NCT04021589CompletedPhase 2
A Study of Chemotherapy With WeiLeShu Versus Chemotherapy Alone in Patients With Metastatic Colorectal Cancer
Zhejiang University1 site in 1 country40 target enrollmentStarted: July 11, 2019Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- progression free survival
Study Overview
Brief Summary
A total of 50 patients with metastatic colorectal cancer will be enrolled in the study. The patients were randomly divided into the WLS-intervention group and the control group. The two groups of patients were given the most appropriate medication according to the specific conditions of the disease. Patients in the intervention group received additional oral administration of Weileshu, a probiotics product (Tongchuang Biotechnology).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •At least 18 years of age, of any race or sex who are eligible to sign written consent and have undergone prior resection of histological evidence of colorectal cancer
- •Hematologic function: ANC ≥ 1.5 x 10 /L, platelets ≥ 75 x 10 /L, and hemoglobin > 9 g/dL Adequate liver function as measured by: total bilirubin ≤ 2.0 mg/dl, AST and ALT ≤ 5 ULN, albumin ≥ 2.5 g/dl Adequate renal function as measured by: creatinine ≤ 2.9 mg/dl, > 50 ml/min calculated by the C-G equation Non-pregnant women of childbearing potential and fertile men are required to use effective contraception (negative pregnancy test for women of child-bearing age) ECOG status ≤ 1 at screening
Exclusion Criteria
- Not provided
Arms & Interventions
WLS-intervention group
Experimental
chemotherapy + WLS
Intervention: Weileshu (Drug)
WLS-intervention group
Experimental
chemotherapy + WLS
Intervention: Chemotherapy (Drug)
the control group
Active Comparator
chemotherapy
Intervention: Chemotherapy (Drug)
Outcomes
Primary Outcomes
progression free survival
Time Frame: up to approximately half a year
time from randomization to progression
Secondary Outcomes
- overall survival(up to approximately two years)
Investigators
Weijia Fang, MD
director
Zhejiang University
Study Sites (1)
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