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.
This is a prospective, single-center, single-arm clinical study evaluating the efficacy and safety of oral fecal microbiota transplantation (FMT) capsules in patients with advanced hepatocellular carcinoma (HCC) whose disease has progressed during immune checkpoint inhibitor (ICI) plus tyrosine kinase inhibitor (TKI) therapy. After enrollment, participants will continue the same ICI-TKI regimen according to its prescribed schedule. In addition, oral FMT capsules (300 mg per capsule) will be administered at 6 capsules per day for 10 consecutive days in each 21-day cycle, for a total of 4 cycles. ICI-TKI therapy will continue until disease progression, unacceptable toxicity, withdrawal of consent, or another protocol-defined discontinuation criterion. The primary endpoint is progression-free survival (PFS), defined as the 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. Secondary endpoints include overall survival (OS), defined as the time from the first dose of FMT capsules to death from any cause; objective response rate (ORR), defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR) according to RECIST version 1.1; duration of response (DOR), defined for participants with CR or PR as the time from the first documented response to radiographic disease progression or death from any cause, whichever occurs first; and disease control rate (DCR), defined as the proportion of participants with CR, PR, or stable disease (SD) according to RECIST version 1.1. Adverse events will be evaluated and graded according to CTCAE version 5.0. Other assessments include protocol-specified imaging, laboratory tests, and quality-of-life measures.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Shenzhen Third People's Hospital
Shenzhen, China
RECRUITINGProgression-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.
Time frame: From the first dose of FMT capsules to radiographic disease progression or death, up to approximately 1 year
Overall Survival (OS)
Time from the first dose of FMT capsules to death from any cause.
Time frame: From the first dose of FMT capsules to death from any cause, up to approximately 1 year
Objective Response Rate (ORR)
Proportion of participants with a best overall response of complete response or partial response according to RECIST version 1.1.
Time frame: From the first dose of FMT capsules through approximately 1 year
Duration of Response (DOR)
For participants with a complete or partial response, time from the first documented response to radiographic disease progression or death from any cause, whichever occurs first.
Time frame: From the first documented response to disease progression or death, up to approximately 1 year
Disease Control Rate (DCR)
Proportion of participants with a best overall response of complete response, partial response, or stable disease according to RECIST version 1.1.
Time frame: From the first dose of FMT capsules through approximately 1 year
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