A Multicenter, Prospective, Single-arm Clinical Study Evaluating the Efficacy and Safety of Epalrestat Combined With Hepatic Arterial Chemotherapy Infusion (HAIC), Donafenib and Tislelizumab as First-line Treatment for Patients With Unresectable Hepatocellular Carcinoma and Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- 12-month Event-free survival (EFS) Rate
研究概览
简要总结
The purpose of this study is to evaluate the comprehensive therapeutic efficacy and safety profile of the epalrestat combined with hepatic artery infusion chemotherapy (HAIC), donafenib and tislelizumab quadruple regimen in patients with unresectable hepatocellular carcinoma (HCC) and diabetes.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes mellitus combined with unresectable advanced HCC (BCLC stage C);
- •Patients who have the need for treatment, prevention and improvement of diabetic neuropathy;
- •Liver function at Child-Pugh grade A or B (≤ 7 points), ECOG PS 0-1;
- •Age 18-80 years old. Confirmed as unrectable HCC through pathological or imaging diagnosis;
排除标准
- •Severe liver dysfunction: Child-Pugh C grade (≥ 8 points) or active hepatic encephalopathy Illness;
- •Extensive extrahepatic metastases (e.g., lung, bone, or peritoneum metastases);
- •Severe cardiovascular diseases: Uncontrolled heart failure, recent myocardial infarction;
- •Renal failure: Creatinine clearance rate < 30 mL/min;
- •Thrombocytopenia (less than 50×10⁹/L) or coagulation dysfunction (INR greater than 1.5);
- •Active infection (such as uncontrolled hepatitis B virus replication with HBV-DNA > 2000 IU/mL);
- •ECOG PS ≥ 2 or extremely poor overall condition;
- •Diabetic patients with acute ketoacidosis or during the period of severe infection;
- •Pregnant and lactating women;
- •Known history of other malignancy.
研究组 & 干预措施
Epalrestat plus HAIC, donafenib and tislelizumab
Epalrestat 50mg tid, donafenib 0.2g bid, tislelizumab 200mg per 21days, HAIC (FOLFOX or RALOX) per 21days
干预措施: Donafenib + Tislelizumab (Drug)
Epalrestat plus HAIC, donafenib and tislelizumab
Epalrestat 50mg tid, donafenib 0.2g bid, tislelizumab 200mg per 21days, HAIC (FOLFOX or RALOX) per 21days
干预措施: HAIC (Procedure)
Epalrestat plus HAIC, donafenib and tislelizumab
Epalrestat 50mg tid, donafenib 0.2g bid, tislelizumab 200mg per 21days, HAIC (FOLFOX or RALOX) per 21days
干预措施: Epalrestat (Drug)
结局指标
主要结局
12-month Event-free survival (EFS) Rate
时间窗: From treatment to the first occurrence of a predefined event (progression of disease, death for any reason, terminate the treatment due to intolerable AEs), assessed up to 2 years.
The proportion of patients who have remained event-free from the start of treatment until the 12-month time point.(Predefined events include: progression of disease, death for any reason, terminate the treatment due to intolerable AEs.)
次要结局
- Event-free survival (EFS)(From treatment to the first occurrence of a predefined event (progression of disease, death for any reason, terminate the treatment due to intolerable AEs), assessed up to 2 years.)
- Overall survival (OS)(Up to approximately 2 years)
- Progression free survival(PFS) (Overall)(From enrollment to progressive disease (according to mRECIST) or death due to any cause, up to 2 years.)
- Progression free survival(PFS) of intra-hepatic lesions(From the enrollment to the first documented progressive disease of intra-hepatic lesions or death due to any cause, up to 2 years.)
- Progression free survival(PFS) of extra-hepatic lesions(From the enrollment to the first documented appearance of extra-hepatic lesions or death due to any cause, up to 2 years.)
- Objective response rate(ORR) per RESCIST 1.1(Up to approximately 2 years)
- ORR per mRECIST(Up to approximately 2 years)
- PVTT response rate per mRECIST(Up to approximately 2 years)
- Disease control rate(DCR) per RESCIST 1.1(Up to approximately 2 years)
- DCR per mRECIST(Up to approximately 2 years)
- Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0(Up to approximately 2 years)
研究者
Haibo Shao
Professor, MD, PhD
First Hospital of China Medical University