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

PHASE2RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

June 18, 2024

Primary Completion Date

January 31, 2028

Study Completion Date

June 30, 2028

Conditions
Metastatic Colorectal Cancer
Interventions
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."

Trial Locations (1)

3584CX

RECRUITING

UMC Utrecht, Utrecht

All Listed Sponsors
lead

UMC Utrecht

OTHER