shozopanib, which inhibits VEGF, PDGF, and c kit, showed evidence of activity. Phase II trials of erlotinib plus bevacizumab are promising. In 16 previously untreated patients, the combination led to a median TTP of 2.3 months and median survival of 13.7 months. In 40 patients, 73 of whom were previously LY2228820 untreated, the response rate was 25 , median PFS was 9.0 months, and median survival was 15.7 months. In 58 patients, 76 of whom were previously untreated, median PFS times were 8.8 months in patients with no prior therapy, 7.9 months in patients previously treated with sorafenib, and 6.6 months in those previously treated with therapy other than sorafenib. Corresponding median survival times were 15.6 months, 13.3 months, and 14.4 months. In all studies, adverse events were consistent with the individual drug profiles.
Asian Panel Opinions on Clinical Trial Design In 2008, the American Association for the Study of Liver Diseases published a framework for clinical trial design in HCC. During the current expert panel meeting, participants provided their views about clinical trial design from an Asian perspective. These views are outlined in Table 2. The Asian panel also Mubritinib provided additional insights into clinical trial issues specific to disease stage. The panel noted a great need for trials in resectable disease. The panel felt that testing compounds in the adjuvant setting before establishing efficacy in the metastatic setting is possible, citing positive phase II adjuvant results with muparfostat and noting the need for effective therapies in this setting.
The panel also expressed interest in chemoprevention with sorafenib and other agents after resection or local ablation. In unresectable disease, especially where locoregional therapy is indicated, placebo controlled trials remain feasible, though the panel acknowledged opportunities are limited. In this setting, it may be beneficial to limit enrollment to patients who experience a maximal response after TACE based on modified EASL criteria. Such a requirement would facilitate identification of subsequent disease progression across patients. However, additional research is necessary to identify the best clinical endpoints in this setting. Because it remains difficult to differentiate recurrent disease from a second primary cancer, time to development of a new lesion may be an appropriate outcome in this setting.
Finally, in the advanced metastatic setting, the panel felt that developing new agents in the second line setting is warranted. Summary Hepatocellular carcinoma is a disease of variable incidence and etiology that is managed differently worldwide. This expert panel has identified key areas that need to be addressed to facilitate clinical trials in Asia. Stratification by viral etiology is desirable within Asia and by region in global trials. Antiviral therapy should also be considered as a stratification factor and incorporated into HCC management in trials. The panel agreed with AASLD tha