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Enrolling by invitationNCT05443217Updated Sep 13, 2023

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

An observational study in Liver Cancer, Microbiota and Adverse Event, sponsored by First Affiliated Hospital of Wenzhou Medical University. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-09-13.

Sponsored by First Affiliated Hospital of Wenzhou Medical University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

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Keywords

  • HCC
  • microbiota
  • Adverse Event
  • prognosis
  • efficacy
03

In context

Liver Neoplasms

1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.

This study's planned enrollment of 200 is close to the median of 200 across 350 observational studies indexed under Liver Neoplasms.

Browse Liver Neoplasms studies →

Lead sponsor

First Affiliated Hospital of Wenzhou Medical University is the lead sponsor of 82 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients with unresectable HCC who received systemic therapies

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • patients with response to systemic therapies

    Diagnostic Test: questionnaire survey

  • patients with no response to systemic therapies

    Diagnostic Test: questionnaire survey

Interventions

  • Diagnostic testquestionnaire survey

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

06

What researchers measure

Primary outcomes

  1. Post-treatment adverse events

    Post-treatment complications are recorded

    Time frame: 3 months

  2. Long-term outcomes after treatment

    Overall survival and progression-free survival

    Time frame: 1 year

Secondary outcomes

  1. Objective response rate

    Tumor response

    Time frame: 3 months

07

Study locations

1 site
  • Gang Chen
    Wenzhou, Zhejiang 325000, China
08

References and documents

Publications

  • 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. PubMed 35228752 ↗
  • 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. PubMed 31337439 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05443217
Lead sponsor
First Affiliated Hospital of Wenzhou Medical University
Collaborators
The First Affiliated Hospital of Zhejiang Chinese Medical University, Qilu Hospital of Shandong University, Eastern Hepatobiliary Surgery Hospital
Responsible party
Gang Chen, MD (Clinical Professor, Principal Investigator, First Affiliated Hospital of Wenzhou Medical University) — Principal investigator
First posted
Jul 5, 2022
Start date
Jun 1, 2022
Primary completion
Dec 1, 2024 (estimated)
Completion
Dec 1, 2024 (estimated)
Last update
Sep 13, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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