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The purpose of the study is to evaluate the safety and effectiveness of Brucea javanica oil emulsion injection in patients with advanced colorectal cancer who failed to undergo multi-line treatment
this study included a prospective, multicenter, randomized controlled clinical trial. About 60 patients will be recruited in the randomized clinical trial. Participants will be randomly divided into experimental group (n=30) and control group (n=30). The patients in the experimental group will receive Brucea javanica oil emulsion injection combined with the best supportive treatment, based on the NCCN best palliative treatment guidelines (2022. V1). The patients in the control group received the best supportive treatment based on the NCCN's best palliative treatment guidelines (2022. V1). The primary end point was PFS (progression-free survival). The research protocol was approved by the relevant ethics committee. The research was conducted in accordance with the Helsinki Declaration and good clinical practice guidelines. The patient has written informed consent to participate in the trial.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China
Jiangsu Province Hospital of Chinese Medicine
Nanjing, Jiangsu, China, China
The Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, China, China
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai, China, China
Start Date
June 16, 2023
Primary Completion Date
December 1, 2025
Completion Date
December 1, 2025
Last Updated
June 9, 2023
60
ESTIMATED participants
Brucea javanica oil emulsion injection
OTHER
The best supportive treatment
OTHER
Lead Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
NCT06696768
NCT04704661
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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