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OncoMatch/Clinical Trials/NCT06563986

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

Is NCT06563986 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Systemic treatment (FTD-TPI and bevacizumab) and Radioembolization with 166-Ho microspheres for metastatic colorectal cancer.

Phase 2RecruitingUMC UtrechtNCT06563986Data as of Jun 2026Location: Netherlands

Treatment: Systemic treatment (FTD-TPI and bevacizumab) · Radioembolization with 166-Ho microspheresExtrahepatic 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.

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Extracted eligibility criteria

Treatments studied

Targeted therapy

Systemic treatment (FTD-TPI and bevacizumab)

Other

Radioembolization with 166-Ho microspheres

Cancer type

Colorectal Cancer

Disease stage

Metastatic disease required

Unresectable liver dominant mCRC; At least one measurable liver lesion according to the PERCIST 1.0

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: fluoropyrimidine — metastatic

Prior therapy with fluoropyrimidine for the treatment of metastatic colorectal cancer and had demonstrated progressive disease or intolerance to their last regimen

Must have received: oxaliplatin — metastatic

Prior therapy with oxaliplatin for the treatment of metastatic colorectal cancer and had demonstrated progressive disease or intolerance to their last regimen

Must have received: irinotecan — metastatic

Prior therapy with irinotecan for the treatment of metastatic colorectal cancer and had demonstrated progressive disease or intolerance to their last regimen

Cannot have received: radioembolization

Previous or current treatment with radioembolization

Cannot have received: chemotherapy

Exception: within 28 days prior to study treatment

Receipt of chemotherapy within 28 days prior to study treatment

Lab requirements

Blood counts

WBC ≥ 3.0 x 10^9/L, platelets ≥ 100 x 10^9/L, absolute neutrophil count > 1.5 x 10^9/L, Hemoglobin (Hb) > 5 mmol/L (>8.1 g/dL)

Kidney function

eGFR ≥ 35 ml/min

Liver function

Serum transaminases (AST & ALT) ≤ 5 x upper limit of normal (ULN), Total bilirubin ≤ ULN, Albumin > 3 g/dL

Adequate organ function as measured by: WBC ≥ 3.0 x 10^9/L, platelets ≥ 100 x 10^9/L, absolute neutrophil count > 1.5 x 10^9/L, Hemoglobin (Hb) > 5 mmol/L (>8.1 g/dL), eGFR ≥ 35 ml/min, Serum transaminases (AST & ALT) ≤ 5 x upper limit of normal (ULN), Total bilirubin ≤ ULN, Albumin > 3 g/dL

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT06563986 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior radioembolization, chemotherapy disqualifies patients from enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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