Liver Metastasis Colon CancerPhase 1/2SYS-CAPLIOXNCT04701281
Study of Intra-Arterial Oxaliplatin Plus Capecitabine to Treat Liver Metastases From Colorectal Cancer
A Phase 1/2 study testing Intra-arterial LIOX + Capecitabine in people with Liver Metastasis Colon Cancer, run by AllVascular at 5 sites in Australia.
Trial summary
The treatment proposed in this trial is to administer intra-arterial chemotherapy to liver metastases from colorectal cancer when the blood flow to and from the liver has been isolated via balloon catheters through a vascular access system called the AVAS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Metastasis Colon Cancer
- What is being tested?
- Intra-arterial LIOX + Capecitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 5 sitesAustralia
- Study dates
- 2 Mar 2022to 19 Oct 2022
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females, aged 18 years or older, with hepatic metastases from histologically proven adenocarcinoma of the colon/rectum;
- Limited extrahepatic metastases in the lung or lymph nodes;
- Confirmed non-progressive disease in the liver, per RECIST v1.1, halfway into the first-line systemic chemotherapy regimen after a minimum of 4 cycles of FOLFOX/XELOX ± monoclonal antibodies OR liver-dominant pre-treated or refractory patients;
- Genotype: RAS mutant for first line patients only. All genetic mutations allowable for pre-treated or refractory patients;
- Prior treatment with monoclonal antibody treatment is ≥ 4 weeks before implantation;
- Considered medically fit for repeated general anaesthesia;
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- ECOG performance status 0-1;
- Adequate bone marrow function (within 14 days of enrolment):
- Haemoglobin ≥ 100 g/L; ANC ≥ 1.5 × 10^9/L; Platelet Count ≥ 100 × 10^9/L;
- Adequate renal function (within 14 days of enrolment):
- Serum Creatinine ≤ 1.5 × Upper Limit of Normal;
- Adequate liver function (within 14 days of enrolment):
- Bilirubin ≤2.0 × Upper Limit of Normal; AST ≤ 5 × Upper Limit of Normal;
- Normal coagulation (within 14 days of enrolment):
- INR ≤ 1.5;
- Able to understand the risks and benefits of the study and provide signed, written informed consent to participate;
- Willing and able to comply with all study requirements and assessments;
Who cannot join
- CT-angiogram confirms unsuitable vascular anatomy;
- No measurable liver disease per RECIST v1.1;
- Evidence of ascites, cirrhosis, portal hypertension, main portal venous tumour involvement or main portal venous thrombosis;
- Allergies to contrast agents;
- Previous hypersensitivity or laryngo-pharyngeal dysaesthesia associated with oxaliplatin;
- Previous allergies associated with 5-FU or oxaliplatin;
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- Grade > 2 peripheral neuropathy (CTCAE 5.0);
- Significant co-morbidities;
- Life expectancy ≤ 3 months;
- Pregnant or breastfeeding women, or women of childbearing potential and men who are not on a reliable form of birth control or barrier method of contraception;
- Enrolled or intend to participate in another clinical trial (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during this clinical study;
- Medical conditions that preclude the testing required by the protocol, or limit study participation;
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Australia5 sites
Lake Macquarie Private Hospital
Gateshead, New South Wales, 2290
GenesisCare, St Leonards
Saint Leonards, New South Wales, 2065
Gold Coast Private Hospital
Southport, Queensland, 4215
Sydney Adventist Hospital
Sydney, New South Wales, 2076
Sydney Southwest Private Hospital
Sydney, New South Wales, 2170
About this study
Official title: Phase Ib/II Study of Intra-Arterial Liver Isolation Chemotherapy in Patients With Hepatic Metastases From Colorectal Cancer
The treatment proposed in this trial is to administer intra-arterial chemotherapy to liver metastases from colorectal cancer when the blood flow to and from the liver has been isolated via balloon catheters through a vascular access system called the AVAS. The objective of this study is to evaluate the tumour response of repeated and isolated intra-arterial liver isolation oxaliplatin compared with the standard systemic chemotherapy (intravenous 5-FU + leucovorin + oxaliplatin [FOLFOX] or oral capecitabine with IV oxaliplatin [XELOX]).
Read the detailed description
The treatment proposed in this study is based on the hypothesis that direct arterial infusion of chemotherapy to metastatic tumours of the liver whilst the blood flow to the organ is isolated could potentially yield benefits that cannot be achieved with existing treatment regimens.
There are three treatment stages; implantation of a vascular access device (known as the AVAS), intra-arterial liver isolation oxaliplatin (LIOX) infusions and explantation of the AVAS.
Implantation: the participant is admitted to hospital and the AVAS is surgically implanted under general anaesthetic. The AVAS is an implantable large bore cannula with one end that can be anastomosed directly onto a peripheral vessel and the opposite end exiting the patient's skin. The device can be opened to access the patient's vasculature when required and closed when the device is not in use. In accordance with the manufacturer's Instructions-For-Use (IFU), the AVAS will be implanted in the axillary artery (i.e. the upper pectoral area) or in the common femoral artery (upper thigh) by a surgeon experienced in vascular disease. The implantation procedure takes around 2 hours. After implantation, the participant is monitored overnight.
Intra-arterial LIOX infusions: the participant is admitted to the angiography suite and under general anaesthetic or conscious sedation, intra-arterial hepatic isolation chemotherapy infusion is administered by an interventional radiologist. The first infusion can be administered 2 days after device implantation and infusions are spread out over an 8-week period at a maximum such that the patient receives 5 to 7 infusions in total, has at least 2 full calendar days between each infusion, and there are no more than 2 infusions over any 7 consecutive days. Each infusion can take between 2-3 hours during the first few infusions but should only take 1-2 hours for the remaining infusions as the radiologist becomes familiarised with the patient's vascular anatomy.
During the Phase Ib stage, the starting dose of the oxaliplatin infused will be 50mg/m^2 and this dose will be escalated by 10mg/m^2 with each patient until an optimal dose is established. The optimal dose will be used for all patients enrolled during the Phase II stage.
Explantation: the final infusion session is followed by the device explantation immediately, or at a later time depending on the availability of operating rooms and the condition of the participant. The surgical removal of the device takes approximately 1-2 hours, the participant is monitored overnight and discharged the next day.
In addition, capecitabine will be administered orally as per standard care (1000 mg/m^2 twice daily in 2 week cycles) throughout the study treatment period (from enrolment to 4 weeks after the AVAS explantation) as a form of systemic disease management. The oncologist may modify the capecitabine dose/frequency based on the patient's response to the medication.
- Conditions
- Liver Metastasis Colon Cancer
- Being tested
- Intra-arterial LIOX + Capecitabine
- Keywords
- liver, metastases, colon, rectal, intra-arterial
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-arterial LIOX + CapecitabineCombination product
5 - 7 LIOX (liver isolation oxaliplatin) intra-arterial infusions over 8 weeks + capecitabine
| Study group | Role | What they receive |
|---|---|---|
| Intra-arterial LIOX + Capecitabine | Experimental | 5 - 7 LIOX (liver isolation oxaliplatin) intra-arterial infusions over 8 weeks + capecitabine Receives: Combination Product: Intra-arterial LIOX + Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver-specific response rate (RR)
Assessed via clinical imaging and tumour markers using RECIST v1.1;
Measured: 4 weeks post explantation of AVAS;
Secondary outcomes (7)
Two-year survival rate;
During follow-up;
Measured: 3, 6, 9, 12, 18 and 24 months post end of treatment and AVAS explantation;
Progression free survival (PFS);
During follow-up;
Measured: 3, 6, 9, 12, 18 and 24 months post end of treatment and AVAS explantation;
Systemic side effects to chemotherapy
Assessed by collection of adverse events using Common Terminology Criteria for Adverse Events (CTCAE v5.0);
Measured: From enrolment until primary outcome is assessed (4 weeks post AVAS explantation);
Organ isolation capability
Determined by pressure readings on catheters;
Measured: Measured after each infusion treatment, through study completion, up to 8 weeks;
Conversion to resection rate;
Measured: Assessed at end of treatment, 4 weeks post AVAS explanation;
Health-related Quality of life (QoL);
Assessed quality of life questionnaire : comprising of 28 lifestyle and health questions using a four point scale (not at all, a little, quite a bit, very much) and 2 questions measuring overall health and overall quality of life on a visual analogue scale (1 very poor - 7 excellent);
Measured: Through study completion, an average of 8 weeks;
Health-related Quality of life (QoL);
Assessed via quality of life questionnaire : comprising 10 digestion and and health questions using a four point scale (not at all, a little, quite a bit, very much);
Measured: Through study completion, an average of 8 weeks;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start2 Mar 2022
- Primary completion19 Sep 2022
- Study completion19 Oct 2022
Why it stopped: Funding depleted to continue study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Metastasis Colon CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, two cohorts: Cohort 1: 1st line patients, RAS mutant; Cohort 2: pre-treated or refractory patients, no specific mutation
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- AllVascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nick Pavlakis, A/Prof, Study chair, GenesisCare, St Leonards
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701281
- Sponsor's protocol ID
- SYS-CAPLIOX
- Acronym
- SYS-CAPLIOX
- Status last verified
- Sep 2025
- First submitted
- 4 Jan 2021
- Last updated
- 18 Sep 2025
- 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 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib/II Study of Intra-Arterial Liver Isolation Chemotherapy in Patients With Hepatic Metastases From Colorectal Cancer
- ClinicalTrials.gov ID
- NCT04701281
- Acronym / sponsor ID
- SYS-CAPLIOX / SYS-CAPLIOX
- Conditions
- Liver Metastasis Colon Cancer
- Keywords
- liver, metastases, colon, rectal, intra-arterial
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding depleted to continue study
- Enrolment
- 5 participants (actual)
- Lead sponsor
- AllVascularIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 19 Sep 2022 (actual)
- Study completion
- 19 Oct 2022 (actual)
- First posted
- 8 Jan 2021 (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.
The treatment proposed in this trial is to administer intra-arterial chemotherapy to liver metastases from colorectal cancer when the blood flow to and from the liver has been isolated via balloon catheters through a vascular access system called the AVAS. The objective of this study is to evaluate the tumour response of repeated and isolated intra-arterial liver isolation oxaliplatin compared with the standard systemic chemotherapy (intravenous 5-FU + leucovorin + oxaliplatin [FOLFOX] or oral capecitabine with IV oxaliplatin [XELOX]).
Detailed description
The treatment proposed in this study is based on the hypothesis that direct arterial infusion of chemotherapy to metastatic tumours of the liver whilst the blood flow to the organ is isolated could potentially yield benefits that cannot be achieved with existing treatment regimens.
There are three treatment stages; implantation of a vascular access device (known as the AVAS), intra-arterial liver isolation oxaliplatin (LIOX) infusions and explantation of the AVAS.
Implantation: the participant is admitted to hospital and the AVAS is surgically implanted under general anaesthetic. The AVAS is an implantable large bore cannula with one end that can be anastomosed directly onto a peripheral vessel and the opposite end exiting the patient's skin. The device can be opened to access the patient's vasculature when required and closed when the device is not in use. In accordance with the manufacturer's Instructions-For-Use (IFU), the AVAS will be implanted in the axillary artery (i.e. the upper pectoral area) or in the common femoral artery (upper thigh) by a surgeon experienced in vascular disease. The implantation procedure takes around 2 hours. After implantation, the participant is monitored overnight.
Intra-arterial LIOX infusions: the participant is admitted to the angiography suite and under general anaesthetic or conscious sedation, intra-arterial hepatic isolation chemotherapy infusion is administered by an interventional radiologist. The first infusion can be administered 2 days after device implantation and infusions are spread out over an 8-week period at a maximum such that the patient receives 5 to 7 infusions in total, has at least 2 full calendar days between each infusion, and there are no more than 2 infusions over any 7 consecutive days. Each infusion can take between 2-3 hours during the first few infusions but should only take 1-2 hours for the remaining infusions as the radiologist becomes familiarised with the patient's vascular anatomy.
During the Phase Ib stage, the starting dose of the oxaliplatin infused will be 50mg/m^2 and this dose will be escalated by 10mg/m^2 with each patient until an optimal dose is established. The optimal dose will be used for all patients enrolled during the Phase II stage.
Explantation: the final infusion session is followed by the device explantation immediately, or at a later time depending on the availability of operating rooms and the condition of the participant. The surgical removal of the device takes approximately 1-2 hours, the participant is monitored overnight and discharged the next day.
In addition, capecitabine will be administered orally as per standard care (1000 mg/m^2 twice daily in 2 week cycles) throughout the study treatment period (from enrolment to 4 weeks after the AVAS explantation) as a form of systemic disease management. The oncologist may modify the capecitabine dose/frequency based on the patient's response to the medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, two cohorts: Cohort 1: 1st line patients, RAS mutant; Cohort 2: pre-treated or refractory patients, no specific mutation
| Arm | Type | Receives |
|---|---|---|
| Intra-arterial LIOX + Capecitabine | Experimental | Combination Product: Intra-arterial LIOX + Capecitabine5 - 7 LIOX (liver isolation oxaliplatin) intra-arterial infusions over 8 weeks + capecitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Males or females, aged 18 years or older, with hepatic metastases from histologically proven adenocarcinoma of the colon/rectum;
- Limited extrahepatic metastases in the lung or lymph nodes;
- Confirmed non-progressive disease in the liver, per RECIST v1.1, halfway into the first-line systemic chemotherapy regimen after a minimum of 4 cycles of FOLFOX/XELOX ± monoclonal antibodies OR liver-dominant pre-treated or refractory patients;
- Genotype: RAS mutant for first line patients only. All genetic mutations allowable for pre-treated or refractory patients;
- Prior treatment with monoclonal antibody treatment is ≥ 4 weeks before implantation;
Key exclusion criteria (12 listed)
- CT-angiogram confirms unsuitable vascular anatomy;
- No measurable liver disease per RECIST v1.1;
- Evidence of ascites, cirrhosis, portal hypertension, main portal venous tumour involvement or main portal venous thrombosis;
- Allergies to contrast agents;
- Previous hypersensitivity or laryngo-pharyngeal dysaesthesia associated with oxaliplatin;
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 |
|---|---|---|
| Intra-arterial LIOX + Capecitabine5 - 7 LIOX (liver isolation oxaliplatin) intra-arterial infusions over 8 weeks + capecitabine | Combination product | Intra-arterial LIOX + Capecitabine |
Primary outcome
Liver-specific response rate (RR)
Time frame: 4 weeks post explantation of AVAS;
Assessed via clinical imaging and tumour markers using RECIST v1.1;
7 secondary outcomes
Two-year survival rate;
Time frame: 3, 6, 9, 12, 18 and 24 months post end of treatment and AVAS explantation;
Progression free survival (PFS);
Time frame: 3, 6, 9, 12, 18 and 24 months post end of treatment and AVAS explantation;
Systemic side effects to chemotherapy
Time frame: From enrolment until primary outcome is assessed (4 weeks post AVAS explantation);
Organ isolation capability
Time frame: Measured after each infusion treatment, through study completion, up to 8 weeks;
Conversion to resection rate;
Time frame: Assessed at end of treatment, 4 weeks post AVAS explanation;
Health-related Quality of life (QoL);
Time frame: Through study completion, an average of 8 weeks;
Health-related Quality of life (QoL);
Time frame: Through study completion, an average of 8 weeks;
Results and safety
The study was stopped early (reason given: Funding depleted to continue study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Related InfoLink provided by the sponsor.
- 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.
Nick Pavlakis, A/Prof study chair
GenesisCare, St Leonards
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intra-arterial LIOX + Capecitabine in people with Liver Metastasis Colon Cancer, run by AllVascular at 5 sites in Australia.
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 17 inclusion and 12 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: stopped early, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Funding depleted to continue study). Results are not available in the source record.
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?
Liver-specific response rate (RR) (time frame: 4 weeks post explantation of AVAS;). 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 18 Sep 2025.