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NCT Number: NCT06557213

a Cohort Study (Gut Microbiota and HCC)

To analyze the predictive role of intestinal microbiota in tyrosine kinase inhibitors (TKIs) combined with immunotherapy response in patients with intermediate and advanced liver cancer.

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Key information

Conditions

Liver Cancer Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

About this study

This is a prospective, observational cohort study. Patients with intermediate and advanced hepatocellular carcinoma who meet the enrollment and exclusion criteria are judged to be unresectable after evaluation by professional physicians, and are intended to be treated with anti-angiogenic targeted drugs combined with immune checkpoint inhibitors. During the treatment according to clinical needs, stool and blood samples were taken regularly, and the treatment response of patients was judged according to RECIST V1.1 criteria, and the common adverse reactions during treatment were evaluated by the CTCAE5.0 grading system, and the relationship between intestinal microbiota and liver cancer treatment response was analyzed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-75 years old, gender unlimited
  • Diagnosed as HCC through pathological or clinical examination
  • BCLC Phase B or C
  • Previously without systematic treatment
  • Irremovable
  • Intended to receive targeted anti-angiogenic drugs combined with immune checkpoint inhibitors for treatment
  • ≥ 1 measurable lesion (RECIST V1.1)
  • ECOG PS 0-1
  • The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.

Exclusion criteria

  • Received attenuated live vaccine within 4 weeks prior to enrollment or planned during the study period
  • Active, known or suspected autoimmune diseases
  • Known history of primary immunodeficiency
  • Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
  • Pregnant or lactating female patients
  • Uncontrolled concurrent diseases
  • Currently conducting clinical trials for other drugs
  • Other patients deemed unsuitable for inclusion by researchers

Treatment and study plan

Primary outcomes

  1. Objective Progression-Free Survival (PFS)

    Time frame: Up to approximately 1 years

    To analyse the Progression-Free Survival (PFS) of patients

  2. Objective Secondary Clinical Endpoints - Overall Growth Phase (OS)

    Time frame: Up to approximately 1 years

    To analyse the Secondary Clinical Endpoints - Overall Growth Phase (OS) of patients

  3. Objective Objective Response Rate (ORR)

    Time frame: Up to approximately 1 years

    To exprole the Objective Response Rate (ORR) of patients

  4. ObjectiveDuration of Response (DOR)

    Time frame: Up to approximately 1 years

    To analyse the Duration of Response (DOR) of patients

  5. Diversity analysis

    Time frame: 0 weeks, 12 weeks, 24 weeks and 48 weeks

    We will use 16S rRNA sequencing to measure fecal sample. The alpha and beta diversity of gut microbiota will be analyzed, including a series of statistical analysis indexes such as Chao, Shannon, Simpsonace, Simpson and Coverage, in order to reflect the microbial community diversity.

  6. Species differential analysis

    Time frame: 0 weeks, 12 weeks, 24 weeks and 48 weeks

    We will use 16S rRNA sequencing to measure fecal sample. Based on the results of species annotation, the PCA、PCoA and NMDS analysis will be used to assess the similarities and differences in species composition.

  7. Feces Metabolomics

    Time frame: 0 weeks, 12 weeks, 24 weeks and 48 weeks

    Changes of metabolites in feces measured by metabolomic mass spectrometry, unsupervised PCA (principal component analysis) was performed by statistics function prcomp, identified metabolites were annotated using KEGG Compound database.

  8. Serum Metabolomics

    Time frame: 0 weeks, 12 weeks, 24 weeks and 48 weeks

    Changes of metabolites in serum measured by metabolomic mass spectrometry, unsupervised PCA (principal component analysis) was performed by statistics function prcomp, identified metabolites were annotated using KEGG Compound database.

Study contacts

Contact information is provided by the study sponsor or research team.

Dongmei Gou, Dr

CONTACT

[email protected]

13696020717

Sponsors and collaborators

Lead sponsor

Xu Yong, MD

Other

Collaborators

  • Nanjing Xiershou Biotechnology Co., Ltd

Registry information

Official study title

Prediction of Liver Cancer Treatment Response Based on Gut Microbiota: a Cohort Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 16, 2024
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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