Clinical Study on the Effect of Brucea Javanica Oil Emulsion Injection on the Survival of Patients With Advanced Colorectal Cancer Who Failed to Receive Multi-line Treatment
NCT ID: NCT05897749
Last Updated: 2023-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
60 participants
INTERVENTIONAL
2023-06-16
2025-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental group: Brucea javanica oil emulsion injection+The best supportive treatment
Brucea javanica oil emulsion injection
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
The best supportive treatment:According to the NCCN Best Palliative Treatment Guidelines (2022. V1), provide the best supportive treatment
control group:The best supportive treatment
The best supportive treatment
The best supportive treatment:According to the NCCN Best Palliative Treatment Guidelines (2022. V1), provide the best supportive treatment
Interventions
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Brucea javanica oil emulsion injection
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
The best supportive treatment:According to the NCCN Best Palliative Treatment Guidelines (2022. V1), provide the best supportive treatment
Eligibility Criteria
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Inclusion Criteria
* Male or female aged 18-75years # Eastern Cooperative Oncology Group (ECOG) performance score 0-2
* Life expectancy of at least 3 months # At least one radiographically measurable lesion per RECIST 1.1 # Willing to join the clinic trail and sign informed consent,and able to comply with scheduled visits and treatments
Exclusion Criteria
* Patients with primary tumors at other sites
* Pregnant or breastfeeding woman
* Fertile patients who are unwilling or unable to take effective contraceptive measures during the research period until 6 months after the study end later
* A history of mental disorders # Patients with severe cardiac, cerebrovascular, liver, kidney, hematopoietic system dysfunction or primary disease without effective control # Participated in other clinical trials of small molecule research drugs within 28 days prior to enrollment, or participated in other clinical trials of large molecule research drugs within 3 months before enrollment # Known allergy or intolerance to study medications
18 Years
75 Years
ALL
No
Sponsors
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Guang'anmen Hospital of China Academy of Chinese Medical Sciences
OTHER
Responsible Party
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Ying Zhang
professor
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Hanrui Chen, professor
Role: primary
Peng Shu, professor
Role: primary
Huijie Li, professor
Role: primary
Yabin Gong, professor
Role: primary
References
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Fang L, Wang Y, Fang Y, Wang R, Xie Y, Yang S, Liu S, Zhang Y. Brucea javanica oil emulsion plus supportive care for refractory advanced colorectal cancer: a pilot RCT protocol. Front Pharmacol. 2025 Jul 21;16:1610575. doi: 10.3389/fphar.2025.1610575. eCollection 2025.
Other Identifiers
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ZYYCXTD-C-202205
Identifier Type: -
Identifier Source: org_study_id
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