Colorectal Cancer Liver MetastasesPhase 3RIDERNCT05794971
Regorafenib Combined With Irinotecan Drug-Eluting Beads for Colorectal Cancer Liver Metastases
A Phase 3 study testing Regorafenib and DIBIRI and Regorafenib in people with Colorectal Cancer Liver Metastases and Regorafenib, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colorectal Cancer Liver Metastases, Regorafenib
- What is being tested?
- Regorafenib and DIBIRI and Regorafenib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2023to 31 Mar 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bo Zhang, M.D contact
China1 site, 1 recruiting
- Recruiting
Bo Zhang
Guangdong, Guangzhou
Bo Zhang, M.D, +8613660397903, zhangb28@mail.sysu.edu.cn
Bo Zhang
About this study
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)
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
- Being tested
- Regorafenib and DIBIRI, Regorafenib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regorafenib and DIBIRIDrug
Also called Drug: Irinotecan, Procedure: TACE, Device: drug eluting-bead
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.
RegorafenibDrug
Drug: Regorafenib Regorafenib will be given 3 weeks on/1 week off (initial dose: 80 mg od po.)
| Study group | Role | What they receive |
|---|---|---|
| Irinotecan Drug-Eluting Beads combined with regorafenib | Experimental | Not described Receives: Drug: Regorafenib and DIBIRI |
| regorafenib | Active comparator | Not described Receives: Drug: Regorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (5)
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.
Measured: 24 months
Objective Response Rate (ORR)
The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR)
Measured: 24 months
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)
Measured: 24 months
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
Measured: 24 months
Adverse enents
Safety variables will be summarized using descriptive statistics based on adverse events collection
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start10 Jun 2023 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer Liver MetastasesStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhong Deng, Sun Yat-sen University
- Investigators
- Bo Zhang, M.D, Study director, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794971
- Sponsor's protocol ID
- SYSU-IC-01
- Acronym
- RIDER
- Status last verified
- May 2023
- First submitted
- 20 Mar 2023
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05794971
- Acronym / sponsor ID
- RIDER / SYSU-IC-01
- Conditions
- Colorectal Cancer Liver Metastases, Regorafenib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 10 Jun 2023 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Irinotecan Drug-Eluting Beads combined with regorafenib | Experimental | Drug: Regorafenib and DIBIRI |
| regorafenib | Active comparator | Drug: Regorafenib |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regorafenib and DIBIRIAlso: Drug: Irinotecan, Procedure: TACE, Device: drug eluting-beadDrug: 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. | Drug | Irinotecan Drug-Eluting Beads combined with regorafenib |
| RegorafenibDrug: Regorafenib Regorafenib will be given 3 weeks on/1 week off (initial dose: 80 mg od po.) | Drug | regorafenib |
Primary outcome
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.
5 secondary outcomes
Progression-Free Survival (PFS)
Time frame: 24 months
Objective Response Rate (ORR)
Time frame: 24 months
Disease Control Rate (DCR)
Time frame: 24 months
Duration of response (DOR)
Time frame: 24 months
Adverse enents
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bo Zhang, M.D contact
Bo Zhang, M.D study director
Sixth Affiliated Hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Regorafenib and DIBIRI and Regorafenib in people with Colorectal Cancer Liver Metastases and Regorafenib, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bo Zhang, M.D (86-13660397903, zhangb28@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.