Colorectal Cancer Liver MetastasisNCT06021015
Safety and Efficacy of Polyvinyl Alcohol Sodium Acrylate Embolization Microspheres for CRLM
A study testing Irinotecan and polyvinyl alcohol sodium acrylate embolization microspheres（Unipearls®） and Irinotecan and HepaSphere Microspheres in people with Colorectal Cancer Liver Metastasis, run by Zhongda Hospital.
Trial summary
This study is a prospective, multicenter, randomized controlled clinical trial to evaluate the safety and efficacy of polyvinyl alcohol sodium acrylate embolization microspheres and HepaSphere Microspheres loaded with irinotecan for the treatment of colorectal cancer with hepatic metastases through arterial… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer Liver Metastasis
- What is being tested?
- Irinotecan and polyvinyl alcohol sodium acrylate embolization microspheres（Unipearls®） and Irinotecan and HepaSphere Microspheres
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2023to 31 Dec 2025
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range from 18 to 80 years old (including threshold), regardless of gender；
- Imaging or pathology/cytology clearly diagnosed as colorectal cancer liver metastases, with complete resection of the primary lesion and no local recurrence;
- Researchers believe that liver metastases are not feasible or suitable, or patients refuse surgical resection；
- ECOG score ≤ 2 points, Child Pugh grade A or B；
- At least one measurable liver metastasis with a diameter greater than 1 cm without embolization treatment (the maximum diameter of the target lesion is less than 10 cm)；
- Voluntarily participate in this clinical trial and sign the informed consent form.
Who cannot join
- Patients with known severe allergy to contrast agents (iodine contrast agents, gadolinium contrast agents, etc.) or embolic materials (polyvinyl alcohol sodium acrylate copolymer) ;
- White blood cell count<3.0×109/L, platelet count<75×109/L，hemoglobin<70 g/L；
- Total bilirubin>2 times the upper limit of normal value, Alanine transaminase (ALT) or aspartate aminotransferase (AST) >5 times the upper limit of normal value, Alkaline phosphatase>2.5 times the upper limit of normal value, albumin<30 g/L;
- Creatinine>1.5 times the upper limit of normal value, creatinine clearance rate<30 mL/min;
- Prothrombin time and activated partial thromboplastin time>1.5 times the upper limit of normal value;
- Target lesion blood supply artery cannot undergo TACE treatment (the blood supply artery is too thin，vasospasm or suspected vasospasm，peripheral vascular resistance of the blood supply artery hinders the entry of embolic microspheres into the lesion site，severe Atherosclerosis, etc) or there is a risk of embolism (collateral vascular pathway endangers normal areas, etc)；
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- The expected survival time is less than 3 months;
- Patients who have received embolization therapy for the target lesion or undergo the first TACE treatment for the target lesion after enrollment and require combined ablation/radiotherapy;
- Pregnant and lactating women, or those who plan to conceive during the study period;
- Those who have participated in other intervention clinical trials within one month before the trial;
- The researchers believe that the subjects are intolerant and other unsuitable candidates for participating in this clinical trial.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Clinical Trial on the Safety and Efficacy of Polyvinyl Alcohol Sodium Acrylate Embolization Microspheres for Transcatheter Arterial Chemoembolization of Colorectal Cancer Liver Metastases
This study is a prospective, multicenter, randomized controlled clinical trial to evaluate the safety and efficacy of polyvinyl alcohol sodium acrylate embolization microspheres and HepaSphere Microspheres loaded with irinotecan for the treatment of colorectal cancer with hepatic metastases through arterial chemoembolization.
Read the detailed description
This study is a prospective, multicenter, randomized controlled clinical trial. Seventy-two patients with colorectal cancer liver metastases that are not feasible or suitable for surgical resection will be enrolled in this study. The experimental group received transcatheter arterial chemoembolization (TACE) treatment with polyvinyl alcohol sodium acrylate embolization microspheres loaded with 100mg irinotecan and the control group received TACE treatment with HepaSphere Microspheres loaded with 100mg irinotecan. All patients received 1-2 TACE treatment as needed. The primary end point of this study is disease control rate (DCR) of target lesions 1 month after the last TACE treatment.
- Conditions
- Colorectal Cancer Liver Metastasis
- Being tested
- Irinotecan and polyvinyl alcohol sodium acrylate embolization microspheres（Unipearls®）, Irinotecan and HepaSphere Microspheres
- Keywords
- colorectal cancer, liver metastasis, embolization microspheres, efficacy, safety, transcatheter arterial chemoembolization
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan and polyvinyl alcohol sodium acrylate embolization microspheres（Unipearls®）Device
Irinotecan and polyvinyl alcohol sodium acrylate embolization microspheres（Unipearls®）
Irinotecan and HepaSphere MicrospheresDevice
Irinotecan and HepaSphere Microspheres
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Irinotecan and polyvinyl alcohol sodium acrylate embolization microspheres（Unipearls®） Receives: Device: Irinotecan and polyvinyl alcohol sodium acrylate embolization microspheres（Unipearls®） |
| Control group | Active comparator | Irinotecan and HepaSphere Microspheres Receives: Device: Irinotecan and HepaSphere Microspheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control rate (DCR) of target lesions 1 month after the last TACE treatment
Disease control rate (DCR) of target lesions 1 month after the last TACE treatment
Measured: 3 month
Secondary outcomes (4)
Success rate
The success rate of embolization techniques for target lesions
Measured: 3 month
Disease control rate (DCR) of target lesions 1 month after first TACE treatment
Disease control rate (DCR) of target lesions 1 month after first TACE treatment
Measured: 1 month
Objective response rate (ORR)
Objective response rate (ORR) of target lesions 1 month after the first TACE treatment and 1 month after the last TACE treatment
Measured: 3 month
Equipment performance evaluation
Equipment performance evaluation: evaluation of conveying performance and degree of embolism
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start10 Sep 2023 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer Liver MetastasisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao-jun Teng, Zhongda Hospital
- Investigators
- Gao-Jun Teng, MD, Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021015
- Sponsor's protocol ID
- DEBIRI-TACE
- Status last verified
- Aug 2023
- First submitted
- 27 Aug 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weng S, Hu W, Tu J, Xi J, Shi H, Wu M, Huang J, Zhu H, Yang Z. Spatial Acid-Associated Niches Inform Irinotecan-Based DEB-TACE in Colorectal Liver Metastases: A Multicentre Randomized Trial. Liver Int. 2026 Dec;46(12):e70931. doi: 10.1111/liv.70931.
PubMed 42969685
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Clinical Trial on the Safety and Efficacy of Polyvinyl Alcohol Sodium Acrylate Embolization Microspheres for Transcatheter Arterial Chemoembolization of Colorectal Cancer Liver Metastases
- ClinicalTrials.gov ID
- NCT06021015
- Acronym / sponsor ID
- DEBIRI-TACE
- Conditions
- Colorectal Cancer Liver Metastasis
- Keywords
- colorectal cancer, liver metastasis, embolization microspheres, efficacy, safety, transcatheter arterial chemoembolization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 10 Sep 2023 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Sep 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 prospective, multicenter, randomized controlled clinical trial to evaluate the safety and efficacy of polyvinyl alcohol sodium acrylate embolization microspheres and HepaSphere Microspheres loaded with irinotecan for the treatment of colorectal cancer with hepatic metastases through arterial chemoembolization.
Detailed description
This study is a prospective, multicenter, randomized controlled clinical trial. Seventy-two patients with colorectal cancer liver metastases that are not feasible or suitable for surgical resection will be enrolled in this study. The experimental group received transcatheter arterial chemoembolization (TACE) treatment with polyvinyl alcohol sodium acrylate embolization microspheres loaded with 100mg irinotecan and the control group received TACE treatment with HepaSphere Microspheres loaded with 100mg irinotecan. All patients received 1-2 TACE treatment as needed. The primary end point of this study is disease control rate (DCR) of target lesions 1 month after the last TACE treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Irinotecan and polyvinyl alcohol sodium acrylate embolization microspheres（Unipearls®）Irinotecan and polyvinyl alcohol sodium acrylate embolization microspheres（Unipearls®） |
| Control group | Active comparator | Device: Irinotecan and HepaSphere MicrospheresIrinotecan and HepaSphere Microspheres |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age range from 18 to 80 years old (including threshold), regardless of gender；
- Imaging or pathology/cytology clearly diagnosed as colorectal cancer liver metastases, with complete resection of the primary lesion and no local recurrence;
- Researchers believe that liver metastases are not feasible or suitable, or patients refuse surgical resection；
- ECOG score ≤ 2 points, Child Pugh grade A or B；
- At least one measurable liver metastasis with a diameter greater than 1 cm without embolization treatment (the maximum diameter of the target lesion is less than 10 cm)；
Key exclusion criteria (11 listed)
- Patients with known severe allergy to contrast agents (iodine contrast agents, gadolinium contrast agents, etc.) or embolic materials (polyvinyl alcohol sodium acrylate copolymer) ;
- White blood cell count<3.0×109/L, platelet count<75×109/L，hemoglobin<70 g/L；
- Total bilirubin>2 times the upper limit of normal value, Alanine transaminase (ALT) or aspartate aminotransferase (AST) >5 times the upper limit of normal value, Alkaline phosphatase>2.5 times the upper limit of normal value, albumin<30 g/L;
- Creatinine>1.5 times the upper limit of normal value, creatinine clearance rate<30 mL/min;
- Prothrombin time and activated partial thromboplastin time>1.5 times the upper limit of normal value;
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 |
|---|---|---|
| Irinotecan and polyvinyl alcohol sodium acrylate embolization microspheres（Unipearls®）Irinotecan and polyvinyl alcohol sodium acrylate embolization microspheres（Unipearls®） | Device | Experimental group |
| Irinotecan and HepaSphere MicrospheresIrinotecan and HepaSphere Microspheres | Device | Control group |
Primary outcome
Disease control rate (DCR) of target lesions 1 month after the last TACE treatment
Time frame: 3 month
Disease control rate (DCR) of target lesions 1 month after the last TACE treatment
4 secondary outcomes
Success rate
Time frame: 3 month
Disease control rate (DCR) of target lesions 1 month after first TACE treatment
Time frame: 1 month
Objective response rate (ORR)
Time frame: 3 month
Equipment performance evaluation
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Derived from this study: PubMed 42969685Weng S, Hu W, Tu J, Xi J, Shi H, Wu M, Huang J, Zhu H, Yang Z. Spatial Acid-Associated Niches Inform Irinotecan-Based DEB-TACE in Colorectal Liver Metastases: A Multicentre Randomized Trial. Liver Int. 2026 Dec;46(12):e70931. doi: 10.1111/liv.70931.
- 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.
Gao-Jun Teng, MD principal investigator
Zhongda Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Irinotecan and polyvinyl alcohol sodium acrylate embolization microspheres（Unipearls®） and Irinotecan and HepaSphere Microspheres in people with Colorectal Cancer Liver Metastasis, run by Zhongda Hospital.
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 6 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 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Jian Lu, MD (+8615850654644, lujian43307131@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease control rate (DCR) of target lesions 1 month after the last TACE treatment (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06021015, which also lists 1 linked publication.
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 1 Sep 2023.