A Real-world Study of Lenvatinib Combined With Chinese Herbal Medicine for Patients With Unresectable Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Survival analysis
研究概览
简要总结
This study aims to assess the effectiveness and safety of lenvatinib plus Chinese Herbal Medicine (CHM) for patients with uHCC in China.
详细描述
Liver resection is one of the most important treatments for hepatocellular carcinoma (HCC). However, only a minority of patients have the opportunity to undergo surgery. The development of systemic therapy has dramatically changed the management of unresectable HCC (uHCC). And lenvatinib garners a recommendation as the primary treatment for uHCC. Many patients with uHCC in Asian countries seek complementary and alternative therapies with traditional Chinese medicine (TCM). However, the impact of lenvatinib combined with CHM on uHCC patients remains unclear. In this study, we conducted a retrospective cohort study to assess the effectiveness and safety of lenvatinib plus CHM for patients with uHCC in China.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 18 years old
- •histologically confirmed HCC unsuitable for resection
- •lenvatinib as first- or second-line therapy
排除标准
- •patients with other primary tumors
- •patients who had only one visit record and were lost to follow-up or refused follow-up
- •patients with any other factors affecting study data collection
研究组 & 干预措施
Lenvatinib combined with Chinese Herbal Medicine
干预措施: Chinese Herbal Medicine (Drug)
结局指标
主要结局
Survival analysis
时间窗: 2022/10/01-2023/12/31
Kaplan-Meier estimates of progression-free survival (PFS)
Efficacy outcomes
时间窗: after 8 weeks of the initiation of Lenvatinib combined with Chinese Herbal Medicine
Tumor Response after 8 weeks of treatment according to the modified Response Evaluation Criteria in Solid Tumor (mRECIST)
次要结局
- Adverse Events assessment(after 8 weeks of the initiation of Lenvatinib combined with Chinese Herbal Medicine)
研究者
Donghua Liu
Director
Guangzhou University of Chinese Medicine