Effect of Brucea Javanica Oil on Survival in Advanced Colorectal Cancer Patients
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
This study is testing if an oil made from Brucea javanica can help people with advanced colorectal cancer live longer and feel better after other treatments have not worked.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Guang'anmen Hospital of China Academy of Chinese Medical Sciences Academic / other |
| Locations | 4 sites (Guangzhou, Guangdong and 3 other locations) |
| Trial ID | NCT05897749 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the safety and effectiveness of Brucea javanica oil emulsion injection in patients with advanced colorectal cancer who have failed multiple lines of treatment. It is a multicenter, randomized controlled trial involving approximately 60 patients, who will be divided into an experimental group receiving the oil emulsion injection along with best supportive care, and a control group receiving only the best supportive care. The primary endpoint of the study is progression-free survival (PFS), and the trial adheres to ethical guidelines and good clinical practices.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with stage IV colorectal cancer who have experienced treatment failure after at least three lines of therapy.
Not a fit: Patients with brain metastasis, specific genetic mutations, or severe organ dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with advanced colorectal cancer who have limited treatment options.
How similar studies have performed: While the use of Brucea javanica oil is less common in Western medicine, similar studies involving herbal treatments have shown promise, though this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * # 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 Exclusion Criteria: * 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
Where this trial is running
Guangzhou, Guangdong and 3 other locations
- The First Affiliated Hospital of Guangzhou University of Chinese Medicine — Guangzhou, Guangdong, China (Recruiting)
- Jiangsu Province Hospital of Chinese Medicine — Nanjing, Jiangsu, China, China (Recruiting)
- The Affiliated Hospital of Shandong University of Traditional Chinese Medicine — Jinan, Shandong, China, China (Recruiting)
- Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine — Shanghai, Shanghai, China, China (Recruiting)
Study contacts
- Study coordinator: Ying Zhang, proffessor
- Email: zylzy501@163.com
- Phone: 13311027150
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.