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

NCT ID: NCT05443217

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2024-12-01

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.

Conditions

Liver Cancer; Microbiota; Adverse Event; Prognosis; Efficacy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

patients with response to systemic therapies

questionnaire survey

Intervention Type: DIAGNOSTIC_TEST

All patients received lifestyle questionnaire, physical performance, and imaging evaluation before treatment.

patients with no response to systemic therapies

questionnaire survey

Intervention Type: DIAGNOSTIC_TEST

All patients received lifestyle questionnaire, physical performance, and imaging evaluation before treatment.

Interventions

questionnaire survey

All patients received lifestyle questionnaire, physical performance, and imaging evaluation before treatment.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Zhejiang Chinese Medical University

OTHER

Sponsor Role: collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role: collaborator

Eastern Hepatobiliary Surgery Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Gang Chen, MD

Clinical Professor, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gang Chen

Wenzhou, Zhejiang, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 35228752 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31337439 (View on PubMed)

Other Identifiers

microbiota

Identifier Type: -

Identifier Source: org_study_id