Condition category
Cancer
Date applied
29/05/2008
Date assigned
19/06/2008
Last edited
04/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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
-
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

http://www.international.uni-halle.de/

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

  1. 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.

Additional files

Editorial Notes