Fecal Microbiota Transplantation Combined With QL1706 Plus Bevacizumab for Advanced HCC

Condition(s) studied

Investigational drug(s) / intervention(s)

FMT combined with QL1706 plus Bevacizumab: Oral 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Objective response rate （ORR） — Every 9 weeks from the first dose of FMT administration until the first documented disease progression, death or study completion, up to approximately 1 year.
  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）.

Trial sites (1)

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