To hear about similar clinical trials, please enter your email below
Trial 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
NCT ID:
NCT05897749
Condition:
Colorectal Cancer
Chinese Herbal Medicine
Progression-free Survival
Quality of Life
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
Colorectal Cancer
Javanica oil emulsion injection
Chinese Herbal Medicine
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Brucea javanica oil emulsion injection
Description:
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
Arm group label:
Experimental group: Brucea javanica oil emulsion injection+The best supportive treatment
Intervention type:
Other
Intervention name:
The best supportive treatment
Description:
The best supportive treatment:According to the NCCN Best Palliative Treatment Guidelines
(2022. V1), provide the best supportive treatment
Arm group label:
Experimental group: Brucea javanica oil emulsion injection+The best supportive treatment
Arm group label:
control group:The best supportive treatment
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Address:
City:
Guangzhou
Zip:
510405
Country:
China
Status:
Recruiting
Contact:
Last name:
Hanrui Chen, professor
Facility:
Name:
Jiangsu Province Hospital of Chinese Medicine
Address:
City:
Nanjing
Zip:
210029
Country:
China
Status:
Recruiting
Contact:
Last name:
Peng Shu, professor
Facility:
Name:
The Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Address:
City:
Jinan
Zip:
250014
Country:
China
Status:
Recruiting
Contact:
Last name:
Huijie Li, professor
Facility:
Name:
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine
Address:
City:
Shanghai
Zip:
200437
Country:
China
Status:
Recruiting
Contact:
Last name:
Yabin Gong, professor
Start date:
June 16, 2023
Completion date:
December 1, 2025
Lead sponsor:
Agency:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Agency class:
Other
Source:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05897749
