Chemotherapy w/wo WeiLeShu in Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

A Study of Chemotherapy With WeiLeShu Versus Chemotherapy Alone in Patients With Metastatic Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04021589
• Other study ID #: Microbio-WLS001
• Status: Completed
• Phase: Phase 2
• Start date: July 11, 2019
• Est. completion date: October 30, 2021

Study information

• Verified date: January 2023
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 30, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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: -

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Communicable Diseases
• Infections
• Microbial Colonization

Intervention

Drug:
• Weileshu
a probiotics products which help to rebuild homeostasis of gut microbiome
• Chemotherapy
chemotherapy

Locations

Country	Name	City	State
China	First affiliated hospital, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival	time from randomization to progression	up to approximately half a year
Secondary	overall survival	time from randomization to death	up to approximately two years