Study on Preoperative Immunotherapy with Atezolizumab and Tiragolumab for Patients with Colorectal Liver Metastases

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What is this study about?

This clinical trial is focused on studying a treatment for patients with colorectal liver metastases, which is a condition where cancer from the colon or rectum spreads to the liver. The treatment being tested involves two medications: atezolizumab, also known by its brand name Tecentriq, and tiragolumab. Atezolizumab is a type of immunotherapy, which means it helps the body’s immune system fight cancer. Tiragolumab is another immunotherapy drug that works in a similar way. Both medications are given as a solution through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of this study is to see how well these medications work in shrinking the tumors before surgery. Patients will receive the treatment for a period of time before their scheduled surgery to remove the cancer. The study will monitor the response of the tumors to the treatment and any side effects that may occur. The goal is to determine if the combination of atezolizumab and tiragolumab can improve the chances of successful surgery by reducing the size of the tumors.

Throughout the study, patients will have regular check-ups and tests to assess their health and the effectiveness of the treatment. These tests may include imaging scans like PET-CT or PET-MRI, which help doctors see how the cancer is responding to the treatment. The study will also look at the rate of successful surgeries and any complications that might arise after the treatment. The trial is expected to continue until 2026, with recruitment starting in 2024.

1 Joining the study

Upon joining the study, the patient will be informed about the trial’s purpose and procedures. The patient must provide informed consent to participate.

Eligibility criteria include being 18 years or older, having colorectal liver metastases, and meeting specific health requirements.

2 Initial assessment

The patient will undergo a series of assessments to confirm eligibility. This includes blood tests, imaging studies, and a review of medical history.

The assessments ensure the patient meets all health criteria, such as adequate liver and kidney function.

3 Preoperative immunotherapy

The patient will receive preoperative immunotherapy with two medications: atezolizumab and tiragolumab.

Atezolizumab, known as Tecentriq, is administered as an intravenous infusion at a dose of 840 mg.

Tiragolumab is also administered as an intravenous infusion. The specific dosage and frequency will be determined by the study protocol.

The duration of this treatment phase is determined by the study protocol and will be communicated to the patient.

4 Surgery

Following the immunotherapy phase, the patient will undergo surgery to remove the colorectal liver metastases.

The timing of the surgery will be based on the patient’s response to the immunotherapy and the study schedule.

5 Postoperative assessment

After surgery, the patient will be monitored for recovery and any potential complications.

The study will assess the pathological response of the tumor to the treatment, using specific grading criteria.

6 Follow-up

The patient will have regular follow-up visits to monitor health status and any long-term effects of the treatment.

These visits will include physical examinations, imaging studies, and laboratory tests as needed.

Who Can Join the Study?

Must be a male or female, 18 years of age or older.
Must have a negative test for the human immunodeficiency virus (HIV).
If you have hepatitis B virus (HBV), your HBV DNA must be less than 500 IU/mL. If you are on anti-viral medication, you must have started treatment at least 2 weeks before joining the study and continue for at least 6 months after the study treatment ends.
Must have a negative test for hepatitis C virus (HCV) antibodies, or if positive, a negative HCV RNA test.
For women who can have children: Must have a negative pregnancy test within 14 days before joining the study and agree to use effective birth control during the study and for at least 5 months after the last study drug. Abstinence or reliable birth control methods are required.
For men: Must agree to use birth control or remain abstinent during the study and for 90 days after the last dose of the study drug. Must not donate sperm during this time.
Must be willing and able to follow the study rules, including attending treatment and scheduled visits.
Must sign an informed consent form, agreeing to participate in the study.
Must have a confirmed type of cancer called adenocarcinoma in the colon or rectum with liver metastases that can be surgically removed with the aim of curing the disease.
The liver metastases must be accessible for a biopsy, which is a small sample of tissue taken for testing.
Must have a type of disease called microsatellite stable (MSS) or proficient mismatch repair (pMMR), determined from a biopsy or removed tumor tissue.
Must not have any disease outside of the liver and primary tumor, except for local lymph node metastases. If the primary tumor is still present, it must be removable.
Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1, which means you are fully active or have some symptoms but can carry out light work.
Must have adequate blood, liver, and kidney function, as shown by specific laboratory test results within 14 days before starting the study treatment.

Who Cannot Join the Study?

Patients with other types of cancer besides colorectal liver metastases cannot participate. This means if you have cancer that started in a different part of the body, you are not eligible.
Individuals who are not within the specified age range for the study cannot join. The study is looking for participants within certain age groups.
People who are part of a vulnerable population, which means they might need special protection or care, are not eligible for this study.
Participants must be able to undergo routine medical procedures, such as tumor removal and examination, as part of the study.
Both men and women can participate, but they must meet all other criteria.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Unyxqkhgzhupqsdzywmks Esdvg Aoz	Essen	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not yet recruiting	15.07.2024

Trial locations

Investigated drugs:

Atezolizumab is a type of immunotherapy used in this trial. It works by helping the immune system recognize and attack cancer cells. It is often used to treat various types of cancer by blocking a protein that prevents the immune system from attacking cancer cells.

Tiragolumab is another immunotherapy drug being tested in this trial. It is designed to enhance the body’s immune response against cancer cells. By targeting specific proteins, it aims to improve the effectiveness of the immune system in identifying and destroying cancer cells.

Investigated diseases:

Colorectal Liver Metastases – This condition occurs when cancer cells from the colon or rectum spread to the liver. It is a common progression for colorectal cancer, as the liver is a frequent site for metastasis due to its blood supply. The disease typically progresses as cancerous cells travel through the bloodstream or lymphatic system to the liver, forming new tumors. These metastatic tumors can grow and potentially affect liver function. The progression of the disease can vary, with some tumors growing slowly while others may expand more rapidly. The presence of liver metastases often indicates an advanced stage of colorectal cancer.

Trial ID:

2022-503044-40-00

Protocol code:

PURPLE

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Preoperative Immunotherapy with Atezolizumab and Tiragolumab for Patients with Colorectal Liver Metastases

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