NCT06935175尚未招募2 期
A Study of SHR-1826 Monotherapy or in Combination With Immunotherapy in Patients With Advanced Hepatocellular Cancer
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2025年5月1日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR) by RECIST V1.1
研究概览
简要总结
The study was designed to evaluate the efficacy and safety of SHR-1826 monotherapy or in combination with immunotherapy in the treatment of advanced hepatocellular cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •1.18-75 years old, male or female.
- •2.Hepatocellular carcinoma diagnosed histologically or cytologically, and not suitable for radical surgery;
- •3.Failure of at least one line of standard treatment (progression or intolerance);
- •4.According to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), there is at least one measurable lesion diagnosed by imaging (a lesion that has received local treatment needs to show clear progression to be considered a measurable lesion);
- •5.Expected survival time ≥ 12 weeks;
- •6.Normal function of major organs;
- •7.The subject voluntarily participates in this study, signs the informed consent form, has good compliance, and cooperates with the follow-up.
排除标准
- •Known or suspected to have a severe allergic history to the drugs related to this study (including drugs of the same type);
- •Evidence of liver decompensation: including but not limited to symptomatic ascites, esophageal-gastric variceal bleeding, hepatic encephalopathy, hepatorenaHave central nervous system metastasis;l syndrome, sepsis, etc.;
- •Have central nervous system metastasis;
- •Have a history of organ transplantation or are preparing for organ transplantation (including but not limited to liver transplantation);
- •Have a history of abdominal wall fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months before the start of treatment in the study;
- •Other situations in which the investigator deems that the subject should not be included.
研究组 & 干预措施
SHR-1826 monotherapy arm
Experimental
干预措施: SHR-1826 (Drug)
SHR-1826 and immunotherapy combination therapy
Experimental
干预措施: SHR-1826 and immunotherapy combination therapy (Drug)
结局指标
主要结局
Objective Response Rate (ORR) by RECIST V1.1
时间窗: up 2 years
The ORR is defined as complete remission (CR) rate + partial remission (PR) rate by RECIST V1.1.
次要结局
- Progression-free survival (PFS)(up 2 years)
- Objective Response Rate (ORR) by mRECIST(up 2 years)
- Disease control rate (DCR) by RECIST V1.1(up 2 years)
- Overall survival (OS)(up 2 years)
研究者
研究点 (1)
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