Phase II Study Evaluating the Efficacy of Tremelimumab (T) Plus Durvalumab (D) With Lenvatinib Combined With Concurrent Hepatic Arterial Infusion Chemotherapy (HAIC) in Patients (Pts) With Unresectable Hepatocellular Carcinoma (uHCC)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
The treatment options for unresectable HCC have rapidly developed, and immunotherapy has shown significant survival benefits in hepatocellular carcinoma. The STRIDE regimen of Single Tremelimumab (high, priming 300-mg dose) Regular Interval Durvalumab (1500 mg every 4 weeks) improved OS vs sorafenib in pts with unresectable HCC. In Asian region, HAIC is applied for HCC patients who are not suitable for surgical resection or local ablation treatment. Retrospective studies suggested a potent antitumor effect and survival benefit of HAIC plus programmed death-1 inhibitor and Lenvatinib. This phase II study was aimed to evaluate the efficacy and safety of STRIDE plus lenvatinib, given concurrently with HAIC in pts with unresectable HCC.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 ~ 70 years old (including 70 years old), male and female;
- •Patients with hepatohcellular carcinoma diagnosed clinically or confirmed by histology / cytology ;
- •Patients with unresectable or metastatic hepatocellular carcinoma;
- •No systematic treatment. Patients recieved previously systematic treatment and progressed can also be included in the group;
- •Patients who underwent hepatectomy in the past should be R0 resection, and the tumor recurrence should be more than 6 months after operation;
- •At least one assessable lesion (mRECIST criteria);
- •Expected survival time ≥ 3 months;
- •ECOG 0 ~ 1;
- •Child Pugh ≤ 7;
- •Be able to cooperate to observe adverse events;
- •Major organs are functioning normally:
- •Hemoglobin ≥ 90 g / L;
- •ANC ≥ 1.5 × 109/L；
- •Platelet count ≥ 75 × 109/L；
- •Albumin ≥ 28 g / L;
- •Total bilirubin ≤ 2 × ULN;
- •AST, ALT ≤ 5 × ULN；
- •ALP ≤ 5 × ULN；
- •Creatinine ≤ 1.5 × ULN；
- •INR or PT ≤ 1.5 × ULN； J) APTT ≤ 1.5 × ULN。
排除标准
- •History of symptomatic congestive heart failure, unstable angina pectoris,
- •Uncontrolled cardia arrhythmia
- •History of hepatic encephalopathy
- •Uncontrolled arterial hypertension
- •Co-infection with HBV and HDV
研究组 & 干预措施
Treating with a Designed Protocol
干预措施: HAIC+STRIDE+Len (Drug)
结局指标
主要结局
ORR
时间窗: about 1 year
objective response rate
次要结局
- OS(about 3 year)
- AE(about 3 year)
- PFS(about 1.5 year)
- DCR(about 1 year)
研究者
Sulai Liu
Hepatobiliary Surgical Department
Hunan Provincial People's Hospital