Comparing the Efficacy of ICIs With and Without MWA in Advanced Hepatocellular Carcinoma in Real-World Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
Immunotherapy has become the main treatment recommendation for HCC. MWA treatment induces peripheral immune response, which may enhance the effectiveness of immunotherapy for advanced HCC. This study aims to compare the efficacy and safety of ICIs combined with MWA compared to ICIs alone.
The study will compare two groups: ICIs and ICIs+MWA. Main objectives: OS, PFS Secondary objectives: CR PR、SD、PD、ORR、DCR、AEs This study addresses the efficacy and safety of using ICIs in combination with MWA compared to ICIs alone for advanced HCC patients.
The investigators' study aims to evaluate the necessity of immunotherapy combined with targeted drugs or microwave ablation in patients with advanced hepatocellular carcinoma in the real world, providing relevant clinical data for the treatment selection of HCC patients.
详细描述
Research Title: Comparing the Efficacy of ICIs with and without MWA in Advanced Hepatocellular Carcinoma in Real Clinical Practice Background: Immunotherapy has become the main treatment recommendation for cancer. Ablation therapy induces peripheral immune response, which may enhance the effectiveness of immunotherapy in patients with advanced hepatocellular carcinoma (HCC).
Main objectives: OS, PFS Secondary objectives: CR PR、SD、PD、ORR、DCR、AEs Research Design: This is a single center, retrospective cohort study. This study addresses the efficacy and safety of using ICIs in combination with MWA compared to ICIs alone for advanced HCC patients.
Meaning: The investigators' study aims to evaluate the necessity of immunotherapy combined with targeted drugs or microwave ablation in patients with advanced hepatocellular carcinoma in the real world, providing relevant clinical data for the treatment selection of HCC patients.
Innovation: The innovation of this paper lies in the first verification of the efficacy and safety of microwave ablation (MWA) combined with immune checkpoint inhibitors (ICIs) in the treatment of advanced hepatocellular carcinoma (HCC) patients.
Expected results: The innovation of this paper lies in the first validation of the significant efficacy of microwave ablation (MWA) combined with immune checkpoint inhibitors (ICIs) in the treatment of advanced hepatocellular carcinoma (HCC) patients, significantly improving overall survival (OS) and progression free survival (PFS), as well as objective response rate (ORR) and disease control rate (DCR).
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
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gender is not limited, age range is 19-80 years old.
- •Meets the clinical diagnostic criteria for HCC.
- •Progress after first-line treatment.
- •CNLC staging: Stage IIa, IIb, or IIIb of advanced HCC.
- •Child Pugh liver function grading score 5-7 points.
- •The ECOG (Eastern Cooperative Oncology Group) score ranges from 0 to
- •The patient has a certain degree of compliance with the treatment plan and follow-up performance.
- •For patients infected with hepatitis B, antiviral treatment with anti hepatitis B virus drugs should be carried out before receiving treatment; And the hepatitis B DNA titer of the patient was less than 10^2 IU/ml.
排除标准
- •It has been determined that the inclusion criteria cannot be met.
- •Enhanced CT or MRI shows more than 3 active lesions in the liver, and the shortest diameter of a single lesion is greater than 3cm.
- •There is a portal vein cancer thrombus present.
- •The extrahepatic metastatic lesions have not been well controlled.
- •Other treatments were received during the process of receiving immunotherapy or immunotherapy combined with MWA treatment.
- •There is active bleeding present.
- •There are interstitial lung diseases, pulmonary fibrosis, and autoimmune diseases present.
研究组 & 干预措施
ICIs
ICIs mainly refer to PD-1 drug therapy, including pembrolizumab, camrizumab, toripalimab, tislelizumab, and sintilimab. The dosage and duration of ICIs comply with the manufacturer's guidelines.
干预措施: ICIs (Drug)
MWA+ICIs
ICIs mainly refer to PD-1 drug therapy, including pembrolizumab, camrizumab, toripalimab, tislelizumab, and sintilimab. The dosage and duration of ICIs comply with the manufacturer's guidelines. All patients, except for those enrolled in ICIs, should also undergo MWA treatment.
干预措施: ICIs+MWA (Procedure)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Progression-Free Survival was assessed from the date of treatment initiation until the date of first documented disease progression or death from any cause, whichever occurred first, assessed up to 24 months.
Time from treatment initiation to disease progression or death from any cause.
Overall Survival (OS)
时间窗: Overall Survival was measured from the date of treatment initiation until death from any cause or patients who were still alive at the last follow-up were censored at that time point, assessed up to 36 months.
Time from treatment initiation to disease progression or death from any cause.
次要结局
- objective response rate (ORR)(Objective response rate was measured from baseline to 24 months, every 8 weeks or until disease progression, unacceptable toxicity, or withdrawal from the study, whichever occurs first.)
研究者
Ou Jiang
Director of Cancer Center
Neijiang No.2 People's Hospital