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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Drug: Brucea javanica oil emulsion injection Brucea javanica oil emulsion injection: intravenous drip, 30ml each time (add 250ml sterile physiological saline),once a day, 14 consecutive days as a cycle, at least 2 cycles completed. The best supportive treatment:According to the NCCN Best Palliative Treatment Guidelines (2022. V1), provide the best supportive treatment
The best supportive treatment:According to the NCCN Best Palliative Treatment Guidelines (2022. V1), provide the best supportive treatment
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China
RECRUITINGJiangsu Province Hospital of Chinese Medicine
Nanjing, Jiangsu, China, China
RECRUITINGThe Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, China, China
RECRUITINGYueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai, China, China
RECRUITINGPFS
Progression Free Survival
Time frame: Randomization until disease progression, death, or 12 months after randomized enrollment, whichever occurs first.]
ORR
Objective Response Rate
Time frame: Every two cycles(each cycle is 28 days) until disease progression, death, or 12 months after randomized enrollment, whichever occurs first.
quality of life
equlity of life assessed by the MDASI \[followed by its scale information in the Description\]")
Time frame: Before and after each cycle (each cycle is 28 days) of treatment, assessed up to 12 months after randomized enrollment, equlity of life assessed by the MDASI. The higher the score, the worse the quality of life.
quality of life
equlity of life assessed by the EORTC QLQ-C30 \[followed by its scale information in the Description\]")
Time frame: Before and after each cycle (each cycle is 28 days) of treatment, assessed up to 12 months after randomized enrollment, equlity of life assessed by the EORTC QLQ-C30. The higher the score, the worse the quality of life.
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