colorectal cancer liver metastases
Conditions
Interventions
• Individualized 166Ho radioembolization combined with:
• 35 mg/m2 FTD-TPI day 1-5 and 8-12, every 4 weeks
• 5 mg/kg bevacizumab iv. on day 1 and 15, every 4 weeks
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Unresectable liver dominant mCRC • Prior therapy with fluoropyrimidine, oxaliplatin, and irinotecan for the treatment of advanced colorectal cancer and had demonstrated progressive disease or intolerance to their last regimen • Written informed consent • Age >=18 years • Estimated hepatic tumor replacement >= 10% and = 3.0 x 109/L, platelets >= 100 x 109/L, absolute neutrophil count > 1.5 x 109/L, Hemoglobin > 5 mmol/L (>8.1 g/dL) o eGFR >= 35 ml/min o Serum transaminases (AST & ALT) 3 g/dL • At least one measurable liver lesion according to the PERCIST 1.0 • Included in PLCRC
Exclusion criteria
Exclusion criteria: • Significant extrahepatic disease, defined as symptomatic extrahepatic disease, greater than 10 pulmonary nodules (maximum diameter of each lung metastasis 20 Gy, as calculated using scout dose SPECT/CT • Absorbed tumor dose =3 antihypertensive drugs, arterial (cerebro)vascular event within the past 6 months, history of severe bleeding, history of GI perforation, or presence of fistulae • Any serious and/or chronic liver disease preventing the safe administration of radioembolization • Uncorrectable extrahepatic deposition of scout dose activity; activity in the falciform ligament, portal lymph nodes and gallbladder is accepted • Pregnancy or breastfeeding • Body weight over 150 kg (because of maximum table load) • Known severe allergy for intravenous contrast fluids • Participation to another investigational study which may compromise any endpoint of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess activity of radioembolization, FTD-TPI, and bevacizumab in terms of hepatic objective tumor response (hORR) determined by PERCIST 1.0 | — |
Secondary
| Measure | Time frame |
|---|---|
| Activity • Hepatic objective response rate (hORR) (RECIST 1.1) • Overall and extra-hepatic ORR (RECIST 1.1, PERCIST 1.0) Safety • SAE*s • Grade >=3 adverse events (CTCAE 5.0) • Occurrence of REILD (see 8.1.2) • Radioembolization related vascular events Tolerability • Dose reductions, dose delays of FTD-TPI • Radioembolization completion rate Efficacy • Progression-free survival • Overall survival | — |
Countries
Netherlands
Outcome results
None listed