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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05897749
• Other study ID #: ZYYCXTD-C-202205
• Status: Recruiting
• Phase: Phase 4
• Start date: June 16, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: June 2023
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Ying Zhang, proffessor
• Phone: 13311027150
• Email: zylzy501[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Chinese Herbal Medicine
• Colorectal Cancer
• Colorectal Neoplasms
• Progression-free Survival
• Quality of Life

Intervention

Other:
• Brucea 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
• The best supportive treatment
The best supportive treatment:According to the NCCN Best Palliative Treatment Guidelines (2022. V1), provide the best supportive treatment

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

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.