| 1 | The landscape of investigator‐initiated oncology trials conducted in China's Mainland during the past decade(2010–2019)显示文摘The number of clinical trials conducted in China's Mainland,including investigator‐initiated trials(IITs),has increased rapidly in recent years.However,there are few data on the characteristics of cancer‐related IITs.We performed a comprehensive analysis of the landscape of cancer‐related IITs in China's Mainland in the past decade.All cancer‐related IITs registered on two clinical trial registries in the United States(www.clinicaltrials.gov,CT.gov)and China's Mainland(www.chictr.org.cn,ChiCTR)from 2010 to 2019 were identified.IITs were reviewed manually to validate classification,subcategorized by cancer type,and stratified by design characteristics to facilitate comparison across cancer types and with other specialties.A total of 8199 cancer‐related IITs were identified.The number of trials registered annually increased over time,especially in the last 5 years.Although interventional studies were predominant,randomized double‐blind studies accounted for only 8%of IITs.In the past decade,the trend for interventional studies conducted with different drugs increased year on year,although the increase in hormonal therapy IITs was not significant.Additionally,cancerrelated IITs were unevenly geographically distributed,with half concentrated in the economically developed cities Shanghai,Beijing,and Guangdong.We also found an increase in registration before participant enrollment(64.9%for trials in conducted in 2015–2019 vs.40.2%in 2010–2014,p<0.001)and data monitoring committee use(44.5%vs.40.0%,p=0.001)and a decrease in randomization(51.5%vs.62.7%,p<0.001)and funding(36.4%vs.56.3%,p<0.001)between these periods.We also observed changes in intervention type(decrease in cytotoxic drug therapy[34.8%vs.48.9%,p<0.001];increase in targeted therapy[17.8%vs.14.2%,p=0.004],immune checkpoint inhibitor therapy[6.6%vs.0.0%,p<0.001],and immune cell therapy[9.6%vs.4.5%,p<0.001]).Details of cancer‐related IITs conducted during the past decade illustrate the merits of oncology research in China's Mainland.Although the increased quantity of IITs is encouraging,limitations remain regarding the quality of clinical trials,regional imbalances,and funding allocation. | Ye Cao Lin‐Miao Ye Zhong Fan Wei Yang Li‐Ying Chen Yun Mei De‐Ying He Wen‐Jin Mo | 2023 | Cancer Innovation2023,2,1: | 0 |
| 2 | Tolerance and acceptance of hepatic venous pressure gradient measurement in cirrhosis(CHESS1904):An international multicenter study显示文摘Aim:To determine the tolerance and acceptance of hepatic venous pressure gradient(HVPG)measurements in patients with liver cirrhosis.Methods:This prospective international multicenter study included 271 patients with cirrhosis who were scheduled to undergo HVPG measurement between October 2019 and June 2020.Data related to the tolerance and acceptance of HVPG measurements were collected using descriptive questionnaires.Results:HVPG measurements were technically successful in all 271 patients,with 141(52.0%)undergoing HVPG measurement alone.The complication rate was 0.4%.Postoperative pain was significantly lower than preoperative expected pain(p<0.001)and intraoperative pain(p<0.001),and intraoperative pain was also significantly lower than preoperative expected pain(p=0.036).No,mild,moderate,severe,and intolerable discomfort scores were reported by 36.9%,44.6%,11.1%,6.3%,and 0.4%of these patients,respectively,during HVPG measurement and by 54.6%32.5%,11.4%,1.5%,and 0%,respectively,after HVPG measurement.Of these patients,39.5%had little understanding and 10%had no understanding of the value of HVPG measurement,with 35.1%and 4.1%regarding HVPG measurements as being of little or no help,respectively.Most patients reported that they would definitely(15.5%),probably(46.9%),or possibly(29.9%)choose to undergo additional HVPG measurements again,and 62.7%regarded the cost of the procedure as acceptable.Conclusion:HVPG measurement was safe and well‐tolerated in patients with cirrhosis,but patient education and communication are warranted to improve the acceptance of this procedure. | Jun‐Hui Sun He Zhao Haijun Zhang Lei Li NecatiÖrmeci Zi‐Niu Yu Xun Li Shuangxi Li Xujun Yang Huaping Wei Xiaoliang Zhu Zhengcong Zhang Yajin Wang Zhongwei Zhao Jianting Mao Qiaohong Wu Xiaole Sun Huiling Xiang Kefeng Jia Chao Yang Wei Wu Xiuqing Lin Haixin Yao Changzeng Zuo Jitao Wang Bo Zhang Chunqing Zhang Xiaoling Wu Guangchuan Wang Shengjuan Yao Ruihang Wang Li Zhou Hui Huan Qingli Tu Xue Pu Feng Zhang Qin Yin Linpeng Zhang Ying Guo Jian Wang Kohei Kotani Sawako Uchida‐Kobayashi Norifumi Kawada He Zhu Li Li Wei Wang Guo Zhang Lei Yu Xudong Cui Qingliang Zhu Hailong Zhang Xiaoli Hu Rafael OXimenes Adriano Gonçalves de Araújo Giulliano Gardenghi Yubao Zheng Zebin Wu Mingsheng Huang Xiaoyong Chen Jun Wu Feng Xie Yang Bo Shengjuan Hu Linke Ma Xiao Li Xiaolong Qi | 2022 | Portal Hypertension & Cirrhosis2022,1,1: | 0 |