Retrospective Cohort Study on the Therapeutic Effects of Immunotherapy and Targeted Therapy Combined With or Without Radiotherapy for Hepatocellular Carcinoma Based on Real-world Data
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
The objective of this retrospective cohort study is to investigate the therapeutic effects of combined immunotherapy and targeted therapy, with or without radiotherapy, in patients with hepatocellular carcinoma.
The main question it aims to answer is:
Does the addition of radiotherapy to immunotherapy and targeted therapy enhance the therapeutic effect more significantly compared to immunotherapy and targeted therapy alone for patients with hepatocellular carcinoma?
详细描述
A retrospective analysis will be conducted on the clinical data of patients with hepatocellular carcinoma who underwent combined immunotherapy and targeted therapy with radiotherapy, as well as those who received immunotherapy and targeted therapy alone, at Zhongshan Hospital, Fudan University, from January 1, 2017, to December 31, 2023. The pmary objective is to assess the disparities in treatment efficacy and treatment-related adverse events between the two cohorts.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hepatocellular carcinoma confirmed by histopathological/cytopathological examination, or fulfilling the clinical diagnostic criteria for primary liver cancer according to the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2024 edition).
- •Patients with hepatocellular carcinoma who received targeted therapy and immunotherapy at Zhongshan Hospital affiliated with Fudan University from January 1, 2017, to December 31,
- •Tumor staging meeting at least one of the following criteria: 1) CNLC stage IIIa or IIIb hepatocellular carcinoma with concurrent vascular invasion or extrahepatic metastasis; 2) CNLC stage IIb hepatocellular carcinoma presenting as a localized lesion unsuitable for surgical resection or transarterial chemoembolization (TACE); 3) Presence of main portal vein or inferior vena cava tumor thrombus; 4) Disease progression observed after multiple local treatments (such as surgical resection, TACE, radiofrequency ablation, etc.).
- •Availability of complete clinical and follow-up information.
- •Patients have provided informed consent for donation of biological samples, allowing the donated samples and related information to be used for all medical research purposes.
排除标准
- •Contraindications for radiotherapy include hepatocellular carcinoma with diffuse intrahepatic lesions, PS score of 3-4, Child-Pugh C liver function, or the presence of severe underlying medical conditions.
- •Known components of the patient population include cholangiocarcinoma (ICC), mixed hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or fibrolamellar carcinoma.
- •Exclusion criteria encompass a history of malignancies other than hepatocellular carcinoma within the past 5 years, except for limited-stage tumors considered cured, such as cervical carcinoma in situ, basal cell carcinoma, and prostate carcinoma in situ.
- •Any other circumstances that the investigator deems unsuitable for participation in the study are also exclusion criteria.
结局指标
主要结局
Progression Free Survival
时间窗: Up to 2 years
Progression free survival is defined as the duration between the date of of initial administration of targeted therapy and immunotherapy to the date of first documented progression or death due to any cause or date of last follow-up, whichever is earlier.
次要结局
- Overall Survival(Up to 2 years)
- Treatment-related Adverse Effects(Up to 2 years)