RecruitingRare disease

Study on Imatinib and Atezolizumab for Patients with Advanced Gastrointestinal Stromal Tumors After Standard Treatments Fail

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 gastrointestinal stromal tumors (GIST). These tumors can be locally advanced, meaning they have grown significantly in the area where they started, or they can be unresectable, which means they cannot be removed with surgery. They can also be metastatic, indicating that the cancer has spread to other parts of the body. The study is investigating the effectiveness of a treatment that combines two medications: imatinib and atezolizumab. Imatinib is a medication that has been used to treat GIST, while atezolizumab is a type of drug known as an immunotherapy, which helps the body's immune system fight cancer.

The purpose of this study is to compare the effectiveness of resuming treatment with imatinib alone versus combining it with atezolizumab in patients whose GIST has not responded to standard treatments. Participants in the study will be randomly assigned to one of two groups. One group will receive imatinib alone, and the other group will receive both imatinib and atezolizumab. The study will last for a period of up to 12 months, during which the participants will receive their assigned treatments and be monitored regularly to assess the progress of their disease.

Throughout the study, researchers will be looking at several outcomes, including how long patients live without their disease getting worse, the overall response to the treatment, and the quality of life of the participants. The study aims to provide valuable information on whether the combination of imatinib and atezolizumab offers better outcomes for patients with advanced GIST compared to imatinib alone. Participants will receive their treatments either orally, in the case of imatinib, or through an intravenous infusion, in the case of atezolizumab.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment
Upon joining the study, the patient will provide a signed and dated informed consent form. This indicates that the patient has been informed of all aspects of the trial.
A negative serum pregnancy test is required for women of childbearing potential within 72 hours prior to starting the study treatment.
Step 2
Initial assessment
The patient will undergo an initial assessment to confirm eligibility. This includes a review of medical history and a physical examination.
Laboratory tests will be conducted to ensure adequate bone marrow, liver, and kidney function.
Step 3
Treatment allocation
The patient will be randomly assigned to one of two treatment groups: imatinib alone or imatinib combined with atezolizumab.
Imatinib is taken orally, while atezolizumab is administered through an intravenous infusion.
Step 4
Treatment administration
The patient will begin the assigned treatment regimen. Imatinib is taken daily by mouth.
Atezolizumab is given as an intravenous infusion every three weeks.
Step 5
Regular monitoring
The patient will attend regular follow-up visits to monitor the response to treatment and any side effects.
These visits will include physical examinations, blood tests, and imaging studies as needed.
Step 6
Progress evaluation
The patient's progress will be evaluated periodically to assess the effectiveness of the treatment.
The primary measure of success is progression-free survival, which means the length of time during and after treatment that the patient lives with the disease without it getting worse.
Step 7
End of treatment
The treatment will continue until the disease progresses, unacceptable side effects occur, or the patient decides to withdraw from the study.
At the end of the treatment, a final assessment will be conducted to evaluate the overall response and any long-term effects.

Who can join the trial?

15 criteria

Must be a male or female aged 18 years or older.
Must agree to use effective birth control during the study if you are a woman who can have children or a man.
Must have medical insurance.
Must have a confirmed diagnosis of Gastrointestinal Stromal Tumor (GIST). A sample of the tumor must be available for research. If not, a biopsy (a small sample of tissue) must be taken before starting treatment.
Must have advanced or metastatic disease that can be measured by medical tests.
Must have previously tried and not responded to at least three specific treatments: imatinib, sunitinib, and regorafenib. Not responding means the disease got worse or the treatment was not tolerated.
Must have a Performance Status of 0 or 1 on the ECOG scale, which means you are fully active or have some symptoms but can still do light work.
Must have adequate bone marrow and organ function as shown by specific blood test results:
Bone marrow: Hemoglobin (a protein in red blood cells) of at least 9.0 g/dl, enough white blood cells (Absolute Neutrophils Count of at least 1.5 G/l), and enough platelets (at least 100 G/l).
Coagulation: Blood clotting time should be within normal limits unless you are on blood thinners, in which case the dose must be stable.
Liver function: Total bilirubin (a liver product) should be within 1.5 times the normal limit, except for those with Gilbert's syndrome, where it can be up to 3 times the normal limit. Liver enzymes (ASAT/ALAT) should be within 2.5 times the normal limit, or 5 times if there are liver metastases. Alkaline Phosphatases should be within 2.5 times the normal limit, or 5 times if there are bone metastases.
Kidney function: Serum creatinine (a waste product in the blood) should be within 1.5 times the normal limit, or the creatinine clearance rate should be at least 40 ml/min/1.73m².
Must be willing and able to follow the study requirements.
Must provide written consent after being informed about all aspects of the trial.
Women who can have children must have a negative pregnancy test within 72 hours before starting the study treatment. If a urine test is positive, it must be confirmed by a blood test.

Who cannot join the trial?

10 criteria

Patients who have not failed standard treatments for their condition cannot participate.
Patients with other types of cancer that are not related to Gastrointestinal Stromal Tumor (GIST) are excluded.
Patients with severe or uncontrolled medical conditions that could interfere with the study are not eligible.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients who have had an organ transplant are excluded.
Patients with a history of severe allergic reactions to the study drugs cannot participate.
Patients who are currently participating in another clinical trial are not eligible.
Patients with active infections that require treatment are excluded.
Patients with a history of drug or alcohol abuse that could interfere with the study are not eligible.
Patients who have received certain medications or treatments that could interfere with the study are excluded.

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Verified sites

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

Assistance Publique Hopitaux De Marseille
Verified
Marseille, France
Centre De Lutte Contre Le Cancer Eugene Marquis
Verified
Rennes, France
Centre Hospitalier Regional Universitaire De Tours
Verified
Tours, France

Trial locations

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Investigated drugs

Imatinib
is a medication used to treat certain types of cancer, including gastrointestinal stromal tumors (GIST). It works by blocking the action of a protein that signals cancer cells to multiply. In this trial, imatinib is being used to see if restarting the treatment can help control the cancer after other treatments have failed.
Atezolizumab
is a type of immunotherapy that helps the body's immune system fight cancer. It works by blocking a protein that prevents the immune system from attacking cancer cells. In this study, atezolizumab is being combined with imatinib to see if the combination is more effective in treating advanced gastrointestinal stromal tumors than imatinib alone.

What is already known about the treatment

Imatinib
Imatinib is taken orally in the form of a tablet and is used to treat certain types of tumors in the gastrointestinal tract, specifically gastrointestinal stromal tumors (GIST) that are locally advanced, cannot be surgically removed, or have spread to other parts of the body. It works by blocking a specific protein that cancer cells need to grow, thereby slowing or stopping the growth of the tumor. Imatinib is classified as a tyrosine kinase inhibitor, a type of targeted cancer therapy. It is well-documented in medical literature and is a standard treatment for GIST, although this trial is exploring its use in combination with another drug after standard treatments have failed.
Atezolizumab
Atezolizumab is administered through an intravenous infusion, meaning it is given directly into a vein, and is being studied for its potential to treat advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed or have spread. It is an immunotherapy drug that works by helping the immune system recognize and attack cancer cells more effectively. Atezolizumab is classified as a monoclonal antibody and is part of a newer class of cancer treatments that aim to boost the body's natural defenses against cancer. This trial is investigating its effectiveness when combined with imatinib in patients who have not responded to standard treatments.

Investigated diseases

Locally Advanced Gastrointestinal Stromal Tumor (GIST)
This is a type of tumor that occurs in the digestive tract, most commonly in the stomach or small intestine. It originates from special cells in the gastrointestinal tract wall known as interstitial cells of Cajal. As the tumor grows, it may cause symptoms like abdominal pain or discomfort, and sometimes bleeding. The term "locally advanced" indicates that the tumor has grown significantly but has not spread to distant parts of the body. Over time, the tumor may invade nearby tissues and organs. It is considered a rare disease.
Unresectable Gastrointestinal Stromal Tumor (GIST)
This form of GIST cannot be surgically removed due to its size, location, or involvement with critical structures. It arises from the interstitial cells of Cajal in the gastrointestinal tract. The tumor may cause symptoms such as pain, bleeding, or obstruction in the digestive system. As it progresses, it can grow larger and affect nearby organs. Despite being unresectable, it remains localized without distant spread. It is classified as a rare disease.
Metastatic Gastrointestinal Stromal Tumor
This type of GIST has spread from its original site in the gastrointestinal tract to other parts of the body, such as the liver or peritoneum. It begins in the interstitial cells of Cajal and can cause symptoms like pain, fatigue, or weight loss. The metastatic spread indicates that the tumor cells have traveled through the bloodstream or lymphatic system. As the disease progresses, it can lead to the formation of new tumors in distant organs. It is recognized as a rare disease.