NCT06031480尚未招募2 期
Study of Combination Treatment Using Anlotinib and TQB2450 in Patients With Advanced Hepatocellular Carcinoma Who Failed Prior Immune Checkpoint Inhibitor Therapies: a Single Arm, Multicenter Clinical Trial
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2023年10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
- 尚未招募
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR, RECIST v1.1)
研究概览
简要总结
This is an multi-center, single arm, exploratory study to evaluate the efficacy and safety of anlitinib combined with TQB2450 in patients with advanced hepatocellular carcinoma （HCC）who failed prior immune checkpoint inhibitor therapies.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participants must be required to sign an informed consent
- •Hepatocellular carcinoma patients confirmed by pathological or cytological examination, or who meet the clinical diagnostic criteria of the "Guidelines for the Diagnosis and Treatment of primary hepatocellular carcinoma" (2022)
- •At least one measurable lesion (RECIST 1.1)
- •Chinese Liver Cancer Staging (CNLC): CNLC-IIa, IIb, IIIa, IIIb (BCLC-B and C) that are not suitable for local treatment (TACE, HAIC, etc.) or that have progressed after local treatment
- •The previous treatment plan for patients before enrollment was a standard treatment plan containing immune checkpoint inhibitors, and patients with progression or intolerance were evaluated based on the RECIST v1.1 standard
- •Child-Pugh Score, Class A or better B
- •ECOG performance status 0 or 1
- •Adequate organ function
- •Life expectancy of at least 3 months
排除标准
- •Patients who have received local treatment (including TACE, ablation, HAIC, radiotherapy) and are less than 1 month after enrollment
- •Patients who have received ≥ 2 treatments with immune checkpoint inhibitor regimens
- •Adverse events above level 1(NCI-CTCAE v5.0) caused by any previous treatment that have not returned to ≤ level 1 (excluding hair loss); Patients with previous severe immune-related AEs requiring permanent cessation of immunotherapy
- •Pregnant or lactating wome
研究组 & 干预措施
anlotinib+TQB2450
Experimental
干预措施: Anlotinib and TQB2450 (Drug)
结局指标
主要结局
Objective response rate (ORR, RECIST v1.1)
时间窗: 24 months
ORR is defined as the proportion of subjects with complete response (CR) or partial response (PR) to study drugs
次要结局
未报告次要终点
研究者
研究点 (1)
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