Unresectable Colorectal Liver MetastasisNCT03264716
Transarterial Chemoembolization by Hepasphere Microspheres for the Treatment of Unresectable Colorectal Liver Metastasis
A study testing HepaSphere TACE (transarterial chemoembolization) in people with Unresectable Colorectal Liver Metastasis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Colorectal cancer is the third most frequently diagnosed cancer and the third leading cause of cancer related deaths in Taiwan. Of the 10,248 new colorectal patients diagnosed each year approximately 60% will develop liver metastasis during the course of their disease. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Unresectable Colorectal Liver Metastasis
- What is being tested?
- HepaSphere TACE (transarterial chemoembolization)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Aug 2017to 11 Sep 2018
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all of the following inclusion criteria in order to be entered into the study:
- Liver dominant metastatic colorectal cancer
- Metastatic colorectal patients who have failed first-line and second-line systemic chemotherapy.
- ECOG 0 to 1 or a Karnofsky Performance score of 80-100%;
- Age 20 years or older
- Patient has signed informed consent
Who cannot join
- If patients meet any of the following criteria they may not be entered into the study:
- History of severe allergy or intolerance to any contrast media not controlled with premedication
- Severe peripheral vascular disease that would preclude catheterization
- Significant extra-hepatic disease, generally in excess of 50% of the overall whole body tumor bulk outside the liver, or any tumor burden that represented an imminent threat to the patient's life
- Greater than 75% hepatic parenchymal involvement. Previous treatment with any form of transarterial embolization for liver tumors
- Female patients who are pregnant, breastfeeding, or premenopausal and not using an effective method of contraceptive g. Any contraindication to arteriography or hepatic embolization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Open-label Study of Transarterial Chemoembolization by Hepasphere Microspheres for the Treatment of Unresectable Colorectal Liver Metastasis
Colorectal cancer is the third most frequently diagnosed cancer and the third leading cause of cancer related deaths in Taiwan. Of the 10,248 new colorectal patients diagnosed each year approximately 60% will develop liver metastasis during the course of their disease. In approximately 30% of these patients who develop liver metastasis the metastatic disease will remain confined to the liver.
For the 70-75% of colorectal patients with colorectal liver metastasis not suitable for hepatic resection or similarly ablative therapy with curative intent, systemic chemotherapy is the standard initial management. However, after a patient has failed first- line and in some cases second-line chemotherapy, response rates fall to as low as 12% (Chen HX 2006). Transarterial chemoembolization (TACE) with microsphere is an alternative treatment because normal liver tissue receives most of its blood supply from the portal vein, while colorectal liver metastases derive most of their flow from the hepatic artery. Several clinical trials have explored the feasibility and the efficacy of TACE with microsphere as a treatment for patients with colorectal liver metastasis. HepaSphere represents a novel drug delivery system for chemoembolization, which can add two benefits to embolization therapy. First, by ionically binding the doxorubicin throughout the microspheres, more drug can be delivered into the tumor, with less escape into peripheral circulation. Second, conformability to the architecture of the vessel lumen, providing more contact surface area with the embolic material and the vessel intima, leading to a more complete occlusion. However, there are limited experiences in using HepaSphere TACE for colorectal liver metastasis in Taiwan. In this pilot study, we will evaluate the initiate safety and efficacy of Hepasphere microspheres loaded with a chemotherapeutic agent doxorubicin for the treatment of patients who have failed first-line and second-line systemic chemotherapy.
Read the detailed description
This is an open-label, non-comparative study aimed to evaluate the safety profiles and efficacy of patients with unresectable colorectal liver metastases treated by selective TACE (transarterial chemoembolization) using HepaSphere load with doxorubicin. Total of 15 patients will be planned to recruit.
The study procedures will consist of a screening period in which patient eligibility will be determined. Patients meeting the study entry criteria will receive one HepaSphere treatments. Computed tomography (CT) will be done 4 weeks after treatment to determine tumor response.
Hepatic progression free survival will be followed from the date of first study HepaSphere procedure until a date of target liver tumor progression is obtained or the patient is lost to follow-up. Treatments for liver metastases after the study HepaSphere treatments are complete will be documented during the survival period to the extent possible.
The investigators will evaluate subjects' previous treatments and response, and determine to use doxorubicin for subjects. 100 mg doxorubicin will be loaded onto the HepaSphere Microspheres (through ionic bonding when the spheres are exposed to doxorubicin solubilized in non-ionic contrast medium) and delivered via microcatheter. No ethiodized oil is used with the microspheres. The occlusion endpoint will be stasis to the second or third branches. If stasis has not been reached when the target dosage of doxorubicin has been delivered, additional bland embolic agent will be used to achieve a consistent endpoint. Other concurrent chemotherapy, such as Xeloda, 5-fluorouracil but not limited, can be used in combination with HepaSphere Tx.
The study will evaluate safety throughout the protocol specified treatment phase of the investigation by assessing adverse events, as well as changes from baseline in laboratory values, findings on physical examination including vital signs and Eastern Cooperative Oncology Group (ECOG) performance status. Concomitant medication usage will also be assessed.
- Conditions
- Unresectable Colorectal Liver Metastasis
- Being tested
- HepaSphere TACE (transarterial chemoembolization)
- Keywords
- TACE (transarterial chemoembolization), colorectal liver metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HepaSphere TACE (transarterial chemoembolization)Device
100 mg doxorubicin will be loaded onto the HepaSphere Microspheres and delivered via microcatheter.
| Study group | Role | What they receive |
|---|---|---|
| HepaSphere TACE (transarterial chemoembolization) | Experimental | Using HepaSphere TACE (transarterial chemoembolization) for colorectal liver metastasis. TACE using HepaSphere load with doxorubicin. Receives: Device: HepaSphere TACE (transarterial chemoembolization) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic Progression free survival
To define all participants from the day of the first HepaSphere Tx until the date that hepatic progression or death is first reported, whichever comes first.
Measured: up to one year
Secondary outcomes (1)
An overall tumor response classification
The tumor response will be assessed using modified Response Evaluation Criteria In Solid Tumors (mRECIST) criteria to evaluate tumor necrosis, and includes assessment of viable tumor, which is defined as uptake of contrast agent in the arterial phase of computed tomography (CT).
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start31 Aug 2017
- Primary completion26 Jan 2018
- Study completion11 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Colorectal Liver MetastasisStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kai-Wen Huang, MD. PhD., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264716
- Sponsor's protocol ID
- 201701124DIPB
- Status last verified
- Jun 2019
- First submitted
- 11 May 2017
- Last updated
- 15 Jul 2019
- 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 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Open-label Study of Transarterial Chemoembolization by Hepasphere Microspheres for the Treatment of Unresectable Colorectal Liver Metastasis
- ClinicalTrials.gov ID
- NCT03264716
- Acronym / sponsor ID
- 201701124DIPB
- Conditions
- Unresectable Colorectal Liver Metastasis
- Keywords
- TACE (transarterial chemoembolization), colorectal liver metastasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 31 Aug 2017 (actual)
- Primary completion
- 26 Jan 2018 (actual)
- Study completion
- 11 Sep 2018 (actual)
- First posted
- 29 Aug 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.
Colorectal cancer is the third most frequently diagnosed cancer and the third leading cause of cancer related deaths in Taiwan. Of the 10,248 new colorectal patients diagnosed each year approximately 60% will develop liver metastasis during the course of their disease. In approximately 30% of these patients who develop liver metastasis the metastatic disease will remain confined to the liver.
For the 70-75% of colorectal patients with colorectal liver metastasis not suitable for hepatic resection or similarly ablative therapy with curative intent, systemic chemotherapy is the standard initial management. However, after a patient has failed first- line and in some cases second-line chemotherapy, response rates fall to as low as 12% (Chen HX 2006). Transarterial chemoembolization (TACE) with microsphere is an alternative treatment because normal liver tissue receives most of its blood supply from the portal vein, while colorectal liver metastases derive most of their flow from the hepatic artery. Several clinical trials have explored the feasibility and the efficacy of TACE with microsphere as a treatment for patients with colorectal liver metastasis. HepaSphere represents a novel drug delivery system for chemoembolization, which can add two benefits to embolization therapy. First, by ionically binding the doxorubicin throughout the microspheres, more drug can be delivered into the tumor, with less escape into peripheral circulation. Second, conformability to the architecture of the vessel lumen, providing more contact surface area with the embolic material and the vessel intima, leading to a more complete occlusion. However, there are limited experiences in using HepaSphere TACE for colorectal liver metastasis in Taiwan. In this pilot study, we will evaluate the initiate safety and efficacy of Hepasphere microspheres loaded with a chemotherapeutic agent doxorubicin for the treatment of patients who have failed first-line and second-line systemic chemotherapy.
Detailed description
This is an open-label, non-comparative study aimed to evaluate the safety profiles and efficacy of patients with unresectable colorectal liver metastases treated by selective TACE (transarterial chemoembolization) using HepaSphere load with doxorubicin. Total of 15 patients will be planned to recruit.
The study procedures will consist of a screening period in which patient eligibility will be determined. Patients meeting the study entry criteria will receive one HepaSphere treatments. Computed tomography (CT) will be done 4 weeks after treatment to determine tumor response.
Hepatic progression free survival will be followed from the date of first study HepaSphere procedure until a date of target liver tumor progression is obtained or the patient is lost to follow-up. Treatments for liver metastases after the study HepaSphere treatments are complete will be documented during the survival period to the extent possible.
The investigators will evaluate subjects' previous treatments and response, and determine to use doxorubicin for subjects. 100 mg doxorubicin will be loaded onto the HepaSphere Microspheres (through ionic bonding when the spheres are exposed to doxorubicin solubilized in non-ionic contrast medium) and delivered via microcatheter. No ethiodized oil is used with the microspheres. The occlusion endpoint will be stasis to the second or third branches. If stasis has not been reached when the target dosage of doxorubicin has been delivered, additional bland embolic agent will be used to achieve a consistent endpoint. Other concurrent chemotherapy, such as Xeloda, 5-fluorouracil but not limited, can be used in combination with HepaSphere Tx.
The study will evaluate safety throughout the protocol specified treatment phase of the investigation by assessing adverse events, as well as changes from baseline in laboratory values, findings on physical examination including vital signs and Eastern Cooperative Oncology Group (ECOG) performance status. Concomitant medication usage will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HepaSphere TACE (transarterial chemoembolization) | Experimental | Device: HepaSphere TACE (transarterial chemoembolization)Using HepaSphere TACE (transarterial chemoembolization) for colorectal liver metastasis. TACE using HepaSphere load with doxorubicin. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must meet all of the following inclusion criteria in order to be entered into the study:
Key exclusion criteria (6 listed)
- If patients meet any of the following criteria they may not be entered into the study:
- History of severe allergy or intolerance to any contrast media not controlled with premedication
- Severe peripheral vascular disease that would preclude catheterization
- Significant extra-hepatic disease, generally in excess of 50% of the overall whole body tumor bulk outside the liver, or any tumor burden that represented an imminent threat to the patient's life
- Greater than 75% hepatic parenchymal involvement. Previous treatment with any form of transarterial embolization for liver tumors
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 |
|---|---|---|
| HepaSphere TACE (transarterial chemoembolization)100 mg doxorubicin will be loaded onto the HepaSphere Microspheres and delivered via microcatheter. | Device | HepaSphere TACE (transarterial chemoembolization) |
Primary outcome
Hepatic Progression free survival
Time frame: up to one year
To define all participants from the day of the first HepaSphere Tx until the date that hepatic progression or death is first reported, whichever comes first.
1 secondary outcome
An overall tumor response classification
Time frame: up to one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- 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.
Kai-Wen Huang, MD. PhD. principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HepaSphere TACE (transarterial chemoembolization) in people with Unresectable Colorectal Liver Metastasis, run by National Taiwan University Hospital at 1 site in Taiwan.
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 6 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: finished, as of the sponsor's last update on 15 Jul 2019. 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 Taiwan. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatic Progression free survival (time frame: up to one year). 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 Jul 2019.