Namodenoson in the Treatment of Advanced Hepatocellular Carcinoma in Patients With Child-Pugh Class B7 Cirrhosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCan-Fite BioPharma
About this trial
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 criteria
Qualifiers
Males and females at least 18 years of age.
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Namodenoson
- Placebo
Treatment groups
471 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov