关键词: 骨肉瘤；ClinicalTrials.gov；临床试验 

Abstract: Objective To analyze the global registration of osteosarcoma clinical trials, to understand the research status and trend of the field, and to provide the latest information for osteosarcoma research and clinical diagnosis and treatment. Methods The data of osteosarcoma clinical trials registered in ClinicalTrials.gov from 2001 to 2021 were collected and statistically analyzed in terms of regional distribution, annual trend, trial progress, research type, clinical stage, and number of participating institutions. Results From 2001 to 2021, a total of 514 global osteosarcoma clinical trials were registered, mainly in North America and Europe. Among them, 416 (80.9%) were interventional clinical trials, 87.0% (362/416) were drug⁃related treatments, and 127 were anti⁃tumor drug studies. The results showed that only 147 (35.3%) interventional clinical trials had been completed, including 71 (48.3%) published papers and 33 (46.5%) published trial results. Compared with 2001-2011, the proportion of interventional clinical trials for osteosarcoma registered in Asia increased from 6.1% (10/163) to 15.0% (38/253) between 2012 and 2021, and the proportion of pre⁃recruitment registrations increased from 1.2% (2/163) to 43.9% (111/253), However, the number of phase Ⅱ clinical trials still accounted for the largest proportion in these two periods, which were 46.0% (75/163) and 37.9% (96/253), respectively. Conclusions The majority of global osteosarcoma studies are interventional clinical trials, mainly focusing on drug⁃related treatments, and antitumor drugs are still the first choice for the osteosarcoma drug intervention research. The number of osteosarcoma interventional clinical trials registered in Asia has increased significantly, but the quality and quantity of these researches are still quite different from those in North America and Europe.

Key words: Osteosarcoma, ClinicalTrials.gov, Clinical trials