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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05443217
Other study ID # microbiota
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date June 1, 2022
Est. completion date December 1, 2024

Study information

Verified date September 2023
Source First Affiliated Hospital of Wenzhou Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 200
Est. completion date December 1, 2024
Est. primary completion date December 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Intervention

Diagnostic Test:
questionnaire survey
All patients received lifestyle questionnaire, physical performance, and imaging evaluation before treatment.

Locations

Country Name City State
China Gang Chen Wenzhou Zhejiang

Sponsors (4)

Lead Sponsor Collaborator
First Affiliated Hospital of Wenzhou Medical University Eastern Hepatobiliary Surgery Hospital, Qilu Hospital of Shandong University, The First Affiliated Hospital of Zhejiang Chinese Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Post-treatment adverse events Post-treatment complications are recorded 3 months
Primary Long-term outcomes after treatment Overall survival and progression-free survival 1 year
Secondary Objective response rate Tumor response 3 months
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