An observational study in Hepatocellular Carcinoma Non-resectable, sponsored by Fujian Provincial Hospital. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-10-16.
Sponsored by Fujian Provincial Hospital · Observational
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.
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 15 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.
Browse Carcinoma studies →Fujian Provincial Hospital is the lead sponsor of 40 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Key organ function indicators meet the following requirements:
Hematology: Absolute neutrophil count ≥1.5×10\^9/L, Hb ≥9.0g/L, Platelets ≥75×10\^9/L Liver function: Total bilirubin ≤1.5 times the upper limit of normal (ULN) (≤2.5 times ULN after biliary drainage for obstructive jaundice); Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) ≤5 times ULN, Albumin ≥30g/L Renal function: Serum creatinine ≤1.5mg/dL, Creatinine clearance rate ≥60ml/min Coagulation function: International normalized ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤1.5 times ULN
Exclusion Criteria:
The triple therapy consists of: Transarterial Chemoembolization (TACE): This procedure will be performed every 4-6 weeks based on the presence of significant arterial blood supply to the tumor, with a maximum of 4 TACE treatments allowed. Lenvatinib: The generic name of the drug is lenvatinib. It will be administered orally in a dosage of 12mg per day for patients weighing 60kg or more, and 8mg per day for patients weighing less than 60kg. The treatment will be continuous with a fixed daily dosing schedule. Sintilimab: It will be given every 3 weeks (Q3W). Fecal Microbiota Transplantation (FMT): The 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).
Other: Fecal Microbiota Transplantation
The 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.
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 surgery
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 months
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 months
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 months
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 surgery
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)
Gut Microbiome Metabolomic Changes after Fecal Microbiota Transplantation
The changes in serum and fecal metabolomics before and after FMT.
Time frame: Baseline and at the end of each treatment cycle (up to 6 cycles)
Gut Microbiome Immune Subset Variations after Fecal Microbiota Transplantation
The changes in immune cell subsets before and after FMT.
Time frame: Baseline and at the end of each treatment cycle (up to 6 cycles)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fujian Provincial Hospital