Back to resultsClinical 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
Primary Purpose
Colorectal Cancer, Chinese Herbal Medicine, Progression-free Survival
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Brucea javanica oil emulsion injection
The best supportive treatment
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Colorectal Cancer, Javanica oil emulsion injection, Chinese Herbal Medicine
Eligibility 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
Sites / Locations
- The First Affiliated Hospital of Guangzhou University of Chinese MedicineRecruiting
- Jiangsu Province Hospital of Chinese MedicineRecruiting
- The Affiliated Hospital of Shandong University of Traditional Chinese MedicineRecruiting
- Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental group: Brucea javanica oil emulsion injection+The best supportive treatment
control group:The best supportive treatment
Arm Description
Outcomes
Primary Outcome Measures
PFS
Progression Free Survival
Secondary Outcome Measures
ORR
Objective Response Rate
quality of life
equlity of life assessed by the MDASI [followed by its scale information in the Description]")
quality of life
equlity of life assessed by the EORTC QLQ-C30 [followed by its scale information in the Description]")
Full Information
NCT ID
NCT05897749
First Posted
May 9, 2023
Last Updated
June 1, 2023
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05897749
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2023 (Anticipated)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Chinese Herbal Medicine, Progression-free Survival, Quality of Life
Keywords
Colorectal Cancer, Javanica oil emulsion injection, Chinese Herbal Medicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group: Brucea javanica oil emulsion injection+The best supportive treatment
Arm Type
Experimental
Arm Title
control group:The best supportive treatment
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Brucea javanica oil emulsion injection
Intervention 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
Intervention Type
Other
Intervention Name(s)
The best supportive treatment
Intervention Description
The best supportive treatment:According to the NCCN Best Palliative Treatment Guidelines (2022. V1), provide the best supportive treatment
Primary Outcome Measure Information:
Title
PFS
Description
Progression Free Survival
Time Frame
Randomization until disease progression, death, or 12 months after randomized enrollment, whichever occurs first.]
Secondary Outcome Measure Information:
Title
ORR
Description
Objective Response Rate
Time Frame
Every two cycles(each cycle is 28 days) until disease progression, death, or 12 months after randomized enrollment, whichever occurs first.
Title
quality of life
Description
equlity of life assessed by the MDASI [followed by its scale information in the Description]")
Time Frame
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.
Title
quality of life
Description
equlity of life assessed by the EORTC QLQ-C30 [followed by its scale information in the Description]")
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Zhang, proffessor
Phone
13311027150
Email
zylzy501@163.com
Facility Information:
Facility Name
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510405
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanrui Chen, professor
Facility Name
Jiangsu Province Hospital of Chinese Medicine
City
Nanjing
State/Province
Jiangsu, China
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Shu, professor
Facility Name
The Affiliated Hospital of Shandong University of Traditional Chinese Medicine
City
Jinan
State/Province
Shandong, China
ZIP/Postal Code
250014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huijie Li, professor
Facility Name
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai, China
ZIP/Postal Code
200437
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yabin Gong, professor
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The results of the study will be issued to publications through scientific journals and conference reports.
Learn more about this trial
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
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