The Efficacy of Sequential Radiotherapy After the Combination of Transcatheter Arterial Chemoembolization With Lenvatinib and Anti-PD-1 Antibodies for Unresectable Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- OS
研究概览
简要总结
Triple therapy of transcatheter arterial chemoembolization (TACE) combined with lenvatinib and anti-PD-1 antibodies has demonstrated excellent efficacy in unresectable hepatocellular carcinoma (uHCC). However, tumor drug resistance is still a major problem and many patients fail to achieve complete necrosis of the lesions after treatment. This study aimed to investigate the efficacy and safety of sequential radiotherapy after triple therapy in patients with uHCC to improve tumor response rate.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with HCC and assessed as unresectable by multidisciplinary team (MDT)
- •Patients who achieved PR or SD after triple therapy according to the mRECIST and did not meet the criteria for radical surgical resection or could not tolerate surgical treatment
- •Patients who received sequential radiotherapy
- •Age between 18 and 75 years
- •Child-Pugh class A or B
- •Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-1
排除标准
- •Previous acceptance of other antitumor treatments
- •Treatment in conjunction with other treatment regimens, such as radiofrequency ablation and chemotherapy
- •History of other malignancies
- •Incomplete data.
研究组 & 干预措施
sequential radiotherapy after triple therapy
Patients with unresectable hepatocellular carcinoma received sequential radiotherapy after the combination of transcatheter arterial chemoembolization with lenvatinib and anti-PD-1 antibodies
干预措施: sequential radiotherapy after the combination of transcatheter arterial chemoembolization (TACE) combined with lenvatinib and anti-PD-1 antibodies (Drug)
结局指标
主要结局
OS
时间窗: From date of randomization until the date of date of death from any cause or the most recent follow-up, whichever came first, assessed up to 100 months
overall survival
次要结局
- PFS(From date of randomization until the date of first documented progression, the date of death from any cause or the date of most recent follow-up, whichever came first, assessed up to 100 months)
- ORR(From date of randomization until the date of the best tumor response is achieved, assessed up to 100 months)
研究者
Mao-Lin Yan
professor
Fujian Provincial Hospital