Safety and Efficacy of Lenvatinib as an Adjuvant Therapy in Patients With Hepatocellular Carcinoma Following Radical Resection: A Single-Arm and Open-Label Prospective Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- 1-year RFS rate
研究概览
简要总结
Lenvatinib is the standard of care for patients with advanced hepatocellular carcinoma (HCC). The aim of the single-arm, open-label, phase II clinical trial is to evaluate the efficacy and safety of lenvatinib as an adjuvant therapy for patients underwent radical resection of HCC with a high risk of tumor recurrence.
Investigator hypothesize that lenvatinib may be an effective adjuvant treatment for HCC, and 12-month adjuvant treatment with lenvatinib can improve one-year recurrence-free survival rate (RFS) of HCC patients after surgical resection.
详细描述
There's no widely accepted adjuvant therapy for patients with HCC. Lenvatinib, a multi-targeted tyrosine kinase inhibitor, was approved for advanced or unresectable HCC. In this study, investigators aim to evaluate the effects and safety of adjuvant apatinib therapy for the patients who underwent curative resection for HCC with high risk of disease recurrence.
Participants who underwent radical resection for HCC with high risk of tumor recurrence will be recruited in this study. During 4 to 6 weeks after surgery, each participant will receive a screening visit to exclude residual tumors. Each eligible participant will be treated with lenvatinib until tumor recurrence, intolerant adverse effect, participant' refusal, or completing 12-month treatment.
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
- •Male or female patients aged 18-75;
- •Histological diagnosis of HCC;
- •Tumor stage before surgery: IIb/IIIa stage (>3 tumor nodules, or vascular invasion) HCC according to China Liver Cancer Staging System (or BCLC B/C/PVTT);
- •Underwent R0 resection (microscopic or macroscopic tumor clearance) in four to six weeks before recruitment; no residual tumor before recruitment by imaging study (MRI/CT), nor metastases to other organs;
- •Adequate liver, renal functions;
- •Written informed consent;
- •ECOG 0-1 and Child-Pugh A.
排除标准
- •WBC<4.0*10^9/L, HB<80 g/L, and PLT<75*10^9/L at blood screening;
- •Coagulation function: (prothrombin time) international normalized ratio (INR) >2.3, or extension of prothrombin time>6 seconds;
- •Liver function: serum albumin (ALB)<2.8 g/dl, total bilirubin (TBIL)>51.3μmol/L, alanine aminotransferase and aspartate aminotransferase (ALT and AST)>5 times the upper limit of normal range;
- •Renal function: serum creatinine (Cr)>1.5 times the upper limit of normal range;
- •lymph node metastases;
- •The participant has uncontrolled ascites, hepatic encephalopathy, Gilbert's syndrome, and sclerosing cholangitis, etc.;
- •The participant was included in other clinical trials 30 days before the selection;
- •Other conditions that the investigators considered that not unsuitable for inclusion.
研究组 & 干预措施
Lenvatinib Arm
Experimental: Participants will be given lenvatinib (12 mg/d for body weight≥60kg, 8 mg/d for body weight < 60kg) for 12 months until disease recurrence or intolerance AEs or death.
干预措施: Lenvima 4 mg Oral Capsule (Drug)
结局指标
主要结局
1-year RFS rate
时间窗: 1 year after LPI
1-year RFS rate is defined as the percentage of patients who do not experience tumor recurrence or death from any cause after 1-year treatment.
次要结局
- Health-related quality of life(13 months)
- Overall survival (OS)(3 years)
- Adverse events(13 months)
- Serious adverse events(SAE)(13 months)
研究者
Jian Zhou
Professor of Surgery
Shanghai Zhongshan Hospital