397903
Email
zhangb28@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Bo Zhang

12. IPD Sharing Statement

Plan to Share IPD
No

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

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