Not recruiting

Study on Holmium-166 TARE and Maintenance Therapy with Capecitabine, Bevacizumab, and Drug Combination for Patients with Unresectable Liver-Colorectal Cancer

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer known as liver-limited unresectable colorectal cancer. This is a condition where the cancer originates in the colon or rectum and has spread to the liver, but cannot be removed through surgery. The study aims to evaluate a treatment approach that begins with a procedure called Holmium-166 TARE (Transarterial Radioembolization), which involves delivering radiation directly to the liver tumors. This is followed by maintenance therapy using specific medications.

The medications involved in this study include capecitabine, fluorouracil, and calcium folinate, which are types of chemotherapy drugs. Additionally, the study uses bevacizumab, panitumumab, and cetuximab, which are monoclonal antibodies. Monoclonal antibodies are proteins designed to target specific parts of cancer cells. The study is divided into two groups, or cohorts. One group will receive maintenance therapy with fluoropyrimidine and anti-EGFR (epidermal growth factor receptor) drugs, while the other group will receive fluoropyrimidine and anti-VEGF (vascular endothelial growth factor) drugs.

The purpose of the study is to assess how effective this treatment approach is in preventing the cancer from progressing over a period of several months. Participants will undergo the initial Holmium-166 TARE procedure, followed by regular administration of the maintenance therapy drugs. The study will monitor the participants' health and the progression of their cancer over time to gather data on the treatment's effectiveness and safety. Some participants may receive a placebo as part of the study design. The study is expected to continue until 2026.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be required to provide written informed consent. This means you agree to participate and understand the procedures involved.
A series of initial tests will be conducted to confirm eligibility, including assessments of renal function and a blood pregnancy test for women of childbearing potential.
Step 2
Treatment initiation
The treatment phase begins with a procedure called Holmium-166 TARE, which is a targeted therapy for liver cancer.
Following this, you will start maintenance therapy based on your specific cohort. This involves taking medications to help manage your condition.
Step 3
Medication regimen
For Cohort A, the maintenance therapy includes fluoropyrimidine and anti-EGFR medications. These are administered to help prevent cancer progression.
For Cohort B, the maintenance therapy includes fluoropyrimidine and anti-VEGF medications. These are also aimed at preventing cancer progression.
Step 4
Ongoing assessments
Throughout the trial, regular assessments will be conducted to monitor your health and the effectiveness of the treatment.
These assessments may include blood tests, imaging studies, and evaluations of your overall well-being.
Step 5
End of trial
The trial is expected to last until December 2026, with regular follow-ups to assess your condition.
At the end of the trial, a final evaluation will be conducted to determine the overall impact of the treatment on your health.

Who can join the trial?

21 criteria

Provide written informed consent to participate in the study.
Have a creatinine clearance greater than 50 mL/min or a serum creatinine level less than 1.5 times the upper normal limit. This means your kidneys are working well enough.
Women who can have children must have a negative blood pregnancy test at the start of the study.
Participants and their partners must agree to use effective birth control during the study and for 180 days after the last dose of chemotherapy.
Be willing and able to follow the study rules and procedures.
For Cohort A: Have a RAS/BRAF wild-type and left-sided primary tumor.
For Cohort A: Have received up to 6-12 cycles of first-line chemotherapy with FOLFOX or FOLFIRI plus anti-EGFR (cetuximab or panitumumab).
For Cohort B: Have a RAS mutated and/or right-sided primary tumor.
For Cohort B: Have received up to 6-12 cycles of first-line chemotherapy with FOLFOX, FOLFIRI, XELOX plus bevacizumab, or FOLFOXIRI plus bevacizumab.
Be at least 18 years old.
Have a confirmed diagnosis of colorectal adenocarcinoma, with or without the primary tumor still present.
Have liver-only disease that affects less than 50% of the liver, as shown in medical imaging tests.
Have an ECOG Performance Status of 2 or less, which means you are able to carry out all self-care but are unable to carry out any work activities.
Have a partial response or stable disease according to RECIST 1.1 criteria after 6-12 cycles of first-line chemotherapy, and the cancer cannot be surgically removed.
Have a life expectancy of at least 12 weeks.
Have adequate hematopoietic function, which means:
- An absolute neutrophil count of at least 1,500/mm³
- A platelet count of at least 100,000/mm³
- A hemoglobin level of at least 9 g/dL
- Have adequate liver function, which means:
  - Total bilirubin level less than or equal to 1.5 times the upper normal limit
  - Alkaline phosphatase level less than or equal to 5 times the upper normal limit
  - AST level less than or equal to 5 times the upper normal limit

Who cannot join the trial?

10 criteria

Patients with any other type of cancer that is not limited to the liver and cannot be removed by surgery.
Patients who have had another cancer in the past, unless it was a type that is not expected to come back.
Patients who have had a heart attack or severe heart problems in the last 6 months.
Patients with uncontrolled high blood pressure.
Patients with severe liver disease, not related to the cancer being studied.
Patients with severe kidney disease.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures or attend the required visits.
Patients who have participated in another clinical trial within the last 30 days.
Patients with known allergies to the study drugs or their components.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Verified
Azienda Unita Sanitaria Locale Della Romagna
Faenza, Italy

Trial locations

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Investigated drugs

Holmium-166 TARE
is a type of treatment that uses tiny radioactive beads to target and treat cancer in the liver. These beads are delivered directly to the liver through the blood vessels, where they release radiation to kill cancer cells. This therapy is used for patients whose liver cancer cannot be removed by surgery.
Fluoropyrimidine
is a type of chemotherapy drug that helps stop the growth of cancer cells. It works by interfering with the DNA and RNA of the cancer cells, which are essential for their growth and reproduction. This medication is often used as a maintenance therapy to help keep cancer from coming back after initial treatment.
Anti-EGFR
therapy involves medications that target a specific protein on the surface of cancer cells known as the epidermal growth factor receptor (EGFR). By blocking this protein, the therapy helps prevent the cancer cells from growing and spreading. This treatment is often used for certain types of colorectal cancer.
Anti-VEGF
therapy includes medications that target a protein called vascular endothelial growth factor (VEGF). This protein helps cancer cells form new blood vessels, which they need to grow. By blocking VEGF, this therapy helps starve the cancer cells by cutting off their blood supply. It is used as a maintenance treatment to help control cancer growth.

What is already known about the treatment

Holmium-166 TARE – Holmium-166 TARE is administered directly into the liver through a procedure called transarterial radioembolization, where tiny radioactive beads are delivered to the tumor site. It is currently being studied in clinical trials for its effectiveness in treating liver-limited unresectable colorectal cancer, particularly after initial chemotherapy and targeted therapy. The main therapeutic indication is to slow down the progression of cancer in the liver. At the molecular level, it works by emitting radiation that damages the DNA of cancer cells, leading to their death. It is classified as a radiopharmaceutical agent.

Investigated diseases

Liver-limited unresectable colorectal cancer – This condition refers to colorectal cancer that has spread to the liver but cannot be surgically removed. The cancer originates in the colon or rectum and metastasizes to the liver, where it forms secondary tumors. As the disease progresses, the liver tumors may grow in size and number, potentially affecting liver function. The progression of the disease can lead to symptoms such as abdominal pain, jaundice, and weight loss. The liver's ability to filter toxins and produce essential proteins may be compromised as the disease advances. The condition is typically monitored for changes in tumor size and liver function.