Relationship Between Microbiota and Prognosis of Hepatocellular Carcinoma(HCC) After Systemic Treatments

Sponsor
First Affiliated Hospital of Wenzhou Medical University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05443217
Collaborator
The First Affiliated Hospital of Zhejiang Chinese Medical University (Other), Qilu Hospital of Shandong University (Other), Eastern Hepatobiliary Surgery Hospital (Other)
200
1
30
6.7

Study Details

Study Description

Brief Summary

By tracking the short-term and long-term results of HCC patients treated with systemic therapies,the difference of microbiota between responded patients and non-responded patients was analyzed, and the correlation between gut and oral microbiota and short-term and long-term results was explored, so as to improve people's awareness of microbiota and pay attention to its prevention and treatment.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: questionnaire survey

Detailed Description

The investigators consecutively admit patients the questionnaire and collect the fecal. And by tracking the short-term and long-term outcomes of HCC patients treated with systemic therapies,the difference of gut microbiota between responded patients and non-responded patients is analyzed, and the correlation between gut and oral microbiota and short-term and long-term results is explored.Adverse events (AE) are recorded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (version 4.0).Tumor response is mainly evaluated by experienced hepatologists using radiological method within 4-12 weeks after treatments according to the RECIST 1.1 and Modified Response Evaluation Criteria in Solid Tumors (mRECIST).Overall survival (OS) and Progression-free survival (PFS) are recorded.

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Intestinal and Oral Microbiota Signatures of Clinical Response and Adverse Events in HCC Treated With Systemic Therapies
Actual Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
patients with response to systemic therapies

Diagnostic Test: questionnaire survey
All patients received lifestyle questionnaire, physical performance, and imaging evaluation before treatment.

patients with no response to systemic therapies

Diagnostic Test: questionnaire survey
All patients received lifestyle questionnaire, physical performance, and imaging evaluation before treatment.

Outcome Measures

Primary Outcome Measures

  1. Post-treatment adverse events [3 months]

    Post-treatment complications are recorded

  2. Long-term outcomes after treatment [1 year]

    Overall survival and progression-free survival

Secondary Outcome Measures

  1. Objective response rate [3 months]

    Tumor response

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • clinically or pathologically diagnosed HCC

  • didn't receive prior anti-tumor treatments

  • didn't receive prior antibiotics

  • Eastern Cooperative Oncology Group performance status (ECOG-PS) 0-1

  • Child-Pugh score of ≤7

  • complete clinical and follow-up information.

Exclusion Criteria:
  • combined with other malignancies

  • receive surgical treatment

  • lost follow-up

  • Child-Pugh score of>7

  • uncompleted clinical and follow-up information

  • overall survival less than 1 month

  • receive prior antibiotics

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gang Chen Wenzhou Zhejiang China 325000

Sponsors and Collaborators

  • First Affiliated Hospital of Wenzhou Medical University
  • The First Affiliated Hospital of Zhejiang Chinese Medical University
  • Qilu Hospital of Shandong University
  • Eastern Hepatobiliary Surgery Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Gang Chen, MD, Clinical Professor, Principal Investigator, First Affiliated Hospital of Wenzhou Medical University
ClinicalTrials.gov Identifier:
NCT05443217
Other Study ID Numbers:
  • microbiota
First Posted:
Jul 5, 2022
Last Update Posted:
Jul 7, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Gang Chen, MD, Clinical Professor, Principal Investigator, First Affiliated Hospital of Wenzhou Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 7, 2022