Actively Recruiting
FTD-TPI, Bevacizumab, and Radioembolization With 166Ho-microspheres in Refractory Metastatic Colorectal Cancer
Led by UMC Utrecht · Updated on 2024-08-21
40
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
FTD-TPI, Bevacizumab, and Radioembolization With 166Ho-microspheres in Refractory Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Unresectable liver-dominant metastatic colorectal cancer
- Prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan showing disease progression or intolerance
- Patients who discontinued standard treatment due to unacceptable toxicity or who refuse oxaliplatin or irinotecan
- Recurrence within 6 months after adjuvant chemotherapy counts as treatment for metastatic disease
- Written informed consent provided
- Estimated hepatic tumor replacement between 10% and 50% of total liver volume
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Adequate organ function including specific blood counts, kidney function, liver enzymes, bilirubin, and albumin levels
- At least one measurable liver lesion according to PERCIST 1.0 criteria
You will not qualify if you...
- Significant extrahepatic disease, including symptomatic disease, more than 10 lung nodules under 20 mm, or peritoneal carcinomatosis
- Eligible for local liver metastasis treatments like surgery or ablation
- Lung shunt greater than 20 Gy based on scout dose SPECT/CT
- Tumor dose under 90 Gy at maximum normal liver dose
- Other malignancies affecting prognosis
- Chemotherapy within 28 days before study treatment
- Prior or current radioembolization treatment
- Major surgery within 28 days or unhealed surgical wounds
- Serious comorbidities preventing safe use of anti-VEGF treatments, including uncontrolled hypertension, recent arterial events, severe bleeding, gastrointestinal perforation, or fistulae
- Serious or chronic liver disease preventing safe radioembolization
- Uncorrectable extrahepatic deposition of scout dose activity except in certain accepted areas
- Pregnancy or breastfeeding
- Body weight over 150 kg
- Known severe allergy to intravenous contrast agents
- Participation in another investigational study that may affect study outcomes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UMC Utrecht
Utrecht, Netherlands, 3584CX
Actively Recruiting
Research Team
G
Guus Bol, dr.
CONTACT
D
Dania Al-Toma, drs.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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