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Completed

NCT Number: NCT04021589

Chemotherapy w/wo WeiLeShu in 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).

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Key information

Conditions

Microbial Colonization Colonic Diseases Colorectal Cancer Colorectal Neoplasms Communicable Diseases Digestive System Diseases Digestive System Neoplasms Disease Attributes Gastrointestinal Diseases Gastrointestinal Neoplasms Infections Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

First affiliated hospital, Zhejiang University

Hangzhou, Zhejiang, 310006, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Weileshu

Drug

a probiotics products which help to rebuild homeostasis of gut microbiome

Chemotherapy

Drug

chemotherapy

Primary outcomes

  1. progression free survival

    Time frame: up to approximately half a year

    time from randomization to progression

Secondary outcomes

  1. overall survival

    Time frame: up to approximately two years

    time from randomization to death

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 16, 2019
Registry last updated
Jan 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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