Fecal Microbiota Transplantation in Reversing Drug Resistance in Unresectable HCC (TALENP004)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorFujian Provincial Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with intermediate to advanced Hepatocellular Carcinoma (HCC) who have experienced disease progression (PD) after treatment with the triple therapy of Transarterial Chemoembolization (TACE), lenvatinib, and sintilimab.
Patients must have at least one measurable lesion according to the mRECIST 1.1 criteria (the longest diameter of measurable lesions on CT/MRI scan ≥10mm).
Expected survival time greater than 3 months.
No prior treatment with Fecal Microbiota Transplantation (FMT).
Disqualifiers
Mixed hepatocellular-cholangiocarcinoma.
Severe tumor progression (tumor volume occupies two-thirds or more of the liver volume or diffuse intrahepatic lesions).
History of allergy to PD-1, lenvatinib, or their components.
History of other malignant tumors within the past 5 years, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, and papillary thyroid cancer.
Trial population
The study population consists of adults aged 18 to 75 with unresectable hepatocellular carcinoma that has progressed after triple therapy, eligible for fecal microbiota transplantation to overcome treatment resistance.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Fecal Microbiota Transplantation
Other interventionThe FMT capsules will be prepared by matching the gut microbiome profiles of healthy donors with those of patients who achieved a complete response to the triple therapy. The FMT capsules will be taken orally at a dosage of 30 capsules per day for the first 3 days of each treatment cycle. The FMT intervention will be administered in 6 cycles, with each cycle lasting for 21 days (Q3W). The duration of the treatment will be determined by the response to therapy, with a maximum of 6 cycles or until disease progression, intolerable toxicity, or participant withdrawal of consent. The FMT capsules are intended to modify the gut microbiome to reverse the resistance to the triple therapy and enhance the therapeutic response.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: FMT-Resistant HCC Cohort1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate, ORR
The Objective response rate (ORR) was defined as the complete response (CR) rate or the partial response (PR) rate according to RECIST1.1.
Time frame
Four weeks after the initiation of medication until the day before surgery2
Adverse events
Grade 1-5 AEs according to NCI-CTCAE V5.0.
Time frame
From the initiation of medication, with recordings made whenever an adverse reaction occurs, assessed up to 12 monthsSecondary outcomes
1
Overall survival, OS
The Overall survival (OS) was defined as the time between receiving treatment and observing death or loss of follow-up for any reason.
Time frame
From date of enrollment until the date of death from any cause, assessed up to 60 months2
Progression free survival, PFS
The Progression free survival (PFS) was defined as the time between the start of treatment and the progression of intrahepatic and/or extrahepatic tumors, or the occurrence of death or loss of follow-up for any reason.
Time frame
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months3
Disease control rate, DCR
The Disease control rate (DCR) was defined as the complete response (CR) rate or the partial response (PR) rate or stable disease (SD) rate according to RECIST1.1.
Time frame
Four weeks after the initiation of medication until the day before surgery4
Gut Microbiome Composition after Fecal Microbiota Transplantation
The changes in the gut microbiome composition before and after FMT treatment, including diversity and similarity to the donor microbiome.
Time frame
Baseline and at the end of each treatment cycle (up to 6 cycles)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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