Treatment of advanced liver cell cancer with the drug thymostimulin
| ISRCTN | ISRCTN29319366 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29319366 |
| Protocol serial number | N/A |
| Sponsor | Martin-Luther-University Halle-Wittenberg (Germany) |
| Funder | Martin-Luther-University Halle-Wittenberg (Germany) - First Department of Medicine |
- 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
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
| Primary study design | Interventional |
|---|---|
| Study design | Prospective uncontrolled single-centre phase II treatment study to assess efficacy and safety |
| Secondary study design | Randomised controlled trial |
| Scientific title | Thymostimulin in advanced hepatocellular carcinoma: a phase II trial |
| Study objectives | 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(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) 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. 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 / device / biological / vaccine name(s) | Thymostimulin |
| Primary outcome measure(s) |
Overall survival as well as 1-, 2- and 3-year survival. |
| Key secondary outcome measure(s) |
1. Tumour response and progression-free survival according to standard World Health Organization (WHO) criteria. Timepoints are: |
| Completion date | 31/03/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 48 |
| Total final enrolment | 44 |
| Key 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 |
| 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 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 enrolment | 01/07/2000 |
| Date of final enrolment | 30/09/2002 |
Locations
Countries of recruitment
- Germany
Study participating centre
University of Leipzig Hospitals and Clinics
Leipzig
04103
Germany
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 | 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.
