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Study Comparing Toripalimab and Lenvatinib with Placebo and Lenvatinib for First-Line Treatment in Patients with Advanced Liver Cancer

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What is this study about?

This clinical trial is focused on studying a type of liver cancer known as advanced hepatocellular carcinoma (HCC). The study is investigating the effectiveness of a treatment combination involving two medications: Toripalimab and Lenvatinib. Toripalimab, also known by its code name JS001, is a type of medication called a monoclonal antibody, which is a protein designed to help the immune system fight cancer. Lenvatinib is a chemical compound that comes in the form of hard capsules and is used to slow down the growth of cancer cells.

The purpose of this study is to compare the effects of Toripalimab combined with Lenvatinib against a placebo combined with Lenvatinib as the first treatment option for patients with advanced HCC. Participants in the study will be randomly assigned to receive either the combination of Toripalimab and Lenvatinib or the placebo and Lenvatinib. The study will be conducted over a period of time, and participants will receive their treatments through intravenous use for Toripalimab and oral intake for Lenvatinib. The study aims to observe and evaluate the overall survival of patients receiving these treatments.

Throughout the study, participants will be monitored for any side effects or changes in their health. The study will also collect information on how well the treatments work in controlling the cancer and improving the patients’ quality of life. This research is important for understanding how these medications can be used effectively to treat advanced HCC and potentially improve outcomes for patients with this type of cancer.

1 joining the study

Upon joining the study, the patient is randomly assigned to one of two groups: the experimental group or the control group.

The experimental group receives a combination of toripalimab and lenvatinib, while the control group receives a placebo combined with lenvatinib.

2 medication administration

Toripalimab is administered intravenously. The specific dosage and frequency are determined by the study protocol and the healthcare team.

Lenvatinib is taken orally in the form of 4 mg hard capsules. The dosage and frequency are also determined by the study protocol.

3 treatment duration

The treatment continues as per the study protocol until the study’s completion or until the healthcare team advises otherwise based on the patient’s health status.

4 monitoring and assessments

Regular monitoring and assessments are conducted to evaluate the patient’s response to the treatment. This includes checking overall survival, which is the primary endpoint of the study.

Secondary endpoints include evaluating the treatment’s efficacy and safety, as well as monitoring any adverse events.

5 study completion

The study is estimated to end by June 30, 2025. Upon completion, the data collected will be analyzed to determine the effectiveness and safety of the treatment.

Who Can Join the Study?

  • Participants must be between 18 and 75 years old, and can be male or female.
  • If a participant has certain markers for hepatitis B (HBsAg or HBcAb), their HBV DNA level must be less than 1000 IU/mL. They must continue their current hepatitis B treatment or start a specific medication during the study.
  • Women who can have children must take a pregnancy test within 7 days before starting the study, and it must be negative. They must agree to use effective birth control during the study and for 5 months after the last treatment. Men whose partners can have children must also agree to use effective birth control during the study and for 5 months after the last treatment.
  • Participants must willingly join the study, understand the information provided, and sign a consent form.
  • Participants must have a confirmed diagnosis of hepatocellular carcinoma (HCC), a type of liver cancer, either through a tissue sample or by meeting specific clinical criteria.
  • The cancer must be at an intermediate or advanced stage, as determined by a specific staging system, and not suitable for surgery or local treatment, or it must have worsened after such treatments.
  • Participants must not have received any previous systemic treatment for HCC, including chemotherapy, drugs that target blood vessels, or certain types of immunotherapy.
  • Participants must have at least one measurable tumor that has not been treated before, or if treated, it must show progression according to specific criteria.
  • Participants must have a Child-Pugh class of A or B, which is a way to assess liver function, and no history of hepatic encephalopathy, a condition affecting the brain due to liver disease.
  • Participants must have an ECOG Performance Status score of 0-1, which measures their ability to perform daily activities.
  • Participants must have an expected survival time of at least 12 weeks.
  • Main organ functions must meet specific requirements, including:
    • No blood transfusion within 14 days before screening.
    • No use of certain blood cell growth factors or human albumin.
    • Specific levels for blood cells, proteins, and liver and kidney function tests.
    • Urine protein must be less than 2+, or if higher, a 24-hour urine test must show less than 1.0g of protein.

Who Cannot Join the Study?

  • Patients with any other type of cancer besides advanced hepatocellular carcinoma (HCC) cannot participate. HCC is a type of liver cancer.
  • Patients who have received previous treatment for HCC are not eligible.
  • Patients with severe heart problems, such as heart failure or recent heart attack, cannot join the study.
  • Patients with uncontrolled high blood pressure are excluded. This means their blood pressure is not well-managed with medication or lifestyle changes.
  • Patients with active infections, such as hepatitis B or C, or HIV, cannot participate.
  • Patients with a history of severe allergic reactions to similar medications are not eligible.
  • Patients who are pregnant or breastfeeding cannot join the study.
  • Patients with a history of autoimmune diseases, where the immune system attacks the body, are excluded.
  • Patients with brain metastases, which means cancer has spread to the brain, cannot participate.
  • Patients who are currently participating in another clinical trial are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Pratia S.A. Skorzewo Poland
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Asfcvwy Owbrmqeyapi Uvxghztqyznmr Cfjtuzzusuzw Drijb Sbgqzy E Dmqfl Sqzwfpj Dg Tcxgqd Turin Italy
Nvefaqjb Ibylrnrc Okftsgybh Ina Mgdmb Sffojsuqazngztjvfwjewczwohed Ixtipeby Bhrszpwr Cracow Poland

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

Trial status

Country Status Recruitment Start
Italy Italy
Not recruiting
30.06.2021
Poland Poland
Not recruiting
30.06.2021

Trial locations

Investigated drugs:

Toripalimab (JS001) is an experimental medication used in this clinical trial. It is designed to help the body’s immune system recognize and attack cancer cells. In this study, it is being tested to see if it can improve the survival of patients with advanced liver cancer when used in combination with another medication.

Lenvatinib is a medication that is already used to treat certain types of cancer. It works by blocking the growth of new blood vessels that tumors need to grow. In this trial, lenvatinib is used in combination with toripalimab to see if the combination is more effective than lenvatinib alone in treating advanced liver cancer.

Investigated diseases:

Advanced Hepatocellular Carcinoma – This is a type of liver cancer that occurs when malignant cells form in the tissues of the liver. It is considered advanced when the cancer has spread beyond the liver to other parts of the body or when it cannot be surgically removed. The disease often progresses with symptoms such as abdominal pain, weight loss, and jaundice. As the cancer advances, it may lead to liver dysfunction and other complications. The progression of the disease can vary, but it typically involves the growth and spread of cancerous cells, affecting liver function and potentially other organs.

Trial ID:
2024-514207-34-00
Protocol code:
JS001-III-HCC-027
NCT ID:
NCT04523493
Trial Phase:
Therapeutic confirmatory (Phase III)

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