|ECR 2018 / C-3001|
|Transarterial Chemo-embolisation with degradable starch microspheres(DSM-TACE) in intermediate/advanced HCC patients dismissing or inelegible for Sorafenib|
Methods and materials
A single-center phase II study was conducted on 24 consecutive HCC patients (13 intermediate-stage non responder and 11-advanced stage stage) dismissing Sorafenib due to unbearable side effects or worsened clinical conditions (deteriorated liver function), who underwent DSM-TACE.
Under local anesthesia, through femoral approach, the treatment was performed after selective lobar hepatic artery catheterization. Based on extent and distribution of the disease and according to the protocol, each cycle of therapy consists into two consecutive treatments performed within one month. In particular, in case of unilobar disease, patients underwent two session treatment in one month while in case of bilobar disease they underwent four session treatment, two for each lobe with a two week interval between sessions.
Tumor response was evaluated, according to mRECIST criteria, with MDCT exam performed 1 month after complete treatment and every 3 months thereafter.
Primary endpoints were safety, tolerance and overall disease control (ODC); secondary endpoints were progression free survival (PFS) and overall survival (OS).
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