NCT06361758撤回2 期
Second-line Treatment With CAdonilimab and LEnvatinib for Unresectable HCC: A Single Arm, Multicenter, Phase II Trial. (SCALE)
Shanghai Zhongshan Hospital3 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年5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
- 撤回
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Objective Response Rate (ORR) per RECIST v1.1
研究概览
简要总结
This is an open-label, multi-center, single-arm, phase II study to evaluate the efficacy and safety of lenvatinib in combination with cadonilimab as second-line therapy in subjects with advanced hepatocellular carcinoma (HCC) who failed first-line standard therapy of immunotheray and antiangiogenic therapy.
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 and be able to comply with the visit and related procedures required by the study protocol
- •Age 18-75 years old, Male of Female
- •ECOG PS 0-1
- •histologically/cytologically or clinically (according to Chinese guidelines for primary liver cancer diagnosis and treatment (2022) criteria) confirmed initial diagnosis of HCC
- •Not suitable for radical surgery and/or local treatment, BCLC stage C or stage B who failed local treatment
- •Patients who progressed on first-line standard system therapy (Atezolizumab plus bevacizumab, sintilimab combined with bevacizumab, or Camrelizumab and Apatinib, only these three regimenes) or with intolerable toxicity ( except for immunotherapy intolerance)
- •Child Pugh A-B7
- •Expected survival time≥12 weeks
- •At least one measurable lesion (RECIST 1.1)
- •Enough organ and bone marrow function
排除标准
- •Fibrolamellar sarcomatoid or mixed cholangiocarcinoma-hepatocellular carcinoma.
- •Other anti-tumor therapies have been received after first-line systemic anti-tumor therapy.
- •Have history of hepatic encephalopathy, or a history of liver transplantation.
- •There are clinical symptoms requiring drainage of pleural fluid, ascites, pericardial effusion.
- •People with acute or chronic active hepatitis B or hepatitis C, hepatitis B virus (HBV) DNA > 2000IU/ml or 10^4 copies /ml; Hepatitis C virus (HCV) RNA > 10^3 copies /ml; Hepatitis B surface antigen (HbsAg) and anti-HCV antibodies were both positive.
- •Central nervous system metastasis.
- •Previous bleeding from esophageal or fundus varices due to portal hypertension occurred within 6 months.
- •Autoimmune immune disease.
- •HIV infection.
- •Pregnant women.
- •The presence of any serious or uncontrolled systemic disease.
- •Other acute or chronic diseases, psychiatric disorders or abnormal laboratory test values that may lead to the following results: increasing the risk associated with research or drug administration, or interfering with the interpretation of research results. The Investigator considers that there are other potential risks that are not suitable for participation in the study.
研究组 & 干预措施
Cadonilimab+Lenvatinib
Experimental
干预措施: Cadonilimab+Lenvatinib (Drug)
结局指标
主要结局
Objective Response Rate (ORR) per RECIST v1.1
时间窗: Up to two years
Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1.
次要结局
- Objective Response Rate (ORR) per mRECIST(Up to two years)
- Disease control Rate (DCR)(Up to two years)
- Duration of response (DoR)(Up to two years)
- Progression-Free-Survival (PFS)(Up to two years)
- Overall survival Overall survival (OS)(Up to three years)
- Incidence of Adverse Events(Up to two years)
研究者
Hui-Chuan Sun
Director
Shanghai Zhongshan Hospital
研究点 (3)
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