Colorectal Cancer Clinical Trial
Official title:
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
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
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 1, 2025 |
Est. primary completion date | December 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Guangzhou University of Chinese Medicine | Guangzhou | Guangdong |
China | The Affiliated Hospital of Shandong University of Traditional Chinese Medicine | Jinan | Shandong, China |
China | Jiangsu Province Hospital of Chinese Medicine | Nanjing | Jiangsu, China |
China | Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine | Shanghai | Shanghai, China |
Lead Sponsor | Collaborator |
---|---|
Guang'anmen Hospital of China Academy of Chinese Medical Sciences |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PFS | Progression Free Survival | Randomization until disease progression, death, or 12 months after randomized enrollment, whichever occurs first.] | |
Secondary | ORR | Objective Response Rate | Every two cycles(each cycle is 28 days) until disease progression, death, or 12 months after randomized enrollment, whichever occurs first. | |
Secondary | quality of life | equlity of life assessed by the MDASI [followed by its scale information in the Description]") | 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. | |
Secondary | quality of life | equlity of life assessed by the EORTC QLQ-C30 [followed by its scale information in the Description]") | 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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