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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04701281




Registration number
NCT04701281
Ethics application status
Date submitted
4/01/2021
Date registered
8/01/2021

Titles & IDs
Public title
Study of Intra-Arterial Oxaliplatin Plus Capecitabine to Treat Liver Metastases From Colorectal Cancer
Scientific title
Phase Ib/II Study of Intra-Arterial Liver Isolation Chemotherapy in Patients With Hepatic Metastases From Colorectal Cancer
Secondary ID [1] 0 0
SYS-CAPLIOX
Universal Trial Number (UTN)
Trial acronym
SYS-CAPLIOX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Liver Metastasis Colon Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Intra-arterial LIOX + Capecitabine

Experimental: Intra-arterial LIOX + Capecitabine - 5 - 7 LIOX (liver isolation oxaliplatin) intra-arterial infusions over 8 weeks + capecitabine


Other interventions: Intra-arterial LIOX + Capecitabine
5 - 7 LIOX (liver isolation oxaliplatin) intra-arterial infusions over 8 weeks + capecitabine
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Liver-specific response rate (RR)
Assessment method [1] 0 0
Assessed via clinical imaging and tumour markers using RECIST v1.1;
Timepoint [1] 0 0
4 weeks post explantation of AVAS;
Secondary outcome [1] 0 0
Two-year survival rate;
Assessment method [1] 0 0
During follow-up;
Timepoint [1] 0 0
3, 6, 9, 12, 18 and 24 months post end of treatment and AVAS explantation;
Secondary outcome [2] 0 0
Progression free survival (PFS);
Assessment method [2] 0 0
During follow-up;
Timepoint [2] 0 0
3, 6, 9, 12, 18 and 24 months post end of treatment and AVAS explantation;
Secondary outcome [3] 0 0
Systemic side effects to chemotherapy
Assessment method [3] 0 0
Assessed by collection of adverse events using Common Terminology Criteria for Adverse Events (CTCAE v5.0);
Timepoint [3] 0 0
From enrolment until primary outcome is assessed (4 weeks post AVAS explantation);
Secondary outcome [4] 0 0
Organ isolation capability
Assessment method [4] 0 0
Determined by pressure readings on catheters;
Timepoint [4] 0 0
Measured after each infusion treatment, through study completion, up to 8 weeks;
Secondary outcome [5] 0 0
Conversion to resection rate;
Assessment method [5] 0 0
Timepoint [5] 0 0
Assessed at end of treatment, 4 weeks post AVAS explanation;
Secondary outcome [6] 0 0
Health-related Quality of life (QoL);
Assessment method [6] 0 0
Assessed via EORTC Quality of Life Questionnaire C30: comprising 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);
Timepoint [6] 0 0
Through study completion, an average of 8 weeks;
Secondary outcome [7] 0 0
Health-related Quality of life (QoL);
Assessment method [7] 0 0
Assessed via EORTC Quality of Life Questionnaire LMC21: comprising 10 digestion and and health questions using a four point scale (not at all, a little, quite a bit, very much);
Timepoint [7] 0 0
Through study completion, an average of 8 weeks;

Eligibility
Key inclusion criteria
1. Males or females, aged 18 years or older, with hepatic metastases from histologically proven adenocarcinoma of the colon/rectum;
2. Limited extrahepatic metastases in the lung or lymph nodes;
3. 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;
4. Genotype: RAS mutant for first line patients only. All genetic mutations allowable for pre-treated or refractory patients;
5. Prior treatment with monoclonal antibody treatment is = 4 weeks before implantation;
6. Considered medically fit for repeated general anaesthesia;
7. ECOG performance status 0-1;
8. 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;
9. Adequate renal function (within 14 days of enrolment):

Serum Creatinine = 1.5 × Upper Limit of Normal;
10. Adequate liver function (within 14 days of enrolment):

Bilirubin =2.0 × Upper Limit of Normal; AST = 5 × Upper Limit of Normal;
11. Normal coagulation (within 14 days of enrolment):

INR = 1.5;
12. Able to understand the risks and benefits of the study and provide signed, written informed consent to participate;
13. Willing and able to comply with all study requirements and assessments;
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. CT-angiogram confirms unsuitable vascular anatomy;
2. No measurable liver disease per RECIST v1.1;
3. Evidence of ascites, cirrhosis, portal hypertension, main portal venous tumour involvement or main portal venous thrombosis;
4. Allergies to contrast agents;
5. Previous hypersensitivity or laryngo-pharyngeal dysaesthesia associated with oxaliplatin;
6. Previous allergies associated with 5-FU or oxaliplatin;
7. Grade > 2 peripheral neuropathy (CTCAE 5.0);
8. Significant co-morbidities;
9. Life expectancy = 3 months;
10. 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;
11. 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;
12. Medical conditions that preclude the testing required by the protocol, or limit study participation;

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/06/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/07/2023
Actual
Sample size
Target
95
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Lake Macquarie Private Hospital - Gateshead
Recruitment hospital [2] 0 0
GenesisCare, St Leonards - Saint Leonards
Recruitment hospital [3] 0 0
Sydney Adventist Hospital - Sydney
Recruitment hospital [4] 0 0
Sydney Southwest Private Hospital - Sydney
Recruitment hospital [5] 0 0
Gold Coast Private Hospital - Southport
Recruitment postcode(s) [1] 0 0
2290 - Gateshead
Recruitment postcode(s) [2] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [3] 0 0
2076 - Sydney
Recruitment postcode(s) [4] 0 0
2170 - Sydney
Recruitment postcode(s) [5] 0 0
4215 - Southport

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AllVascular
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Nick Pavlakis, A/Prof
Address 0 0
GenesisCare, St Leonards
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sharon Sampath
Address 0 0
Country 0 0
Phone 0 0
+61 02 9438 5228
Email 0 0
trials@allvascular.com
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04701281