NCT07099274招募中2 期
A Single-Arm, Single-Center Clinical Study Evaluating the Efficacy and Safety of Lparomlimab and Tuvonralimab Injection in Combination With TACE and Lenvatinib as Second-Line Therapy for Unresectable Intermediate-to-Advanced Hepatocellular Carcinoma
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2025年8月22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
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
Major objectives To evaluate the efficacy of lparomlimab and Tuvonralimab injection (QL1706, an Anti-PD-1/ CTLA-4 Combined Antibody) in combination with TACE and lenvatinib as second-line therapy in patients with unresectable intermediate-to-advanced hepatocellular carcinoma.
详细描述
This single-arm, single-center clinical study aims to evaluate the efficacy and safety of lparomlimab and Tuvonralimab injection (QL1706, an Anti-PD-1/ CTLA-4 Combined Antibody) in combination with TACE and lenvatinib as second-line therapy in patients with unresectable intermediate-to-advanced hepatocellular carcinoma. This study consists of three phases: screening, treatment, and follow-up. Efficacy evaluation and safety monitoring should be performed throughout the study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Comprehension and voluntary signing of the study's informed consent form;
- •Age ≥18 years, any gender;
- •Histologically or clinically confirmed hepatocellular carcinoma;
- •Documented failure or intolerance to first-line therapy with PD-1/PD-L1 inhibitor plus bevacizumab;
- •ECOG performance status 0-2;
- •Child-Pugh class A or class B (score ≤7) without hepatic encephalopathy history;
- •Life expectancy ≥3 months;
- •At least one measurable target lesion confirmed by screening imaging per RECIST v1.1;
- •Adequate organ and bone marrow function within 7 days prior to initial study treatment;
- •Active HBV/HCV infection requires ongoing antiviral therapy; k.Fertile patients must use highly effective contraception with partners during treatment and ≥180 days post-last dose.
排除标准
- •Inability to comply with the study protocol or procedures;
- •Histologically/cytologically confirmed fibrolamellar HCC, sarcomatoid HCC, cholangiocarcinoma, or mixed hepatocellular-cholangiocarcinoma;
- •History of liver transplantation or planned transplantation;
- •Presence of central nervous system metastases and/or leptomeningeal carcinomatosis;
- •Baseline imaging showing Vp4 portal vein tumor thrombosis;
- •Hypersensitivity to any study drug components or history of severe allergic reactions;
- •Concurrent HBV and HCV co-infection;
- •Clinically significant ascites requiring intervention during screening;
- •Concurrent use of other investigational drugs or participation in another clinical trial within 4 weeks prior to enrollment;
- •Esophageal/gastric variceal bleeding due to portal hypertension within 6 months before treatment initiation, or high-risk varices on endoscopy within 3 months;
- •Current interstitial lung disease (ILD), history of steroid-required ILD, or other pulmonary fibrosis/organizing pneumonia affecting immune-related pulmonary toxicity assessment;
- •Uncontrolled hypertension (SBP≥160 mmHg and/or DBP≥100 mmHg despite medication), coronary artery disease, arrhythmias, or heart failure (NYHA Class ≥II);
- •Uncontrolled clinically significant infections requiring IV antimicrobial therapy;
- •Proteinuria ≥2+ (≥1.0g/24h);
- •History of hemorrhagic tendency regardless of severity within 2 months prior to enrollment;
- •Arterial/venous thromboembolic events within 12 months before treatment initiation (e.g., cerebrovascular accident including TIA);
- •Acute myocardial infarction, acute coronary syndrome, or CABG within 6 months before treatment;
- •Unhealed fractures or chronic non-healing wounds;
- •Coagulopathy, bleeding diathesis, or current therapeutic anticoagulation;
- •Other malignancies within 5 years except curatively resected basal/squamous cell skin carcinoma or cervical carcinoma in situ;
- •Active autoimmune disease or autoimmune disease history requiring immunosuppression within 4 weeks prior to enrollment;
- •Prior allogeneic bone marrow or solid organ transplantation;
- •Investigator assessment of ineligibility based on medical/safety reasons.
研究组 & 干预措施
lparomlimab and Tuvonralimab Injection in Combination with TACE and Lenvatinib
Experimental
lparomlimab and Tuvonralimab Injection in Combination with TACE and Lenvatinib
干预措施: lparomlimab and Tuvonralimab Injection in Combination with TACE and Lenvatinib (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: up to 12 month
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first.
次要结局
- Overall survival(up to 36 month)
- Objective response rate(up to 12 month)
- Disease Control Rate(up to 12 month)
- Duration of Response(up to 12 month)
- Adverse Events(up to 36 month)
研究者
研究点 (1)
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