Locally advanced or metastasised hepatocellular carcinoma Cancer Hepatocellular carcinoma
Conditions
Interventions
Thymostimulin 75 mg (Thymophysin CytoChemia® 25/50) subcutaneously for 5 days a week in addition to best supportive care as required.
Patients with tumour regress are allowed non-syst
Sponsors
Martin-Luther-University Halle-Wittenberg (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Biopsy- or image-proven locally advanced or metastatic hepatocellular carcinoma not amenable to or failing established treatment 2. Two-dimensional measurable lesion on imaging 3. Life expectancy greater than 3 months 4. Age 18 to 80 years
Exclusion criteria
Exclusion criteria: 1. Pregnancy/lactation 2. Active second malignancy 3. Severe concomitant disease (e.g. New York Heart Association [NYHA] grade III - IV, serum creatinine level greater than 300 µmol/l) 4. Severe decompensated liver function (bilirubin greater than 5 mg/dl, International normalised ratio [INR] greater than or equal to 2.3) 5. Unable to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival as well as 1-, 2- and 3-year survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Tumour response and progression-free survival according to standard World Health Organization (WHO) criteria. Timepoints are: 1.1. Tumour response end of study (three years) 1.2. Overall progression-free survival 2. Toxicity according to Eastern Cooperative Oncology Group (ECOG) criteria | — |
Countries
Germany
Outcome results
None listed