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

Bookmark
Investigational drug late phase More information Active drug More information Moderate burden on patient More information

Trial Details

Sponsor: Can-Fite BioPharma (industry)

Phase: 3

Start date: March 15, 2023

Planned enrollment: 471

Trial ID: NCT05201404
Copy trial ID
More trial details at ClinicalTrials.gov More info

chevron Show Summary from Sponsor

Investigational Drug AI Analysis

chevron Show for: Namodenoson (CF102, Cl-IB-MECA)

HealthScout AI Analysis

Goal: Evaluate whether namodenoson improves overall survival and clinical outcomes versus placebo, and assess safety, in previously treated advanced hepatocellular carcinoma with Child-Pugh B7 cirrhosis.

Patients: Adults with advanced, non-curable HCC (BCLC B or C) whose disease progressed after 1–2 prior systemic regimens; measurable disease by RECIST v1.1; ECOG 0–1; strictly Child-Pugh B7 cirrhosis; adequate hematologic and organ function; no hepatic encephalopathy, recent major bleeding, or significant uncontrolled cardiac disease.

Design: Multicenter, phase 3, randomized, double-blind, placebo-controlled study with 2:1 allocation to investigational drug or placebo. Continuous 28-day cycles until progression or unacceptable toxicity. Imaging every two cycles; safety assessed regularly. Long-term survival follow-up for all consenting randomized patients; option for open-label namodenoson after unblinding for ongoing survivors on blinded therapy.

Treatments: Namodenoson 25 mg orally twice daily versus matching placebo, continued until disease progression or unacceptable adverse events. Namodenoson (CF102; Cl-IB-MECA) is an oral, highly selective adenosine A3 receptor agonist, a target often overexpressed in tumors and inflamed liver tissue. Proposed antitumor and anti-inflammatory effects involve modulation of PI3K/AKT, NF-κB, and Wnt/β-catenin pathways leading to apoptosis and reduced proliferation/inflammation. Prior randomized phase II data in second-line advanced HCC with Child-Pugh B did not meet the overall survival primary endpoint in the intent-to-treat population but showed a prespecified signal in the CPB7 subgroup and a favorable safety profile; additional phase II data in NAFLD/NASH demonstrated biochemical improvements and good tolerability.

Outcomes: Primary: Overall survival. Key secondary: Progression-free survival by RECIST and mRECIST, objective response rate, safety and tolerability (CTCAE v5), and pharmacokinetics. Other outcomes include duration of response, disease control rate, and quality of life by EORTC QLQ-C30 and QLQ-HCC18.

Burden on patient: Moderate. The regimen is oral and administered at home, reducing infusion visits. Study visits include safety assessments and imaging every two cycles (approximately every 8 weeks), which is comparable to standard oncology follow-up. There are no protocol-mandated tumor biopsies, but pharmacokinetic sampling occurs over the first 29 days, adding blood draws. Exclusions and monitoring for comorbid hepatic and cardiac conditions necessitate regular labs and clinical evaluations. Travel frequency aligns with imaging and safety visit schedules typical for phase 3 oral systemic therapy in advanced HCC.

Last updated: Oct 2025

Eligibility More information

chevron Show Criteria

Sites (32)

Sort by distance to:
Clear

842 University Clinical Centre Sarajevo

Sarajevo, Bosnia and Herzegovina

No email / No phone

Status: Not yet recruiting

841 University Clinical Centre of Republic of Srpska

Banja Luka, Bosnia and Herzegovina

No email / No phone

Status: Not yet recruiting

843 University Clinical Hospital Mostar

Mostar, Bosnia and Herzegovina

No email / No phone

Status: Not yet recruiting

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

Sofia, Bulgaria

No email / No phone

Status: Recruiting

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

Burgas, Bulgaria

No email / No phone

Status: Not yet recruiting

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

Plovdiv, Bulgaria

No email / No phone

Status: Not yet recruiting

Medical Center Leo Clinic EOOD Plovdiv

Plovdiv, Bulgaria

No email / No phone

Status: Not yet recruiting

518 Rabin Medical Center Beilinson Hospital

Petah Tikva, Israel

No email / No phone

Status: Recruiting

872 IMSP Institute of Oncology

Chisinau, Moldova

No email / No phone

Status: Recruiting

Site 855

Warsaw, Poland

No email / No phone

Status: Not yet recruiting

Site 858

Koszalin, Poland

No email / No phone

Status: Not yet recruiting

Site 852

Krakow, Poland

No email / No phone

Status: Not yet recruiting

Site 857

Mysłowice, Poland

No email / No phone

Status: Not yet recruiting

Site 859

Przemyśl, Poland

No email / No phone

Status: Not yet recruiting

Site 850

Wroclaw, Poland

No email / No phone

Status: Not yet recruiting

804 Oncomed - Medical Oncology

Timișoara, Romania

No email / No phone

Status: Recruiting

802 Institutul Regional de Gastroenterologie si Hepatologie

Cluj-Napoca, Romania

No email / No phone

Status: Recruiting

807 IOCN, Medical Oncology

Cluj-Napoca, Romania

No email / No phone

Status: Not yet recruiting

809 Spitalul Clinic Judetean de Urgenta Constanta Oncology Dept

Constanța, Romania

No email / No phone

Status: Not yet recruiting

801 Oncology Center "Sf. Nectarie" Medical Oncology

Craiova, Romania

No email / No phone

Status: Recruiting

803 Oncolab SRL

Craiova, Romania

No email / No phone

Status: Recruiting

805 Euroclinic lasi

Iași, Romania

No email / No phone

Status: Recruiting

810 IRO Iasi-Clinica Oncologie Medicala

Iași, Romania

No email / No phone

Status: Recruiting

808 Spitalul Clinic Pelican Oradea Oncology Department

Oradea, Romania

No email / No phone

Status: Recruiting

806 Oncocenter Oncologie Clinica SRL

Timișoara, Romania

No email / No phone

Status: Recruiting

823 Oncology Department, Health Center Kladovo

Kladovo, Serbia

No email / No phone

Status: Not yet recruiting

821 Clinic for Gastroenterology and Hepatology, Military Medical Academy

Belgrade, Serbia

No email / No phone

Status: Not yet recruiting

822 Oncology Institute of Vojvodina

Kamenitz, Serbia

No email / No phone

Status: Not yet recruiting

824 Univ Clin Centre Kragujevac, Dept of Oncology

Kragujevac, Serbia

No email / No phone

Status: Not yet recruiting

Site 865

Košice, Slovakia

No email / No phone

Status: Not yet recruiting

Site 867

Banská Bystrica, Slovakia

No email / No phone

Status: Not yet recruiting

Site 881

Dallas, Texas, 75201, United States

No email / No phone

Status: Not yet recruiting

Back to trials list