RecruitingHepatocellular CarcinomaCirrhosis
Namodenoson in the Treatment of Advanced Hepatocellular Carcinoma in Patients With Child-Pugh Class B7 Cirrhosis
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Can-Fite BioPharma
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 1. Receipt of \>2 prior systemic drug therapies for HCC.
- ✕ 2. 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.
- ✕ 3. Locoregional treatment within 4 weeks prior to the Baseline Visit.
- ✕ 4. Major surgery or radiation therapy within 4 weeks prior to the Baseline Visit.
- ✕ 5. Use of any investigational agent within 4 weeks prior to the Baseline Visit.
- ✕ 6. Concomitant use of P-glycoprotein (P-gp)/breast cancer resistance protein (BCRP) inhibitors and/or substrates with a narrow therapeutic index unless the medication can be taken at least 3 hours before or after taking the investigational product (see Section 12.2).
- ✕ 7. Child-Pugh Class A, B8/9, or C cirrhosis.
- ✕ 8. Hepatic encephalopathy.
Where it's recruiting
Texas
Dallas
Source: ClinicalTrials.gov · NCT05201404 · last updated 2025-04-29