What side effects are associated with this type of intervention?

Common treatments for liver cancer, such as sorafenib, often result in side effects including hand-foot skin reactions, diarrhea, fatigue, and abnormal hepatic function. Serious adverse events can include severe skin reactions, liver dysfunction, and fatigue. Other systemic treatments may have similar side effects, including gastrointestinal issues and increased bilirubin levels. While specific side effects of Namodenoson are not detailed, it is reasonable to expect similar adverse events given its systemic nature.

What prior FDA approvals exist?

The FDA has approved several treatments for liver cancer, including targeted therapies and immunotherapies. Sorafenib (Nexavar) was the first targeted therapy approved for advanced hepatocellular carcinoma (HCC). Other approved treatments include lenvatinib (Lenvima), regorafenib (Stivarga), and cabozantinib (Cabometyx), which are tyrosine kinase inhibitors. Immunotherapy options like nivolumab (Opdivo) and pembrolizumab (Keytruda) have also been approved for HCC. While Namodenoson, an A3 Adenosine Receptor Agonist, is still under investigation, these existing therapies provide a range of options for managing advanced liver cancer.

What other types of research exist?

Promising novel alternatives to Namodenoson for liver cancer patients include: 1) Atezolizumab plus Bevacizumab, which has shown efficacy in high-risk HCC after curative resection or ablation (IMbrave 050 trial). 2) Cabozantinib, which demonstrated improved overall survival and progression-free survival in the phase III CELESTIAL study. 3) Tremelimumab plus Durvalumab, which is being investigated for unresectable HCC (Ph III study). These therapies represent advanced and effective options for HCC treatment.

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Namodenoson for Liver Cancer (LIVERATION Trial)

Phase 3

Recruiting

Research Sponsored by Can-Fite BioPharma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cirrhosis classified as CPB7

HCC is advanced and no standard therapies are expected to be curative

Must not have

Specific cirrhosis classifications and conditions

Receipt of >2 prior systemic drug therapies for HCC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the time of randomization until the date of death from any cause, assessed up to 60 months

Awards & highlights

Pivotal Trial

Summary

This trial tests an oral medication on patients with advanced liver cancer who have not responded to previous treatments. The goal is to see if this medication can slow down or stop the growth of cancer cells in the liver. The medication is being developed to treat liver cancer, where longer survival was observed in patients with advanced liver disease.

Who is the study for?

Adults with advanced liver cancer (hepatocellular carcinoma) and specific liver cirrhosis (Child-Pugh Class B7), who have tried at least one treatment but no more than two, can join this trial. They should be in a condition to follow the trial procedures and not have had certain treatments or surgeries recently. Women must not be pregnant and participants must agree to use effective contraception.

What is being tested?

The trial is testing Namodenoson, a new potential drug for advanced liver cancer, against a placebo to see if it's safe and works better. Participants will either receive Namodenoson or a placebo without knowing which one they are getting.

What are the potential side effects?

While the side effects of Namodenoson aren't detailed here, common side effects for cancer drugs include nausea, fatigue, blood count changes, risk of infection increase, liver function changes, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My liver condition is classified as moderate.

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My liver cancer is advanced and cannot be cured with standard treatments.

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My liver cancer is at an intermediate or advanced stage.

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My liver cancer has worsened after 1 or 2 treatments.

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I can carry out all my self-care activities without assistance.

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I have been diagnosed with liver cancer, with or without liver cirrhosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My liver disease is classified as cirrhosis.

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I have had more than two treatments for liver cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the time of randomization until the date of death from any cause, assessed up to 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the time of randomization until the date of death from any cause, assessed up to 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time of randomization until the date of death from any cause, assessed up to 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival (OS)

Secondary study objectives

Incidence and nature of treatment-emergent adverse events

Objective Response Rate (ORR)

Pharmacokinetics (PK) of namodenoson in this population

+1 more

Other study objectives

Disease Control Rate (DCR)

Duration Of Response (DOR)

Quality of Life (QOL) using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30)

+1 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Namodenoson (CF102)Experimental Treatment1 Intervention

Namodenoson 25 mg orally BID, until disease progression or unacceptable adverse events

Group II: PlaceboPlacebo Group1 Intervention

Matching placebo orally BID, until disease progression or unacceptable adverse events

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for liver cancer include surgical resection, radiofrequency ablation, transarterial chemoembolization (TACE), and systemic therapies such as tyrosine kinase inhibitors (e.g., sorafenib) and immune checkpoint inhibitors (e.g., nivolumab). Namodenoson, an A3 Adenosine Receptor Agonist, works by selectively targeting the A3 adenosine receptor, which is overexpressed in liver cancer cells. This activation leads to apoptosis (programmed cell death) and inhibition of tumor growth. Understanding these mechanisms is crucial for liver cancer patients as it helps in selecting the most appropriate treatment based on the tumor's characteristics and the patient's overall health, potentially improving outcomes and minimizing side effects.