This is a prospective, single-center, single-arm Phase II pilot study designed to evaluate the efficacy and safety of FMT in combination with QL1706 and Bevacizumab as first-line treatment for advanced Hepatocellular carcinoma.
Age >18 years.
Confirmed imaging or histological diagnosis of unresectable HCC.
Treatment-naïve unresectable or metastatic HCC.
BCLC Stage C.
Prior treatment with an immune checkpoint inhibitor, or prior systemic therapy for advanced HCC.
Histologic subtypes other than hepatocellular carcinoma, including fibrolamellar HCC, sarcomatoid HCC, and mixed hepatocellular cholangiocarcinoma.
Active or prior autoimmune disease, immunodeficiency requiring systemic immunosuppressive therapy.
Clinically significant bleeding risk, coagulopathy, or untreated high-risk esophagogastric varices.
Single group
FMT combined with QL1706 plus Bevacizumab
DrugOral Fecal Microbiota Transplantation （FMT） capsules: Full-dose FMT (80-100g) will be administered on Days 0,28, and 49. Iparomlimab and Tuvonralimab （QL1706）: QL1706 will be administered intravenously at a dose of 7.5 mg/kg, with the first administration on Day 7, followed by subsequent administrations on Days 28 and 49, thereafter every 21 days. Bevacizumab: Bevacizumab will be administered intravenously at a dose of 15 mg/kg body weight, with the first administration on Day 7, followed by subsequent administrations on Days 28 and 49, thereafter every 21 days.
Objective response rate （ORR）
To assess the efficacy of FMT combined with QL1706 plus Bevacizumab as first-line treatment for metastatic HCC with respect to Objective Response Rate （ORR）.
Disease Control Rate （DCR）
To observe and evaluate the efficacy of FMT combined with QL1706 plus Bevacizumab as first-line treatment for unresectable or metastatic HCC with respect to Disease Control Rate （DCR) determined by the radiologist per mRECIST v1.1 criteria.
Progression-Free Survival （PFS)
Time from the start of treatment to the first documented disease progression as determined by the radiologist per mRECIST/ RECIST v1.1 criteria or death from any cause.
Overall Survival （OS）
To observe and evaluate the efficacy of FMT combined with QL1706 plus Bevacizumab as first-line treatment for metastatic HCC with respect to overall survival （OS).
Adverse events （AEs）
To observe and evaluate the safety of FMT combined with QL1706 plus Bevacizumab as first-line treatment for metastatic HCC with respect to adverse events （AEs） AEs will be graded according to NCI-CTCAE V5.0 Safety assessments will be performed from baseline through 30 days （±7 days） after the last dose of study treatment
Changes in patient gut microbiome composition following FMT
Changes in patient gut microbiome will be determined by analysis of gut bacterial composition in patient stool samples at baseline and post-FMT
Multi-Omics prognosis biomarker Profiles
Changes from baseline in prespecified metabolomic and immune-related biomarkers measured using metabolomic analysis and immunological assays, respectively, and their associations with clinical and associated mechanisms.
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