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

Sponsor
UMC Utrecht
Study ID
NCT06563986
Phase
PHASE2
Status
Recruiting
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Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Systemic treatment (FTD-TPI and bevacizumab) — DRUG
    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.
  • Radioembolization with 166-Ho microspheres — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Aug 21, 2024
Start date
Jun 18, 2024
Status verified
Aug 2024
Primary completion
Jan 31, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention: Systemic treatment (FTD-TPI + bevacizumab) and radioembolization
    * Individualized dose 166Ho radioembolization, combined with systemic treatment: * 35 mg/m2 FTD-TPI on day 1-5 and 8-12 every 4 weeks * 5 mg/kg bevacizumab iv. on day 1 and 15 every 4 weeks

Primary Outcome Measure

Hepatic objective response rate (hORR) (PERCIST 1.0) [ Time Frame: Evaluated every 8 weeks after the start of treatment until 1 year after the start of treatment or until disease progression, whichever comes first. ]

Central Contacts

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