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Namodenoson for Advanced Liver Cancer with Cirrhosis

This study is for people with advanced liver cancer (hepatocellular carcinoma or HCC) and a specific type of liver scarring (Child-Pugh Class B7 cirrhosis) whose cancer has worsened after at least one previous treatment. It is testing a drug called namodenoson against a placebo (an inactive substance) to see if namodenoson is safe and effective. The main goal is to see if namodenoson helps people live longer. You must be at least 18 years old and have a confirmed diagnosis of HCC to participate. The study is currently recruiting 471 participants.

Study design
This is a randomized, double-blind, placebo-controlled study where participants are randomly assigned to receive either namodenoson or a placebo. About 471 participants are planned for this study.
What's involved
You would take namodenoson or placebo twice daily in 28-day cycles. You will have regular safety evaluations and tumor imaging every two cycles until your disease worsens or you cannot tolerate the drug.
Compensation
Not stated in the trial record.
Follow-up
After stopping the study drug, you will have a follow-up visit 28 days later. Your survival status will be tracked indefinitely if you consent to long-term follow-up.

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NCT05201404

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Can-Fite BioPharma
~471 participants
Updated 2025-04-29 on ClinicalTrials.gov
What's tested:NamodenosonPlacebo

At a glance

Recruiting sites
11 of 32 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Survival (OS)
Measured over From the time of randomization until the date of death from any cause, assessed up to 60 months

Conditions

Hepatocellular Carcinoma
Cirrhosis

Explore related trials

CirrhosisHepatocellular Carcinoma

Where it's being run

32 sites across 9 states
Romania10
Poland6
Bulgaria4
Serbia4
Bosnia and Herzegovina3
Slovakia2
Texas1
Israel1

Study leadership

  • Michael H Silverman, MD · STUDY_DIRECTOR · BioStrategics Consulting Ltd

Who to contact

Zivit Harpaz
[email protected]
+972 3 924 1114
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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). 3. HCC is advanced (i.e., treatment-refractory or metastatic) and no standard therapies are expected to be curative. 4. HCC has progressed on at least 1, but no more than 2, prior systemic treatment regimens; prior locoregional therapy is allowed. 5. Barcelona Clinic Liver Cancer (BCLC) Stage B or C (Llovet 1999). 6. Prior HCC treatment was discontinued for at least 2 weeks prior to the Baseline Visit. 7. Measurable disease by RECIST v1.1 (Eisenhauer 2009). 8. ECOG PS of ≤ 1. 9. 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). 10. 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. 11. Life expectancy of ≥ 6 weeks. 12. For women of childbearing potential, negative serum pregnancy test result. 13. Provide written informed consent to participate. 14. Willing to comply with scheduled visits, treatment plans, laboratory assessments, and other trial-related procedures.

What this trial measures

  • Overall Survival (OS)From the time of randomization until the date of death from any cause, assessed up to 60 months

    Median duration of survival