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

NCT05443217 | Unknown

• 1 other identifier: microbiota
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cancer; Microbiota; Adverse Event; Prognosis; Efficacy

Keywords

HCC; microbiota; Adverse Event; prognosis; efficacy

Outcome Measures

Primary Outcomes (2)

• Post-treatment adverse events

  Post-treatment complications are recorded

  3 months

• Long-term outcomes after treatment

  Overall survival and progression-free survival

  1 year

Secondary Outcomes (1)

• Objective response rate

  3 months

Study Arms (2)

patients with response to systemic therapies

Diagnostic Test: questionnaire survey

patients with no response to systemic therapies

Diagnostic Test: questionnaire survey

Interventions

questionnaire survey DIAGNOSTIC_TEST

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

patients with no response to systemic therapies; patients with response to systemic therapies

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with unresectable HCC who received systemic therapies

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Wenzhou Medical University: lead
• The First Affiliated Hospital of Zhejiang Chinese Medical University: collaborator
• Qilu Hospital of Shandong University: collaborator
• Eastern Hepatobiliary Surgery Hospital: collaborator

Study Sites (1)

Gang Chen

Wenzhou, Zhejiang, 325000, China

Location

Related 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.

  PMID: 35228752 BACKGROUND

• 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.

  PMID: 31337439 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

fecal sample, saliva

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Principal Investigator

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 5, 2022
• Study Start: June 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)