Radioactive beads offer hope for frail cancer patients
NCT ID NCT05092880
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a treatment called radioembolization for elderly or frail patients whose colorectal cancer has spread only to the liver and cannot be removed by surgery. Instead of standard chemotherapy, tiny radioactive beads are injected into the liver's blood supply to target tumors directly. The goal was to see if this approach could control the cancer with fewer side effects and better quality of life. The trial was terminated early after enrolling only 18 participants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- holmium-166 microspheres
- What this could lead to
- If it works, this could offer a less toxic, more convenient treatment option for elderly or frail patients with colorectal cancer that has spread to the liver.
- What could go wrong
- This was a small, early-phase trial that was terminated early, so results are limited. The treatment may not control the cancer as well as standard therapy, and there are risks from radiation exposure to the liver.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
18 people
The number who actually took part.
- Started
-
Jun 2022
- Finished
-
Sep 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients must have given written informed consent. 2. Female or male patients aged ≥18 years. 3. Metastatic colorectal cancer, with metastases confined to the liver, previously not systemically treated. 4. Previous local treatment of liver metastases by resection of a maximum of two liver segments and/or local ablation is allowed. 5. Elderly/frail patients, according to the local investigator not eligible for local treatments or intensive systemic regimens with combination chemotherapy. 6. ECOG Performance status 0-2 (Table 1). 7. Eligible for systemic treatment with capecitabine + anti-VEGF antibody. 8. Adequate bone marrow (Hb ≥ 6 mmol/L, WBC ≥ 3x109/L, platelets ≥ 100x109/L), liver (serum bilirubin ≤ 1x upper limit of normal (ULN), ASAT/ALAT ≤ 5x ULN), and renal (GFR ≥ 40 ml/min) functions. Exclusion Criteria: 1. Previous systemic treatment for metastatic disease. 2. Previous adjuvant treatment completed within 6 months prior to randomization. 3. Symptoms of primary tumour, if in situ, that require intervention; prior treatment with (chemo)radiotherapy and/or resection of primary tumor is allowed. 4. Resection of more than 2 liver segments, 2-stage procedures and/or radiotherapy of liver metastases. 5. Eligible for more intensive systemic regimens (i.e. doublet or triplet chemotherapy). 6. Eligible for local treatment of liver metastases (e.g. surgical resection, ablation). 7. Presence of extrahepatic metastases; the presence of small (≤ 1 cm) lesions outside the liver on CT scan that are not clearly suspicious for metastases and/or the presence of enlarged hilar lymph nodes in the liver up to a maximal diameter of 2 cm is allowed. 8. Non-correctable INR \>2.0. 9. Any serious comorbidity preventing the safe administration of anti-VEGF antibody treatment. This includes uncontrolled hypertension or treatment with ≥3 antihypertensive drugs, arterial (cerebro)vascular event within the past 12 months, history of bleeding, history of GI perforation, or presence of fistulae. 10. Pregnancy or breastfeeding. 11. Mental disorders that may compromise patient compliance. 12. Active second malignancy within the previous 5 years, with the exception of adequately treated basal cell carcinoma of skin and in situ carcinoma of cervix. 13. Body weight over 150 kg (because of maximum table load). 14. Known severe allergy for intravenous contrast fluids. 15. Participation to another investigational study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
UMC Utrecht
Utrecht, Utrecht, 3584 CX, Netherlands
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