A Phase III, Randomized, Double-blinded, Multicenter Study of Cadonilimab (AK104) + Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 469
- 试验地点
- 4
- 主要终点
- Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
研究概览
简要总结
A study to evaluate cadonilimab (AK104) + lenvatinib in combination with transarterial chemoembolization (TACE) versus TACE in participants with incurable/non-metastatic hepatocellular carcinoma
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
- •Has a diagnosis of HCC confirmed by histology/cytology，or meet the clinical diagnostic criteria of the American Association for the Study of Liver Diseases (AASLD)
- •No evidence of metastasis
- •Not amenable to curative surgery or transplantation or curative ablation but amenable to TACE
- •Child Pugh score class A
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
- •Measurable disease by RECIST 1.1
- •Adequate organ function
排除标准
- •History of liver transplantation
- •History of hepatic encephalopathy
- •Uncontrolled arterial hypertension
- •Deep venous thrombosis within 3 months before first treatment
- •Bleeding events within the last 6 months
- •Co-infection with HBV and HCV
研究组 & 干预措施
Arm A
AK104+ Lenvatinib in Combination With Transarterial Chemoembolization (TACE)
干预措施: AK104 (Drug)
Arm A
AK104+ Lenvatinib in Combination With Transarterial Chemoembolization (TACE)
干预措施: Lenvatinib (Drug)
Arm A
AK104+ Lenvatinib in Combination With Transarterial Chemoembolization (TACE)
干预措施: TACE (Procedure)
Arm B
Placebo for AK104 + Placebo for Lenvatinib in Combination With TACE
干预措施: TACE (Procedure)
Arm B
Placebo for AK104 + Placebo for Lenvatinib in Combination With TACE
干预措施: Placebo for AK104 (Other)
Arm B
Placebo for AK104 + Placebo for Lenvatinib in Combination With TACE
干预措施: Placebo for Lenvatinib (Other)
Arm C
AK104 + Placebo for Lenvatinib in Combination With TACE
干预措施: AK104 (Drug)
Arm C
AK104 + Placebo for Lenvatinib in Combination With TACE
干预措施: TACE (Procedure)
Arm C
AK104 + Placebo for Lenvatinib in Combination With TACE
干预措施: Placebo for Lenvatinib (Other)
结局指标
主要结局
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
时间窗: Up to approximately 2 years
PFS is defined as the time from randomization to the first documented progressive disease or death due to any cause, whichever occurs first. Responses are according to RECIST 1.1 as assessed by blinded independent central review (BICR).
次要结局
- Overall Survival (OS)(Up to approximately 2 years)
- PFS per RECIST 1.1(Up to approximately 2 years)
- Objective Response Rate (ORR) per RECIST 1.1 and Modified Response Evaluation Criteria in Solid Tumors (mRECIST)(Up to approximately 2 years)
- Time to Response (TTR) per RECIST 1.1 and mRECIST(Up to approximately 2 years)
- Duration of Response (DOR) per RECIST 1.1 and mRECIST(Up to approximately 2 years)
- Disease Control Rate (DCR) per RECIST 1.1 and mRECIST(Up to approximately 2 years)