NCT04635527终止1 期
A Phase Ib Study to Evaluate the Safety and Efficacy of IBI318 Combined With Conventional TACE (cTACE) as a Perioperative Treatment for Potentially Resected Hepatocellular Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of participants experiencing clinical and laboratory adverse events (AEs)
研究概览
简要总结
The purpose of this phase Ib study is to assess the safety, tolerability and effectiveness of IBI318 in combination with conventional TACE (cTACE) in patients with potentially resected 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
- •Aged ≥ 18 years and ≤ 75 years at the time of consent.
- •Hepatocellular carcinoma confirmed by histology/cytology.
- •Lesions with measurable disease at baseline by mRECIST.
- •Barcelona Clinic Liver Cancer stage A or B for hepatocellular carcinoma exceeding Milan criteria.
- •Child-Pugh: <=6
- •Adequate organ and bone marrow function.
排除标准
- •With fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma components in tumor tissues.
- •Having previously received standard systemic therapy, ablative therapy, interventional therapy and surgical treatment for hepatocellular carcinoma.
- •Potential liver transplant candidates
- •Have a history of hepatic encephalopathy or have a history of liver transplantation.
- •With clinical symptoms requires drainage of pleural effusion, ascites or pericardial effusion.
研究组 & 干预措施
IBI318 combined with conventional TACE (cTACE)
Experimental
干预措施: IBI318 (Drug)
IBI318 combined with conventional TACE (cTACE)
Experimental
干预措施: cTACE (Procedure)
Placebo combined with conventional TACE (cTACE)
Placebo Comparator
干预措施: cTACE (Procedure)
Placebo combined with conventional TACE (cTACE)
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Number of participants experiencing clinical and laboratory adverse events (AEs)
时间窗: Up to 90 days post last dose
次要结局
- Overall survival (OS) in two arms(3 years)
- The percentage of subjects with pathological Complete Response (pCR) after liver resection(3 years)
- The percentage of subjects with R0 resection(3 years)
- The percentage of subjects with major pathological response (MPR) after liver resection(3 years)
- Objective response rate (ORR) in two arms based on mRECIST by investigator(3 years)
- Disease-free survival (DFS) in two arms based on mRECIST by investigator(3 years)
研究者
研究点 (1)
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