RecruitingPhase 3NCT05201404

Namodenoson in the Treatment of Advanced Hepatocellular Carcinoma in Patients With Child-Pugh Class B7 Cirrhosis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Namodenoson in the Treatment of Advanced Hepatocellular Carcinoma in Patients With Child-Pugh Class B7 Cirrhosis

Sponsor

Can-Fite BioPharma

Enrollment

471 participants

Start Date

Mar 15, 2023

Study Type

INTERVENTIONAL

Conditions

Hepatocellular Carcinoma Cirrhosis

Summary

This is a clinical trial in patients with advanced hepatocellular carcinoma (HCC) and Child-Pugh Class B7 (CPB7) cirrhosis whose disease has progressed on at least 1st-line therapy. The trial will evaluate the efficacy and safety of namodenoson as compared to placebo.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called namodenoson as a treatment for advanced liver cancer (hepatocellular carcinoma, or HCC) in patients with moderately impaired liver function due to cirrhosis — a group that is often excluded from other cancer trials. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of advanced liver cancer (HCC) - Your liver has moderate damage from cirrhosis (Child-Pugh Class B7) - Your cancer has progressed on 1–2 prior treatments - There are no standard treatments expected to cure your cancer **You may NOT be eligible if...** - You have severe liver failure (Child-Pugh class C) - You have received more than 2 prior systemic treatments for HCC - You stopped your last HCC treatment within the past 2 weeks - You have significant other health conditions that would prevent you from tolerating treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNamodenoson

Adenosine A3 Receptor (A3AR) agonist

DRUGPlacebo

Control arm

Locations(32)

Site 881

Dallas, Texas, United States

841 University Clinical Centre of Republic of Srpska

Banja Luka, Bosnia and Herzegovina

843 University Clinical Hospital Mostar

Mostar, Bosnia and Herzegovina

842 University Clinical Centre Sarajevo

Sarajevo, Bosnia and Herzegovina

831 Dept of Medical Oncology, Complex Oncology Ctr - Burgas EOOD

Burgas, Bulgaria

835 First Department of Medical Oncology, Gastroenterology and Pulmology, Complex Oncology Center - Plovdiv EOOD, Plovdiv

Plovdiv, Bulgaria

Medical Center Leo Clinic EOOD Plovdiv

Plovdiv, Bulgaria

834 Medical Oncology Dept, Univ Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski" EAD, Sofia

Sofia, Bulgaria

518 Rabin Medical Center Beilinson Hospital

Petah Tikva, Israel

872 IMSP Institute of Oncology

Chisinau, Moldova

Site 858

Koszalin, Poland

Site 852

Krakow, Poland

Site 857

Mysłowice, Poland

Site 859

Przemyśl, Poland

Site 855

Warsaw, Poland

Site 850

Wroclaw, Poland

802 Institutul Regional de Gastroenterologie si Hepatologie

Cluj-Napoca, Romania

807 IOCN, Medical Oncology

Cluj-Napoca, Romania

809 Spitalul Clinic Judetean de Urgenta Constanta Oncology Dept

Constanța, Romania

801 Oncology Center "Sf. Nectarie" Medical Oncology

Craiova, Romania

803 Oncolab SRL

Craiova, Romania

805 Euroclinic lasi

Iași, Romania

810 IRO Iasi-Clinica Oncologie Medicala

Iași, Romania

808 Spitalul Clinic Pelican Oradea Oncology Department

Oradea, Romania

804 Oncomed - Medical Oncology

Timișoara, Romania

806 Oncocenter Oncologie Clinica SRL

Timișoara, Romania

821 Clinic for Gastroenterology and Hepatology, Military Medical Academy

Belgrade, Serbia

822 Oncology Institute of Vojvodina

Kamenitz, Serbia

823 Oncology Department, Health Center Kladovo

Kladovo, Serbia

824 Univ Clin Centre Kragujevac, Dept of Oncology

Kragujevac, Serbia

Site 867

Banská Bystrica, Slovakia

Site 865

Košice, Slovakia

View Full Details on ClinicalTrials.gov

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