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
1 other identifier
interventional
60
1 country
4
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 colorectal-cancer
Started Jun 2023
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2023
CompletedFirst Posted
Study publicly available on registry
June 9, 2023
CompletedStudy Start
First participant enrolled
June 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedJune 9, 2023
June 1, 2023
2.5 years
May 9, 2023
June 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PFS
Progression Free Survival
Randomization until disease progression, death, or 12 months after randomized enrollment, whichever occurs first.]
Secondary Outcomes (3)
ORR
Every two cycles(each cycle is 28 days) until disease progression, death, or 12 months after randomized enrollment, whichever occurs first.
quality of life
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
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.
Study Arms (2)
Experimental group: Brucea javanica oil emulsion injection+The best supportive treatment
EXPERIMENTALcontrol group:The best supportive treatment
ACTIVE COMPARATORInterventions
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
Eligibility Criteria
You may qualify if:
- \# Colorectal cancer patients with stage IV third line or above treatment failure confirmed by pathology
- 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
You may not qualify if:
- With brain metastasis, BRAF-V600E mutation, HER-2 overexpression, MSI-H, NTRK fusion gene patients
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, 510405, China
Jiangsu Province Hospital of Chinese Medicine
Nanjing, Jiangsu, China, 210029, China
The Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, China, 250014, China
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai, China, 200437, China
Related Publications (1)
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.
PMID: 40761400DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
May 9, 2023
First Posted
June 9, 2023
Study Start
June 16, 2023
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
June 9, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
The results of the study will be issued to publications through scientific journals and conference reports.