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

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05443217
• Other study ID #: microbiota
• Status: Enrolling by invitation
• 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
• 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

Related Conditions & MeSH terms

• Adverse Event
• Efficacy
• Liver Cancer
• Liver Neoplasms
• Microbiota
• Prognosis

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