Adverse Event, Efficacy, Liver Cancer, Microbiota, Prognosis
Conditions
Keywords
HCC, microbiota, Adverse Event, prognosis, efficacy
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.
Interventions
DIAGNOSTIC_TESTquestionnaire survey
All patients received lifestyle questionnaire, physical performance, and imaging evaluation before treatment.
Sponsors
The First Affiliated Hospital of Zhejiang Chinese Medical University
Qilu Hospital of Shandong University
Eastern Hepatobiliary Surgery Hospital
First Affiliated Hospital of Wenzhou Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-treatment adverse events | 3 months | Post-treatment complications are recorded |
| Long-term outcomes after treatment | 1 year | Overall survival and progression-free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | 3 months | Tumor response |
Countries
China
Outcome results
None listed