Chemotherapy w/wo WeiLeShu in Metastatic Colorectal Cancer

January 27, 2023 updated by: Weijia Fang, MD, Zhejiang University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • First affiliated hospital, Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: WLS-intervention group
chemotherapy + WLS
Drug: Chemotherapy
chemotherapy
Drug: Weileshu
a probiotics products which help to rebuild homeostasis of gut microbiome
Active Comparator: the control group
chemotherapy
Drug: Chemotherapy
chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free survival
Time Frame: up to approximately half a year
time from randomization to progression
up to approximately half a year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: up to approximately two years
time from randomization to death
up to approximately two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang University

Investigators

  • Principal Investigator: Weijia Fang, Doctor, First affiliated Hospital of Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2019

Primary Completion (Actual)

October 30, 2021

Study Completion (Actual)

October 30, 2021

Study Registration Dates

First Submitted

July 11, 2019

First Submitted That Met QC Criteria

July 12, 2019

First Posted (Actual)

July 16, 2019

Study Record Updates

Last Update Posted (Estimate)

January 30, 2023

Last Update Submitted That Met QC Criteria

January 27, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Microbio-WLS001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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