Study on the Effects of Atezolizumab, Bevacizumab, Oxaliplatin, and Capecitabine in Patients with Colorectal Cancer and Liver Metastasis

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What is this study about?

This clinical trial is focused on studying a type of cancer known as colorectal cancer that has spread mainly to the liver. The study aims to evaluate the effectiveness and safety of combining several treatments for this condition. The treatments being tested include a standard chemotherapy regimen called XELOX, which is a combination of two drugs, capecitabine and oxaliplatin. Additionally, the study involves the use of targeted therapies, specifically bevacizumab (also known as Avastin) and atezolizumab (also known as Tecentriq or RO5541267), which is an immune checkpoint inhibitor. These treatments are combined with a specialized form of radiation therapy that targets the liver.

The purpose of the study is to assess how well these combined treatments work in preventing the cancer from getting worse over a period of nine months. Participants in the study will receive these treatments through intravenous infusions, which means the medication is delivered directly into the bloodstream through a vein. The study will monitor the participants’ health and the progression of their cancer over time to gather information on the effectiveness and any potential side effects of the treatment combination.

This trial is designed to provide valuable insights into the potential benefits of combining chemotherapy, targeted therapy, immunotherapy, and internal radiation therapy for patients with liver-dominant metastatic colorectal cancer. The study is open-label, meaning both the researchers and participants know which treatments are being administered. The ultimate goal is to improve treatment outcomes for patients with this specific type of cancer.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, health status, and specific medical conditions related to colorectal cancer with liver metastasis.

The assessment ensures that the patient has not received prior treatment for metastatic disease and meets other criteria such as adequate organ function and measurable disease.

2 treatment initiation

The treatment phase begins with the administration of several medications. These include atezolizumab, oxaliplatin, bevacizumab, and capecitabine.

Atezolizumab is given as an intravenous infusion at a dose of 1,200 mg.

Oxaliplatin is administered intravenously as a 5 mg/ml solution.

Bevacizumab is provided as a 25 mg/ml concentrate for infusion.

Capecitabine is taken orally in the form of 500 mg film-coated tablets.

3 treatment schedule

The medications are administered according to a specific schedule. Intravenous treatments are typically given in cycles, with rest periods in between to allow the body to recover.

The exact frequency and duration of each medication will be determined by the healthcare team based on individual patient needs and response to treatment.

4 monitoring and evaluation

Throughout the trial, regular monitoring is conducted to evaluate the effectiveness of the treatment and to check for any side effects.

Progression-free survival is assessed at 9 months using specific criteria to determine the response to treatment.

5 completion of trial

The trial is expected to continue until December 2028. Upon completion, the results will be analyzed to determine the overall efficacy and safety of the treatment combination.

Who Can Join the Study?

Must be over 18 years old.
Must have adequate hematological function, which means the blood is working well.
Must have adequate hepatic function, meaning the liver is working well.
Must have adequate renal function, meaning the kidneys are working well.
Must be part of a social security system and have signed a consent form after being informed about the study.
Must have a type of colorectal cancer that is mismatch repair proficient or microsatellite stable (MSS), which are specific characteristics of the cancer.
Must have cancer that mainly affects the liver, with up to 6 other small spots outside the liver, but not in the belly area, and these spots should not cause symptoms or affect organ function.
Must have cancer that can be measured using a specific method called RECIST 1.1.
Must have cancer that cannot be removed by surgery at first, as decided by a team of doctors, and should be suitable for a treatment called radioembolization according to a radiologist.
The tumor should take up less than 50% of the total liver volume.
Must not have had any cancer treatment for the spread of cancer. However, treatment given after surgery or before surgery to the pelvic area is allowed if it was completed at least 6 months before joining the study. Pain relief treatment for cancer spread is allowed except for liver spots and must be finished at least 14 days before joining.
Must have a WHO performance status, which is a way to measure how well a person can perform daily activities.
Must have an estimated life expectancy of at least 3 months.

Who Cannot Join the Study?

Patients with a type of colorectal cancer that is not microsatellite stable (MSS). This means the cancer cells have a specific genetic feature that is not stable.
Patients whose cancer has not spread mainly to the liver. This means the cancer should primarily affect the liver.
Patients who are not within the specified age range for the study. The study has specific age requirements.
Patients who belong to a group that is not included in the study. The study may have specific groups it is focusing on.
Patients who are not male or female, as the study includes both genders.
Patients who are considered part of a vulnerable population. This means people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centr Georges Francois Leclerc	Dijon	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Hospital Edouard Herriot	Lyon	France
Centre Hospitalier De Perpignan	Perpignan	France
Centre Henri Becquerel	Rouen	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Cwtavr Huxdwlnsvif Uoitvvsuifbnr Db Dfirw	Dijon	France
Aeneeeyitn Pzlzclnk Hgvimcqa Dt Penak	Paris	France
Ajtwgxpwez Pctxcxgw Hudsinug Dz Mhizatvob	Marseille	France
Cquo Dp Nnmjr	Vandoeuvre Les Nancy	France
Htpptfm Hfxtk Mvoowr &vytrea 1 rul Gmsylgo Evfdwl	Creteil	France
Ikszuhyn Phscxlbgfurbded Cjysoz Cfrjch	Marseille	France
Hobbionn Udypicpovtkquy Sakdomriol &cnfttv Hpawiek do Hbzrdfpsiod	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	16.11.2020

Trial locations

Investigated drugs:

Selective Internal Radiation Therapy (SIRT) is a treatment that involves delivering radiation directly to the liver. It is used to target liver tumors by sending tiny radioactive beads into the blood vessels that supply the tumors. This therapy aims to shrink the tumors and slow their growth.

XELOX is a combination of two chemotherapy drugs, capecitabine and oxaliplatin. Capecitabine is taken orally and is designed to interfere with the growth of cancer cells, while oxaliplatin is given intravenously and works by damaging the DNA of cancer cells, preventing them from multiplying.

Bevacizumab is a medication that helps to slow the growth of new blood vessels that tumors need to grow. It is often used in combination with other cancer treatments to enhance their effectiveness by cutting off the blood supply to the tumor.

Atezolizumab is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells. It works by blocking a protein that prevents the immune system from attacking the cancer, thereby boosting the body’s natural defenses to fight the cancer.

Investigated diseases:

Microsatellite Stable (MSS) Colorectal Cancer with Liver-Dominant Metastasis – This type of colorectal cancer is characterized by the absence of microsatellite instability, meaning the DNA repair system is functioning normally. It primarily affects the colon or rectum and has spread predominantly to the liver. The disease progresses as cancer cells grow and multiply, forming tumors in the liver. Over time, these tumors can interfere with liver function and may cause symptoms such as abdominal pain or jaundice. The progression of the disease is monitored through imaging studies to assess tumor size and spread.

Trial ID:

2024-517204-11-00

Protocol code:

FFCD 1709 – SIRTCI

NCT ID:

NCT04659382

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of Atezolizumab, Bevacizumab, Oxaliplatin, and Capecitabine in Patients with Colorectal Cancer and Liver Metastasis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?