Locally advanced or metastasised hepatocellular carcinoma Cancer Malignant neoplasm of liver and intrahepatic bile ducts
Conditions
Interventions
Thymostimulin 75 mg (Thymophysin CytoChemia® 25/50) subcutaneously for 5 days a week in addition to best supportive care as required versus placebo (subcutaneous injection) and best supportive care.
follow-up: 12 months as for treatment
if patient is alive after 12 months, three-monthly follow-up for overall survival.
Sponsors
Martin-Luther-University Halle-Wittenberg (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Biopsy-proven locally advanced or metastasised hepatocellular carcinoma not amenable to or failing established treatment 2. Two-dimensional measurable lesion on imaging 3. Karnofsky score equal or greater than 60% 4. Aged 18 to 80 years, either sex
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 micromol/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 |
|---|---|
| Six and 12-month survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall survival 2. Tumour response and progression-free survival according to standard World Health Organization (WHO) criteria. Timepoints are: 2.1. Tumour response after one year 2.2. Overall progression-free survival 3. Toxicity according to Eastern Cooperative Oncology Group (ECOG) criteria 4. Quality of life assessed by means of the Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep) questionnaire Timepoints for all primary and secondary outcomes: after 12 months. | — |
Countries
Germany
Outcome results
None listed