Liver Cancer Clinical Trial
Official title:
Intestinal and Oral Microbiota Signatures of Clinical Response and Adverse Events in HCC Treated With Systemic Therapies
Verified date | September 2023 |
Source | First Affiliated Hospital of Wenzhou Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Gang Chen | Wenzhou | Zhejiang |
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 |
China,
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
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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