Not recruiting

Study of Durvalumab and Tremelimumab for Patients with Resectable Liver Cancer

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 liver cancer known as Hepatocellular Carcinoma (HCC), which can be surgically removed. The study is investigating the use of two medications, Durvalumab and Tremelimumab, as a treatment option. These medications are given through an infusion, which means they are delivered directly into the bloodstream through a vein. The purpose of the study is to assess the safety of using these medications before surgery in patients with resectable HCC.

Participants in the study will receive treatment with Durvalumab and Tremelimumab over a period of time before their scheduled surgery. The study will monitor the safety of these medications by observing any side effects that may occur. The treatment period for Durvalumab can last up to 52 weeks, while Tremelimumab is administered over a shorter period of up to 4 weeks. The study will also track any delays in surgery that might be caused by treatment-related side effects.

The trial aims to gather information on how well the treatment works in reducing the size of the tumor and ensuring that the cancer does not return after surgery. Researchers will also collect blood and stool samples for further analysis to understand the effects of the treatment on the immune system and the cancer itself. The study is expected to continue until 2027, with recruitment of participants starting in late 2024.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, health status, and medical history.
Consent is required to participate, and a biopsy sample must be provided before treatment begins.
Step 2
Pre-operative treatment
The treatment involves the administration of two medications: durvalumab and tremelimumab.
Both medications are given through an infusion, which is a method of delivering medication directly into the bloodstream.
The main objective of this phase is to assess the safety of these medications before surgery.
Step 3
Surgery
After the pre-operative treatment, surgery is performed to remove the hepatocellular carcinoma.
The timing of the surgery may be adjusted based on the patient's response to the treatment.
Step 4
Post-operative follow-up
Following surgery, regular follow-up visits are scheduled to monitor recovery and any potential side effects.
The study aims to track the number of adverse events and the overall survival rate.
Step 5
Long-term monitoring
Long-term monitoring includes regular assessments to evaluate the recurrence-free survival and the presence of any viable tumor.
Blood and stool samples may be collected for further analysis to understand the treatment's impact.

Who can join the trial?

14 criteria

The patient must be able to provide written permission to participate in the study.
For women who can have children, they must show they are not pregnant or are past menopause.
Women who can have children and men who have partners who can have children must agree to use a reliable form of birth control during the study and for 6 months after the last treatment.
The patient must have normal functioning of organs and bone marrow, which includes having enough red blood cells, white blood cells, and platelets, as well as normal levels of bilirubin, creatinine, and albumin in the blood.
The patient must be willing and able to follow the study rules, including attending treatment sessions and check-ups.
The patient must weigh more than 30 kilograms (about 66 pounds).
The patient must be older than 18 years at the time they join the study.
The patient must have a type of liver cancer called **resectable hepatocellular carcinoma (HCC)**, which means the cancer can be removed by surgery. This is determined by a group of doctors.
The patient must agree to provide a sample of their tumor before starting treatment.
The patient must have a good level of daily functioning, as measured by a scale called the **Eastern Cooperative Oncology Group (ECOG) performance status**, with a score of 0 or 1.
The patient must have a **Child-Pugh score** of 5 or 6, which is a way to measure liver function.
The patient must have an **ALBI grade 1**, which is a score based on levels of albumin and bilirubin in the blood.
If the patient has a **hepatitis B virus (HBV) infection**, they must be on antiviral medication to control the virus before joining the study and continue this treatment during the study and for 6 months after the last treatment.
If the patient has a **hepatitis C virus (HCV) infection**, they must manage this condition according to local medical practices throughout the study.

Who cannot join the trial?

10 criteria

Patients with any other type of cancer besides resectable hepatocellular carcinoma cannot participate. Resectable means the cancer can be removed by surgery.
Patients who have had previous treatment with the study drugs, Durvalumab or Tremelimumab, are not eligible. These are medications used to help the immune system fight cancer.
Patients with severe or uncontrolled medical conditions that could interfere with the study are excluded. This means if you have a serious health issue that is not well-managed, you cannot join.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients with a history of severe allergic reactions to any of the study drugs or similar drugs are not allowed to participate.
Patients with active infections, such as hepatitis or HIV, are excluded from the study.
Patients who have had a major surgery within 4 weeks before starting the study treatment are not eligible.
Patients who are currently participating in another clinical trial or have done so within the last 30 days cannot join this study.
Patients with a history of autoimmune diseases, which are conditions where the immune system attacks the body, are excluded.
Patients with a history of organ transplant are not eligible to participate.

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Verified sites

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

Verified
Fondazione I.R.C.C.S. Istituto Neurologico Besta
Milan, Italy
Verified
Hospital Universitario De Navarra
Pamplona, Spain

Trial locations

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Investigated drugs

Durvalumab
is a medication used in this trial to help the body's immune system fight cancer. It works by blocking a specific protein that can stop the immune system from attacking cancer cells, allowing the immune system to better target and destroy these cells.
Tremelimumab
is another medication used in the trial that also helps the immune system attack cancer cells. It works by targeting a different protein that can inhibit the immune response, thereby enhancing the body's ability to fight cancer.

What is already known about the treatment

Durvalumab
Durvalumab is administered as an intravenous infusion, typically given in a clinical setting under the supervision of healthcare professionals. It is currently being studied in clinical trials for its effectiveness in treating resectable hepatocellular carcinoma, a type of liver cancer. The medication works by blocking a protein called PD-L1, which helps cancer cells evade the immune system, thereby allowing the immune system to better attack the cancer. Durvalumab is classified as an immune checkpoint inhibitor, a type of immunotherapy.
Tremelimumab
Tremelimumab is also administered via intravenous infusion, usually in a hospital or clinic. It is being investigated in clinical trials for its potential to treat resectable hepatocellular carcinoma. The drug functions by targeting and inhibiting CTLA-4, a protein that downregulates the immune response, thus enhancing the body's ability to fight cancer cells. Tremelimumab is part of the immune checkpoint inhibitor class of medications, which are designed to boost the immune system's response against cancer.

Investigated diseases

Hepatocellular Carcinoma – Hepatocellular carcinoma is a type of liver cancer that originates in the liver cells, known as hepatocytes. It often develops in the context of chronic liver disease, such as cirrhosis or hepatitis. The disease progresses as the cancerous cells multiply and form a tumor, which can disrupt liver function. Over time, the tumor may grow larger and potentially spread to other parts of the body. Symptoms may include abdominal pain, weight loss, and jaundice. Early stages might not present noticeable symptoms, making regular monitoring important for those at risk.