Study of Intra-Arterial Oxaliplatin Plus Capecitabine to Treat Liver Metastases From Colorectal Cancer

NCT04701281 | Terminated Phase 1 DMC

• 1 other identifier: SYS-CAPLIOX
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 5

Brief 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. 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 \[XELOX\]).

Conditions

Liver Metastasis Colon Cancer

Keywords

liver; metastases; colon; rectal; intra-arterial

Outcome Measures

Primary Outcomes (1)

• Liver-specific response rate (RR)

  Assessed via clinical imaging and tumour markers using RECIST v1.1;

  4 weeks post explantation of AVAS;

Secondary Outcomes (7)

• Two-year survival rate;

  3, 6, 9, 12, 18 and 24 months post end of treatment and AVAS explantation;

• Progression free survival (PFS);

  3, 6, 9, 12, 18 and 24 months post end of treatment and AVAS explantation;

• Systemic side effects to chemotherapy

  From enrolment until primary outcome is assessed (4 weeks post AVAS explantation);

• Organ isolation capability

  Measured after each infusion treatment, through study completion, up to 8 weeks;

• Conversion to resection rate;

  Assessed at end of treatment, 4 weeks post AVAS explanation;

Study Arms (1)

Intra-arterial LIOX + Capecitabine

EXPERIMENTAL

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

Combination Product: Intra-arterial LIOX + Capecitabine

Interventions

Intra-arterial LIOX + Capecitabine COMBINATION_PRODUCT

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

Intra-arterial LIOX + Capecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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;

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• AllVascular: lead

Study Sites (5)

Lake Macquarie Private Hospital

Gateshead, New South Wales, 2290, Australia

Location

GenesisCare, St Leonards

Saint Leonards, New South Wales, 2065, Australia

Location

Sydney Adventist Hospital

Sydney, New South Wales, 2076, Australia

Location

Sydney Southwest Private Hospital

Sydney, New South Wales, 2170, Australia

Location

Gold Coast Private Hospital

Southport, Queensland, 4215, Australia

Location

Related Links

• Related Info

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Nick Pavlakis, A/Prof

  GenesisCare, St Leonards

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single arm, two cohorts: Cohort 1: 1st line patients, RAS mutant; Cohort 2: pre-treated or refractory patients, no specific mutation

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 8, 2021
• Study Start: March 2, 2022
• Primary Completion: September 19, 2022
• Study Completion: October 19, 2022
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (5)