Oral Fecal Microbiota Transplantation in Advanced Hepatocellular Carcinoma After Progression on ICI-TKI Therapy

NCT06563947 | Recruiting Phase 2 DMC

• 1 other identifier: KY2024-178
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, single-center, single-arm phase 2 study evaluates the efficacy and safety of adding oral fecal microbiota transplantation (FMT) capsules to continued immune checkpoint inhibitor (ICI) plus tyrosine kinase inhibitor (TKI) therapy in adults with advanced hepatocellular carcinoma (HCC) whose disease has progressed during ICI-TKI therapy.

Conditions

Advanced Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  Time from the first dose of FMT capsules to the first documented radiographic disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first.

  From the first dose of FMT capsules to radiographic disease progression or death, up to approximately 1 year

Secondary Outcomes (4)

• Overall Survival (OS)

  From the first dose of FMT capsules to death from any cause, up to approximately 1 year

• Objective Response Rate (ORR)

  From the first dose of FMT capsules through approximately 1 year

• Duration of Response (DOR)

  From the first documented response to disease progression or death, up to approximately 1 year

• Disease Control Rate (DCR)

  From the first dose of FMT capsules through approximately 1 year

Other Outcomes (4)

• Gut microbiome diversity by shotgun metagenomic sequencing

  Up to approximately 1 year

• Gut microbiome taxonomic and functional profiling by shotgun metagenomic sequencing

  Up to approximately 1 year

• Single-cell transcriptomics

  Up to approximately 1 year

Study Arms (1)

Oral Fecal Microbiota Transplantation Plus Continued ICI-TKI Therapy

EXPERIMENTAL

Participants continue their pre-enrollment ICI-TKI regimen and receive oral fecal microbiota transplantation (FMT) capsules (300 mg per capsule) at 6 capsules per day for 10 consecutive days in each 21-day cycle, for a total of 4 cycles.

Biological: Oral fecal microbiota transplantation capsules

Interventions

Oral fecal microbiota transplantation capsules BIOLOGICAL

Oral fecal microbiota transplantation capsules (300 mg per capsule) are administered at a dose of 6 capsules per day for 10 consecutive days in each 21-day cycle, for a total of 4 cycles. Participants continue their pre-enrollment ICI-TKI regimen during FMT treatment.

Oral Fecal Microbiota Transplantation Plus Continued ICI-TKI Therapy

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 class A or B, with a score of ≤7;
• ≥ 1 measurable lesion (RECIST v1.1)
• ECOG PS 0-2

You may not qualify if:

• Use of antibiotics within 4 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

Study Sites (1)

Shenzhen Third People's Hospital

Shenzhen, 518112, China

RECRUITING

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Yong Xu, Dr

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cineng Xu, Dr

CONTACT

13530871434; 822265652@qq.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, open-label, single-arm phase 2 study. Participants continue their pre-enrollment ICI-TKI regimen and receive oral fecal microbiota transplantation (FMT) capsules at 6 capsules per day for 10 consecutive days in each 21-day cycle, for a total of 4 cycles.

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 21, 2024
• Study Start: September 3, 2024
• Primary Completion (Estimated): May 20, 2027
• Study Completion (Estimated): November 20, 2027
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)