A Multicenter, Open-label Phase II/III Clinical Trial of VRT106 in Combination With Camrelizumab and Apatinib in Patients With Advanced Hepatocellular Carcinoma Who Have Failed Immune Checkpoint Inhibitor Therapy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Incidence of Dose-Limiting Toxicities
研究概览
简要总结
This is an open-label phase II/III clinical trial enrolling patients with advanced HCC who have failed prior ICIs. The phase II portion consists of a part A dose-escalation stage and a part B dose-expansion stage. The phase III study will be initiated following discussions with National Medical Products Administration (NMPA) regarding the phase III protocol, based on accumulated data from phase II including safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD).
详细描述
Phase II Part A: To evaluate the safety and tolerability of VRT106 in combination with camrelizumab and apatinib at different dose levels in patients with HCC who have failed prior ICIs, and to determine the recommended phase II dose (RP2D).
Phase II Part B: To evaluate the progression-free survival (PFS) of VRT106 in combination with camrelizumab and apatinib at the RP2D versus investigator's choice of standard of care in patients with advanced HCC who have failed prior ICIs.
Phase III: To evaluate the overall survival (OS) of VRT106 in combination with camrelizumab and apatinib versus investigator's choice of standard of care in patients with advanced HCC who have failed prior ICIs.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Voluntarily sign the informed consent form (ICF), understand the nature of this study, and agree to comply with and complete all required study procedures.
- •Be aged between 18 and 75 years (inclusive) on the date of signing the ICF, regardless of gender.
- •Have a histologically or cytologically confirmed diagnosis of advanced hepatocellular carcinoma (HCC), or a clinical diagnosis of advanced HCC according to the Standard for Diagnosis and Treatment of Primary Liver Cancer(2024 Edition).
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or
- •Have an anticipated life expectancy of ≥ 3 months.
- •Have no severe hematologic, hepatic, renal, coagulation, or cardiac function abnormalities.
排除标准
- •Prior receipt of camrelizumab, apatinib, oncolytic viruses, or other gene therapies.
- •Receipt of other unapproved investigational drugs/devices within 4 weeks or 5 half-lives (whichever is shorter) prior to first dose administration in this study, or immunocompromised status.
- •History of splenectomy.
- •Pregnant or breastfeeding women.
研究组 & 干预措施
VRT106 Combination
VRT106 in combination with camrelizumab and apatinib
干预措施: VRT106 in combination with camrelizumab and apatinib (Drug)
Standard of Care
Investigator's Choice of Standard of Care
干预措施: Investigator's Choice of Standard of Care (Drug)
VRT106 Monotherapy
VRT106
干预措施: VRT106 (Drug)
结局指标
主要结局
Incidence of Dose-Limiting Toxicities
时间窗: Dose-limiting toxicity (DLT) will be assessed within 56 days following the first administration of VRT106.
Safety assessments included: AEs, SAEs, physical examination, vital signs, ECOG PS, 12-lead ECG, echocardiography, and clinical laboratory evaluations.
次要结局
- Progression-Free Survival(About 2 years)
- Overall survival(About 2 years)