NCT07081633进行中（未招募）2 期
An Open-label, Multi-center Phase II Study of Durvalumab and Tremelimumab With Lenvatinib as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 114
- 试验地点
- 24
- 主要终点
- Progression free survival (PFS) per RECIST 1.1
研究概览
简要总结
This is a Phase II, single-arm, multicentre study, assessing the efficacy and safety of durvalumab and tremelimumab with lenvatinib in participants 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed HCC based on histopathological findings from tumor tissues or radiologically findings.
- •Must not have received prior systemic therapy for unresectable HCC.
- •Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C.
- •Child-Pugh Score class A.
- •ECOG performance status of 0 or 1 at enrollment.
- •At least 1 measurable lesion per RECSIT 1.1 guidelines
排除标准
- •Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) Grade ≥2 from previous anticancer therapy.
- •History of hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy.
- •Clinically meaningful ascites.
- •Patients with main portal vein thrombosis.
- •Active or prior documented GI bleeding.
- •Patient currently exhibits symptomatic or uncontrolled hypertension.
- •Patients co-infected with HBV and HCV, or co-infected with HBV and hepatitis D virus (HDV)
- •Uncontrolled intercurrent illness
研究组 & 干预措施
Single Arm
Experimental
Durvalumab and Tremelimumab with Lenvatinib
干预措施: Durvalumab (Drug)
Single Arm
Experimental
Durvalumab and Tremelimumab with Lenvatinib
干预措施: Tremelimumab (Drug)
Single Arm
Experimental
Durvalumab and Tremelimumab with Lenvatinib
干预措施: Lenvatinib (Combination Product)
结局指标
主要结局
Progression free survival (PFS) per RECIST 1.1
时间窗: From the date of first dose until the date of objective PD per RECIST 1.1 or death, whichever came first. It will be assessed when approximately 69 PFS events have occurred (60% maturity), approximately 8 months after the last patients dosed.
Efficacy endpoint
次要结局
- Grade ≥ 3 TRAE within 6 months after the initiation of study intervention(From first dose to 6 months after the initiation of study intervention)
- Overall Survival (OS)(From the date of the first dose of study intervention until death due to any cause. It will be assessed when approximately 69 OS events have occurred (60% maturity), approximately 24 months after last participant has been assigned to study intervention.)
- Objective Response Rate (ORR) per RECIST 1.1(From the date of the first dose of study intervention until the date of objective PD per RECIST 1.1. It is anticipated that this analysis will be performed approximately 8 months after the last patient has been assigned to study intervention.)
- Disease Control Rate (DCR) per RECIST 1.1(From the date of the first dose of study intervention until the date of objective PD per RECIST 1.1. It is anticipated that this analysis will be performed approximately 8 months after the last patient has been assigned to study intervention.)
- Duration of response (DoR) per RECIST 1.1(From the date of response until the date of objective PD per RECIST 1.1 or death, whichever came first. It is anticipated that this analysis will be performed approximately 8 months after the last patient dosed.)
- Progression Free Survival (PFS) per mRECIST(From the date of the first dose until the date of objective PD per mRECIST or death, whichever came first. It will be assessed when approximately 69 PFS events have occurred (60% maturity), approximately 8 months after the last patients dosed.)
研究者
研究点 (24)
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