Study Comparing Regorafenib-Pembrolizumab with TACE/TARE for Intermediate Stage Liver Cancer

Sponsor: Translational Research in Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04777851

Provider View

This clinical trial is testing two different treatments for intermediate stage liver cancer: a combination of the drugs regorafenib and pembrolizumab, and a procedure called TACE or TARE. The study aims to find out which treatment is more effective and safe for patients.

Patient Parameters

Program Overview

The REPLACE study is a large international trial to compare two treatments for liver cancer that is at an intermediate stage. The trial will involve about 496 patients from around 80 locations worldwide. Patients will be randomly assigned to one of two groups: one group will receive a combination of the drugs regorafenib and pembrolizumab, while the other group will receive a treatment called TACE or TARE, which targets the liver directly. The study will continue until the cancer progresses, side effects become too severe, or other reasons for stopping treatment occur. After stopping the trial treatment, patients will receive further care based on their doctor's advice.

Description

The REPLACE study is a phase III trial that involves multiple centers and is open-label, meaning both doctors and patients know which treatment is being given. It aims to compare the effectiveness and safety of two different treatments for intermediate-stage liver cancer. Patients will be randomly assigned to receive either a combination of regorafenib and pembrolizumab or a liver-targeted treatment called TACE or TARE. The study will include patients who have been diagnosed with liver cancer that cannot be cured but can be treated with TACE or TARE. Patients must have a good overall health status and meet specific criteria related to their liver function and cancer stage. The trial will have three phases: screening, treatment, and follow-up. Patients in the investigational group will take regorafenib orally and receive pembrolizumab through an IV infusion. Those in the control group will receive TACE or TARE as needed to manage their liver tumors. Treatment will continue until the cancer progresses, side effects become too severe, or other reasons for stopping treatment occur.

Eligibility Criteria

Inclusion Criteria

  • Signed and dated consent form
  • 18 years or older
  • Confirmed diagnosis of liver cancer
  • Intermediate-stage liver cancer that is localized to the liver and cannot be cured
  • Good liver function and overall health
  • Cancer that can be treated with TACE or TARE
  • No previous treatments for liver cancer
  • Willing to follow study procedures and attend scheduled visits
  • Women of childbearing potential must have a negative pregnancy test and use effective contraception
  • Patients with hepatitis C or B can participate if they meet specific criteria

Exclusion Criteria

  • No measurable tumor of a specific type
  • Certain rare types of liver cancer
  • Significant fluid buildup in the abdomen
  • Previous treatment with specific cancer drugs
  • Recent major surgery or injury
  • Active or history of autoimmune disease
  • Need for immune-suppressing medications
  • Certain lung diseases
  • Specific heart conditions
  • Other active or recent cancers
  • Severe kidney problems
  • Pregnant or breastfeeding women, or those planning to become pregnant or breastfeed during the trial

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