Tislelizumab or Tislelizumab Combined With Lenvatinib Neo-adjuvant Treatment for Resectable Recurrent Hepatocellular Carcinoma：Phase II Non-randomized Control Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Disease-free survival rate
研究概览
简要总结
This non-randomized phase II clinical trial aimed to explore the efficacy and safety of Tislelizumab or Tislelizumab combined with Lenvatinib as neoadjuvant treatment for resectable RHCC patients
详细描述
Hepatocellular carcinoma (HCC) patients have about 70% of 5-year recurrence rate after curative treatment. Only 30% of recurrent HCC (RHCC) patients are resectable when diagnosed. Neoadjuvant treatment may reduce tumor burden and recurrence rate after surgery for RHCC patients. Immune checkpoint inhibitors combined with or without antiangiogenic agents have already been reported effective in advanced HCC patients as first-line therapy, and in several early-stage solid tumors as neoadjuvant therapy. According to several preclinical results, immune infiltration and the expression of PD-1 were higher in RHCC tumors than in paired primary tumors. So, immune checkpoint inhibitors combined with or without antiangiogenic agents might have a better response in RHCC patients than primary HCC patients. Herein, we designed this phase II clinical trial to explore the efficacy and safety of Tislelizumab (PD-1 inhibitor) or Tislelizumab combined with Lenvatinib as neoadjuvant treatment for resectable RHCC patients. Enrolled resectable RHCC patients will be divided into two non-randomized seperate arms, sequentially (arm 1: neoadjuvant tislelizumab; arm 2: neoadjuvant tislelizumab and lenvatinib). Each arm was estimated to enroll 40 patients. We have already enrolled 17 patients in arm 1, and have terminated the enrollment of arm 1 due to modest treatment responses. The enrollment of arm 2 is ongoing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Diagnosed as recurrent hepatocellular carcinoma after curative treatment;
- •The criteria for resectability is met;
- •Has at least one evaluable lesion according to the RECIST 1.1 standard and has not received local treatment;
- •Eastern Cooperative Oncology Group score 0-1, Child-pugh score 5-7;
- •Agree to biopsy and blood sample collection;
- •Adequate organ and marrow function.
排除标准
- •Previously received any transarterial chemoembolization and immune therapy and other local or systemic liver cancer treatments, except for curative ablation;
- •Extrahepatic metastasis;
- •History of gastroesophageal varices or active cardia ulcers associated with a high risk of bleeding;
- •History of autoimmune disease or need to take immunosuppressant drugs for a long time;
- •History of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS);
- •Abnormal organ function
研究组 & 干预措施
Tislelizumab
Tislelizumab is one kind of PD-1 inhibitors. Patients enrolled will receive Tislelizumab as neoadjuvant treatment before surgery (200mg q3w*2 cycles) and as adjuvant treatment after surgery for 1 year
干预措施: Tislelizumab (Drug)
Tislelizumab Combined Lenvatinib
Patients enrolled will receive Tislelizumab combined Lenvatinibas neoadjuvant treatment before surgery (Tislelizumab: 200mg q3w*2 cycles+Lenvatinib 8/12mg qd*4weeks) and as adjuvant treatment after surgery for 1 year
干预措施: Tislelizumab combined with Levatinib (Drug)
结局指标
主要结局
Disease-free survival rate
时间窗: 1 year
Defined as the percent of patients without recurrence, progression or death in one year after enrollment
次要结局
- Objective response rate(At time of surgery)
- Incidence of severe adverse events(Three months after treatment)
- Major pathological response rate(At time of surgery)
研究者
Ming Kuang
Professor
Sun Yat-sen University