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OncoMatch/Clinical Trials/NCT05201404

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

Is NCT05201404 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Namodenoson for hepatocellular carcinoma.

Phase 3RecruitingCan-Fite BioPharmaNCT05201404Data as of May 2026

Treatment: NamodenosonThis 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.

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Extracted eligibility criteria

Cancer type

Hepatocellular Carcinoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Max 2 prior lines
Min 1 prior line

Must have received: systemic therapy — HCC

HCC has progressed on at least 1, but no more than 2, prior systemic treatment regimens

Cannot have received: systemic drug therapy

Receipt of >2 prior systemic drug therapies for HCC

Cannot have received: systemic cancer therapy

Exception: within 14 days prior to the Baseline Visit or concurrently during the trial

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

Cannot have received: locoregional treatment

Exception: within 4 weeks prior to the Baseline Visit

Locoregional treatment within 4 weeks prior to the Baseline Visit

Cannot have received: major surgery or radiation therapy

Exception: within 4 weeks prior to the Baseline Visit

Major surgery or radiation therapy within 4 weeks prior to the Baseline Visit

Cannot have received: investigational agent

Exception: within 4 weeks prior to the Baseline Visit

Use of any investigational agent within 4 weeks prior to the Baseline Visit

Lab requirements

Blood counts

ANC ≥ 1.5 × 10^9/L; Platelet count at least 75 × 10^9/L

Kidney function

Creatinine clearance at least 50 mg/dL (estimated by Cockcroft-Gault or MDRD methods)

Liver function

AST and ALT ≤ 5 × ULN; Total bilirubin ≤ 3.0 mg/dL; Serum albumin ≥ 2.8 g/dL

ANC ≥ 1.5 × 10^9/L; Platelet count at least 75 × 10^9/L; Creatinine clearance at least 50 mg/dL; AST and ALT ≤ 5 × ULN; Total bilirubin ≤ 3.0 mg/dL; Serum albumin ≥ 2.8 g/dL

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Site 881 · Dallas, Texas

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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