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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 (May 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 May 2026

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

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.

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