[Phase II clinical trial on XXXX in the treatment of stage IIIB-IV @entity1149 ].

@entity1 @entity137 @entity390 @entity1149 @entity900 @entity391 @entity1503 @entity1277 @entity70825 @entity136
OBJECTIVE: To evaluate the efficacy and safety of domestic @entity136 in the treatment of @entity1 with stage IIIB approximately IV @entity1149 ( @entity1149 ). METHODS: 124 @entity1149 @entity1 were randomized into three groups: Group A: single drug group, 40 cases, @entity136 1 000 mg/m(2) + NS 100 ml or 200 ml was infused within 30 approximately 60 minutes on D1, 8 and 15, with 28 days taken as one cycle. Group B: combined treatment group, 36 cases, in addition to the above protocol, @entity900 30 mg/m(2) was infused within 60 approximately 120 min, on @entity70825 . Group C: combined control group: 39 cases, the protocol applied was the same as group B except domestic @entity136 being replaced by imported gemzar. The efficacy and side effects of treatment were evaluated after 8 weeks of treatment. RESULTS: 115 @entity1 could be evaluated for response rate. PR was observed in 9/40 (22.5%) of group A, 15/36 (41.6%) in group B and 15/39 (38.36%) in group C. There was no significant difference of PR rates between group B and group C (P = 0.552). 117 @entity1 who received the second cycle of treatment were evaluated for @entity137 . The incidence of grade III approximately IV @entity390 , @entity391 and @entity1277 was much higher in group B. @entity1503 of groups B and C was higher than that of group A. There was no significant difference between groups B and C. CONCLUSION: The efficacy and incidence of side effects between domestic @entity136 and the imported gemzar are similar.
