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

ISRCTN	ISRCTN64487365
DOI	https://doi.org/10.1186/ISRCTN64487365
Protocol serial number	N/A
Sponsor	Martin-Luther-University Halle-Wittenberg (Germany)
Funders	Cytochemia AG (Germany), Martin-Luther-University Halle-Wittenberg (Germany)

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

Primary study design	Interventional
Study design	Prospective randomised placebo-controlled double-blind multicentre phase III trial
Secondary study design	Randomised controlled trial
Scientific title	Thymostimulin versus placebo for treatment of advanced hepatocellular carcinoma: a prospective randomised, placebo-controlled, double-blind, multicentre study
Study objectives	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(s)	Ethik-Kommission of the Medical Faculty of the Martin-Luther-University Halle-Wittenberg (Germany), July 2002
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Thymostimulin
Primary outcome measure(s)	Six and 12-month survival.
Key secondary outcome measure(s)	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.
Completion date	31/03/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	135
Key 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
Key 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
Date of first enrolment	01/10/2002
Date of final enrolment	31/03/2005

Locations

Countries of recruitment

Germany

Study participating centre

University of Leipzig Hospitals and Clinics

Leipzig
04103
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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