Fecal Microbiota Transplantation （FMT） Combined With QL1706 Plus Bevacizumab as First-line Treatment for Advanced HCC
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Objective response rate （ORR）
研究概览
简要总结
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.
详细描述
Iparomlimab and Tuvonralimab （QL1706）, constitute a bifunctional antibody target both programmed death-1 and cytotoxic T lymphocyte-associated protein-4.
The purpose of this pilot study is to assess the efficacy and safety of fecal microbiota transplantation （FMT） combined with QL1706 Plus Bevacizumab as first-line treatment for advanced HCC.
The primary objective is to test the efficacy of FMT combined with QL1706 Plus Bevacizumab, as measured by objective response rate （ORR）.
The secondary objectives are to assess and test the safety of FMT in combination with QL1706 Plus Bevacizumab as first-line treatment for advanced HCC as measured by Disease Control Rate （DCR）, Duration of Response（DoR), Progression-Free Survival （PFS）, Overall Survival （OS), and Adverse Events （AEs).
Furthermore, this study aims to investigate multi-omics prognosis prediction biomarkers and their associated mechanisms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years.
- •Confirmed imaging or histological diagnosis of unresectable HCC.
- •Treatment-naïve unresectable or metastatic HCC.
- •BCLC Stage C.
- •Child-Pugh A.
- •ECOG PS 0-
排除标准
- •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.
- •Any contraindication to fecal microbiota transplantation.
- •Uncontrolled intercurrent illness, including active infection, clinically significant cardiovascular disease, central nervous system metastases.
- •Pregnancy or breastfeeding.
研究组 & 干预措施
FMT combined with QL1706 plus Bevacizumab
FMT combined with QL1706 plus Bevacizumab
干预措施: FMT combined with QL1706 plus Bevacizumab (Drug)
结局指标
主要结局
Objective response rate （ORR）
时间窗: 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）.
次要结局
- Disease Control Rate （DCR）(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.)
- Progression-Free Survival （PFS)(From first study treatment until the first documented disease progression or death from any cause, whichever occurs first, up to approximately 1 year.)
- Overall Survival （OS）(Starting from the time of treatment until death from any cause assessed from the date of the first intervention up to 24 months.)
- Adverse events （AEs）(30 days)