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Study on the Effectiveness and Safety of Nofazinlimab and Lenvatinib for Patients with Advanced Liver Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of liver cancer known as advanced hepatocellular carcinoma. The study is investigating the effectiveness and safety of a new treatment combination. The treatment being tested includes a medication called CS1003, which is a special type of protein designed to help the immune system fight cancer, used together with another medication called lenvatinib, which is taken orally in capsule form. The study will compare this combination to a treatment using a placebo with lenvatinib.

The purpose of the study is to see how well the combination of CS1003 and lenvatinib works compared to the placebo and lenvatinib in treating patients with advanced liver cancer. Participants in the study will receive either the new treatment combination or the placebo combination. The study will last for a period of up to 12 months for the CS1003 treatment and up to 52 weeks for the lenvatinib treatment. The study aims to determine if the new treatment can improve overall survival and response rates in patients.

Throughout the study, participants will be monitored closely to assess the safety and effectiveness of the treatment. The study is designed to provide valuable information that could lead to better treatment options for people with advanced liver cancer in the future.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be informed about the trial's purpose and procedures. You will be required to sign an informed consent form, confirming your understanding and willingness to participate.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes verifying your age, medical condition, and overall health status. You must have advanced liver cancer that cannot be treated with surgery and meet specific health criteria.

  3. Step 3

    Randomization

    You will be randomly assigned to one of two groups. One group will receive the medication CS1003 in combination with lenvatinib, while the other group will receive a placebo in combination with lenvatinib.

  4. Step 4

    Treatment administration

    If you are in the group receiving CS1003, it will be administered as an intravenous solution. Lenvatinib will be taken orally. The exact dosage and frequency will be determined by the study protocol and your healthcare provider.

  5. Step 5

    Regular monitoring

    Throughout the study, you will have regular appointments to monitor your health and the effects of the treatment. This includes physical exams, blood tests, and imaging studies to assess the cancer's response to the treatment.

  6. Step 6

    End of treatment

    The treatment phase will continue until the study's end date or until it is determined that the treatment is no longer beneficial for you. The estimated end date for the study is June 30, 2025.

  7. Step 7

    Follow-up

    After completing the treatment phase, follow-up visits will be scheduled to monitor your long-term health and gather additional data on the treatment's effectiveness.

Who can join the trial?

12 criteria

  • Must be at least 18 years old (in Taiwan, at least 20 years old).
  • Have a condition called unresectable advanced hepatocellular carcinoma (HCC), which means the liver cancer cannot be removed by surgery and is in an advanced stage.
  • Must have a confirmed diagnosis of HCC, either through a tissue sample (histologically or cytologically) or based on specific clinical criteria.
  • Have at least one tumor that can be measured by doctors.
  • Have a performance status of 0 or 1, which means you are fully active or have some symptoms but can still do light work.
  • Have a life expectancy of at least 3 months.
  • Have a Child-Pugh A liver function score, indicating good liver function.
  • Have not received any previous systemic treatment for advanced HCC.
  • If you have a hepatitis B virus (HBV) infection, you must be willing to continue antiviral treatment during the study.
  • Have adequate function of organs and bone marrow, which are important for overall health.
  • Female participants who can have children must have a negative pregnancy test before starting the study.
  • All participants who can have children must agree to use effective birth control methods during the study and for at least 6 months after the last dose of the study medication.

Who cannot join the trial?

10 criteria

  • Patients with other types of cancer that are not the main focus of this study.
  • Patients who have had a previous organ transplant.
  • Patients with serious heart problems.
  • Patients with uncontrolled high blood pressure.
  • Patients with active infections that need treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had another cancer treatment within the last 4 weeks.
  • Patients with known allergies to the study drugs.
  • Patients with a history of bleeding disorders.
  • Patients with severe liver disease not related to the main condition being studied.
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Investigated drugs

  • CS1003

    is a medication being studied for its potential to help treat advanced liver cancer, specifically hepatocellular carcinoma. It is being tested to see if it can work effectively when used together with another medication called lenvatinib. CS1003 is designed to help the body's immune system fight cancer cells more effectively. In this trial, researchers are looking to see if adding CS1003 to the treatment plan can improve outcomes for patients compared to using lenvatinib alone.

  • Lenvatinib

    is a medication that is already used to treat certain types of cancer, including liver cancer. It works by blocking certain proteins that help cancer cells grow and spread. In this clinical trial, lenvatinib is being used as a standard treatment, and researchers are testing whether combining it with another medication, CS1003, can make it more effective for patients with advanced liver cancer. Lenvatinib is taken by mouth and is part of the first-line therapy, meaning it is one of the first treatments given to patients with this type of cancer.

What is already known about the treatment

  • CS1003

    CS1003 is administered as an injection and is currently being studied in clinical trials for its potential use in treating advanced liver cancer that cannot be surgically removed. It is being tested in combination with another medication called lenvatinib to see if it is more effective than lenvatinib alone. CS1003 works by targeting specific proteins on cancer cells, helping the immune system recognize and attack these cells. It is classified as an immunotherapy drug, which means it helps the body's immune system fight cancer.

  • Lenvatinib

    Lenvatinib is taken orally in the form of a capsule and is already approved for use in treating certain types of cancer, including advanced liver cancer. In the current study, it is being used in combination with CS1003 to evaluate its effectiveness as a first-line treatment for advanced liver cancer. Lenvatinib works by blocking certain proteins that promote the growth of cancer cells and blood vessels that supply tumors, thereby slowing down or stopping the growth of cancer. It is classified as a tyrosine kinase inhibitor, a type of targeted cancer therapy.

Investigated diseases

Unresectable advanced hepatocellular carcinoma – Hepatocellular carcinoma is a type of liver cancer that originates in the liver cells, known as hepatocytes. In its advanced stage, the cancer has spread within the liver or to other parts of the body, making surgical removal (resection) not possible. The disease progresses as the cancerous cells multiply and form tumors, which can disrupt liver function. As the tumors grow, they may invade blood vessels and spread to nearby organs or distant sites. This progression can lead to symptoms such as abdominal pain, weight loss, and jaundice. The disease's advancement is marked by the increasing size and number of tumors and the extent of their spread.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517331-48-00Protocol codeCS1003-305Estimated enrolment534 patientsSponsorCstone Pharmaceuticals (Suzhou) Co. Ltd.

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