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Sponsors and Collaborators: |
Progen Pharmaceuticals Medigen Biotechnology Corporation |
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Information provided by: | Progen Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00247728 |
The purpose of this study is to evaluate the efficacy of PI-88 to inhibit or reduce tumor recurrence in patients with hepatocellular carcinoma following hepatectomy.
Condition | Intervention | Phase |
---|---|---|
Carcinoma, Hepatocellular |
Drug: PI-88 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Multi-Centre, Efficacy Evaluation of PI-88 in Patients With Hepatocellular Carcinoma After Hepatectomy - A Phase II Study |
Estimated Enrollment: | 343 |
Study Start Date: | June 2004 |
Estimated Study Completion Date: | June 2008 |
Although early diagnosis and treatment improve survival, hepatocellular carcinoma (HCC) is rarely cured and recurs frequently after regional therapy or transplantation. Hepatic resection can improve 5-year recurrence-free survival by up to 25%. Micrometastases of HCC have been detected by molecular techniques in 88% of patients at the time of surgery, and probably cause postoperative recurrence. Efforts to reduce the risk of recurrence after a curative resection have been tried, including various regimens of adjuvant and neoadjuvant therapy.
In this study , an anti-angiogenic agent, PI-88, is being used as an adjuvant therapy for HCC patients after curative hepatic resection. The efficacy endpoints, including tumour non-recurrence rate, time to first recurrence and 1-year survival rate are being evaluated. Several risk factors associated with tumour recurrence are also being analysed. There are two stages to this study. In stage 1 there are three arms - untreated control and two arms are two different PI-88 dose. In stage 2 the better of the two PI-88 arms will be continued against the control arm.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with adequate renal, hepatic, and haematopoietic function as defined by:
Exclusion Criteria:
Taiwan | |
National Taiwan University Hospital | |
Taipei, Taiwan, 100 | |
Chang Gung Memorial Hospital-Linkou Medical Centre | |
Kwei-Shan, Taiwan, 333 | |
Taichung Veterans General Hospital | |
Taichung, Taiwan, 407 | |
National Cheng Kung University Hospital | |
Tainan, Taiwan, 704 | |
Kaohsiung Veterans General Hospital | |
Kaohsiung, Taiwan, 813-46 | |
China Medical University Hospital | |
Taichung, Taiwan, 404 |
Principal Investigator: | Pei-Jer Chen, MD, PhD | National Taiwan University Hospital |
Study ID Numbers: | MG 002, PR88204 |
Study First Received: | November 1, 2005 |
Last Updated: | October 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00247728 History of Changes |
Health Authority: | United States: Food and Drug Administration; Taiwan: Department of Health |
PI-88 post resection hepatoma adjuvant therapy hepatectomy hepatoma |
Liver Neoplasms Liver Diseases Digestive System Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Adjuvants, Immunologic |
Gastrointestinal Neoplasms Hepatocellular Carcinoma Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |
Liver Neoplasms Liver Diseases Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms |
Neoplasms by Histologic Type Carcinoma, Hepatocellular Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |