NCT05201404 Namodenoson in the Treatment of Advanced Hepatocellular Carcinoma in Patients With Child-Pugh Class B7 Cirrhosis
| NCT ID | NCT05201404 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Can-Fite BioPharma |
| Condition | Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 471 participants |
| Start Date | 2023-03-15 |
| Primary Completion | 2026-02 |
Trial Parameters
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Brief Summary
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
Inclusion Criteria: 1. Males and females at least 18 years of age. 2. 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). 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 class
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