A Real-world Study on the Addition of Lenalidomide to Reverse Resistance After First-line Treatment Lenvatinib Combined With PD-1 Therapy in Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 1 year PFS
研究概览
简要总结
This study is a real-world, single-arm, observational study primarily collecting data on patients with hepatocellular carcinoma who experienced disease progression after receiving lenvatinib in combination with PD-1 inhibitors as part of routine clinical practice, and evaluating the efficacy of adding lenalidomide to their treatment regimen.
详细描述
This study is a real-world, single-arm, observational study primarily collecting data on patients with hepatocellular carcinoma who experienced disease progression after receiving lenvatinib in combination with PD-1 inhibitors as part of routine clinical practice, and evaluating the efficacy of adding lenalidomide to their treatment regimen.
The treatment drugs used in this study are: Lenvatinib mesylate capsules (imported or domestically produced), immunotherapy: PD-1 inhibitors (approved for marketing in China and abroad), and Lenalidomide capsules.
The study population was divided into three groups: 1. Patients with advanced, unresectable hepatocellular carcinoma treated with lenvatinib in combination with a PD-1 inhibitor, who showed imaging evidence of disease progression (defined as an increase in the maximum diameter of the primary tumor by more than 20% or the emergence of new lesions) and were planned to receive additional treatment with lenalidomide; 2. Patients currently receiving lenvatinib plus PD-1 inhibitor plus lenalidomide therapy due to disease progression; 3. Patients who have previously received lenvatinib plus PD-1 inhibitor plus lenalidomide therapy; Participants in categories 1 and 2 will sign an informed consent form and be enrolled in this study for symptomatic treatment. Category 3 study participants, who have previously received this treatment regimen, cannot obtain informed consent. Therefore, this study has applied for informed consent waiver for Category 3 study participants (this option is not available in the reporting system).
According to standard clinical treatment principles, collect hematological examination data from patients one week and one month after receiving combination therapy with lenvatinib + PD-1 inhibitor + lenalidomide.Collect hematological and imaging examination data two months after combination therapy, and evaluate the imaging data at the two-month mark to determine whether the tumor has progressed.Each observation cycle lasts two months.
Enrollment standard：
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
- •Age ≥ 18 years old;
- •Patients with hepatocellular carcinoma who previously received lenvatinib and PD-1 inhibitors and whose tumors progressed on imaging (enhanced MRI, enhanced CT, or PET-CT) were treated with lenalidomide；
- •Expected survival period exceeding 3 months;
- •Patients with a history of other malignant tumors who have been disease-free for more than 2 years after initial treatment (such as non-melanoma skin cancer or cervical carcinoma in situ);
- •Participants of childbearing age agreed to use contraception during the study period;
排除标准
- •Fibrous plate layer or sarcomatoid HCC or mixed type HCC-ICC;
- •Currently participating in and receiving other experimental treatments;
- •Previously underwent solid organ transplantation, diagnosed with immunodeficiency;
- •Bleeding from esophageal or gastric varices within 3 months prior to enrollment;
- •Hepatic encephalopathy in the past 6 months, or obvious ascites at enrollment;
- •Active infection requiring systemic treatment;
- •CTCAE grading Platelet count < 50 × 10⁹/L or neutrophil count < 1 × 10⁹/L
- •Pregnant or breastfeeding women;
- •Patients with myocardial ischemia or myocardial infarction graded CTCAE grade II or higher, or uncontrolled arrhythmia;
- •Patients who have previously used pomalidomide or thalidomide;
- •Patients who have previously received CTLA-4 in combination with PD-1/PD-L1 inhibitors;
- •Other situations deemed unsuitable for participation in this trial by researchers;
研究组 & 干预措施
Treatment group
In clinical practice, for patients with hepatocellular carcinoma (HCC) who have received targeted therapy combined with immune checkpoint inhibitors as first-line treatment and subsequently experienced disease progression, lenalidomide capsules are incorporated into the regimen (administered orally on days 1-21, followed by a 7-day treatment-free interval, repeating every 28 days per cycle).
干预措施: lenalidomide (Drug)
结局指标
主要结局
1 year PFS
时间窗: Following the administration of lenalidomide combination therapy, imaging examinations of lesion sites should be performed every two months to assess tumor status.
The time from enrollment in the clinical study until the first evidence of disease progression or death.Every two month, up to 1 year
OS
时间窗: For one year or longer, until death
From the start of treatment until death from any cause
次要结局
未报告次要终点