Study of Nivolumab and Ipilimumab for Patients with Advanced Liver Cancer (Hepatocellular Carcinoma) as First-Line Treatment

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What is this study about?

This clinical trial is focused on studying a type of liver cancer known as Hepatocellular Carcinoma (HCC). The study is investigating the effectiveness and safety of a combination of two medications, Nivolumab and Ipilimumab, compared to two other medications, Sorafenib and Lenvatinib, which are commonly used as standard treatments. The main goal is to see if the combination of Nivolumab and Ipilimumab can help patients live longer than the standard treatments.

Participants in the study will receive either the combination of Nivolumab and Ipilimumab or one of the standard treatments, Sorafenib or Lenvatinib. Nivolumab and Ipilimumab are given through an infusion, which means they are delivered directly into the bloodstream through a vein. Sorafenib and Lenvatinib are taken as oral tablets. The study will monitor participants over a period to assess the effects of these treatments on their health and the progression of their cancer.

Throughout the study, participants will be closely observed to ensure their safety and to gather information on how well the treatments are working. The study aims to provide valuable insights into the best first-line treatment options for people with advanced Hepatocellular Carcinoma who have not received prior systemic therapy. A placebo may be used in some cases to compare the effects of the active treatments.

1 joining the study

Upon joining the study, the participant is confirmed to have advanced hepatocellular carcinoma (HCC) through histological confirmation.

The participant must have at least one measurable lesion that has not been treated before, a Child-Pugh score of 5 or 6, and an ECOG performance status of 0 or 1.

2 randomization

The participant is randomly assigned to one of the treatment groups. The options include a combination of nivolumab and ipilimumab, or standard care with either sorafenib or lenvatinib.

3 treatment administration

If assigned to the nivolumab and ipilimumab group, the participant receives these medications through intravenous infusion. Nivolumab is administered as a 10 mg/mL solution, and ipilimumab as a 5 mg/mL solution.

If assigned to the standard care group, the participant takes sorafenib orally in the form of 200 mg film-coated tablets or lenvatinib orally.

4 monitoring and evaluation

Throughout the study, the participant’s health and response to treatment are closely monitored. This includes regular assessments to measure the size of tumors and overall health status.

The primary goal is to compare overall survival between the treatment groups. Secondary goals include evaluating the response rate, duration of response, time to symptom deterioration, progression-free survival, and time to progression.

5 completion of study

The study is estimated to conclude by June 30, 2025. At the end of the study, the data collected will be analyzed to determine the effectiveness and safety of the treatments.

Who Can Join the Study?

  • Participants must have a diagnosis of Hepatocellular Carcinoma (HCC), which is a type of liver cancer, confirmed by a test called histological confirmation.
  • Participants must have an advanced stage of HCC.
  • Participants must have at least one tumor that can be measured using a specific set of guidelines called Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. This tumor should not have been treated before.
  • Participants must have a Child-Pugh score of 5 or 6. This score is used to assess the liver’s function and how well it is working.
  • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. This is a scale used to determine how well a person can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but still able to do light work.

Who Cannot Join the Study?

  • Patients who have received prior systemic therapy for their liver cancer cannot participate. Systemic therapy means treatment that affects the entire body, like certain medications.
  • Patients with other serious health conditions that might interfere with the study cannot participate. This includes conditions that affect the heart, lungs, or other important organs.
  • Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of both the mother and the baby.
  • Patients who have had another type of cancer in the past, unless it was successfully treated and has not come back, cannot participate.
  • Patients who have an active infection that requires treatment cannot participate. This is to prevent any complications during the study.
  • Patients who have a known allergy to any of the study medications cannot participate. An allergy is when the body reacts negatively to a substance.
  • Patients who are unable to follow the study procedures or attend the required visits cannot participate. This is important for collecting accurate study results.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Hopital Beaujon Clichy France
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Azienda Unita Locale Socio Sanitaria N 8 Berica Vicenza Italy
Copernicus Podmiot Leczniczy Sp. z o.o. Gdansk Poland
Europejskie Centrum Zdrowia Otwock Sp. z o.o. Otwock Poland
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Candiolo Italy
Hospital Clinic De Barcelona Barcelona Spain
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Centre Hospitalier Universitaire De Nice Nice France
Hospital Paul Brousse Villejuif France
Fundeni Clinical Institute Bucharest Romania
Aghfmlb Oosphvunntg Upglqcwwlqffw Pmkga Parma Italy
Hxzzvfkk Uithhiefodono Mdygzgo Dq Vkdixysqfi Santander Spain
Unespqyvso Hekzmtwb Cjobygd Cologne Germany
Clid Dt Nhoex Vandoeuvre Les Nancy France
Nbcqkqat Irqwwowy Oetjbnfpe Ikl Mlxce Svrigvdwpypmykhehkbtmrzzoomw Isuowqtp Bmvphhnr Cracow Poland
Gojfjw Uqzifnxuen Fjbmplwgm Frankfurt Germany
Cib Ccwfe Rrfgzcosyqw Lyon France
Hbwohqwr Vuhn dbxtesoz Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
30.09.2019
Belgium Belgium
Not recruiting
30.09.2019
France France
Not recruiting
30.09.2019
Germany Germany
Not recruiting
30.09.2019
Italy Italy
Not recruiting
30.09.2019
Poland Poland
Not recruiting
30.09.2019
Romania Romania
Not recruiting
30.09.2019
Spain Spain
Not recruiting
30.09.2019

Trial locations

Nivolumab is a medication used in this trial to help the body’s immune system fight cancer cells. It works by blocking a protein that stops the immune system from attacking cancer cells, allowing the immune system to better target and destroy them.

Ipilimumab is another medication used in combination with nivolumab in this trial. It also helps the immune system attack cancer cells by blocking a different protein that can prevent the immune system from working effectively against cancer.

Sorafenib is a standard treatment option in this trial. It is a type of medication that works by blocking certain proteins that help cancer cells grow and spread. It is used to slow down the growth of cancer cells and reduce the size of tumors.

Lenvatinib is another standard treatment option in this trial. It works similarly to sorafenib by targeting proteins that contribute to the growth and spread of cancer cells. It helps to slow down the progression of the cancer and can shrink tumors.

Investigated diseases:

Hepatocellular Carcinoma – This is the most common type of primary liver cancer, originating in the liver cells known as hepatocytes. It often develops in the context of chronic liver disease, such as cirrhosis or hepatitis. The disease typically progresses by forming a mass in the liver, which can grow and spread to other parts of the body. As it advances, it may cause symptoms like abdominal pain, weight loss, and jaundice. The progression can vary, with some tumors growing slowly while others may spread rapidly. It is often diagnosed at an advanced stage due to the lack of early symptoms.

Trial ID:
2023-508635-31-00
Protocol code:
CA209-9DW
NCT ID:
NCT04039607
Trial Phase:
Therapeutic confirmatory (Phase III)

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