NCT04835324|Unknown
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Sponsor study identifier
observational
650
1 country
2
Study Start
October 1, 2020
Actual (reported)Primary Completion
February 1, 2022
Actual (reported)Study Completion
October 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This is a multi-center, retrospective, real-world study. The purpose of this study is to observe the effectiveness and safety of regorafenib in Chinese advanced colorectal cancer patients. The main observational goals include overall survival(OS), 6 month OS rate, 1 year OS rate, and treatment time failure (TTF), other study goals include objective response rate( ORR)、Disease control rate（DCR）and adverse event(AE) of regorafenib.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 1, 2020
Actual (reported)March 28, 2021
Actual (reported)April 8, 2021
Actual (reported)February 1, 2022
Actual (reported)October 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
6-month Overall Survival rate
6 months OS rate of patients who received regorafenib treatment.
6 month
1 year Overall Survival rate
1 year OS rate of patients who received regorafenib treatment.
1 year
overall survival
overall survival of patients who received regorafenib treatment.
1 year
objective response rate
1 year
Disease control rate
1 year
Incidence of Adverse Events (AEs)
1 year
About 1000 patients in this observational study were recruited in 10 Chinese medical centers since July 2017 to October 2020.
Cancer Hospital,Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College
Beijing, 100021, China
Qu W, Liu Z, Chen X, Liu B, Zhao Y, Yan H, Qu X, Li S, Zang A, Sun Y, Zhu L, Zhou A. Regorafenib monotherapy or combined with an immune-checkpoint inhibitor as later-line treatment for metastatic colorectal cancer: a multicenter, real-world retrospective study in China. BMC Cancer. 2024 Jan 2;24(1):22. doi: 10.1186/s12885-023-11700-w.
Yunbo Zhao
Beijing Hospital
Liangjun Zhu
Jiangsu Cancer Institute & Hospital
Zimin Liu
The Affiliated Hospital of Qingdao University
Wei Bai
Shanxi Province Cancer Hospital
650 participants (actual enrollment reported by the registry).
First Submitted
March 28, 2021
First Posted
April 8, 2021
Study Start
October 1, 2020
Actual (reported)Contact the study team to confirm eligibility.
Aimin Zang
Affiliated Hospital of Hebei University
Bo Liu
Shandong Cancer Hospital and Institute
Hong Zong
The First Affiliated Hospital of Zhengzhou University
Shengmian Li
The fourth hospital of Hebei medical university and hebei cancer hospital
Xiujuan Qu
First Hospital of China Medical University
Aiping Zhou
Cancer Hospital Chinese Academy of Medical Science
Primary Completion
February 1, 2022
Actual (reported)Study Completion
October 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 11, 2022
Record last verified: 2022-03
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