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Gns561

Clinical trials are studying Gns561 in people with unresectable hepatocellular carcinoma, a type of liver cancer that cannot be removed with surgery. The main goal is to see whether adding Gns561 to standard treatment can improve outcomes, especially progression-free survival. The trial also looks at first-line treatment in adults with this condition.

Table of Contents

Trial overview

The main study in the data is NCT05448677, called ABE-LIVER, which is a randomized Phase 2 trial in unresectable hepatocellular carcinoma.[1] It studies Gns561 as part of first-line treatment, meaning the first treatment given for this cancer.[1] The study is completed and planned to include 196 participants.[1]

Who the trial is for

This trial is for people with unresectable hepatocellular carcinoma, which is a liver cancer that cannot be removed with surgery.[1] The study focuses on patients who need first-line treatment for this condition.[1]

What treatment is being tested

The trial compares standard treatment with and without Gns561.[1] The standard treatment in the study is atezolizumab-bevacizumab, and Gns561 is given in the treatment arm being tested.[1] The source also lists several brand names linked to bevacizumab and atezolizumab used in the study record, but the key research question is whether adding Gns561 improves results compared with standard care alone.[1]

Trial design and phase

This is an interventional study, which means researchers assign the treatment rather than only observing usual care.[1] It is a Phase 2 trial, a stage that usually looks at whether a treatment may work well enough to justify further study.[1] The trial uses randomization, so participants are assigned to groups by chance.[1]

What the trial measures

The main endpoint is progression-free survival (PFS).[1] PFS means the time from randomization until the cancer gets worse or the person dies from any cause, whichever happens first.[1] The study uses a centralized tumor response assessment and RECIST version 1.1, which is a standard way to measure changes in tumors on scans.[1]

What this means for patients

For patients, this trial asks a simple but important question: can adding Gns561 to standard first-line treatment help people with unresectable hepatocellular carcinoma stay free from cancer growth for longer?[1] Because the study is completed, the trial record gives a clear picture of the research plan, including the target population, phase, and main outcome being measured.[1]

Trial ID Phase Condition studied Status Enrollment
NCT05448677 Phase 2 Unresectable hepatocellular carcinoma Completed 196

FAQ

  • What is being studied in the Gns561 trial? The trial is testing Gns561 together with standard treatment for unresectable hepatocellular carcinoma. It compares this combination with standard treatment alone.
  • Who can take part in the trial? The study is for patients with unresectable hepatocellular carcinoma. This means the liver cancer cannot be removed by surgery.
  • What phase is the Gns561 trial? This is a Phase 2 trial. Phase 2 studies usually look more closely at whether a treatment works and continue to monitor safety.
  • What is the main result the trial is measuring? The main result is progression-free survival, called PFS. This means the time from randomization until the cancer gets worse or the patient dies from any cause.
  • How many people were planned for the Gns561 study? The trial planned to include 196 people. It is an interventional study, which means researchers assign treatments rather than only observing care.

Ongoing Clinical Trials on Gns561

  • Study of Ezurpimtrostat with Atezolizumab and Bevacizumab for Patients with Unresectable Liver Cancer

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

Glossary

  • Unresectable hepatocellular carcinoma: A type of liver cancer that cannot be removed with surgery.
  • First-line treatment: The first treatment given for a disease after it is diagnosed.
  • Phase 2: A stage of clinical research that studies whether a treatment may work and continues to check safety.
  • Interventional study: A trial where researchers give specific treatments and compare the results.
  • Randomization: A method that assigns people to treatment groups by chance.
  • Progression-free survival (PFS): The length of time after randomization before the cancer gets worse or the person dies.
  • Disease progression: When cancer grows, spreads, or gets worse.
  • Overall survival: The length of time a person lives after joining a study.
  • Centralized tumor response assessment: A review of scan results by a central team to judge how the tumor is changing.
  • RECIST version 1.1: A standard way doctors use scan results to measure whether cancer is shrinking, stable, or growing.

References