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
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)
研究者
Haibo Shao
Professor, MD, PhD
First Hospital of China Medical University