Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Thymostimulin in advanced hepatocellular carcinoma: a phase II trial
Acronym
Study hypothesis
To assess efficacy and safety of thymostimulin in the treatment of advanced hepatocellular carcinoma.
Please note that the phase III study of this trial is registered under http://www.controlled-trials.com/ISRCTN64487365.
Ethics approval
Ethics approval received from the Ethik-Kommission of the Medical Faculty of the Martin-Luther-University Halle-Wittenberg (Germany) in May 2000.
Study design
Prospective uncontrolled single-centre phase II treatment study to assess efficacy and safety
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Locally advanced or metastasised hepatocellular carcinoma
Intervention
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-systemic concomitant treatment with Radiofrequency Thermal Ablation (RFTA) or Transarterial Chemoembolisation (TACE), if the tumour is accessible secondary to the study treatment. In case of tumour progress, patients are allowed to receive salvage therapy.
Intervention type
Drug
Phase
Phase II
Drug names
Thymostimulin
Primary outcome measure
Overall survival as well as 1-, 2- and 3-year survival.
Secondary outcome measures
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
Overall trial start date
01/07/2000
Overall trial end date
31/03/2004
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
48 participants
Participant 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
Recruitment start date
01/07/2000
Recruitment end date
30/09/2002
Locations
Countries of recruitment
Germany
Trial participating centre
University of Leipzig Hospitals and Clinics
Leipzig
04103
Germany
Sponsor information
Organisation
Martin-Luther-University Halle-Wittenberg (Germany)
Sponsor details
First Department of Medicine
Ernst-Grube-Strasse 40
Halle
06114
Germany
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Martin-Luther-University Halle-Wittenberg (Germany) - First Department of Medicine
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list