a Cohort Study (Gut Microbiota and HCC)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Cancer

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Dongmei Gou, Dr; Phone Number: 13696020717; Email: gdm4726@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

1. Age 18-75 years old, gender unlimited
2. Diagnosed as HCC through pathological or clinical examination
3. BCLC Phase B or C
4. Previously without systematic treatment
5. Irremovable
6. Intended to receive targeted anti-angiogenic drugs combined with immune checkpoint inhibitors for treatment
7. ≥ 1 measurable lesion (RECIST V1.1)
8. ECOG PS 0-1
9. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Xu Yong, MD
• Collaborators: Nanjing Xiershou Biotechnology Co., Ltd
• Investigators: Study Chair: Yong Xu, Dr, Secretary of the Party Committee of the Shenzhen Third People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 30, 2024
• Primary Completion (Estimated): May 20, 2026
• Study Completion (Estimated): November 20, 2026

Study Registration Dates

• First Submitted: August 7, 2024
• First Submitted That Met QC Criteria: August 15, 2024
• First Posted (Actual): August 16, 2024

Study Record Updates

• Last Update Posted (Actual): August 16, 2024
• Last Update Submitted That Met QC Criteria: August 15, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: KY2024-176

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No