Phase 3 Study of Namodenoson Versus Placebo for Advanced Liver Cancer in Patients with Child-Pugh B7 Cirrhosis

What this Trial Is About

Researchers are studying advanced hepatocellular carcinoma HCC in patients who have Child-Pugh Class B7 cirrhosis and whose cancer has worsened after at least one prior treatment. This clinical trial aims to compare the safety and effectiveness of the drug namodenoson with a placebo in this group of patients. The trial is a Phase 3, multicenter, randomized, double-blind study designed to provide clear evidence on the benefits and risks of namodenoson for this condition. Participants will be randomly assigned to receive either namodenoson 25 mg or a matching placebo by mouth twice daily in 28-day cycles. Treatment continues until the disease progresses or side effects become unacceptable. Tumor imaging is performed every two cycles to monitor disease status. After stopping the study drug, patients will have a follow-up visit 28 days later, and those who agree will be monitored long-term for survival. If results allow, some patients may continue taking namodenoson openly beyond the blinded phase. During the study, participants will regularly visit the clinic for safety checks, laboratory tests, and tumor imaging. The main outcome measured is overall survival up to 60 months after randomization. Secondary outcomes include progression-free survival, objective response rate, and the nature of side effects. Pharmacokinetics of namodenoson will also be studied. Long-term survival data will be collected for those who consent to follow-up, ensuring thorough monitoring throughout the study period.

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