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

W

Wenzhou Medical University

Status

Invitation-only

Conditions

Adverse Event
Efficacy
Prognosis
Liver Cancer
Microbiota

Treatments

Diagnostic Test: questionnaire survey

Study type

Observational

Funder types

Other

Identifiers

NCT05443217
microbiota

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

patients with response to systemic therapies
Treatment:
Diagnostic Test: questionnaire survey
patients with no response to systemic therapies
Treatment:
Diagnostic Test: questionnaire survey

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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