Condition category
Cancer
Date applied
19/12/2007
Date assigned
21/12/2007
Last edited
12/06/2015
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 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

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 measures

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

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

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes