NCT05489289招募中3 期
A Randomized, Double-blind, Phase III Clinical Study on the Efficacy and Safety of AK104 Versus Placebo as Adjuvant Therapy for Hepatocellular Carcinoma With High Risk of Recurrence After Curative Resection
Akeso1 个研究点 分布在 1 个国家目标入组 570 人开始时间: 2023年1月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 570
- 试验地点
- 1
- 主要终点
- Recurrence free survival (RFS) by BICR
研究概览
简要总结
The efficacy and safety of AK104 as adjuvant therapy in hepatocellular carcinoma of high recurrence risk after curative resection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Pathological diagnosis of HCC without any metastasis;
- •Receiving radical resection as the only anti-tumor treatment;
- •No evidence of residual cancer found during or after the operation;
- •Presence of any high risk factor of postoperative recurrence;
- •Child-Pugh grade: A;
- •ECOG score: 0;
- •Controlled underlying causes of HCC.
排除标准
- •Fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc;
- •Any anti-tumor treatment other than radical surgery before randomization;
- •Precarious liver function indicated by severe complications;
- •Recent procedures or medications leading to high risk of bleeding;
- •Poorly controlled or symptomatic hypertension, congestive heart failure, arrhythmia, etc;
- •Failure of performing enhanced CT or MRI scans of the liver;
- •Recent severe infections or systemic antibiotics use;
- •Active autoimmune diseases;
- •History of other incurable malignant tumors;
- •History of transplantation;
研究组 & 干预措施
AK104
Active Comparator
AK104 IV every three weeks
干预措施: AK104 (Biological)
placebo
Placebo Comparator
Placebo IV every three weeks
干预措施: placebo (Biological)
结局指标
主要结局
Recurrence free survival (RFS) by BICR
时间窗: Up to 48 months
The time comfirmed by BICR from randomization to recurrence or death.
次要结局
- 12-months recurrence free survival (RFS-12)(12 months)
- Time to recurrence (TTR)(Up to 48 months)
- 24-months recurrence free survival (RFS-24)(24 months)
- Types and proportions of adverse events (AEs)(Up to 48 months)
- Overall survival (OS)(Up to 48 months)
研究者
研究点 (1)
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