Study of Nivolumab for Patients with Liver Cancer at High Risk of Recurrence After Surgery or Ablation

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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 effects of a treatment called Nivolumab, which is also known by its code name BMS-936558. Nivolumab is a medication that is given through an infusion, which means it is delivered directly into the bloodstream through a vein. The trial is comparing Nivolumab to a placebo to see how well it works in preventing the return of cancer in patients who have had surgery or other treatments to remove or destroy their liver tumors.

The purpose of the study is to see if Nivolumab can help patients with HCC who are at high risk of their cancer coming back after they have had surgery or a procedure to remove or destroy the cancer. Participants in the study will receive either Nivolumab or a placebo. The study will monitor the participants over time to see if the cancer returns and to assess their overall health and survival.

Participants will be randomly assigned to receive either the Nivolumab treatment or a placebo. The study will follow them for a period to observe the effects of the treatment. The main goal is to determine if Nivolumab can help keep the cancer from returning and to understand its impact on the participants’ survival. This study is part of a larger effort to find better treatments for liver cancer and improve outcomes for patients at high risk of recurrence.

1 randomization

Upon joining the study, participants are randomly assigned to one of two groups: one receiving the medication nivolumab and the other receiving a placebo. This process is double-blind, meaning neither the participants nor the researchers know which group each participant is in.

2 treatment administration

Participants in the treatment group receive nivolumab, which is a medication administered through an intravenous infusion. The dosage is 10 mg/mL, and it is given as a solution for infusion.

The placebo group receives an infusion that does not contain the active medication. Both groups receive their respective infusions at regular intervals as determined by the study protocol.

3 monitoring and follow-up

Participants undergo regular monitoring to assess their health status and the effects of the treatment. This includes imaging studies to confirm disease-free status and to monitor for any recurrence of hepatocellular carcinoma.

The primary goal is to evaluate recurrence-free survival, which is the time from randomization to the first documented disease recurrence or death from any cause.

4 study completion

The study is estimated to conclude by December 16, 2025. At the end of the study, data from all participants will be analyzed to determine the effectiveness of nivolumab in preventing the recurrence of hepatocellular carcinoma compared to the placebo.

Who Can Join the Study?

  • Participants must be males or females who are 18 years old or older.
  • Participants should have a first diagnosis of Hepatocellular Carcinoma (HCC), which is a type of liver cancer, that can be treated with surgery or local treatment aimed at curing the disease.
  • Participants can join if their HCC is not related to viruses, or if it is related to Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV).
  • Participants must have had either:
    • Hepatic resection, which is a surgery to remove part of the liver, with specific tumor characteristics: up to three tumors with at least one larger than 5 cm, or none larger than 5 cm but with certain aggressive features; or more than three tumors, none larger than 5 cm.
    • Local ablation, which is a treatment that destroys cancer cells using heat, with specific tumor characteristics: a single tumor larger than 3 cm but no more than 5 cm, or multiple tumors (up to 4), none larger than 5 cm.
  • Participants must have a complete response to resection, meaning the tumor was fully removed, or must have proof of complete removal after local ablation.
  • Participants need to have imaging tests showing no signs of the disease at least 4 weeks after complete tumor removal and within 4 weeks before starting the trial.
  • Participants must have a Child-Pugh Score of 5 or 6, which is a system used to assess liver function.
  • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which measures how well they can perform daily activities.

Who Cannot Join the Study?

  • Patients with other types of cancer besides Hepatocellular Carcinoma cannot participate. Hepatocellular Carcinoma is a type of liver cancer.
  • Patients who have had a recurrence of their cancer after treatment are not eligible.
  • Patients who are currently receiving treatment with other experimental drugs cannot join the study.
  • Patients with severe or uncontrolled medical conditions that could interfere with the study are excluded.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have a history of severe allergic reactions to similar drugs are not eligible.
  • Patients who have participated in another clinical trial within the last 30 days are excluded.

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
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Virgen del Rocío University Hospital Sevilla Spain
Hospital Clinic De Barcelona Barcelona Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Klinik Favoriten Vienna Austria
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Centre Hospitalier Universitaire De Rennes Rennes France
A.O.U. Policlinico G. Martino Di Messina Messina Italy
Azienda Ospedaliera Universitaria Di Cagliari Monserrato Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Hospital Paul Brousse Villejuif France
Otto Von Guericke Universitaet Magdeburg Magdeburg Germany
Fundeni Clinical Institute Bucharest Romania
Cvkkzwnsl Uneydsnrtbvdew Sggovvcaw Woluwe-Saint-Lambert Belgium
Cpqkga Hrpcaaurvty Ushpccpfwueyg Rxrql Reims France
Uscjfpxlycctycuheijbz Epoiv Aie Essen Germany
Pssc Tbeog Hrclfuru Uqmwmgykfooj Sabadell Spain
Mwaudzf Ukwjwusakq On Gpki Graz Austria
Cdoq Dg Ntauj Vandoeuvre Les Nancy France
Hljnqoxh Uuwlnfhrwfyod Dhgjueuj Donostia / San Sebastian Spain
Gecosq Upycijkjuo Fulnrmufx Frankfurt Germany
Ajgdtpo Uedtu Suxjufpst Lspuhl Ds Burlpko Bologna Italy
Cud Cdvez Rwhcujvbmlo Lyon France
Hvchlslv Vkam duuocbhw 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
02.05.2018
Belgium Belgium
Not recruiting
02.05.2018
France France
Not recruiting
02.05.2018
Germany Germany
Not recruiting
02.05.2018
Italy Italy
Not recruiting
02.05.2018
Romania Romania
Not recruiting
02.05.2018
Spain Spain
Not recruiting
02.05.2018
The Netherlands The Netherlands
Not recruiting
02.05.2018

Trial locations

Investigated drugs:

Nivolumab is a medication used in this clinical trial to help prevent the return of liver cancer after surgery or other treatments. It works by helping the immune system recognize and attack cancer cells more effectively. This trial is testing whether nivolumab can improve the chances of staying cancer-free compared to not using it.

Investigated diseases:

Hepatocellular Carcinoma – Hepatocellular carcinoma is a type of liver cancer that originates in the hepatocytes, the main type of liver cell. It often develops in the context of chronic liver disease, such as cirrhosis or hepatitis infection. The disease may initially present with symptoms like abdominal pain, weight loss, or jaundice. As it progresses, the tumor can grow and spread to other parts of the liver or beyond. The progression of the disease can lead to liver dysfunction and complications related to tumor growth. Early stages might not show significant symptoms, making regular monitoring important for those at risk.

Trial ID:
2023-508726-10-00
Protocol code:
CA209-9DX
Trial Phase:
Therapeutic confirmatory (Phase III)

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