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Hepatocellular CarcinomaPhase 3LIVERATIONNCT05201404

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

A Phase 3 study testing Namodenoson in people with Hepatocellular Carcinoma and Cirrhosis, run by Can-Fite BioPharma at 32 sites in 9 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma, Cirrhosis
What is being tested?
Namodenoson
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
471 participants
Where
32 sitesin 9 countries
Study dates
15 Mar 2023to Oct 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and females at least 18 years of age.
  • Diagnosis of HCC:
  • For patients without cirrhosis at the time of diagnosis, histologic confirmation is required (archival tissue is acceptable).
  • For patients with underlying cirrhosis at the time of diagnosis, diagnosis of HCC established according to the American Association for the Study of Liver Diseases Practice Guideline algorithm (Marrero 2018).
  • HCC is advanced (i.e., treatment-refractory or metastatic) and no standard therapies are expected to be curative.
  • HCC has progressed on at least 1, but no more than 2, prior systemic treatment regimens; prior locoregional therapy is allowed.
Show all 22Show fewer
  • Barcelona Clinic Liver Cancer (BCLC) Stage B or C (Llovet 1999).
  • Prior HCC treatment was discontinued for at least 2 weeks prior to the Baseline Visit.
  • Measurable disease by RECIST v1.1 (Eisenhauer 2009).
  • ECOG PS of ≤ 1.
  • Cirrhosis classified as CPB7; if ascites is used as a scoring criterion, it must be classified as Grade ≥2 by the Clinical Practice Guidelines of the European Association for the Study of the Liver (EASL 2010).
  • The following laboratory values must be documented within ten days prior to the first dose of study drug:
  • Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
  • Platelet count at least 75 × 10^9/L
  • Creatinine clearance at least 50 mg/dL (estimated glomerular filtration rate by the Cockcroft-Gault or the Modification of Diet in Renal Disease methods)
  • AST and ALT ≤ 5 × the upper limit of normal (ULN)
  • Total bilirubin ≤ 3.0 mg/dL
  • Serum albumin ≥ 2.8 g/dL.
  • Life expectancy of ≥ 6 weeks.
  • For women of childbearing potential, negative serum pregnancy test result.
  • Provide written informed consent to participate.
  • Willing to comply with scheduled visits, treatment plans, laboratory assessments, and other trial-related procedures.

Who cannot join

  • Receipt of >2 prior systemic drug therapies for HCC.
  • Receipt of systemic cancer therapy, immunomodulatory drug therapy, immunosuppressive therapy, or corticosteroids > 20 mg/day prednisone or equivalent within 14 days prior to the Baseline Visit or concurrently during the trial.
  • Locoregional treatment within 4 weeks prior to the Baseline Visit.
  • Major surgery or radiation therapy within 4 weeks prior to the Baseline Visit.
  • Use of any investigational agent within 4 weeks prior to the Baseline Visit.
  • Concomitant use of P-glycoprotein (P-gp)/breast cancer resistance protein (BCRP) inhibitors and/or substrates with a narrow therapeutic index unless the medication can be taken at least 3 hours before or after taking the investigational product (see Section 12.2).
Show all 21Show fewer
  • Child-Pugh Class A, B8/9, or C cirrhosis.
  • Hepatic encephalopathy.
  • Occurrence of esophageal or other gastrointestinal hemorrhage requiring transfusion within 4 weeks prior to the Baseline Visit.
  • Uncontrolled or clinically unstable thyroid disease, per judgment of the Principal Investigator.
  • Active bacterial, viral, or fungal infection requiring systemic therapy or operative or radiological intervention.
  • Known human immunodeficiency virus- or acquired immunodeficiency syndrome-related illness.
  • Liver transplant.
  • Active malignancy other than HCC.
  • Uncontrolled arterial hypertension or congestive heart failure (New York Heart Association Classification 3 or 4).
  • Angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months prior to initiation of study drug.
  • History of, or ongoing, cardiac dysrhythmias requiring treatment, atrial fibrillation of any grade, or persistent prolongation of the QTc (Fridericia) interval to > 470 msec (patients with bundle branch block will not be excluded for QTc reasons).
  • Pregnant or lactating female.
  • Women of childbearing potential, unless they agree to use dual contraceptive methods which, in the opinion of the Investigator, are effective and adequate for the patient's circumstances while on study drug.
  • Men who partner with a woman of childbearing potential, unless they agree to use effective, dual contraceptive methods (i.e., a condom, with female partner using oral, injectable, or barrier method) while on study drug and for 3 months afterward.
  • Any severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with trial participation or study drug administration; may interfere with the informed consent process and/or with compliance with the requirements of the trial; or may interfere with the interpretation of trial results and, in the Investigator's opinion, would make the patient inappropriate for entry into this trial.

Trial locations and contacts

32 sites in 9 countries. Contact the study team or a site near you to ask about taking part.

Zivit Harpaz contact

+972 3 924 1114

Zivit@canfite.co.il

32 sites in 9 countries

Romania10 sites, 10 recruiting

  • 802 Institutul Regional de Gastroenterologie si Hepatologie

    Cluj-Napoca

    Study Coordinator

    Recruiting

  • 807 IOCN, Medical Oncology

    Cluj-Napoca

    Study Coordinator

    Not yet recruiting

  • 809 Spitalul Clinic Judetean de Urgenta Constanta Oncology Dept

    Constanța

    Study Coordinator

    Not yet recruiting

  • 801 Oncology Center "Sf. Nectarie" Medical Oncology

    Craiova

    Study Coordinator

    Recruiting

  • 803 Oncolab SRL

    Craiova

    Study Coordinator

    Recruiting

  • 805 Euroclinic lasi

    Iași

    Study Coordinator

    Recruiting

  • 810 IRO Iasi-Clinica Oncologie Medicala

    Iași

    Study Coordinator

    Recruiting

  • 808 Spitalul Clinic Pelican Oradea Oncology Department

    Oradea

    Study Coordinator

    Recruiting

  • 804 Oncomed - Medical Oncology

    Timișoara

    Study Coordinator

    Recruiting

  • 806 Oncocenter Oncologie Clinica SRL

    Timișoara

    Study Coordinator

    Recruiting

Other trials in Romania

Poland6 sites, 6 recruiting

  • Site 858

    Koszalin

    Study Coordinator

    Not yet recruiting

  • Site 852

    Krakow

    Study Coordinator

    Not yet recruiting

  • Site 857

    Mysłowice

    Study Coordinator

    Not yet recruiting

  • Site 859

    Przemyśl

    Study Coordinator

    Not yet recruiting

  • Site 855

    Warsaw

    Study Coordinator

    Not yet recruiting

  • Site 850

    Wroclaw

    Study Coordinator

    Not yet recruiting

Other trials in Poland

Bulgaria4 sites, 4 recruiting

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

    Burgas

    Study Coordinator

    Not yet recruiting

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

    Plovdiv

    Study Coordinator

    Not yet recruiting

  • Medical Center Leo Clinic EOOD Plovdiv

    Plovdiv

    Study Coordinator

    Not yet recruiting

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

    Sofia

    Study Coordinator

    Recruiting

Other trials in Bulgaria

Serbia4 sites, 4 recruiting

  • 821 Clinic for Gastroenterology and Hepatology, Military Medical Academy

    Belgrade

    Study Coordinator

    Not yet recruiting

  • 822 Oncology Institute of Vojvodina

    Kamenitz

    Study Coordinator

    Not yet recruiting

  • 823 Oncology Department, Health Center Kladovo

    Kladovo

    Study Coordinator

    Not yet recruiting

  • 824 Univ Clin Centre Kragujevac, Dept of Oncology

    Kragujevac

    Study Coordinator

    Not yet recruiting

Other trials in Serbia

Bosnia and Herzegovina3 sites, 3 recruiting

  • 841 University Clinical Centre of Republic of Srpska

    Banja Luka

    Study Coordinator

    Not yet recruiting

  • 843 University Clinical Hospital Mostar

    Mostar

    Study Coordinator

    Not yet recruiting

  • 842 University Clinical Centre Sarajevo

    Sarajevo

    Study Coordinator

    Not yet recruiting

Other trials in Bosnia and Herzegovina

Slovakia2 sites, 2 recruiting

  • Site 867

    Banská Bystrica

    Study Coordinator

    Not yet recruiting

  • Site 865

    Košice

    Study Coordinator

    Not yet recruiting

Other trials in Slovakia

United States1 site, 1 recruiting

  • Site 881

    Dallas, Texas, 75201

    Study Coordinator

    Not yet recruiting

Other trials in United States

Israel1 site, 1 recruiting

  • 518 Rabin Medical Center Beilinson Hospital

    Petah Tikva

    Salomon Stemmer, MD

    Recruiting

Other trials in Israel

Moldova1 site, 1 recruiting

  • 872 IMSP Institute of Oncology

    Chisinau

    Study Coordinator

    Recruiting

Other trials in Moldova

About this study

Official title: 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

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.

Read the detailed description

This is a multicenter, randomized, double-blind, placebo-controlled clinical trial in patients with advanced HCC and 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. Patients will be randomly assigned in a 2:1 ratio to treatment with oral doses of either namodenoson 25 mg or matching placebo administered twice daily for consecutive 28-day cycles. Patients will be evaluated regularly for safety. Tumor imaging will be performed every two cycles. Treatment will continue until the patient experiences PD or unacceptable drug-related intolerability. Patients will return for a follow-up visit 28 days after completion of the last dose of study drug, and survival data will be obtained for all randomized patients who consent to long-term follow-up. Patients who discontinue dosing and consent to follow-up will be followed indefinitely for survival status.

Once the requisite number of events has been observed and the blind is broken for analysis of the trial results, any surviving patients who remain on blinded drug will be offered the opportunity to continue dosing with OL namodenoson 25 mg twice daily indefinitely.

Being tested
Namodenoson, Placebo
Keywords
Hepatocellular carcinoma, HCC, Liver cancer, Child-Pugh Class B7 cirrhosis, CPB7
Medical subject headings
Carcinoma, Hepatocellular, Fibrosis, Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NamodenosonDrug

    Also called CF102

    Adenosine A3 Receptor (A3AR) agonist

  • PlaceboDrug

    Also called Inactive control

    Control arm

Study groups in NCT05201404
Study groupRoleWhat they receive
Namodenoson (CF102)ExperimentalNamodenoson 25 mg orally BID, until disease progression or unacceptable adverse events
Receives: Drug: Namodenoson
PlaceboPlacebo comparatorMatching placebo orally BID, until disease progression or unacceptable adverse events
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    Median duration of survival

    Measured: From the time of randomization until the date of death from any cause, assessed up to 60 months

Secondary outcomes (4)

  1. Progression-Free Survival (PFS)

    Median time to disease progression using RECIST and modified RECIST criteria

    Measured: From the time of randomization until the date of disease progression or death from any cause, assessed up to 60 months

  2. Objective Response Rate (ORR)

    Proportion of patients who experience Objective Response (OR) using RECIST and modified RECIST criteria

    Measured: Through study completion, with a median of 9 months

  3. Incidence and nature of treatment-emergent adverse events

    Incidence and nature of treatment-emergent adverse events as assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v5)

    Measured: Through study completion, with a median of 9 months

  4. Pharmacokinetics (PK) of namodenoson in this population

    Plasma concentration of namodenoson

    Measured: 29 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2022
  2. Study start15 Mar 2023
  3. Primary completionFeb 2026 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel group, double-blinded, randomization in a 1:1 ratio to active versus placebo
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
471 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05201404
Sponsor's protocol ID
CF102-301HCC
Acronym
LIVERATION
Status last verified
Apr 2025
First submitted
21 Dec 2021
Last updated
29 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bar-Yehuda S, Stemmer SM, Madi L, Castel D, Ochaion A, Cohen S, Barer F, Zabutti A, Perez-Liz G, Del Valle L, Fishman P. The A3 adenosine receptor agonist CF102 induces apoptosis of hepatocellular carcinoma via de-regulation of the Wnt and NF-kappaB signal transduction pathways. Int J Oncol. 2008 Aug;33(2):287-95.

    PubMed 18636149

  • Cohen S, Stemmer SM, Zozulya G, Ochaion A, Patoka R, Barer F, Bar-Yehuda S, Rath-Wolfson L, Jacobson KA, Fishman P. CF102 an A3 adenosine receptor agonist mediates anti-tumor and anti-inflammatory effects in the liver. J Cell Physiol. 2011 Sep;226(9):2438-47. doi: 10.1002/jcp.22593.

    PubMed 21660967

  • Stemmer SM, Benjaminov O, Medalia G, Ciuraru NB, Silverman MH, Bar-Yehuda S, Fishman S, Harpaz Z, Farbstein M, Cohen S, Patoka R, Singer B, Kerns WD, Fishman P. CF102 for the treatment of hepatocellular carcinoma: a phase I/II, open-label, dose-escalation study. Oncologist. 2013;18(1):25-6. doi: 10.1634/theoncologist.2012-0211. Epub 2013 Jan 8.

    PubMed 23299770

  • Stemmer SM, Manojlovic NS, Marinca MV, Petrov P, Cherciu N, Ganea D, Ciuleanu TE, Pusca IA, Beg MS, Purcell WT, Croitoru AE, Ilieva RN, Natosevic S, Nita AL, Kalev DN, Harpaz Z, Farbstein M, Silverman MH, Bristol D, Itzhak I, Fishman P. Namodenoson in Advanced Hepatocellular Carcinoma and Child-Pugh B Cirrhosis: Randomized Placebo-Controlled Clinical Trial. Cancers (Basel). 2021 Jan 7;13(2):187. doi: 10.3390/cancers13020187.

    PubMed 33430312

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Namodenoson in people with Hepatocellular Carcinoma and Cirrhosis, run by Can-Fite BioPharma at 32 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Romania, Poland, Bulgaria, Serbia, Bosnia and Herzegovina and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zivit Harpaz (+972 3 924 1114, Zivit@canfite.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: From the time of randomization until the date of death from any cause, assessed up to 60 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05201404, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.

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