Treatment of advanced liver cell cancer with the drug thymostimulin in comparison with placebo

ISRCTN ISRCTN64487365
DOI https://doi.org/10.1186/ISRCTN64487365
Secondary identifying numbers N/A
Submission date
29/05/2008
Registration date
19/06/2008
Last edited
04/02/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Wolfgang E Fleig
Scientific

Professor of Medicine
Medical Chairman and Chairman of the Board
University of Leipzig Hospitals and Clinics
Philipp-Rosenthal-Straße 27
Leipzig
04103
Germany

Email wolfgang.fleig@medizin.uni-leipzig.de

Study information

Study designProspective randomised placebo-controlled double-blind multicentre phase III trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleThymostimulin versus placebo for treatment of advanced hepatocellular carcinoma: a prospective randomised, placebo-controlled, double-blind, multicentre study
Study objectivesTo 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(s)Ethik-Kommission of the Medical Faculty of the Martin-Luther-University Halle-Wittenberg (Germany), July 2002
Health condition(s) or problem(s) studiedLocally advanced or metastasised hepatocellular carcinoma
InterventionThymostimulin 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 typeDrug
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)Thymostimulin
Primary outcome measureSix and 12-month survival.
Secondary outcome measures1. 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 study start date01/10/2002
Completion date31/03/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants135 participants
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/10/2002
Date of final enrolment31/03/2005

Locations

Countries of recruitment

  • Germany

Study participating centre

University of Leipzig Hospitals and Clinics
Leipzig
04103
Germany

Sponsor information

Martin-Luther-University Halle-Wittenberg (Germany)
University/education

First Department of Medicine
Ernst-Grube-Strasse 40
Halle
06120
Germany

Website http://www.international.uni-halle.de/
ROR logo "ROR" https://ror.org/05gqaka33

Funders

Funder type

University/education

Cytochemia AG (Germany)

No information available

Martin-Luther-University Halle-Wittenberg (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 24/08/2010 Yes No