Study on Namodenoson for Treating Advanced Liver Cancer in Patients with Moderate Liver Damage

Sponsor: Can-Fite BioPharma

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05201404

Provider View

This clinical trial is testing the effectiveness and safety of a drug called namodenoson for patients with advanced liver cancer and moderate liver damage, who have not responded to at least one previous treatment.

Patient Parameters

Program Overview

This study is for patients with advanced liver cancer (hepatocellular carcinoma) and moderate liver damage (Child-Pugh Class B7 cirrhosis) whose cancer has worsened despite previous treatments. The trial will compare the effects of the drug namodenoson to a placebo to see if it can help control the cancer and is safe to use.

Description

This clinical trial involves patients with advanced liver cancer and moderate liver damage. It is a randomized, double-blind study, meaning neither the patients nor the researchers know who is receiving the actual drug or a placebo. Participants will be divided into two groups, with two-thirds receiving namodenoson and one-third receiving a placebo. The medication is taken orally twice a day in 28-day cycles. Patients will have regular check-ups to monitor safety and will undergo scans every two cycles to check the tumor's response. Treatment will continue until the cancer progresses or side effects become too severe. After stopping the medication, patients will have a follow-up visit 28 days later, and their survival will be tracked if they agree. If the study shows positive results, patients still on the study drug may continue taking namodenoson indefinitely.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Diagnosed with advanced liver cancer (HCC).
  • Cancer has worsened after 1 or 2 previous treatments.
  • No standard treatments are expected to cure the cancer.
  • Have moderate liver damage (Child-Pugh Class B7).
  • Have measurable cancer that can be tracked.
  • Be in good general health with an ECOG score of 0 or 1.
  • Have specific blood test results within normal ranges.
  • Life expectancy of at least 6 weeks.
  • Women must not be pregnant and must agree to use birth control.
  • Willing to sign a consent form and follow study procedures.

Exclusion Criteria

  • Have had more than 2 previous treatments for liver cancer.
  • Have had recent cancer treatments or surgeries.
  • Have severe liver damage or other serious health conditions.
  • Have active infections or other cancers.
  • Have uncontrolled high blood pressure or heart problems.
  • Are pregnant or breastfeeding.
  • Cannot comply with study requirements or have conditions that may interfere with the study.

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