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SYS-CAPLIOX Clinical Trial Inoperable liver metastases from colorectal adenocarcinoma ACTRN12617001268336

2 cohorts

Cohort 1: 1st line patients, RAS mutant

Cohort 2: pre-treated or refractory patients, no specific mutation

 

Exclusion Criteria

  1. Unsuitable vascular anatomy

  2. No measurable disease, per RECIST v1.1

  3. Previous hypersensitivity or allergies associated with 5-FU, oxaliplatin or contrast agents

  4. Grade > 2 peripheral neuropathy

  5. Evidence of ascites, cirrhosis, portal hypotension, main portal venous tumour involvement or main portal venous thrombosis

  6. Significant co-morbidities

  7. Life expectancy ≤ 3 months

Inclusion Criteria

  1. Inoperable liver metastases from colorectal adenocarcinoma

  2. Two cohorts:

    Cohort 1: 1st line patients, RAS mutant

    Cohort 2: pre-treated or refractory patients, no specific mutation

  3. Fit for repeated general anaesthesia

  4. Cohort 1: CT confirmed non-progressive disease after minimum 4 XELOX or FOLFOX cycles

  5. Limited extrahepatic disease in lungs or lymph nodes

  6. ECOG 0 - 1

  7. Four-week washout period with monoclonal

    antibody treatment, i.e. bevacizumab

  8. 18 years of age and over