Fecal Microbiota Transplantation in Reversing Drug Resistance in Unresectable HCC (TALENP004) (NCT06643533) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Fecal Microbiota Transplantation in Reversing Drug Resistance in Unresectable HCC (TALENP004)
15 participantsStarted 2025-01-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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).
✓. No history of taking probiotics after the diagnosis of HCC.
✓. Child-Pugh class A/B.
✓. ECOG performance status: ≤1.
✓. Age between 18 and 75 years old.
Exclusion criteria
✕. Mixed hepatocellular-cholangiocarcinoma.
✕
What they're measuring
1
Objective response rate, ORR
Timeframe: Four weeks after the initiation of medication until the day before surgery
2
Adverse events
Timeframe: From the initiation of medication, with recordings made whenever an adverse reaction occurs, assessed up to 12 months
. 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.
✕. Patients who have undergone organ transplantation or are planning to undergo organ transplantation.
✕. Any active autoimmune disease or autoimmune disease with expected recurrence (such as interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes).
✕. History of immunodeficiency; patients who are using immunosuppressants or systemic corticosteroid therapy for immunosuppression and have continued use within 2 weeks before signing the informed consent.
✕. Known hereditary or acquired bleeding (such as coagulation disorders) or thrombotic tendencies, such as hemophilia patients; currently using or have recently (within 10 days before the start of the study treatment) used full-dose oral or injectable anticoagulants or thrombolytic drugs for therapeutic purposes (preventive use of low-dose aspirin, low molecular weight heparin is allowed).