Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06643533
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-11
Brief Title:
Fecal Microbiota Transplantation in Reversing Drug Resistance in Unresectable HCC TALENP004
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety and Efficacy of Fecal Microbiota Transplantation in Reversing Drug Resistance in Patients With Intermediate-advanced Unresectable Hepatocellular Carcinoma Undergoing Transcatheter Arterial Chemoembolization Combined With Lenvatinib Plus Sintilimab
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to evaluate the safety and efficacy of fecal microbiota transplantation FMT in reversing drug resistance to the triple therapy regimen in patients with unresectable hepatocellular carcinoma HCC The triple therapy consists of transarterial chemoembolization TACE lenvatinib and Sintilimab The study is a prospective single-arm multicenter clinical trial involving 15 participants with mid-to-late stage HCC that has progressed despite the triple therapy FMT capsules will be prepared by matching the gut microbiome profiles of healthy donors to those of patients who achieved complete response CR with the triple therapy The primary endpoints include objective response rate ORR treatment-related adverse events AEs Secondary endpoints will assess overall survival OS progression-free survival PFS and disease control rate DCR changes in gut microbiome metabolomics and immune subsets before and after FMT
Detailed Description:
The study is designed to investigate the potential of FMT in overcoming resistance to a combined treatment approach for HCC The triple therapy under investigation includes TACE lenvatinib and a PD-1 inhibitor which has shown promise in treating HCC but has encountered issues with drug resistance
This prospective single-arm multicenter trial will enroll 15 patients diagnosed with mid-to-late stage HCC that has progressed despite treatment with the triple therapy The primary objective is to assess the safety and efficacy of FMT in this patient population with the primary endpoints being ORR AEs OS PFS and DCR Secondary endpoints will evaluate the changes in the gut microbiome composition metabolomic profiles and immune cell subsets before and after FMT
Eligible participants must have HCC that has progressed following the triple therapy and meet specific inclusion criteria including having at least one measurable lesion an expected survival time greater than three months and no prior FMT treatment Exclusion criteria include a history of other malignancies within the past five years autoimmune diseases and the use of immunosuppressive agents
FMT capsules will be made by analyzing the gut microbiome and metabolite profiles of patients who achieved a complete response to the triple therapy and matching these with healthy donor profiles from a biobank Patients will receive FMT capsules daily for three days along with the continuation of the triple therapy The study will also include procedures for dose adjustments based on adverse events and specific guidelines for managing toxicities related to the study treatments
The study will conclude with a comprehensive analysis of the primary and secondary endpoints This trial aims to provide valuable insights into the role of FMT in enhancing the efficacy of cancer treatments and overcoming drug resistance in HCC
This prospective single-arm multicenter trial will enroll 15 patients diagnosed with mid-to-late stage HCC that has progressed despite treatment with the triple therapy The primary objective is to assess the safety and efficacy of FMT in this patient population with the primary endpoints being ORR AEs OS PFS and DCR Secondary endpoints will evaluate the changes in the gut microbiome composition metabolomic profiles and immune cell subsets before and after FMT
Eligible participants must have HCC that has progressed following the triple therapy and meet specific inclusion criteria including having at least one measurable lesion an expected survival time greater than three months and no prior FMT treatment Exclusion criteria include a history of other malignancies within the past five years autoimmune diseases and the use of immunosuppressive agents
FMT capsules will be made by analyzing the gut microbiome and metabolite profiles of patients who achieved a complete response to the triple therapy and matching these with healthy donor profiles from a biobank Patients will receive FMT capsules daily for three days along with the continuation of the triple therapy The study will also include procedures for dose adjustments based on adverse events and specific guidelines for managing toxicities related to the study treatments
The study will conclude with a comprehensive analysis of the primary and secondary endpoints This trial aims to provide valuable insights into the role of FMT in enhancing the efficacy of cancer treatments and overcoming drug resistance in HCC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None