Clinical Study on TACE Combined With Immune Agents for Inhibiting Tumor Angiogenesis in Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This study investigates the clinical efficacy and safety of transarterial chemoembolization (TACE) combined with the immune agent nivolumab compared to TACE alone for treating hepatocellular carcinoma (HCC). The study aims to determine if the combination therapy can more effectively inhibit tumor angiogenesis, improve clinical benefit rates, and prolong survival, while maintaining a high safety profile.
详细描述
Hepatocellular carcinoma (HCC) is a common malignancy with high mortality. While TACE is a standard treatment, it can paradoxically stimulate tumor angiogenesis. Immune checkpoint inhibitors have shown promise in HCC, but single-agent efficacy is limited. This study was designed to evaluate whether combining TACE with hepatic arterial infusion of an immune agent (nivolumab) could improve outcomes by inhibiting tumor angiogenesis and enhancing anti-tumor immune responses. Patients diagnosed with unresectable HCC (BCLC stages A, B, C; Child-Pugh A or B) were randomized to receive either TACE alone (control group) or TACE combined with hepatic arterial infusion of nivolumab (study group). The study assessed objective response rate (ORR), disease control rate (DCR), changes in angiogenesis factors (VEGF, VEGFR-2, Ang-2) and tumor markers (CEA, AFP, CA199) before and one month after treatment. Adverse reactions, overall survival (OS), and progression-free survival (PFS) were also evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Age >18 years;
- •Diagnosis of HCC according to the Diagnosis and Treatment Guidelines for Primary Liver Cancer (2024 Edition), confirmed by pathological examination;
- •Barcelona Clinic Liver Cancer (BCLC) stages A, B, and C, with non-resectable tumors;
- •Liver function graded as Child-Pugh A or B;
- •At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1;
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
- •No severe hematologic abnormalities or immune deficiencies;
- •Expected survival time >6 months.
排除标准
- •Recurrent liver cancer or metastatic cancer from other organs;
- •Previous treatment with other antitumor therapies, including surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy;
- •History of other malignant tumors;
- •Pregnant or lactating women;
- •Human immunodeficiency virus (HIV) infection;
- •Severe cardiovascular, pulmonary, cerebral, or renal diseases;
- •Active bleeding or coagulopathy outside the liver;
- •Enrollment in another clinical trial or participation in a clinical trial within one month prior to admission;
- •Psychiatric disorders or unstable mental status;
- •Allergic reactions to the study drugs;
- •Severe gastrointestinal diseases, such as active ulcers, or other conditions affecting drug absorption.
研究组 & 干预措施
TACE combined with Nivolumab
Patients received TACE procedure. Additionally, hepatic artery infusion therapy with nivolumab was performed.
干预措施: Transarterial Chemoembolization (TACE) (Procedure)
TACE Alone
Patients received TACE procedure alone.
干预措施: Transarterial Chemoembolization (TACE) (Procedure)
TACE combined with Nivolumab
Patients received TACE procedure. Additionally, hepatic artery infusion therapy with nivolumab was performed.
干预措施: Nivolumab (Combination Product)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Assessed at 1 month post-treatment, and then approximately every 3 months until disease progression, up to 24 months.
Percentage of patients achieving Complete Remission (CR) or Partial Remission (PR) based on RECIST 1.1 criteria. ORR = \[(CR + PR) / total cases\] × 100%.
Disease Control Rate (DCR)
时间窗: Assessed at 1 month post-treatment, and then approximately every 3 months until disease progression, up to 24 months.
Percentage of patients achieving CR, PR, or Stable Disease (SD) based on RECIST 1.1 criteria. DCR = \[(CR + PR + SD) / total cases\] × 100%.
次要结局
- Level of Carbohydrate Antigen 199 (CA199)(Baseline (one day before treatment) and 1 month after treatment.)
- Progression-Free Survival (PFS)(From randomization until disease progression or death, whichever comes first, up to December 2023 (median follow-up 13.87 months).)
- Level of Vascular Endothelial Growth Factor (VEGF)(Baseline (one day before treatment) and 1 month after treatment.)
- Level of VEGF Receptor-2 (VEGFR-2)(Baseline (one day before treatment) and 1 month after treatment.)
- Level of Angiopoietin-2 (Ang-2)(Baseline (one day before treatment) and 1 month after treatment.)
- Level of Carcinoembryonic Antigen (CEA)(Baseline (one day before treatment) and 1 month after treatment.)
- Level of Alpha-fetoprotein (AFP)(Baseline (one day before treatment) and 1 month after treatment.)
- Overall Survival (OS)(From randomization until death or end of study, whichever comes first, up to December 2023 (median follow-up 13.87 months).)
- Incidence of Adverse Reactions(From the first day of treatment until 30 days after the last treatment administration, monitored up to 24 months.)
研究者
Wenhua Ma
Principal Investigator
The First Hospital of Hebei Medical University