 The study had a Simon Optimal two-stage Phase II design α 5, β 10, π0 5, π1 20. The minimum clinically important response rate was 20. The first stage was to include 21 patients and the second stage a total of 41 patients. The treatment would be rejected if there were fewer than 2 responders at the first stage or fewer than 5 responders at the second stage. The treatment would be accepted for further study if there were at least 5 responders out of 41 patients. 