Efficacy and Safety of Immune Checkpoint Inhibitors (ICIs) and Tyrosine Kinase Inhibitors (TKIs) Therapy for Hepatocellular Carcinoma (HCC)：a Multicenter, Retrospective Study on the Real-world in China
试验速览
- 阶段
- 不适用
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- The overall survival (OS)
研究概览
简要总结
China is a high-risk area of Hepatocellular Carcinoma (HCC). Although Chinese population accounts for 18.4% of the global population, the number of new HCC patients accounting for about half of the global, which seriously threatens the lives and health of the people. The investigators establish multi-center, retrospective research methods, collecting the data of HCC treatment with system treatment (ICIs and TKIs) plus or without local treatment in the last 3 years, comprehensive assessment of their efficacy and safety, explore whether the efficacy of system treatment combination local treatment showed better effect compared with system or local monotherapy. Our study will find a new way to improve the prognosis of HCC patients.
详细描述
This was a multi-center, retrospective study involving 2000 patients with HCC receiving ICIs (Programmed cell death protein-1 (PD-1) or Programmed cell death ligand 1 (PDL-1)) and TKIs (Lenvatinib or Sorafenib), ICIs and TKIs plus local treatment (TAC, Hepatic artery infusion chemotherapy (HAIC), radiofrequency (RF) ablation, microwave ablation, radiotherapy, etc.), and local monotherapy between Jan, 2019 and Dec, 2021 in China. Efficacy was evaluated with objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), time to tumor progression (TTP), and 1year and 2 years overall survival (OS). Treatment-related adverse events (TRAEs) were recorded and graded. Efficacy and safety of three groups were compared. Stratified analysis was performed according to patients baseline characteristics and medication regimen for combination therapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of hepatocellular carcinoma
- •Treated with ICIs (PD-1 or PDL-1) therapy plus TKIs (Lenvatinib or sorafenib)
- •Treated with local therapy (TACE, HAIC, RF ablation, microwave ablation, radiotherapy, etc)
- •Treated Treated with ICIs plus TKIs and local therapy
- •Have complete medical record that can complete the OR or 1 year OS assessment and follow-up.
排除标准
- •Patients who do not have complete medical record and follow-up information after treatment；
- •The researchers have evidence that it is not suitable for this study
研究组 & 干预措施
Triple therapy
Systemic therapy plus Local treatment:
ICIs (PD1 or PDL-1)+TKIs (Lenvatinib or Sorafenib) plus local treatment (TACE, HAIC, RF Ablation, Microwave Ablation, Radiotherapy, etc)
干预措施: Lenvatinib Oral Product (Drug)
Systemic therapy
ICIs (PD1 or PDL-1)+TKIs (Lenvatinib or Sorafenib)
干预措施: Lenvatinib Oral Product (Drug)
Systemic therapy
ICIs (PD1 or PDL-1)+TKIs (Lenvatinib or Sorafenib)
干预措施: PD-1 inhibitor (Drug)
Local treatment
local treatment include: TACE, HAIC, RF Ablation, Microwave Ablation, Radiotherapy, etc.
干预措施: Local treatment (Procedure)
Triple therapy
Systemic therapy plus Local treatment:
ICIs (PD1 or PDL-1)+TKIs (Lenvatinib or Sorafenib) plus local treatment (TACE, HAIC, RF Ablation, Microwave Ablation, Radiotherapy, etc)
干预措施: PD-1 inhibitor (Drug)
Triple therapy
Systemic therapy plus Local treatment:
ICIs (PD1 or PDL-1)+TKIs (Lenvatinib or Sorafenib) plus local treatment (TACE, HAIC, RF Ablation, Microwave Ablation, Radiotherapy, etc)
干预措施: Local treatment (Procedure)
结局指标
主要结局
The overall survival (OS)
时间窗: 12 months
1 year OS in three groups were compared
The treatment-related adverse events (TRAEs)
时间窗: 12 months
Rate of participants with treatment-related adverse events as assessed by CTCAE v5.0
The objective response rate (ORR)
时间窗: 8 weeks
ORR in three groups were compared
次要结局
- The progression-free survival (PFS)(8 weeks)