Actively Recruiting
Namodenoson in the Treatment of Advanced Hepatocellular Carcinoma in Patients With Child-Pugh Class B7 Cirrhosis
Led by Can-Fite BioPharma · Updated on 2025-04-29
471
Participants Needed
32
Research Sites
185 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Namodenoson in the Treatment of Advanced Hepatocellular Carcinoma in Patients With Child-Pugh Class B7 Cirrhosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Diagnosis of hepatocellular carcinoma confirmed by biopsy or guidelines
- Advanced HCC that is treatment-resistant or metastatic
- Disease progression after 1 to 2 prior systemic treatments
- Barcelona Clinic Liver Cancer Stage B or C
- Prior HCC treatments stopped at least 2 weeks before baseline
- Measurable disease per RECIST v1.1 criteria
- ECOG performance status of 0 or 1
- Cirrhosis classified as Child-Pugh Class B7 with ascites Grade 2 or higher if used for scoring
- Laboratory values within 10 days before first dose: ANC ≥ 1.5 x 10^9/L, platelets ≥ 75 x 10^9/L, creatinine clearance ≥ 50 mg/dL, AST and ALT ≤ 5 times upper limit of normal, total bilirubin ≤ 3.0 mg/dL, serum albumin ≥ 2.8 g/dL
- Life expectancy of at least 6 weeks
- Negative pregnancy test for women of childbearing potential
- Ability to provide written informed consent
- Willingness to comply with study visits, treatments, and assessments
You will not qualify if you...
- More than 2 prior systemic drug therapies for HCC
- Systemic cancer therapy, immunosuppressive therapy, or corticosteroids > 20 mg/day prednisone equivalent within 14 days before baseline or during the trial
- Locoregional treatment within 4 weeks before baseline
- Major surgery or radiation therapy within 4 weeks before baseline
- Use of investigational agents within 4 weeks before baseline
- Concurrent use of certain drug inhibitors/substrates with narrow therapeutic index unless timing separated by 3 hours
- Child-Pugh Class A, B8/9, or C cirrhosis
- Hepatic encephalopathy
- Recent gastrointestinal bleeding requiring transfusion within 4 weeks
- Uncontrolled thyroid disease
- Active infections requiring systemic therapy or intervention
- Known HIV/AIDS-related illness
- History of liver transplant
- Active cancers other than HCC
- Uncontrolled hypertension or severe heart failure
- Recent serious cardiac events within 3 months
- History of cardiac arrhythmias requiring treatment or prolonged QTc interval
- Pregnant or breastfeeding women
- Women of childbearing potential not agreeing to effective contraception
- Men with partners of childbearing potential not agreeing to effective contraception during and 3 months after the study
- Any severe medical or psychiatric condition or lab abnormality that increases risk or interferes with study participation or results interpretation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 32 locations
1
Site 881
Dallas, Texas, United States, 75201
Not Yet Recruiting
2
841 University Clinical Centre of Republic of Srpska
Banja Luka, Bosnia and Herzegovina
Not Yet Recruiting
3
843 University Clinical Hospital Mostar
Mostar, Bosnia and Herzegovina
Not Yet Recruiting
4
842 University Clinical Centre Sarajevo
Sarajevo, Bosnia and Herzegovina
Not Yet Recruiting
5
831 Dept of Medical Oncology, Complex Oncology Ctr - Burgas EOOD
Burgas, Bulgaria
Not Yet Recruiting
6
835 First Department of Medical Oncology, Gastroenterology and Pulmology, Complex Oncology Center - Plovdiv EOOD, Plovdiv
Plovdiv, Bulgaria
Not Yet Recruiting
7
Medical Center Leo Clinic EOOD Plovdiv
Plovdiv, Bulgaria
Not Yet Recruiting
8
834 Medical Oncology Dept, Univ Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski" EAD, Sofia
Sofia, Bulgaria
Actively Recruiting
9
518 Rabin Medical Center Beilinson Hospital
Petah Tikva, Israel
Actively Recruiting
10
872 IMSP Institute of Oncology
Chisinau, Moldova
Actively Recruiting
11
Site 858
Koszalin, Poland
Not Yet Recruiting
12
Site 852
Krakow, Poland
Not Yet Recruiting
13
Site 857
Mysłowice, Poland
Not Yet Recruiting
14
Site 859
Przemyśl, Poland
Not Yet Recruiting
15
Site 855
Warsaw, Poland
Not Yet Recruiting
16
Site 850
Wroclaw, Poland
Not Yet Recruiting
17
802 Institutul Regional de Gastroenterologie si Hepatologie
Cluj-Napoca, Romania
Actively Recruiting
18
807 IOCN, Medical Oncology
Cluj-Napoca, Romania
Not Yet Recruiting
19
809 Spitalul Clinic Judetean de Urgenta Constanta Oncology Dept
Constanța, Romania
Not Yet Recruiting
20
801 Oncology Center "Sf. Nectarie" Medical Oncology
Craiova, Romania
Actively Recruiting
21
803 Oncolab SRL
Craiova, Romania
Actively Recruiting
22
805 Euroclinic lasi
Iași, Romania
Actively Recruiting
23
810 IRO Iasi-Clinica Oncologie Medicala
Iași, Romania
Actively Recruiting
24
808 Spitalul Clinic Pelican Oradea Oncology Department
Oradea, Romania
Actively Recruiting
25
804 Oncomed - Medical Oncology
Timișoara, Romania
Actively Recruiting
26
806 Oncocenter Oncologie Clinica SRL
Timișoara, Romania
Actively Recruiting
27
821 Clinic for Gastroenterology and Hepatology, Military Medical Academy
Belgrade, Serbia
Not Yet Recruiting
28
822 Oncology Institute of Vojvodina
Kamenitz, Serbia
Not Yet Recruiting
29
823 Oncology Department, Health Center Kladovo
Kladovo, Serbia
Not Yet Recruiting
30
824 Univ Clin Centre Kragujevac, Dept of Oncology
Kragujevac, Serbia
Not Yet Recruiting
31
Site 867
Banská Bystrica, Slovakia
Not Yet Recruiting
32
Site 865
Košice, Slovakia
Not Yet Recruiting
Research Team
Z
Zivit Harpaz
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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