Single Arm Clinical Trial (Gut Microbiota and HCC)

NCT06563947 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: KY2024-178
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the efficacy and safety of oral enterobacterial capsules in patients with intermediate and advanced HCC who have progressed after treating with immune checkpoint inhibitors in combination with anti-angiogenesis targeted agents.

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.

  Up to approximately 1 years

• 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.

  Up to approximately 1 years

• 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.

  Up to approximately 1 years

• 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.

  Up to approximately 1 years

Study Arms (1)

Patients with progressed HCC after treatment were given enterobacterium capsules

EXPERIMENTAL

Patients were given oral enterobacterium capsules (300 mg/per capsule) 6 capsules/day for 10 consecutive days, and then discontinued to the next course of treatment.

Biological: Oral enterobacterium capsules

Interventions

Oral enterobacterium capsules BIOLOGICAL

Enterobacterium capsules (300 mg/per capsule) orally 6 capsules/day for 10 consecutive days.

Patients with progressed HCC after treatment were given enterobacterium capsules

Eligibility Criteria

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

You may qualify if:

• Age 18-75 years old, gender is not limited;
• Confirmed imaging or histological diagnosis of unresectable HCC, BCLC stadium B or C;
• Clinical diagnosis of HCC progression during TKIs combined with ICIs treatment;
• Not suitable for local ablation or chemoembolization;
• Child-Pugh Grade A;
• ≥ 1 measurable lesion (RECIST v1.1)
• ECOG PS 0-1

You may not qualify if:

• Usage of antibiotics within 2 weeks prior enrollment;
• Diagnosis of immunodeficiency (e.g. HIV, immunosuppressants)
• Patients with known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
• Female patients who are pregnant or breastfeeding;
• Patients with untreated acute or chronic active hepatitis B or hepatitis C infection.
• Patients are currently undergoing clinical trials of other drugs;

Sponsors & Collaborators

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

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongmei Gou, Dr

CONTACT

13696020717; gdm4726@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Secretary of the Party Committee & Principal Investigator

Model Details: This is a prospective, single-center, single-arm clinical study. For those who meet the enrollment conditions, the original regimen of immune checkpoint inhibitors combined with anti-angiogenic targeted drugs will remain unchanged after enrollment.On this basis, the study subjects started oral enterobacterial capsules to see whther enterobacterial capsules could improve the efficacy of patients receiving the above treatment regimens.

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 21, 2024
• Study Start: August 24, 2024
• Primary Completion: May 20, 2026
• Study Completion (Estimated): November 20, 2026
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share