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Study of Pembrolizumab as Additional Treatment for Patients with Liver Cancer (Hepatocellular Carcinoma) After Surgery or Local Ablation

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What is this study about?

This study focuses on patients with Hepatocellular Carcinoma (a type of liver cancer) who have had complete removal of visible cancer through surgery or local treatment. The study tests whether additional treatment with pembrolizumab (also known as KEYTRUDA) can help prevent cancer from returning, compared to a placebo.

The medication pembrolizumab is given through an intravenous infusion (a drip into a vein). Participants will receive either pembrolizumab or placebo every three weeks. The maximum single dose is 200 milligrams, and treatment can continue for up to 51 weeks. Neither the doctors nor the participants will know which treatment is being given during the study.

The study aims to determine if pembrolizumab can extend the time before cancer returns and improve overall survival in patients who have had their liver cancer successfully treated. The medication works by helping the body’s immune system fight cancer cells. Throughout the study, doctors will monitor participants’ health and any side effects they may experience.

1 Initial eligibility confirmation

Your eligibility will be confirmed through scans (CT of chest, special CT or MRI of abdomen and pelvis) at least 4 weeks after your surgical procedure or local ablation

Your liver function will be checked to confirm Child-Pugh class A liver score (5-6 points)

Your alpha fetoprotein (AFP) level must be below 400 ng/mL

Your physical condition will be assessed using the ECOG performance status scale, which must be 0 or 1

2 Treatment assignment

You will be randomly assigned to receive either pembrolizumab (KEYTRUDA) or placebo

Neither you nor your doctor will know which treatment you are receiving

Treatment must begin within 12 weeks of your surgical procedure or local ablation

3 Treatment administration

You will receive treatment through intravenous infusion

The medication (KEYTRUDA) concentration is 25 mg/mL in solution form

If you are in the placebo group, you will receive normal saline solution

4 Monitoring and assessment

Your health status will be regularly monitored for any side effects

You will complete quality of life questionnaires (EORTC QLQ-C30, EORTC QLQ-HCC18, EQ-5D-5L) to assess your well-being

Regular scans will be performed to check for any disease recurrence

Your overall survival will be monitored throughout the study period

5 Study duration

The study will continue until August 31, 2029

Your participation may end earlier if you experience significant side effects or if your disease returns

Who Can Join the Study?

  • Must have a diagnosis of liver cancer (HCC) confirmed by imaging tests and/or tissue examination
  • If having surgery, must provide a tumor tissue sample during screening period
  • Must have normal functioning organs
  • Must have imaging scans (chest CT, special abdominal CT or MRI, and pelvis imaging) showing no cancer at least 4 weeks after surgery or ablation treatment. Must join the study within 12 weeks after these procedures
  • Must show no signs of cancer on imaging tests before entering the study
  • Must be able to perform daily activities with minimal or no assistance (ECOG score of 0 or 1) within 7 days before starting treatment
  • Must have good liver function (Child-Pugh class A score between 5-6 points) within 7 days before starting treatment
  • Must have a liver protein level (alpha fetoprotein or AFP) below 400 ng/mL within 28 days before starting treatment
  • Must have controlled hepatitis B infection
  • Must have recovered from any complications from previous surgery or ablation treatment
  • For women: must not be pregnant or breastfeeding, and either:
    • Be unable to become pregnant, or
    • Use effective birth control or abstain from sexual activity (must have negative pregnancy test within 72 hours before starting treatment)

Who Cannot Join the Study?

  • History of previous liver transplantation or currently on waiting list for transplant
  • Active or chronic hepatitis B infection without appropriate antiviral treatment
  • Known HIV infection (Human Immunodeficiency Virus)
  • Currently receiving treatment for other types of cancer
  • Severe heart conditions, including heart failure or recent heart attack (within last 6 months)
  • Severe kidney problems requiring dialysis
  • Uncontrolled high blood pressure
  • Active substance abuse or alcohol dependency within the past year
  • Pregnant or breastfeeding women
  • Mental conditions that could interfere with following study procedures
  • Participation in another clinical trial within the last 30 days
  • Known allergies to the study medications
  • Major surgery planned during the study period
  • Severe liver disease beyond the condition being studied
  • Unable to provide informed consent

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Lille Lille France
Azienda Ospedaliero Universitaria Careggi Florence Italy
Katholieke Universiteit te Leuven Leuven Belgium
Oslo Universitetssykehus HF Oslo Norway
Medizinische Hochschule Hannover Hanover Germany
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie Koszalin Poland
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
ID Clinic Myslowice Poland
Universitaetsklinikum Wuerzburg AöR Wuerzburg Germany
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie Olsztyn Poland
Muenchner Studienzentrum Munich Germany
Semmelweis University Budapest Hungary
Krankenhaus Nordwest GmbH Frankfurt Germany
University Of Debrecen Debrecen Hungary
Virgen del Rocío University Hospital Sevilla Spain
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Centre Hospitalier Universitaire De Toulouse Toulouse France
Karolinska University Hospital Solna Sweden
Universita’ Di Pisa Pisa Italy
Region Midtjylland Aarhus Denmark
Staedtisches Klinikum Dresden Dresden Germany
Region Vaesterbotten Umea Sweden
Universitair Ziekenhuis Gent Gent Belgium
Deutsches Herzzentrum Berlin Berlin Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Hopital Beaujon Clichy France
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Mtz Clinical Research Powered By Pratia Warsaw Poland
Azienda Ospedaliera Ordine Mauriziano Di Torino Turin Italy
Azienda Sanitaria Locale Napoli 1 Centro Naples Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
University Of Szeged Szeged Hungary
Odense University Hospital Odense Denmark
Hospital Paul Brousse Villejuif France
Hopital Saint Eloi Montpellier France
Bqgmurxpfqb Vyjaranqo Oaizhjzlhigx Kecskemet Hungary
Htpfjs Htrzbowx Herlev Denmark
Apdfeohnaf Pmcmjzdv Hhkpivaq Df Msqenophr Marseille France
Uzbmztnwxihvevowshaib Dzjhxcchjth Adc Duesseldorf Germany
Gqtwck Ukgkgicawl Fhkatcahs Frankfurt Germany
Siyrvwphozs Uswkyuvarw Huqtpvpecslzwkn Gnjjcotlnlavmpvds Gothenburg Sweden
Aahbfoj Uieyx Szdzuomgn Lgujra Db Bglowew Bologna Italy
Su Vkcpkpxiigmbndc Uocsrawwth Hyohzans Dublin Ireland
Usdhikmizi Of Aamevcb Edegem Belgium
Uzquuwwtye Mjdpkoo Cpawen Hapiowppelufzyrfd Hamburg Germany
Hzybbpbu Vxwc dganaioo Barcelona Spain
Hxhyhkfb Urzscqjmzawnlz Sgqqkkktvo &wmtmdv Hybkhwy df Hlcyglmoxeb STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
06.05.2019
Denmark Denmark
Not recruiting
06.05.2019
France France
Not recruiting
06.05.2019
Germany Germany
Not recruiting
06.05.2019
Hungary Hungary
Not recruiting
06.05.2019
Ireland Ireland
Not recruiting
06.05.2019
Italy Italy
Not recruiting
06.05.2019
Norway Norway
Not recruiting
06.05.2019
Poland Poland
Not recruiting
06.05.2019
Spain Spain
Not recruiting
06.05.2019
Sweden Sweden
Not recruiting
06.05.2019

Trial locations

Investigated drugs:

Pembrolizumab (also known as MK-3475) is a medication that helps the immune system fight cancer cells. It belongs to a class of drugs called immunotherapy. This medication works by blocking a protein called PD-1 on immune cells, which helps these cells recognize and attack cancer cells more effectively. In this trial, it is being studied as a treatment after surgery or local ablation in patients with liver cancer (hepatocellular carcinoma) who have shown a complete response to initial treatment.

Hepatocellular Carcinoma (HCC) – A primary type of liver cancer that begins in the main type of liver cells (hepatocytes). The disease typically develops in people with chronic liver diseases, such as cirrhosis. HCC often starts as a single tumor that grows larger or as many small cancer nodules throughout the liver. The cancer can spread within the liver and may eventually affect other organs. The condition usually progresses gradually, with changes in liver function occurring over time. The liver may become enlarged as the disease advances.

Trial ID:
2022-501971-24-00
Protocol code:
MK-3475-937
NCT ID:
NCT03867084
Trial Phase:
Therapeutic confirmatory (Phase III)

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