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Sponsored by: |
Federico II University |
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Information provided by: | Federico II University |
ClinicalTrials.gov Identifier: | NCT00495846 |
The hepatocellular carcinoma (HCC) represents more than 5% of all human malignancies, with more than 500,000 deaths per year (1). In Campania region, mortality for HCC is 2 times higher than in the rest of Italy because of a higher locally prevalence of hepatitis-C virus infection.
Development of HCC in liver chirrosis is associated with increased DNA synthesis and regeneration of hepatocytes (2). Hepatocyte growth factor, the transforming growth factor-α, the fibroblast growth factor are well studied (3,4) while the insulin-like growth factor system (IGF-I, IGF-II and their binding proteins) has been less investigated. IGF-I and IGF-II modulate growth, metabolism and cell differentiation and have specific receptors in the liver (5). IGF-I levels in the upper normal range have been associated with an increased risk to develop prostate cancer (6), breast cancer (7) and colon cancer (8). Some data report increased expression of IGF-II in HCC (9,10) and others suggest a role of increased IGF-I bioavailability in HCC (11). We reported increased IGF-I/IGFBP-3 ratio in patients with HCC compared with those with cirrhosis with a similar liver function, so suggesting increased IGF-I bioavailability in HCC (12).
There is no currently medical treatment for patients with advanced HCC which has a very poor prognosis (survival <6 months). Because of limited liver function, classical chemotherapy cannot be applied (13). In patients with HCC without cirrhosis, surgery is possible only in 5% while in those with cirrhosis first-line treatment is still questioned as survival is <50% three years after operation. Patients suitable for local resection of HCC are only those with Child-Pugh's "hyper A" liver function class, who are a minority (14-16). Percutaneous resection treatments may treat approximately 70%-90% of tumors with maximal diameters of <3 cm (15,17-19).
Somatostatin analogues are indicated in patients with neuroendocrine tumors expressing somatostatin receptors type 2 and 5 and has excellent safety profile. In advanced HCC, some studies demonstrated beneficial effects (20,21) while some others did not (22,23).
Only a few data are available on somatostatin receptor expression in HCC (24,25). Somatostatin analogues have also a clear-cut inhibitory effect on circulating IGF-I levels with a potential additional effect in delaying HCC progression.
Condition | Intervention | Phase |
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Advanced Hepatocellular Carcinoma |
Drug: Octreotide-LAR, Lanreotide Autogel Drug: Octreotide-LAR or Lanreotide Autogel Other: Locoregional treatments |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Treatment of Advanced Hepatocellular Carcinoma With Depot Somatostatin Analogues: a Pilot Prospective Study Based on Somatostatin Receptors Tumors Expression |
Estimated Enrollment: | 20 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | December 2007 |
Arms | Assigned Interventions |
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A: Experimental
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Drug: Octreotide-LAR, Lanreotide Autogel
Octreotide-LAR at a dose of 30 mg every 28 days or lanreotide autogel 120 mg every 28 days for 3 months then uptitrated according with the protocol.
Drug: Octreotide-LAR or Lanreotide Autogel
Sandostatin-LAR up to 60 mg/month, Ipstyl up to 240 mg month up to patients survival.
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B
Historical controls
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Other: Locoregional treatments |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Treatment protocol In all patients fulfilling the inclusion criteria, treatment will begin with octreotide-LAR at a dose of 30 mg every 28 days or lanreotide autogel 120 mg every 28 days for 3 months. After 28, 56 and 74 days (immediately before the next injection) all patients will be admitted to the Day Hospital of the IX Division of Internal Medicine of the D. Cotugno Hospital for the clinical examination, blood chemistry, blood sampling for the IGF axis analysis, and abdominal ultrasound. After 74 days, abdominal CT or MRI will also be performed. Then, in all survivors the interval between injection will be reduced to 21 days and follow up for the next 3 months will be done as stated before the day immediately preceding the injection. Then, in the subsequent follow-up the interval between injection will be reduced to 14 days and all procedures will be repeated at monthly intervals.
All the patients fulfilling the inclusion criteria but refusing to participate to the study will be followed with the same methodology of those receiving the somatostatin analogues treatment.
Contact: Annamaria Colao, MD, PhD | +39-0817462132 | colao@unina.it |
Contact: Antonella Di Sarno, MD, PhD | +39-3392921067 | antonella.disarno@yahoo.it |
Italy | |
D. Cotugno Hospital | Recruiting |
Naples, Italy, 80131 | |
Principal Investigator: Antonella Di Sarno, MD, PhD |
Principal Investigator: | Annamaria Colao, MD, PhD | University Federico II of Naples |
Study ID Numbers: | NeuroendoUnit-4 |
Study First Received: | July 2, 2007 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00495846 |
Health Authority: | Italy: Ministry of Health; Italy: National Institute of Health |
Hepatocellular carcinoma Somatostatin analogues Somatostatin receptors Octreotide |
Lanreotide IGF-I IGF-II |
Liver Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Liver neoplasms Angiopeptin Octreotide Somatostatin Carcinoma |
Liver Neoplasms Lanreotide Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Neoplasms, Glandular and Epithelial Hepatocellular carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Gastrointestinal Agents Cardiovascular Agents Hormones Pharmacologic Actions |