Contact information
Type
Scientific
Primary contact
Prof Wolfgang E Fleig
ORCID ID
Contact details
Professor of Medicine
Medical Chairman and Chairman of the Board
University of Leipzig Hospitals and Clinics
Philipp-Rosenthal-Straße 27
Leipzig
04103
Germany
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wolfgang.fleig@medizin.uni-leipzig.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Thymostimulin versus placebo for treatment of advanced hepatocellular carcinoma: a prospective randomised, placebo-controlled, double-blind, multicentre study
Acronym
Study hypothesis
To assess efficacy and safety of thymostimulin versus placebo in the treatment of advanced hepatocellular carcinoma.
Study hypothesis: 20% improvement of one-year survival.
Please note that this is the phase III study of a previously registered trial entitled 'Treatment of advanced liver cell cancer with the drug thymostimulin' (see http://www.controlled-trials.com/ISRCTN29319366).
Ethics approval
Ethik-Kommission of the Medical Faculty of the Martin-Luther-University Halle-Wittenberg (Germany), July 2002
Study design
Prospective randomised placebo-controlled double-blind multicentre phase III trial
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 versus placebo (subcutaneous injection) and best supportive care.
Total duration of treatment: maximum of 12 months or until progression; follow-up: 12 months as for treatment; if patient is alive after 12 months, three-monthly follow-up for overall survival.
Intervention type
Drug
Phase
Phase III
Drug names
Thymostimulin
Primary outcome measures
Six and 12-month survival.
Secondary outcome measures
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.
Overall trial start date
01/10/2002
Overall trial end date
31/03/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
135 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 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
Recruitment start date
01/10/2002
Recruitment end date
31/03/2005
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
06120
Germany
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Cytochemia AG (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Martin-Luther-University Halle-Wittenberg (Germany)
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
Results - basic reporting
Publication summary
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/20735834
Publication citations
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Results
Dollinger MM, Lautenschlaeger C, Lesske J, Tannapfel A, Wagner AD, Schoppmeyer K, Nehls O, Welker MW, Wiest R, Fleig WE, , Thymostimulin versus placebo for palliative treatment of locally advanced or metastasised hepatocellular carcinoma: a phase III clinical trial., BMC Cancer, 2010, 10, 457, doi: 10.1186/1471-2407-10-457.