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

Phase 4

Recruiting

• Conditions: Chinese Herbal Medicine; Colorectal Cancer; Progression-free Survival; Quality of Life
• Interventions: Other: Brucea javanica oil emulsion injection; Other: The best supportive treatment

• Registration Number: NCT05897749
• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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.

Study Timeline

• Study First Submitted: 2023-05-09
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-01
• Last Update Submitted: 2023-06-01
• Study First Posted: 2023-06-09
• Last Update Posted: 2023-06-09
• Study Start: 2023-06-16
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group: Brucea javanica oil emulsion injection+The best supportive treatment	The best supportive treatment	-
Experimental group: Brucea javanica oil emulsion injection+The best supportive treatment	Brucea javanica oil emulsion injection	-
control group:The best supportive treatment	The best supportive treatment	-

Primary Outcome Measures

Name	Time	Method
PFS	Randomization until disease progression, death, or 12 months after randomized enrollment, whichever occurs first.]	Progression Free Survival

Secondary Outcome Measures

Name	Time	Method
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 EORTC QLQ-C30. The higher the score, the worse the quality of life.	equlity of life assessed by the EORTC QLQ-C30 \[followed by its scale information in the Description\]")

Trial Locations

Locations (4)

The First Affiliated Hospital of Guangzhou University of Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China

Jiangsu Province Hospital of Chinese Medicine; 🇨🇳 Nanjing, Jiangsu, China, China

The Affiliated Hospital of Shandong University of Traditional Chinese Medicine; 🇨🇳 Jinan, Shandong, China, China

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine; 🇨🇳 Shanghai, Shanghai, China, China