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.
• 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.
• 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.