Double-Barreled attack: chemo plus targeted liver beads tested for stubborn colon cancer spread
NCT ID NCT04595266
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether adding a liver-directed chemoembolization procedure to standard chemotherapy can better shrink tumors in people with colorectal cancer that has spread only to the liver and has a poor outlook. About 48 participants will receive either chemotherapy alone or chemotherapy plus tiny beads loaded with irinotecan that are infused directly into the liver's blood supply. The main goal is to see if the combination leads to more tumor shrinkage at 6 months, with hopes of improving survival and enabling liver surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- FOLFOX chemotherapy plus a monoclonal antibody (anti-EGFR or bevacizumab), with or without irinotecan-loaded microspheres delivered directly to the liver via chemoembolization
- What this could lead to
- If this works, it could offer a more effective way to control colorectal cancer that has spread only to the liver, potentially shrinking tumors enough for surgery and extending survival.
- What could go wrong
- This is a small, early-phase (phase 2) trial with only 48 participants, so results may not apply to everyone. Adding liver chemoembolization also carries risks like liver damage, infection, or side effects from the extra chemotherapy.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2021
- Expected to finish
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Jan 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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: * Patients aged ≥ 18 years. * Patients with colorectal cancer and exclusive liver metastases with poor prognostic criteria,\> 3 lesions and / or size\> 5 cm. Patients with a diagnosis of liver metastases with synchronous presentation or with a disease-free interval may be included. If the primary tumor has not been resected, it must be clinically stable. * Measurable disease following RECIST version 1.1 criteria * Adequate bone marrow function, according to: 1. Hemoglobin ≥ 9.0 g / dl (patients with hemoglobin \<9 g / dl can be transfused before inclusion in the study 2. Platelet count ≥ 100 x 109 / L 3. Absolute Neutrophil Count (ANC) ≥ 1.5x 109 / L * Adequate liver function, according to: 1. Serum bilirubin ≤ 1.5 x the upper limit of normal (ULN) 2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN. 3. Alkaline phosphatase ≤ 5 x ULN or ≤10 x ULN in the presence of bone metastases 4. Adequate renal function, with creatinine levels \<1.5 mg / dL. Blood Ureic Nitrogen (BUN)\> 50 ml / min. 5. Albumin\> 3.0 g / dL * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. * Patients capable of understanding the information and giving their written informed consent to participate in the study * Women of childbearing potential must commit to sexual abstinence or use of barrier contraceptive methods during the study and must have a negative pregnancy test. Exclusion Criteria: * Extension of the disease\> 50% of the liver parenchyma (evaluated by CT performed within the month prior to inclusion) * Previous chemotherapy treatment for metastatic colorectal cancer * Clinically significant cardiovascular diseases: cerebrovascular accident / stroke (≤ 6 months before inclusion in the trial), myocardial infarction (≤ 6 months before inclusion in the trial), unstable angina, uncontrolled hypertension, congestive heart failure of New York Heart Association (NYHA) grade II or higher or severe cardiac arrhythmia. * History of malignancy in the last three years, except for basal cell carcinoma of the skin or carcinoma in situ of the cervix treated appropriately. * Altered coagulation (Quick\> 50%) * Patients with active infectious processes * Patients with any of the contraindications specified in the technical data sheet of the study drug or with allergies to some of the drugs used * Pregnant or lactating patients * Portal thrombosis * Severe portal hypertension * Extrahepatic metastases
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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
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Complejo Hospitalario de Navarra
Pamplona, Pamplona, Spain
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H. Univ. Ramón y Cajal
Madrid, Madrid, 28044, Spain
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Hospital Clínic
Barcelona, Barcelona, Spain
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Hospital Parc Taulí
Sabadell, Barcelona, Spain
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Hospital Universitari i Politècnic La Fe
Valencia, Valencia, 46026, Spain
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Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain
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Hospital Universitario La Paz
Madrid, Madrid, Spain
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Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
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