Thymostimulin versus placebo for palliative treatment of locally advanced or metastasised hepatocellular carcinoma: a phase III clinical trial

Thymostimulin is a thymic peptide fraction with immune-mediated cytotoxicity against hepatocellular carcinoma (HCC) in vitro and palliative efficacy in advanced HCC in two independent phase II trials. The aim of this study was to assess the efficacy of thymostimulin in a phase III trial. The study w...

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Veröffentlicht in:	BMC cancer 2010-08, Vol.10 (1), p.457-457, Article 457
Hauptverfasser:	Dollinger, Matthias M, Lautenschlaeger, Christine, Lesske, Joachim, Tannapfel, Andrea, Wagner, Anna-Dorothea, Schoppmeyer, Konrad, Nehls, Oliver, Welker, Martin-Walter, Wiest, Reiner, Fleig, Wolfgang E
Format:	Artikel
Sprache:	eng
Schlagworte:	Adolescent Adult Aged Aged, 80 and over Carcinoma, Hepatocellular - drug therapy Carcinoma, Hepatocellular - secondary Care and treatment Clinical medicine Clinical trials Confidence intervals Disease Progression Dosage and administration Double-Blind Method Family medical history Female Follow-Up Studies Hepatoma Humans Immunological adjuvants Interferon Inducers - therapeutic use Kinases Liver cancer Liver Neoplasms - drug therapy Liver Neoplasms - pathology Male Medicine Middle Aged Neoplasm Staging Palliative Care Patient outcomes Placebos Prospective Studies Survival Rate Thymus Extracts - therapeutic use Treatment Outcome Tumors Young Adult
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Zusammenfassung:	Thymostimulin is a thymic peptide fraction with immune-mediated cytotoxicity against hepatocellular carcinoma (HCC) in vitro and palliative efficacy in advanced HCC in two independent phase II trials. The aim of this study was to assess the efficacy of thymostimulin in a phase III trial. The study was designed as a prospective randomised, placebo-controlled, double-blind, multicenter clinical phase III trial. Between 10/2002 and 03/2005, 135 patients with locally advanced or metastasised HCC (Karnofsky >or=60%/Child-Pugh
ISSN:	1471-2407 1471-2407
DOI:	10.1186/1471-2407-10-457