Chemotherapy w/wo WeiLeShu in Metastatic Colorectal Cancer
A Study of Chemotherapy With WeiLeShu Versus Chemotherapy Alone in Patients With Metastatic Colorectal Cancer
1 other identifier
interventional
40
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2019
CompletedStudy Start
First participant enrolled
July 11, 2019
CompletedFirst Posted
Study publicly available on registry
July 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2021
CompletedJanuary 30, 2023
January 1, 2023
2.3 years
July 11, 2019
January 27, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
progression free survival
time from randomization to progression
up to approximately half a year
Secondary Outcomes (1)
overall survival
up to approximately two years
Study Arms (2)
WLS-intervention group
EXPERIMENTALchemotherapy + WLS
the control group
ACTIVE COMPARATORchemotherapy
Interventions
a probiotics products which help to rebuild homeostasis of gut microbiome
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
First affiliated hospital, Zhejiang University
Hangzhou, Zhejiang, 310006, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Weijia Fang, Doctor
First Affiliated Hospital of Zhejiang University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- director
Study Record Dates
First Submitted
July 11, 2019
First Posted
July 16, 2019
Study Start
July 11, 2019
Primary Completion
October 30, 2021
Study Completion
October 30, 2021
Last Updated
January 30, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share