Back to results

Chemotherapy w/wo WeiLeShu in Metastatic Colorectal Cancer

Primary Purpose

Microbial Colonization, Colorectal Cancer

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Weileshu

Chemotherapy

About this trial

This is an interventional treatment trial for Microbial Colonization

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Sites / Locations

First affiliated hospital, Zhejiang University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

WLS-intervention group

the control group

Arm Description

chemotherapy + WLS

chemotherapy

Outcomes

Primary Outcome Measures

progression free survival

time from randomization to progression

Secondary Outcome Measures

overall survival

time from randomization to death

Full Information

NCT ID

NCT04021589

First Posted

July 11, 2019

Last Updated

January 27, 2023

Sponsor

Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT04021589

Brief Title

Chemotherapy w/wo WeiLeShu in Metastatic Colorectal Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

July 11, 2019 (Actual)

Primary Completion Date

October 30, 2021 (Actual)

Study Completion Date

October 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Microbial Colonization, Colorectal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

WLS-intervention group

Arm Type

Experimental

Arm Description

chemotherapy + WLS

Arm Title

the control group

Arm Type

Active Comparator

Arm Description

chemotherapy

Intervention Type

Drug

Intervention Name(s)

Weileshu

Intervention Description

a probiotics products which help to rebuild homeostasis of gut microbiome

Intervention Type

Drug

Intervention Name(s)

Chemotherapy

Intervention Description

chemotherapy

Primary Outcome Measure Information:

Title

progression free survival

Description

time from randomization to progression

Time Frame

up to approximately half a year

Secondary Outcome Measure Information:

Title

overall survival

Description

time from randomization to death

Time Frame

up to approximately two years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Weijia Fang, Doctor

Organizational Affiliation

First Affiliated Hospital of Zhejiang University

Official's Role

Principal Investigator

Facility Information:

Facility Name

First affiliated hospital, Zhejiang University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310006

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Chemotherapy w/wo WeiLeShu in Metastatic Colorectal Cancer

We'll reach out to this number within 24 hrs