Study on the Effects of Volrustomig and Drug Combination for Patients with Advanced Hepatobiliary Cancer

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What is this study about?

This clinical trial is focused on studying treatments for Advanced Hepatobiliary Cancer, which includes cancers that affect the liver, gallbladder, and bile ducts. The study will explore the effectiveness and safety of new treatments called immunomodulators, which are designed to help the immune system fight cancer. These treatments will be tested both on their own and in combination with other cancer-fighting drugs. Some of the medications being studied include Gemcitabine, Cisplatin, Volrustomig (also known as MEDI5752), Bevacizumab, Lenvatinib, Rilvegostomig (also known as AZD2936), and Infliximab.

The purpose of this study is to evaluate how well these treatments work in shrinking tumors and stopping cancer from growing, as well as to assess their safety. Participants will receive these treatments through infusions, which means the medication is given directly into the bloodstream through a vein, or in the form of capsules or tablets taken by mouth. The study will last for up to 12 months, during which participants will be closely monitored by healthcare professionals to track their response to the treatment and any side effects they may experience.

Throughout the study, researchers will collect information on how the cancer responds to the treatments, how long the response lasts, and the overall survival of participants. They will also measure the levels of the immunomodulators in the blood and check for any immune reactions to these new treatments. This information will help determine the potential benefits and risks of these new therapies for people with advanced hepatobiliary cancer.

1 initial visit

Upon joining the study, you will attend an initial visit where medical staff will review your medical history and confirm your eligibility. This includes checking your organ and bone marrow function and ensuring you have a measurable tumor.

You will be asked to provide a tumor sample and sign a consent form to participate in the trial.

2 treatment plan discussion

The medical team will discuss the treatment plan with you. This trial involves testing new medications called immunomodulators, which may be given alone or with other cancer drugs.

The goal is to assess how well these treatments work and how safe they are for patients with advanced hepatobiliary cancer.

3 treatment administration

You will receive medications through different methods. Some drugs, like gemcitabine and cisplatin, are given as a solution for infusion, which means they are administered directly into your vein.

Other medications, such as lenvatinib, are taken orally in the form of capsules. The frequency and dosage will be explained by your healthcare provider.

4 regular monitoring

Throughout the trial, you will have regular check-ups to monitor your health and the effects of the treatment. This includes blood tests, imaging scans, and other assessments as needed.

The medical team will track your response to the treatment and any side effects you may experience.

5 follow-up visits

After completing the treatment phase, you will have follow-up visits to evaluate your overall health and the long-term effects of the treatment.

These visits help the medical team gather important information about the effectiveness and safety of the medications used in the trial.

Who Can Join the Study?

Must be at least 18 years old.
Must provide a signed and dated written consent form agreeing to participate in the study.
Must have a confirmed diagnosis of a locally advanced or metastatic solid tumor, as specified in the study, based on a test called histopathology (a study of tissue under a microscope).
Must have adequate organ and bone marrow function (your organs and bone marrow should be working well enough to participate).
Must have at least one measurable tumor that has not been treated with radiation, as determined by a method called RECIST 1.1 (a standard way to measure tumor size).
Must have a life expectancy of at least 12 weeks at the time of screening.
Must be willing and able to provide a tumor sample for the study.

Who Cannot Join the Study?

Patients with any other type of cancer besides advanced hepatobiliary cancer cannot participate. This includes cancers that affect the liver, bile ducts, and gallbladder.
Patients who have received certain treatments for their cancer within a specific time frame before the study may be excluded. This includes treatments like chemotherapy, radiation, or surgery.
Patients with severe or uncontrolled medical conditions, such as heart disease or infections, may not be eligible.
Patients who are pregnant or breastfeeding cannot participate in the study.
Patients who have participated in another clinical trial within a certain period before this study may be excluded.
Patients with known allergies to the study drugs or similar drugs may not be eligible.
Patients who are unable to comply with the study procedures or follow-up visits may be excluded.
Patients with a history of certain mental health conditions that could interfere with the study may not be eligible.
Patients with a history of substance abuse that could interfere with the study may be excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
IRCCS Humanitas Research Hospital	Rozzano	Italy
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Ospedale San Raffaele S.r.l.	Milan	Italy
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hfgsoorr Vswy dlwhikhj	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	10.04.2023
Spain	Not recruiting	10.04.2023

Trial locations

Investigated drugs:

Novel Immunomodulators are a new type of treatment that helps the body’s immune system fight cancer. These medications work by boosting the immune system’s ability to detect and destroy cancer cells. In this trial, they are being tested both on their own and in combination with other cancer-fighting drugs to see how well they work in treating advanced liver and bile duct cancers.

Anticancer Agents are drugs that are used to treat cancer by killing cancer cells or stopping them from growing. In this trial, these agents are used alongside novel immunomodulators to see if the combination is more effective in treating advanced liver and bile duct cancers than using the immunomodulators alone. The goal is to find the best way to improve the chances of stopping or slowing down the cancer’s progression.

Investigated diseases:

Advanced Hepatobiliary Cancer – This disease refers to cancer that originates in the liver, bile ducts, or gallbladder and has progressed to an advanced stage. It typically begins with the abnormal growth of cells in these organs, forming a tumor. As the disease progresses, the cancerous cells can invade nearby tissues and spread to other parts of the body. Symptoms may include jaundice, abdominal pain, and weight loss. The progression of the disease can lead to significant impairment of liver function and other systemic effects. The disease is often characterized by its aggressive nature and resistance to conventional therapies.

Trial ID:

2022-502317-29-00

Protocol code:

D7987C00001

NCT ID:

NCT05775159

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of Volrustomig and Drug Combination for Patients with Advanced Hepatobiliary Cancer

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