The Open, Multicenters, Double-Arms, Randomized, Parallel Controlled Clinical Trial Of Lobaplatin Or Gemcitabine Combined With Docetaxel As Second-Line Therapy For Advanced Osteosarcoma-The Effectiveness And Safety Analysis.

e22506 Background: to study the progression free survival (PFS), objective response rate (ORR), overall survival (OS) and safety of lobaplatin or gemcitabine combined with docetaxel as second-line therapy for advanced osteosarcoma. Methods: the NO. of clinical trial was HNCA001,a total of 15 cases were enrolled into experiment group adopted lobaplatin combined with docetaxel,and 14 into control group received gemcitabine combined with docetaxel.The trial concluded screening, treatment and follow-up periods.21 dyas as one treatment period,they got drugs at the first day,and were evaluated the effects per two periods, treated at most 6 periods. Results: The baseline characteristics of two groups were no ststistical differences(diastolic blood pressure excluded) (P > 0.05).The PFS rates of 2,4 and 6 periods in experiment group were 87.50%、87.50% and 70.00%,83.33%,27.78% and 0 in control group,middle PFS more than 12 months in experiment group and 3.20 months in control group;while there was no statistical difference of PFS rates(χ2= 2.42,P = 0.1194).The survival rates of 2,4 and 6 periods in experiment group were 100.00%,83.33% and 83.33%,83.33%,83.33% and 0 in control group,the middle OS more than 12 months in the two groups, there was no statistical difference of survival rates (χ2= 0.65,P = 0.4196).The ORR was 6.67% in experiment group and 0 in control group(P = 1.0000).There were no adverse events occurring in the two groups. Conclusions: There is negative results of the trial,most reason may be the samples are greatly less;the next step is samples expanded and follow-up extended for the priority of lobaplatin or gemcitabine combined with docetaxel as second-Line therapy for advanced osteosarcoma. Clinical trial information: NCT02099396.