Clinical trial · Interventional
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
NCT05897749CI-TRIAL-00067056unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chinese Herbal Medicine | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Progression-free Survival | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brucea javanica oil emulsion injection | Other | — | UNRESOLVED |
| The best supportive treatment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental group: Brucea javanica oil emulsion injection+The best supportive treatment
- interventionNames
- Other: Brucea javanica oil emulsion injection
- Other: The best supportive treatment
- type
- ACTIVE_COMPARATOR
- label
- control group:The best supportive treatment
- interventionNames
- Other: The best supportive treatment
Primary outcomes (1)
- measure
- PFS
- timeFrame
- Randomization until disease progression, death, or 12 months after randomized enrollment, whichever occurs first.]
- description
- Progression Free Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDFang 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 40761400