Study of Atezolizumab with Drug Combination for Patients with Unresectable Metastatic Colorectal Cancer

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What is this study about?

This clinical trial is focused on studying treatments for metastatic colorectal cancer, which is a type of cancer that starts in the colon or rectum and has spread to other parts of the body. The study is comparing two treatment options. One group of patients will receive a combination of medications known as FOLFOXIRI plus bevacizumab. FOLFOXIRI is a chemotherapy regimen that includes three drugs: fluorouracil, irinotecan, and oxaliplatin. Bevacizumab is a type of medication called a monoclonal antibody, which helps to prevent the growth of blood vessels that supply tumors. The other group will receive the same combination of FOLFOXIRI and bevacizumab, with the addition of atezolizumab, another monoclonal antibody that helps the immune system attack cancer cells.

The purpose of this study is to evaluate whether adding atezolizumab to the FOLFOXIRI and bevacizumab combination improves the time patients live without their cancer getting worse, known as Progression Free Survival (PFS). Patients participating in the study will be randomly assigned to one of the two treatment groups. The treatments will be given through an infusion, which means the medication is delivered directly into the bloodstream through a vein. The study will last for a period of up to 16 months, during which patients will receive regular treatments and follow-up assessments to monitor their health and the progression of their cancer.

Throughout the study, doctors will also monitor for any side effects or adverse reactions to the treatments. The study aims to provide valuable information on the effectiveness and safety of adding atezolizumab to the existing treatment regimen for patients with metastatic colorectal cancer. This research could potentially lead to improved treatment options for patients with this type of cancer.

1 joining the study

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

2 initial assessment

The patient will undergo an initial assessment to confirm eligibility. This includes verifying a diagnosis of colorectal cancer and ensuring the patient meets specific health criteria, such as blood counts and organ function tests.

3 treatment phase

The patient will receive a combination of medications through infusion. These medications include atezolizumab, calcium folinate, irinotecan hydrochloride, oxaliplatin, fluorouracil, and bevacizumab.

The treatment is administered as a first-line therapy for patients with specific types of metastatic colorectal cancer. The exact dosage and frequency will be determined by the medical team based on the patient’s condition.

4 monitoring and evaluation

The patient’s response to the treatment will be monitored regularly. This includes evaluating the size of cancer lesions every 8 weeks using imaging techniques.

The primary goal is to assess progression-free survival, which measures the time during and after treatment that the patient lives without the cancer worsening.

5 follow-up

After completing the treatment phase, the patient will continue to be monitored for any changes in their condition. This includes regular health assessments and quality of life evaluations using specific questionnaires.

Who Can Join the Study?

Must have a confirmed diagnosis of colorectal cancer.
Previous chemotherapy is allowed only if it was a specific type and more than 6 months have passed since the last treatment.
Blood tests must show certain levels: neutrophils (a type of white blood cell) above a specific count, platelets (cells that help with blood clotting) above a certain level, and hemoglobin (a protein in red blood cells) above a certain level.
Levels of certain substances in the blood, like bilirubin and liver enzymes (AST and ALT), must be within specific limits.
Creatinine clearance (a measure of kidney function) must be above a certain level, or serum creatinine (a waste product in the blood) must be within specific limits.
Blood clotting tests (INR or aPTT) must be within specific limits, unless the patient is on blood-thinning medication.
Urine tests must show low levels of protein. If higher levels are found, further testing is required to confirm low protein levels.
Women who can have children must have a negative pregnancy test before starting the study.
Participants must agree to use effective birth control during the study and for a period after the study ends.
Participants must be willing and able to follow the study procedures.
Must have colorectal cancer that has spread and cannot be removed by surgery, and not previously treated with chemotherapy for this spread.
Must provide written consent to participate in the study.
Tumor tissue must show proficient mismatch repair (pMMR) status, which is a specific characteristic of the cancer cells.
Tumor tissue must have Immunoscore IC-high status, which is another specific characteristic of the cancer cells.
Must have at least one tumor that can be measured according to specific criteria.
Must have enough tumor tissue available for testing.
Must be between 18 and 75 years old.
Must have an ECOG performance status (a measure of daily living abilities) of 2 or less if under 71 years old, or 0 if between 71 and 75 years old.
Must have a life expectancy of at least 12 weeks.

Who Cannot Join the Study?

Patients who have a different type of cancer other than metastatic colorectal cancer cannot participate. Metastatic means the cancer has spread to other parts of the body.
Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study organizers.
Patients who are not able to give informed consent or understand the study requirements cannot participate. This ensures that participants are fully aware of what the study involves.
Patients who have other serious health conditions that might interfere with the study treatment cannot participate. This is to ensure the safety of the participants.
Patients who are pregnant or breastfeeding cannot participate. This is to protect the health of the mother and the baby.
Patients who have previously received certain treatments that might affect the study results cannot participate. This is to ensure the study results are accurate.
Patients who are currently participating in another clinical trial cannot participate. This is to avoid any interference between different study treatments.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
Azienda Ospedaliero Universitaria Di Sassari	Sassari	Italy
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Azienda Sanitaria Locale Viterbo	Viterbo	Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
Azienda USL Toscana Centro	Prato	Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Azienda USL Toscana Sud Est	Arezzo	Italy
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Casa Sollievo Della Sofferenza	San Giovanni Rotondo	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Azienda Unita Sanitaria Locale Di Piacenza	Piacenza	Italy
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Azienda Unita Locale Socio Sanitaria N 8 Berica	Vicenza	Italy
Fondazione Poliambulanza	Brescia	Italy
Pia Fondazione Di Culto E Religione Card G Panico	Tricase	Italy
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Azienda Socio Sanitaria Territoriale Dei Sette Laghi	Varese	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Azienda Ospedaliera Universitaria Di Cagliari	Monserrato	Italy
Azienda Ospedaliero Universitaria Pisana	Pisa	Italy
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari	Bari	Italy
Ibivuybu Rksyijbyg Psh Ll Sdrpgy Dhe Tmescu Djva Abgkswj Iopl Skfinv	Meldola	Italy
Axfmgwz Ugd Iyupl Dd Rhbxee Evpuvp	Reggio Emilia	Italy
Aegnuzk Othjdlnjeoj Ucspslokwkadc Pyqki	Parma	Italy
Ikawzm Ingmbpfn Fsbxunrembahn Oenmnwqpzoh	Rome	Italy
Atiwsax Otkbmouikmr S Gxkoeetd Aszqlrkaxh	Rome	Italy
Anvlpad Ujq Tjoafgx nfhj oirjj	Leghorn	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	01.08.2024

Trial locations

Investigated drugs:

FOLFOXIRI is a combination chemotherapy regimen used to treat colorectal cancer. It includes three chemotherapy drugs: fluorouracil, leucovorin, and irinotecan, along with oxaliplatin. This combination works by stopping the growth of cancer cells and is often used as a first-line treatment for advanced colorectal cancer.

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 chemotherapy to treat various types of cancer, including colorectal cancer. In this trial, it is used alongside FOLFOXIRI.

Atezolizumab is an immunotherapy drug that helps the immune system recognize and attack cancer cells. It is used to treat certain types of cancer by blocking a protein that prevents the immune system from attacking cancer cells. In this study, it is being tested to see if adding it to the FOLFOXIRI and bevacizumab treatment improves outcomes for patients with specific types of colorectal cancer.

Metastatic Colorectal Cancer – This is a type of cancer that originates in the colon or rectum and has spread to other parts of the body, such as the liver or lungs. It typically begins as a growth, called a polyp, on the inner lining of the colon or rectum, which can become cancerous over time. As the disease progresses, cancer cells can break away from the original tumor and travel through the bloodstream or lymphatic system to form new tumors in other organs. The spread of cancer to distant sites is known as metastasis, which can complicate treatment and management. Symptoms may include changes in bowel habits, blood in the stool, abdominal pain, and unexplained weight loss. The progression of the disease can vary, with some patients experiencing rapid spread while others may have a slower progression.

Trial ID:

2023-506632-32-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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