Treatment with stem cell differentiation stage factors of intermediate-advanced hepatocellular carcinoma: An open randomized clinical trial

Tito Livraghi, Franca Meloni, Alberto Frosi, Sergio Lazzaroni, Mariano Bizzarri, Luigi Frati, Pier Mario Biava

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Abstract

There is no standard treatment for patients with advanced hepatocellular carcinoma (HCC). We developed a product containing stem cells differentiation stage factors (SCDSF) that inhibits tumor growth in vivo and in vitro. The aim of this open randomized study was to assess its efficacy in patients with HCC not suitable for resection, transplantation, ablation therapy, or arterial chemoembolization. A total of 179 consecutive patients were enrolled. We randomly assigned the patients to receive either SCDSF or only conservative treatment. Primary end points were tumor response and survival. Secondary end points were performance status and patient tolerance. Randomization was stopped at the second interim analysis (6 months) of the first 32 patients recruited when the inspection detected a significant difference in favor of treatment (p = 0.037). The responses to the therapy obtained in 154 additional patients confirmed previous results. Evaluation of survival showed a significant difference between the group of patients who responded to treatment versus the group with progression of disease (p <0.001). Of the 23 treated patients with a performance status (PS) of 1, 19 changed to 0. The study indicated the efficacy of SCDSF treatment of the patients with intermediate-advanced HCC.

Original languageEnglish
Pages (from-to)399-408
Number of pages10
JournalOncology Research
Volume15
Issue number7-8
Publication statusPublished - 2005

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Keywords

  • Biological response modifiers
  • Differentiation factors
  • Embryo
  • Hepatocellular carcinoma
  • Stem cells

ASJC Scopus subject areas

  • Cancer Research

Cite this

Livraghi, T., Meloni, F., Frosi, A., Lazzaroni, S., Bizzarri, M., Frati, L., & Biava, P. M. (2005). Treatment with stem cell differentiation stage factors of intermediate-advanced hepatocellular carcinoma: An open randomized clinical trial. Oncology Research, 15(7-8), 399-408.