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
Scientific
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 |
Study information
Study design | Prospective randomised placebo-controlled double-blind multicentre phase III trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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 |
Pharmaceutical study type(s) | |
Phase | Phase III |
Drug / device / biological / vaccine name(s) | Thymostimulin |
Primary outcome measure | 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 study start date | 01/10/2002 |
Completion date | 31/03/2006 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 135 participants |
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
04103
Germany
Sponsor information
Martin-Luther-University Halle-Wittenberg (Germany)
University/education
University/education
First Department of Medicine
Ernst-Grube-Strasse 40
Halle
06120
Germany
Website | http://www.international.uni-halle.de/ |
---|---|
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 share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | 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 |