a Cohort Study (Gut Microbiota and HCC)

NCT06557213 | Not Yet Recruiting DMC

• 1 other identifier: KY2024-176
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Liver Cancer

Outcome Measures

Primary Outcomes (8)

• Objective Progression-Free Survival (PFS)

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

  Up to approximately 1 years

• Objective Secondary Clinical Endpoints - Overall Growth Phase (OS)

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

  Up to approximately 1 years

• Objective Objective Response Rate (ORR)

  To exprole the Objective Response Rate (ORR) of patients

  Up to approximately 1 years

• ObjectiveDuration of Response (DOR)

  To analyse the Duration of Response (DOR) of patients

  Up to approximately 1 years

• Diversity analysis

  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.

  0 weeks, 12 weeks, 24 weeks and 48 weeks

• Species differential analysis

  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.

  0 weeks, 12 weeks, 24 weeks and 48 weeks

• Feces Metabolomics

  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.

  0 weeks, 12 weeks, 24 weeks and 48 weeks

• Serum Metabolomics

  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.

  0 weeks, 12 weeks, 24 weeks and 48 weeks

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a prospective, observational cohort study. Patients with advanced hepatocellular carcinoma who meet the enrollment and exclusion criteria, who are judged to be unresectable after evaluation by professional physicians, are planned to be treated with anti-angiogenic targeted drugs combined with immune checkpoint inhibitors, and according to the number of such patients in Shenzhen Third People's Hospital in the case year, this study intends to include 100 study subjects

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Xu Yong, MD: lead
• Nanjing Xiershou Biotechnology Co., Ltd: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Collect patient feces、blood、urine、serum of patients at 0, 12, 24, and 48 weeks

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Yong Xu, Dr

  Secretary of the Party Committee of the Shenzhen Third People's Hospital

  STUDY CHAIR

Central Study Contacts

Dongmei Gou, Dr

CONTACT

13696020717; gdm4726@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Secretary of the Party Committee

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 16, 2024
• Study Start: August 30, 2024
• Primary Completion: May 20, 2026
• Study Completion (Estimated): November 20, 2026
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share