Safety and Efficacy Study of Lenvatinib Combined With VIC-1911 for the Treatment of Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This study is a single-arm, open-label trial to clarify the safety and efficacy of the combined treatment of lenvatinib and VIC-1911 in patients with advanced liver cancer.
详细描述
This study is a single-arm, open-label trial to clarify the safety and efficacy of the combined treatment of lenvatinib and VIC-1911 in patients with advanced liver cancer.
Purpose of the Study:
To observe and determine the safety and efficacy of lenvatinib combined with VIC-1911 in the treatment of patients with advanced liver cancer.
Sample Size:
According to the research plan, the administration of the study medication is divided into two stages, with 3 patients enrolled in the accelerated titration phase and 12 patients in the expansion phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Gender unrestricted, age 18-75 years;
- •HCC conforms to AASLD or EASL clinical diagnostic standards;
- •HCC Barcelona Clinic Liver Cancer (BCLC) staging is C, with at least one measurable tumor in the liver (longest diameter ≥1cm);
- •Liver function Child-Pugh Class A or Class B with a score of 7;
- •ECOG score of 0-1;
- •Platelet count ≥60×10^9/L, PT time prolongation ≤6 seconds.
排除标准
- •Irreversible coagulation dysfunction, with obvious bleeding tendency;
- •Patients who need long-term anticoagulation or antiplatelet treatment and cannot stop medication;
- •Patients with unstable or active ulcers, gastrointestinal bleeding;
- •Patients with untreated heart disease or poorly controlled hypertension as judged by the researcher;
- •Severe dysfunction of important organs, such as severe cardiopulmonary dysfunction;
- •Patients with hepatic encephalopathy or refractory ascites requiring treatment;
- •Human Immunodeficiency Virus (HIV) infection;
- •Active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection (activity defined as viral load > 20000 IU/mL), or HBV, HCV positive patients who refuse to accept standardized antiviral treatment;
- •Inability to swallow oral medication.
- •Gastrointestinal diseases that may affect the absorption or tolerance of the study medication.
- •History of corneal epithelial cysts or other causes of blurred vision, or medical abnormalities found in ophthalmic screening.
- •Known allergy to VIC-1911 or its components.
- •Within 4 weeks before the study, radiotherapy or interventional therapy for the disease under study was performed;
- •Other concurrent antitumor treatments;
- •The researcher assesses that the patient cannot or is unwilling to comply with the requirements of the study protocol.
研究组 & 干预措施
Phase 2: Expansion phase
According to the final dosing regimen selected, enroll 12 patients and observe for 3 months.
干预措施: Lenvatinib Combined with VIC-1911 (Drug)
Phase 1: Accelerated titration phase
Plan to enroll 3 patients. First, enroll 1 patient, give the initial dose of VIC-1911 25mg BID, observe for 1 week, if there is no dose-limiting toxicity (DLT), increase to 50mg BID. At the same time, enroll another 2 patients, give VIC-1911 25mg BID, observe for 1 week, if no DLT, increase to 50mg BID. Observe for 2 weeks at a dose of 50mg, if no DLT occurs, continue to increase to 75mg BID, observe for 4 weeks. If no DLT occurs, continue to increase by 25mg doses, with an observation period of 4 weeks, until one case of dose-limiting toxicity or two cases of moderate toxicity occur during the titration process, then reduce to the previous dose, and determine it as the final dosing regimen.
干预措施: Lenvatinib Combined with VIC-1911 (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: 2 years
Objective Response Rate (ORR) is defined as the proportion of patients experiencing a complete or partial response to a treatment
次要结局
- Overall Survival (OS)(2 years)
- Progression-Free Survival (PFS)(2 years)