NCT06563986

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

Single-arm, Phase II Trial of Trifluridine/Tipiracil (FTD-TPI), Bevacizumab, and Individualized Radioembolization With 166Ho-microspheres in Refractory Metastatic Colorectal Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Extrahepatic disease progression limits clinical efficacy of individualized radioembolization for patients with refractory metastatic colorectal cancer (mCRC). In the same patient population, trifluridine/tipiracil (FTD-TPI) and bevacizumab lead to disease control and overall survival benefit and may be a radiosensitizer. The purpose of this study is to determine safety, tolerability, and activity of individualized radioembolization with 166Holmium (166Ho)-microspheres combined with FTD-TPI and bevacizumab.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Systemic treatment (FTD-TPI and bevacizumab)	Systemic treatment (FTD-TPI and bevacizumab) administration is according to standard clinical practice. Each treatment cycle will be 28 days in duration. One treatment cycle consists of the following: * Days 1-5: oral intake of FTD-TPI and bevacizumab IV infusion on day 1 * Days 8-12: oral intake of FTD-TPI * Day 15: bevacizumab IV infusion Bevacizumab 5.0mg/kg i.v. is repeated every 2 weeks. If toxicity occurs, dose modifications and dose delays should be administered and applied according to standard practice.
DEVICE	Radioembolization with 166-Ho microspheres	Individualized 166Ho radioembolization will be performed via a catheter during angiography. Before the treatment, a scout procedure will be performed to determine individualized 166Ho dose of the treatment. Dosimetry-based treatment planning will be individualized using Q- Suite software. In case of bilateral disease, patients will be treated in two procedures to each hemi-liver, separated by 1 month. Before the first procedure, a scout procedure will be performed in which the individualized 166Ho dose of the first and second procedure will be calculated.

Timeline

• Start date: 2024-06-18
• Primary completion: 2028-01-01
• Completion: 2028-06-01
• First posted: 2024-08-21
• Last updated: 2024-08-21

Locations

1 site across 1 country: Netherlands