Treatment of advanced liver cell cancer with the drug thymostimulin

ISRCTN ISRCTN29319366
DOI https://doi.org/10.1186/ISRCTN29319366
Secondary identifying numbers N/A
Submission date
19/12/2007
Registration date
21/12/2007
Last edited
30/12/2020
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 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

Study information

Study designProspective uncontrolled single-centre phase II treatment study to assess efficacy and safety
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleThymostimulin in advanced hepatocellular carcinoma: a phase II trial
Study objectivesTo 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(s)Ethics approval received from the Ethik-Kommission of the Medical Faculty of the Martin-Luther-University Halle-Wittenberg (Germany) in May 2000.
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.

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 typeDrug
Pharmaceutical study type(s)
PhasePhase II
Drug / device / biological / vaccine name(s)Thymostimulin
Primary outcome measureOverall survival as well as 1-, 2- and 3-year survival.
Secondary outcome measures1. 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 study start date01/07/2000
Completion date31/03/2004

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants48 participants
Total final enrolment44
Key inclusion criteria1. 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
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 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
Date of first enrolment01/07/2000
Date of final enrolment30/09/2002

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
06114
Germany

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

Funders

Funder type

University/education

Martin-Luther-University Halle-Wittenberg (Germany) - First Department of Medicine

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 13/03/2008 30/12/2020 Yes No

Editorial Notes

30/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.