Colon Cancer Liver MetastasisPhase 2/3DEBIRI-CRLMNCT03175016
Irinotecan-Eluting Bead (DEBIRI) for Patients With Liver Metastases From Colorectal Cancer
A Phase 2/3 study testing TACE, Irinotecan and eluting-bead in people with Colon Cancer Liver Metastasis, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This is a multicentre, open labeled, single arm study to determine effectiveness and safety of chemoembolization with Irinotecan-Eluting Bead(DEBIRI) in the treatment of unresectable liver metastases in patients with colorectal cancer after chemotherapy failure. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colon Cancer Liver Metastasis
- What is being tested?
- TACE, Irinotecan and eluting-bead
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2017to Dec 2019
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 75 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 with primary colorectal lesions removed, and negative extrahepatic metastasis
- Patients with at least one measurable liver metastases, with size > 2cm or less than 5 liver metastases,with size smaller than 10cm.
- Patients have received at least six cycle system chemotherapy based irinotecan or oxaliplatin and got a failure outcome; or patients who are intolerance of operation.
- No intervention therapy was received for liver lesions during one year.
- Life expectancy of > 3 months
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- Child-pugh's grade A or B (no more than 7 score).
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of < 2
- Signed, written informed consent
Who cannot join
- Patients with extrahepatic metastasis
- Patients has received TACE,ablation and iodine seed implantation for liver lesions during one year.
- With obvious arterio-venous fistula
- Patients suffered with other cancer(Except for cured basal or squamous cell skin cancer or cervical carcinoma in situ)
- Hematologic function: leukocytes <3000cell/mm3, platelets<50000/mm3, with no hypersplenism.
- Adequate renal function (creatinine ≤ 2.0mg/dl)
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- Alanine transaminase(ALT) and/or glutamic oxalacetic transaminase(AST) >5 times upper limit of normal(ULN)
- International Normalized Ratio (INR) >1.5, or being treated by anticoagulants, or being suffered hemorrhagic disease.
- With serious heart, kidney, bone marrow, or lung, central nervous system diseases.
- With recent infections and received antibiotics.
- Other conditions place the patient at undue risk and that would preclude the safe use of chemoembolization or would interfere with study participation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Zhi Guo, MD, 13920076145, cjr.guozhi@vip.163.com
Xueling Yang, MD, 15620930669, yxueling123@163.com
About this study
Official title: Irinotecan-Eluting Bead (DEBIRI) for Unresectable Liver Metastases From Colorectal Cancer After Systemic Chemotherapy Failure
This is a multicentre, open labeled, single arm study to determine effectiveness and safety of chemoembolization with Irinotecan-Eluting Bead(DEBIRI) in the treatment of unresectable liver metastases in patients with colorectal cancer after chemotherapy failure.
- Conditions
- Colon Cancer Liver Metastasis
- Being tested
- TACE, Irinotecan, eluting-bead
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACEProcedure or surgery
Also called Transcatheter arterial chemoembolization
Transcatheter arterial chemoembolization（TACE）is a minimally invasive procedure performed to restrict a tumor's blood supply.
IrinotecanDrug
Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extracted from the tree Camptotheca acuminata. Irinotecan hydrochloride trihydrate is a pale yellow to yellow crystalline powder, it is mixed in eluting-beads and injected in the tumor.
eluting-beadDevice
The eluting-bead,loaded with irinotecan (DEBIRI) to treat patients with hepatic metastases from colorectal cancer.
| Study group | Role | What they receive |
|---|---|---|
| DEBIRI | Experimental | Transcatheter arterial chemoembolization(TACE) with Irinotecan eluting-bead(DEBIRI) Receives: Procedure: TACE; Drug: Irinotecan; Device: eluting-bead |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Response of two months
Response rate(RR)
Measured: Two months post first treatment
Tumor Response of four months
Response rate(RR)
Measured: four months post first treatment
Tumor Response of six months
Response rate(RR)
Measured: Six months post first treatment
Secondary outcomes (4)
overall survival
overall survival(OS)
Measured: From date of first treatment until the date of death from any cause, whichever came first, assessed up to 24 months
Time to intrahepatic progression
Time to intrahepatic progression(THP)
Measured: From date of first treatment until the date of intrahepatic progression, whichever came first, assessed up to 24 months
Time to extrahepatic progression
Time to extrahepatic progression(TEP)
Measured: From date of first treatment until the date of extrahepatic progression, whichever came first, assessed up to 24 months
Quality of life
Assesment Quality of life by EORTC QOL-C30 questionnaire
Measured: Six months post first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start20 Jun 2017
- Primary completionAug 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon Cancer Liver MetastasisStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175016
- Sponsor's protocol ID
- TMU-CIH-IR-006
- Acronym
- DEBIRI-CRLM
- Status last verified
- May 2017
- First submitted
- 28 May 2017
- Last updated
- 27 Jun 2017
- 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 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Irinotecan-Eluting Bead (DEBIRI) for Unresectable Liver Metastases From Colorectal Cancer After Systemic Chemotherapy Failure
- ClinicalTrials.gov ID
- NCT03175016
- Acronym / sponsor ID
- DEBIRI-CRLM / TMU-CIH-IR-006
- Conditions
- Colon Cancer Liver Metastasis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 5 Jun 2017 (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 is a multicentre, open labeled, single arm study to determine effectiveness and safety of chemoembolization with Irinotecan-Eluting Bead(DEBIRI) in the treatment of unresectable liver metastases in patients with colorectal cancer after chemotherapy failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DEBIRI | Experimental | Procedure: TACE, Drug: Irinotecan, Device: eluting-beadTranscatheter arterial chemoembolization(TACE) with Irinotecan eluting-bead(DEBIRI) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 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 with primary colorectal lesions removed, and negative extrahepatic metastasis
- Patients with at least one measurable liver metastases, with size > 2cm or less than 5 liver metastases,with size smaller than 10cm.
- Patients have received at least six cycle system chemotherapy based irinotecan or oxaliplatin and got a failure outcome; or patients who are intolerance of operation.
- No intervention therapy was received for liver lesions during one year.
Key exclusion criteria (11 listed)
- Patients with extrahepatic metastasis
- Patients has received TACE,ablation and iodine seed implantation for liver lesions during one year.
- With obvious arterio-venous fistula
- Patients suffered with other cancer(Except for cured basal or squamous cell skin cancer or cervical carcinoma in situ)
- Hematologic function: leukocytes <3000cell/mm3, platelets<50000/mm3, with no hypersplenism.
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 |
|---|---|---|
| TACEAlso: Transcatheter arterial chemoembolizationTranscatheter arterial chemoembolization（TACE）is a minimally invasive procedure performed to restrict a tumor's blood supply. | Procedure or surgery | DEBIRI |
| IrinotecanIrinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extracted from the tree Camptotheca acuminata. Irinotecan hydrochloride trihydrate is a pale yellow to yellow crystalline powder, it is mixed in eluting-beads and injected in the tumor. | Drug | DEBIRI |
| eluting-beadThe eluting-bead,loaded with irinotecan (DEBIRI) to treat patients with hepatic metastases from colorectal cancer. | Device | DEBIRI |
Primary outcome
Tumor Response of two months
Time frame: Two months post first treatment
Response rate(RR)
Tumor Response of four months
Time frame: four months post first treatment
Response rate(RR)
Tumor Response of six months
Time frame: Six months post first treatment
Response rate(RR)
4 secondary outcomes
overall survival
Time frame: From date of first treatment until the date of death from any cause, whichever came first, assessed up to 24 months
Time to intrahepatic progression
Time frame: From date of first treatment until the date of intrahepatic progression, whichever came first, assessed up to 24 months
Time to extrahepatic progression
Time frame: From date of first treatment until the date of extrahepatic progression, whichever came first, assessed up to 24 months
Quality of life
Time frame: Six months post first treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing TACE, Irinotecan and eluting-bead in people with Colon Cancer Liver Metastasis, run by Tianjin Medical University Cancer Institute and Hospital 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 9 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 27 Jun 2017. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhi Guo, PhD (13920076145, cjr.guozhi@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor Response of two months (time frame: Two months post first treatment). The study lists 3 primary outcomes in all. 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 27 Jun 2017.