NCT07277192已完成不适用
HAIC vs. TACE Combined With ICIs and TKIs in Intermediate-to-Advanced HCC: A Multicenter Study on Liver Injury and Survival
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 562
- 试验地点
- 1
- 主要终点
- alanine aminotransferase(ALT)
研究概览
简要总结
The purpose of this study is to compare the liver injury induced by HAIC combined with PD-1/PD-L1 inhibitors and TKIs versus triple therapy with TACE in the treatment of patients with advanced HCC; to compare the efficacy of the two triple therapy regimens in the treatment of patients with advanced HCC.
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
- •Patients voluntarily join this study and sign the informed consent form;
- •Aged ≥ 18 years, both male and female;
- •Patients with pathologically or clinically confirmed BCLC stage B or C hepatocellular carcinoma (HCC) who were diagnosed between January 1, 2019, and December 31, 2022;
- •Receiving treatment with PD-1/PD-L1 inhibitors combined with anti-angiogenic drugs (both PD-1/PD-L1 inhibitors and targeted drugs are only approved post-market medications, including but not limited to those with HCC indications);
- •Transarterial chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC) completed within 3 months after the first systemic treatment or within 1 month before the first systemic treatment;
- •Having at least one measurable intrahepatic lesion, with intrahepatic lesions being the main tumor burden. (According to RECIST v1.1, the measurable lesion has a spiral CT scan long diameter ≥ 10 mm or enlarged lymph node short diameter ≥ 15 mm).
排除标准
- •Pathologically/histologically confirmed cholangiocarcinoma, combined hepatocellular-cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, or fibrolamellar hepatocellular carcinoma;
- •Patients with a history of other malignant tumors within the past 3 years or concurrent malignant tumors (except cured basal cell carcinoma of the skin and cervical in situ carcinoma);
- •Concomitant use of other antitumor therapeutic agents, such as antitumor traditional Chinese medicines and proprietary Chinese medicines;
- •Patients who do not meet the definition of combination therapy;
- •Incomplete medical information, such as lack of post-treatment imaging evaluation;
- •Patients with immunodeficiency or those who have undergone organ/bone marrow transplantation;
- •Patients deemed unsuitable to participate in this study by the investigator.
结局指标
主要结局
alanine aminotransferase(ALT)
时间窗: Measurements were conducted one week before the first treatment and at regular intervals for up to six months after the intervention, continuing until the occurrence of unacceptable toxicity, withdrawal of consent, or termination of the study by the spon
次要结局
- The median progression free survival time (mPFS)(From date of first dose of study drug to the date of first documentation of disease progression or death, whichever occurs first (up to approximately 3 years))
- The median overall survival time (mOS)(From date of first dose of study drug to the date of first documentation of disease progression or death, whichever occurs first (up to approximately 3 years))
- Objective response rate (ORR)(From date of first dose of study drug until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to approximately 3 years))
- The disease control rate (DCR)(From date of first dose of study drug until disease progression, stable disease, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to approximately 3 years))
研究者
研究点 (1)
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