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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 (Jun 2026). This Phase 3 trial studies Namodenoson for hepatocellular carcinoma.

Phase 3RecruitingCan-Fite BioPharmaNCT05201404Data as of Jun 2026Location: International · 9 countries

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

Treatments studied

Other

Namodenoson

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 →

Frequently asked questions

Is NCT05201404 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior systemic drug therapy, systemic cancer therapy, locoregional treatment disqualifies patients from enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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