Efficacy and safety of combined sequential treatment with radiofrequency ablation and sorafenib in patients with hepatocellular carcinoma in intermediate stage ineligible for tace: a prospective randomized open study

5^th World Congress on Cancer Therapy

September 28-30, 2015 Atlanta, USA

Posters-Accepted Abstracts: J Cancer Sci Ther

Abstract :

Introduction: TACE is considered the gold standard for patients (pts) with Hepatocellular Carcinoma in Intermediate Stage (BCLC-B HCC). Pts with contraindications or ineligible for TACE are candidates for Sorafenib (S). Aim of the present study is to verify efficacy and safety of a combined treatment Radiofrequency Ablation (RFA)and S in pts with BCLC-B HCC ineligible for TACE. Primary Endpoint: Overall Survival in both groups. Secondary Endpoints: validation of CEUS for evaluation of RFA efficacy; safety and efficacy of combined RFA+S. Methods: A prospective randomized open-label study is expected to enroll during 12 months 124 pts with BCLC-B HCC (3-5 HCCs nodules � 3cm� 5 cm), not eligible for TACE or who refused TACE. Pts will be randomized 1:1 into two arms: Group A: S 400 mg bid; Group B: combined sequential treatment RFA+S. In Group B S will be administered for 2 weeks; then S will be stopped from 15th to 19th day to perform RFA scheduled on day 17. CEUS to assess the extent of necrosis and biochemical tests will be performed 24 hours after RFA. In case of complete necrosis, pts will re-take S 2 days after the RFA and will be followed-up. In case of incomplete necrosis, 2 days after RFA, pts will start again S at full dosage for 11 days, then drug will be stopped 2 days before the 2th RFA and resumed 2 days after procedure ( up to 3 sessions of RFA; up to 2 nodules or a single nodule up to 5 cm, for session). Seven days after the last RFA therapeutic efficacy will be evaluated with CEUS and three-phase contrast-enhanced (CE- CT). Fig.1 shows the follow-up flow-chart . Results: From December 2014 up to March 2015, 18 pts for group were enrolled. To date, statistical evaluation in terms of survival, safety and efficacy of treatment in the 2 group is impossible due to the too small sample size and the short time of observation.

Biography :

Email: giordest1@virgilio.it