NCT06280105招募中2 期
A Single-arm, Multicenter, Phase II Trial of Cadonilimab Plus Regorafenib in Patients With Hepatocellular Carcinoma Who Progressed on Camrelizumab Combined With Apatinib
Meng Chao Hepatobiliary Hospital of Fujian Medical University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年3月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- objective response rate (ORR) per RECIST1.1
研究概览
简要总结
To evaluate the efficacy and safety of cadonilimab combined with Regorafenib in patients with hepatocellular carcinoma who failed camrelizumab plus apatinib.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign a written informed consent form before enrollment;
- •Age >18 years old, both sex;
- •Histological or pathological confirmed intermediate or advanced hepatocellular carcinoma, or patients with cirrhosis who meet the clinical diagnostic criteria for hepatocellular carcinoma of the American Association for the Study of Liver Diseases (AASLD);
- •Have progressed on the combination treatment of camrelizumab and apatinib for HCC
- •Child-Pugh Class A;
- •ECOG PS score: 0~1;
- •At least 1 measurable lesion (RECIST1.1)
- •Expected survival period≥12 weeks
- •The function of vital organs meets the following requirements (excluding the use of any blood components and cell growth factors within 14 days):
- •Blood routine: Neutrophils≥1.5×109/L Platelet count ≥75×109/L Hemoglobin ≥ 90g/L;
- •Liver and kidney function: Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 50 ml/min (Cockcroft-Gault formula); Total bilirubin (TBIL) ≤ 3 times the upper limit of normal (ULN); Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤ 10 times the upper limit of normal (ULN); urine protein < 2+; if urine protein ≥ 2+, 24-hour urine protein quantification shows that the protein must be ≤ 1g;
- •Normal coagulation function, no active bleeding or thrombosis disease
- •International normalized ratio INR≤1.5×ULN;
- •Partial thromboplastin time APTT≤1.5×ULN;
- •Prothrombin time PT≤1.5×ULN;
- •Non-surgical sterilization or female patients of childbearing age
- •Subjects voluntarily join this study, have good compliance, and cooperate with safety and survival follow-up
排除标准
- •Containing components such as fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, and cholangiocarcinoma that have been previously confirmed by histology/cytology;
- •Have a history of hepatic encephalopathy;
- •Have a history of liver transplantation;
- •There is clinically significant pericardial effusion, and there are clinical symptoms of pleural effusion that require drainage;
- •Clinically apparent ascites is defined as meeting the following criteria: ascites can be detected by physical examination during screening or ascites needs to be drained during screening;
- •Simultaneous infection with HBV and HCV (having a history of HCV infection but negative HCV RNA can be considered as not being infected with HCV);
- •Presence of central nervous system metastasis or meningeal metastasis
- •Bleeding from esophageal or gastric varices caused by portal hypertension has occurred within 6 months before the first dose
- •Patients with any bleeding or bleeding event ≥CTCAE grade 3 within 4 weeks before the first dose
- •Arterial and venous thromboembolic events occurred within 6 months before the first dose
- •Uncontrolled high blood pressure
- •Symptomatic congestive heart failure
- •Severe bleeding tendency or coagulation disorder
- •Have a history of gastrointestinal perforation and/or fistula, intestinal obstruction within 6 months before the first dose
- •Active autoimmune disease or a history of autoimmune disease
- •Patients with HIV
- •According to the investigator's judgment, patients with other serious concomitant diseases that endanger the patient's safety or affect the patient's completion of the study.
研究组 & 干预措施
cadonilimab+regorafenib
Experimental
干预措施: Cadonilimab+regorafenib (Drug)
结局指标
主要结局
objective response rate (ORR) per RECIST1.1
时间窗: Up to two years
The proportion of all subjects with the best overall response (BOR) as complete remission (CR) or partial remission (PR) according to RECIST 1.1 criteria.
次要结局
- Progression-free survival（PFS）(Up to two years)
- Overall survival（OS）(Up to three years)
- Duration of response (DOR)(Up to two years)
- Occurence of AE and SAE(Up to two years)
研究者
Yongyi Zeng
Director
Meng Chao Hepatobiliary Hospital of Fujian Medical University
研究点 (1)
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