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. Copyright © 2005 Cognizant Comm. Corp.

Treatment with stem cell differentiation stage factors of intermediate-advanced hepatocellular carcinoma: An open randomized clinical trial / T., Livraghi; F., Meloni; A., Frosi; S., Lazzaroni; Bizzarri, Mariano; Frati, Luigi; P. M., Biava. - In: ONCOLOGY RESEARCH. - ISSN 0965-0407. - STAMPA. - 15:7-8(2005), pp. 399-408.

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

BIZZARRI, Mariano;FRATI, Luigi;
2005

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. Copyright © 2005 Cognizant Comm. Corp.
2005
biological response modifiers; differentiation factors; embryo; hepatocellular carcinoma; stem cells
01 Pubblicazione su rivista::01a Articolo in rivista
Treatment with stem cell differentiation stage factors of intermediate-advanced hepatocellular carcinoma: An open randomized clinical trial / T., Livraghi; F., Meloni; A., Frosi; S., Lazzaroni; Bizzarri, Mariano; Frati, Luigi; P. M., Biava. - In: ONCOLOGY RESEARCH. - ISSN 0965-0407. - STAMPA. - 15:7-8(2005), pp. 399-408.
File allegati a questo prodotto
Non ci sono file associati a questo prodotto.

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/383516
 Attenzione

Attenzione! I dati visualizzati non sono stati sottoposti a validazione da parte dell'ateneo

Citazioni
  • ???jsp.display-item.citation.pmc??? 12
  • Scopus 55
  • ???jsp.display-item.citation.isi??? 48
social impact