Relationship Between Microbiota and Prognosis of Hepatocellular Carcinoma(HCC) After Systemic Treatments
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 |
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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
Arms and Interventions
Arm | Intervention/Treatment |
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patients with response to systemic therapies
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Diagnostic Test: questionnaire survey
All patients received lifestyle questionnaire, physical performance, and imaging evaluation before treatment.
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patients with no response to systemic therapies
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Diagnostic Test: questionnaire survey
All patients received lifestyle questionnaire, physical performance, and imaging evaluation before treatment.
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Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Objective response rate [3 months]
Tumor response
Eligibility Criteria
Criteria
Inclusion Criteria:
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clinically or pathologically diagnosed HCC
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didn't receive prior anti-tumor treatments
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didn't receive prior antibiotics
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Eastern Cooperative Oncology Group performance status (ECOG-PS) 0-1
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Child-Pugh score of ≤7
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complete clinical and follow-up information.
Exclusion Criteria:
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combined with other malignancies
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receive surgical treatment
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lost follow-up
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Child-Pugh score of>7
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uncompleted clinical and follow-up information
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overall survival less than 1 month
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receive prior antibiotics
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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
- McCulloch JA, Davar D, Rodrigues RR, Badger JH, Fang JR, Cole AM, Balaji AK, Vetizou M, Prescott SM, Fernandes MR, Costa RGF, Yuan W, Salcedo R, Bahadiroglu E, Roy S, DeBlasio RN, Morrison RM, Chauvin JM, Ding Q, Zidi B, Lowin A, Chakka S, Gao W, Pagliano O, Ernst SJ, Rose A, Newman NK, Morgun A, Zarour HM, Trinchieri G, Dzutsev AK. Intestinal microbiota signatures of clinical response and immune-related adverse events in melanoma patients treated with anti-PD-1. Nat Med. 2022 Mar;28(3):545-556. doi: 10.1038/s41591-022-01698-2. Epub 2022 Feb 28.
- Zheng Y, Wang T, Tu X, Huang Y, Zhang H, Tan D, Jiang W, Cai S, Zhao P, Song R, Li P, Qin N, Fang W. Gut microbiome affects the response to anti-PD-1 immunotherapy in patients with hepatocellular carcinoma. J Immunother Cancer. 2019 Jul 23;7(1):193. doi: 10.1186/s40425-019-0650-9.
- microbiota