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We aimed to evaluate the efficacy and safety of using combination of B\u2009+\u2009E in treating advanced HCC patients who had failed prior sorafenib treatment. <jats:italic>Methods<\/jats:italic> Eligible advanced HCC patients with documented radiological evidence of disease progression with sorafenib treatment were recruited. All patients received bevacizumab(B) at 10\u00a0mg\/kg every 2\u00a0weeks with erlotinib(E) at 150\u00a0mg daily for a maximum of 6 cycles. Response assessments using both RECIST and modified RECIST criteria were performed after every 6\u00a0weeks. The primary endpoint was clinical benefit (CB) rate and a Simon two-stage design was employed. <jats:italic>Results<\/jats:italic> The trial was halted in the first stage according to the pre-set statistical criteria with 10 patients recruited. The median age was 47\u00a0years (range, 28\u201361) and all patients were in ECOG performance status 1. Eighty percent of patients were chronic hepatitis B carriers and all patients had Child A cirrhosis. Among these 10 patients, none of the enrolled patients achieved response or stable disease. The median time-to-progression was 1.81\u00a0months (95\u00a0% confidence interval [C.I.], 1.08\u20131.74\u00a0months) and overall survival was 4.37\u00a0months (95\u00a0% C.I., 1.08\u201311.66\u00a0months). Rash (70\u00a0%), diarrhea (50\u00a0%) and malaise (40\u00a0%) were the most commonly encountered toxicities. <jats:italic>Conclusion<\/jats:italic> The combination of B\u2009+\u2009E was well tolerated but had no activity in an unselected sorafenib-refractory advanced HCC population. <jats:italic>Condensed abstract<\/jats:italic> The combination of bevacizumab and erlotinib had no clinical activity in sorafenib-refractory HCC population.<\/jats:p>","DOI":"10.1007\/s10637-012-9808-8","type":"journal-article","created":{"date-parts":[[2012,3,8]],"date-time":"2012-03-08T08:07:24Z","timestamp":1331194044000},"page":"2384-2390","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":48,"title":["Phase II study of bevacizumab and erlotinib in the treatment of advanced hepatocellular carcinoma patients with sorafenib-refractory disease"],"prefix":"10.1007","volume":"30","author":[{"given":"Thomas","family":"Yau","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hilda","family":"Wong","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pierre","family":"Chan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"T. 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