FTD-TPI, Bevacizumab, and Radioembolization With 166Ho-microspheres in Refractory Metastatic Colorectal Cancer

Phase 2

Recruiting

• Conditions: Metastatic Colorectal Cancer

• Registration Number: NCT06563986
• Lead Sponsor: UMC Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-6-7
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Inclusion Criteria:<br><br> - Unresectable liver dominant mCRC<br><br> - Prior therapy with fluoropyrimidine, oxaliplatin, and irinotecan for the treatment<br> of metastatic colorectal cancer and had demonstrated progressive disease or<br> intolerance to their last regimen<br><br> - Patients who have withdrawn from standard treatment due to unacceptable<br> toxicity warranting discontinuation of treatment and precluding retreatment<br> with the same agent prior to progression of disease will also be eligible to<br> enter the study.<br><br> - Patients who refuse oxaliplatin or irinotecan will also be eligible to enter<br> the study.<br><br> - Patients who had received adjuvant chemotherapy and had recurrence during or<br> within 6 months of completion of the adjuvant chemotherapy count the adjuvant<br> therapy as treatment of metastatic colorectal cancer.<br><br> - Written informed consent<br><br> - Age >=18 years<br><br> - Estimated hepatic tumor replacement = 10% and = 50% of total liver volume Eastern<br> Cooperative Oncology Group performance status 0-1<br><br> - Adequate organ function as measured by: WBC = 3.0 x 109/L, platelets = 100 x 109/L,<br> absolute neutrophil count > 1.5 x 109/L, Hemoglobin (Hb) > 5 mmol/L (>8.1 g/dL),<br> eGFR = 35 ml/min, Serum transaminases (AST & ALT) = 5 x upper limit of normal (ULN),<br> Total bilirubin = ULN, Albumin > 3 g/dL<br><br> - At least one measurable liver lesion according to the PERCIST 1.0<br><br>Exclusion Criteria:<br><br> - Significant extrahepatic disease, defined as symptomatic extrahepatic disease, more<br> than 10 pulmonary nodules (maximum diameter of each lung metastasis <20mm), and/or<br> peritoneal carcinomatosis.<br><br> - Eligible for ablative local treatment of liver metastases (e.g. surgical resection,<br> ablation)<br><br> - Lung shunt >20 Gy, as calculated using scout dose SPECT/CT<br><br> - Absorbed tumor dose <90 Gy when dosing at a maximum average absorbed normal liver<br> dose<br><br> - Other malignancy confounding prognosis<br><br> - Receipt of chemotherapy within 28 days prior to study treatment<br><br> - Previous or current treatment with radioembolization<br><br> - Major surgery within 28 days or incompletely healed surgical incision before<br> starting study therapy<br><br> - Any serious comorbidity preventing the safe administration of anti-VEGF antibody<br> treatment. This includes uncontrolled hypertension or treatment with =3<br> antihypertensive drugs, arterial (cerebro)vascular event within the past 6 months,<br> history of severe bleeding, history of GI perforation, or presence of fistulae<br><br> - Any serious and/or chronic liver disease preventing the safe administration of<br> radio- embolization<br><br> - Uncorrectable extrahepatic deposition of scout dose activity; activity in the<br> falciform ligament, portal lymph nodes and gallbladder is accepted<br><br> - Pregnancy or breastfeeding<br><br> - Body weight over 150 kg (because of maximum table load)<br><br> - Known severe allergy for intravenous contrast fluids<br><br> - Participation to another investigational study which may compromise any endpoint of<br> the study

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hepatic objective response rate (hORR) (PERCIST 1.0)

Secondary Outcome Measures

Name	Time	Method
Hepatic objective response rate (hORR) (RECIST 1.1);Overall and extra-hepatic ORR (RECIST 1.1);Overall and extra-hepatic ORR (PERCIST 1.0);Serious adverse events (SAE's);Grade =3 adverse events (CTCAE 5.0);Occurrence of radioembolization-induced liver disease (REILD);Radioembolization related vascular events;Dose reductions, dose delays of FTD-TPI;Radioembolization completion rate;Progression free survival (PFS);Overall survival (OS)