Treatment with stem cell differentiation stage factors of intermediate-advanced hepatocellular carcinoma: an open randomized clinical trial.
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.
Department of Radiology, Civil Hospital of Vimercate, Vimercate, Milan, Italy.
Tito
T
Livraghi
Franca
F
Meloni
Alberto
A
Frosi
Sergio
S
Lazzaroni
T Mariano
TM
Bizzarri
Luigi
L
Frati
Pier Mario
PM
Biava
D000368:Aged; D006528:Carcinoma, Hepatocellular / Q000473:pathology / Q000628:therapy*; D002454:Cell Differentiation; D018450:Disease Progression; D005260:Female; D006133:Growth Substances / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D008113:Liver Neoplasms / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D013234:Stem Cells / Q000187:drug effects; D016019:Survival Analysis; D016896:Treatment Outcome
D006133:Growth Substances