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

• Conditions: Adverse Event; Liver Cancer; Microbiota; Efficacy; Prognosis
• Interventions: Diagnostic Test: questionnaire survey

• Registration Number: NCT05443217
• Lead Sponsor: First Affiliated Hospital of Wenzhou Medical University

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.

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 Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2022-06-29
• Study First Submitted QC: 2022-06-29
• Study First Posted: 2022-07-05
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with no response to systemic therapies	questionnaire survey	-
patients with response to systemic therapies	questionnaire survey	-

Primary Outcome Measures

Name	Time	Method
Long-term outcomes after treatment	1 year	Overall survival and progression-free survival
Post-treatment adverse events	3 months	Post-treatment complications are recorded

Secondary Outcome Measures

Name	Time	Method
Objective response rate	3 months	Tumor response

Trial Locations

Locations (1)

Gang Chen; 🇨🇳 Wenzhou, Zhejiang, China