Study of Ezurpimtrostat with Atezolizumab and Bevacizumab for Patients with Unresectable Liver Cancer

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What is this study about?

This clinical trial is focused on studying a type of liver cancer called unresectable hepatocellular carcinoma. The trial is testing a new treatment combination that includes a drug called Ezurpimtrostat, which is an autophagy inhibitor. Autophagy is a process in cells that can help cancer cells survive, and inhibiting it may help in treating cancer. This new treatment is being tested alongside two other medications, Atezolizumab and Bevacizumab, which are already used as a standard treatment for this type of cancer. The purpose of the study is to see if adding Ezurpimtrostat to the standard treatment can improve outcomes for patients.

Participants in the study will receive either the standard treatment of Atezolizumab and Bevacizumab or the combination of Ezurpimtrostat with Atezolizumab and Bevacizumab. The study will compare the effectiveness of these treatments over a period of time. The medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein. The study will last for several months, and participants will have regular check-ups and tests to monitor their health and the progress of the cancer.

The trial aims to understand if the new combination treatment can help patients live longer without the cancer getting worse, which is known as progression-free survival. It will also look at other factors like overall survival, the response of the tumor to the treatment, and the quality of life of the participants. This study is important for finding better ways to treat unresectable hepatocellular carcinoma and could lead to new treatment options for patients in the future.

1 initial visit

Upon joining the clinical trial, the patient will attend an initial visit. During this visit, the patient will undergo a series of assessments to confirm eligibility for the study. These assessments may include blood tests, imaging scans, and a review of medical history.

2 treatment plan discussion

The patient will meet with the study team to discuss the treatment plan. This includes an explanation of the medications involved, their dosages, and the schedule for administration. The patient will receive information about the potential benefits and risks of the treatment.

3 medication administration

The patient will begin treatment with a combination of medications. The first medication, atezolizumab, is administered as an intravenous infusion. The second medication, bevacizumab, is also given as an intravenous infusion. The third medication, gns561, is taken orally in capsule form. The specific dosages and frequency of administration will be provided by the study team.

4 regular follow-up visits

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 to assess the progress of the disease.

5 progress assessment

Throughout the trial, the patient’s progress will be assessed using specific criteria to determine the effectiveness of the treatment. This includes measuring the size of the tumor and evaluating overall health status.

6 end of treatment evaluation

At the end of the treatment period, the patient will undergo a final evaluation. This will include a comprehensive assessment of the treatment’s impact on the disease and any long-term effects experienced by the patient.

Who Can Join the Study?

Males or females who are 18 years of age or older.
Have a life expectancy of at least 12 weeks.
If you have cirrhosis (a liver condition), you must have had an endoscopy (a procedure to look inside the body) to check for esophageal varices (swollen veins in the esophagus) within the last 6 months.
Have adequate blood function before the first dose, which means:
- Enough neutrophils (a type of white blood cell) in your blood.
- Hemoglobin (a protein in red blood cells) level of at least 9 g/dL without a blood transfusion in the last 4 weeks.
- Platelet count (cells that help blood clot) above 50,000/µL without a transfusion in the last 2 weeks.
Have adequate kidney function before the first dose, which means:
- Serum creatinine (a waste product in the blood) less than 1.5 times the normal limit.
- Creatinine clearance (a measure of kidney function) of at least 30 mL/min/m2.
Have adequate liver function before the first dose, with AST/ALT (liver enzymes) levels no more than 5 times the normal limit.
Women who can have children must have a negative pregnancy test and agree to use effective birth control during the study and for 6 months after.
Men who can father children must agree to use birth control and/or not donate sperm during the study and for 6 months after.
Must be able to have a CT scan or MRI for measuring tumor size and follow-up.
No other significant health issues that need medical treatment, as judged by the study doctor.
Willing and able to attend scheduled visits, follow the treatment plan, and complete tests and procedures.
Have a confirmed diagnosis of non-resectable or metastatic hepatocellular carcinoma (HCC) from a liver biopsy in the last 6 months.
Able to understand and sign a written consent form.
Covered by a Health Insurance System.
Have a BCLC C status according to the Barcelona Clinic Liver Cancer staging system.
No previous systemic therapy for advanced HCC.
Liver tumor affects less than 50% of the liver.
Have a Child-Pugh A score (a measure of liver disease severity) without any liver failure in the past 6 months.
If you have hepatitis B, you must be on antiviral therapy.
Have a measurable tumor according to RECIST v1.1 criteria.
Have an ECOG performance status of 0 or 1, which means you are fully active or have some symptoms but can still do light work.

Who Cannot Join the Study?

Patients who have had surgery to remove their liver cancer cannot participate. Unresectable means the cancer cannot be removed by surgery.
Patients who are not in the age range specified for the study cannot participate. The study is for adults only.
Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.
Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
Patients with other serious health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently may not be eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Lille	Lille	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Hopital Prive Jean Mermoz	Lyon	France
Hospices Civils De Lyon	Lyon	France
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Assistance Publique Hopitaux De Paris	Paris	France
Hopital Saint Joseph	Marseille	France
Centre Hospitalier Regional Universitaire De Nancy	Nancy	France
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Hôpital Avicenne	Bobigny	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Hopital Europeen Marseille	Marseille	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Hopital Beaujon	Clichy	France
Hospital Paul Brousse	Villejuif	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
CHU Bordeauxt	Bordeaux	France
Cermgm Hyjnunrgqym Uipqfyvhxrbpb Ahctbb Pubzvced	Amiens	France
Clsqja Hxunoksiitf Eg Ugxoktclmscbl Df Ldbazqb	Limoges	France
Bpgqdctw Ukgrmdgpqc Htowtils Cevurh	Besançon	France
Cwrcra Hdotlzhtjra Rtmmujiv Uiblzvbzljbnr Dn Tuoer	Tours	France
Ccweya Hiiaifwmefm Ukbxlvtknfnkk Riswy	Reims	France
Cpjezz Hcabrkzbxcw Rysldijl Ddlrpmfginkedz	Angers	France
Hytpkvl Hhtdn Mupkdz &ywcylz 1 rbg Gjendft Emrhxe	Creteil	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	07.11.2022

Trial locations

Investigated drugs:

Ezurpimtrostat is a medication being studied for its ability to block a process in cells called autophagy, which is a way cells clean out damaged parts. In this trial, it is being tested to see if it can help treat liver cancer that cannot be removed by surgery. The researchers want to find out if adding Ezurpimtrostat to the usual treatment can improve outcomes for patients.

Atezolizumab is a type of cancer treatment known as immunotherapy. It works by helping the body’s immune system recognize and attack cancer cells. In this trial, Atezolizumab is part of the standard treatment for liver cancer that cannot be surgically removed. It is being used to see if it can help control the cancer when combined with other treatments.

Bevacizumab is a medication that works by blocking the growth of new blood vessels that tumors need to grow. This can help slow down or stop the growth of cancer. In this trial, Bevacizumab is used as part of the standard treatment for liver cancer that cannot be removed by surgery. The study is looking at how well it works when used with other treatments.

Investigated diseases:

Hepatocellular carcinoma

Unresectable Hepatocellular Carcinoma – Hepatocellular carcinoma is a type of liver cancer that originates in the hepatocytes, the main type of liver cell. When the cancer is deemed unresectable, it means that it cannot be removed completely through surgery. This condition often arises due to the tumor’s size, location, or the presence of multiple tumors in the liver. As the disease progresses, the cancer cells can invade nearby tissues and spread to other parts of the body. The progression of unresectable hepatocellular carcinoma can lead to liver dysfunction and other systemic effects. The disease is often associated with underlying liver conditions such as cirrhosis or chronic hepatitis.

Trial ID:

2022-502078-17-00

Protocol code:

38RC210434 ABE LIVER

NCT ID:

NCT05448677

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Ezurpimtrostat with Atezolizumab and Bevacizumab for Patients with Unresectable Liver Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?