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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intestinal and Oral Microbiota Signatures of Clinical Response and Adverse Events in HCC Treated With Systemic Therapies

Conditions
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Liver Cancer, Microbiota, Adverse Event, Prognosis, Efficacy

Intervention / Treatment
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* Diagnostic Test: questionnaire survey


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with response to systemic therapies<br> | Diagnostic Test: questionnaire survey<br>* All patients received lifestyle questionnaire, physical performance, and imaging evaluation before treatment.<br>|
| patients with no response to systemic therapies<br> | Diagnostic Test: questionnaire survey<br>* All patients received lifestyle questionnaire, physical performance, and imaging evaluation before treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-treatment adverse events | Post-treatment complications are recorded | 3 months | 
| Long-term outcomes after treatment | Overall survival and progression-free survival | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate | Tumor response | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCC, microbiota, Adverse Event, prognosis, efficacy