A Multicentre Randomized Controlled Study of Anti-angiogenic Targeted Drugs Combined With Ginsenoside Rg3 to Improve the Efficacy of Transcatheter Arterial Chemoembolization (TACE) in the Treatment of Unresectable Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
The aim of this study is to compare the efficacy and safety of transcatheter arterial chemoembolization (TACE) combined with the anti-angiogenic targeted drugs and ginsenoside Rg3 versus TACE alone in patients with unresectable Barcelona Clinic Liver Cancer (BCLC) stage B/C hepatocellular carcinoma (HCC), who has normal liver function and no extrahepatic metastasis.
详细描述
TACE is widely used in patients with unresectable HCC, which has been proved to significantly improve the survival time by the results from some randomized controlled studies and meta-analyses. However, due to the different blood supply characteristics and biological heterogeneity in HCC nodules, the therapeutic effect of TACE is limited, and which is still considered as a non-radical treatment. Furthermore, vascular embolization by TACE may result in hypoxia in tumor tissue, which will induce increased secretion of angiogenic factors such as vascular endothelial growth factor (VEGF) and tumor angiogenesis, promote proliferation of residual tumor cells, and enhance tumor invasive and metastasis. Accordingly, the effectiveness of TACE is still unsatisfying as a single treatment for HCC.
Both anti-angiogenic targeted drugs and ginsenoside Rg3 have showed synergistic effect with TACE in patients with unresectable HCC. The purpose of this trial is to evaluate the efficacy and safety of the combination of anti-angiogenic targeted drugs and ginsenoside Rg3 plus TACE comparing to TACE alone in patients with unresectable HCC.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unresectable HCC patients clinically diagnosed or confirmed by histopathology and/or cytology according to Guidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2019 edition);
- •At least one measurable lesion (according to mRECIST);
- •BCLC stage B or C (China Liver Cancer Staging [CNLC] IIa, IIb and IIIa);
- •The maximum diameter of a single lesion ≤10cm; No more than 10 lesions; or combined with portal vein thrombus (PVTT) type I and II (Cheng's classification);
- •Child-pugh score <7;
- •Eastern Cooperative Oncology Group (ECOG) PS 0-1;
排除标准
- •Mixed hepatocellular carcinoma and intrahepatic cholangiocarcinoma (HCC-ICC) confirmed by pathology;
- •Extrahepatic metastasis;
- •Previously received hepatectomy, liver transplantation, interventional therapy, ablative therapy and other local therapies for HCC;
- •PVTT type III/IV (Cheng's classification), major hepatic vein invasion or primary to secondary bile duct invasion;
- •A history of gastrointestinal bleeding or a definite tendency of gastrointestinal bleeding in the past 4 weeks;
- •Cardiovascular diseases with significant clinical significance;
- •Active infection;
- •Other significant clinical and laboratory abnormalities that investigators believe affect safety evaluation.
研究组 & 干预措施
Combined group
Anti-angiogenic targeted drug + Rg3 + TACE
干预措施: Anti-angiogenic Targeted Drugs (Drug)
Combined group
Anti-angiogenic targeted drug + Rg3 + TACE
干预措施: Ginsenoside Rg3 (Drug)
Combined group
Anti-angiogenic targeted drug + Rg3 + TACE
干预措施: TACE (Procedure)
Single group
TACE alone
干预措施: TACE (Procedure)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: Up to 2 years
the time from randomization to documented progression
次要结局
- Objective response rate(Up to 2 years)
- Time to TACE untreated progression(Up to 2 years)
- Overall survival(Up to 2 years)
- Adverse events(Up to 2 years)
研究者
Shen Feng
MD
Eastern Hepatobiliary Surgery Hospital