Chinese Herbal Medicine, Colorectal Cancer, Progression-free Survival, Quality of Life
Conditions
Keywords
Colorectal Cancer, Javanica oil emulsion injection, Chinese Herbal Medicine
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
Detailed description
this study included a prospective, multicenter, randomized controlled clinical trial. 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.
Interventions
OTHERBrucea 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
OTHERThe best supportive treatment
The best supportive treatment:According to the NCCN Best Palliative Treatment Guidelines (2022. V1), provide the best supportive treatment
Sponsors
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | Randomization until disease progression, death, or 12 months after randomized enrollment, whichever occurs first.] | Progression Free Survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR | Every two cycles(each cycle is 28 days) until disease progression, death, or 12 months after randomized enrollment, whichever occurs first. | Objective Response Rate |
| 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. | equlity of life assessed by the MDASI \[followed by its scale information in the Description\]) |
Countries
China
Contacts
Primary ContactYing Zhang, proffessor
Outcome results
None listed