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出境医 / 临床实验 / Chemotherapy w/wo WeiLeShu in Metastatic Colorectal Cancer

Chemotherapy w/wo WeiLeShu in Metastatic Colorectal Cancer

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).

Condition or disease Intervention/treatment Phase
Microbial Colonization Colorectal Cancer Drug: Weileshu Drug: Chemotherapy Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Chemotherapy With WeiLeShu Versus Chemotherapy Alone in Patients With Metastatic Colorectal Cancer
Actual Study Start Date : July 11, 2019
Estimated Primary Completion Date : July 11, 2022
Estimated Study Completion Date : July 11, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: WLS-intervention group
chemotherapy + WLS
 Drug: Weileshu
a probiotics products which help to rebuild homeostasis of gut microbiome

Drug: Chemotherapy
chemotherapy
Active Comparator: the control group
chemotherapy
 Drug: Chemotherapy
chemotherapy
Outcome Measures
Primary Outcome Measures :
  1. progression free survival [ Time Frame: up to approximately half a year ]
    time from randomization to progression


Secondary Outcome Measures :
  1. overall survival [ Time Frame: up to approximately two years ]
    time from randomization to death


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

-

Contacts and Locations

Contacts
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Contact: Weijia Fang, Doctor +86 13758211655 dr.weijiafang@139.com

Locations
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China, Zhejiang
First affiliated hospital, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310006
Contact: Weijia fang, MD         
Principal Investigator: Weijia fang, MD         
Sponsors and Collaborators
Zhejiang University
Investigators
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Principal Investigator: Weijia Fang, Doctor First Affiliated Hospital of Zhejiang University
Tracking Information
First Submitted Date  ICMJE July 11, 2019
First Posted Date  ICMJE July 16, 2019
Last Update Posted Date November 24, 2020
Actual Study Start Date  ICMJE July 11, 2019
Estimated Primary Completion Date July 11, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2019) 		progression free survival [ Time Frame: up to approximately half a year ]
time from randomization to progression
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2019) 		overall survival [ Time Frame: up to approximately two years ]
time from randomization to death
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chemotherapy w/wo WeiLeShu in Metastatic Colorectal Cancer
Official Title  ICMJE A Study of Chemotherapy With WeiLeShu Versus Chemotherapy Alone in Patients With Metastatic Colorectal Cancer
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Microbial Colonization
  • Colorectal Cancer
Intervention  ICMJE
  • Drug: Weileshu
    a probiotics products which help to rebuild homeostasis of gut microbiome
  • Drug: Chemotherapy
    chemotherapy
Study Arms  ICMJE
  • Experimental: WLS-intervention group
    chemotherapy + WLS
    Interventions:
    • Drug: Weileshu
    • Drug: Chemotherapy
  • Active Comparator: the control group
    chemotherapy
    Intervention: Drug: Chemotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 12, 2019) 		50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 11, 2022
Estimated Primary Completion Date July 11, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

-
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Weijia Fang, Doctor +86 13758211655 dr.weijiafang@139.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04021589
Other Study ID Numbers  ICMJE Microbio-WLS001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Weijia Fang, MD, Zhejiang University
Study Sponsor  ICMJE Zhejiang University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Weijia Fang, Doctor First Affiliated Hospital of Zhejiang University
PRS Account Zhejiang University
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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