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

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status and phase: Enrolling; Phase 4

Conditions: Chinese Herbal Medicine; Quality of Life; Progression-free Survival; Colorectal Cancer

Treatments: Other: The best supportive treatment; Other: Brucea javanica oil emulsion injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05897749

ZYYCXTD-C-202205

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Experimental group: Brucea javanica oil emulsion injection+The best supportive treatment

Experimental group

Treatment:

Other: The best supportive treatment

Other: Brucea javanica oil emulsion injection

control group:The best supportive treatment

Active Comparator group

Treatment:

Other: The best supportive treatment