Transarterial Chemoembolization With Drug-eluting Beads Plus Hepatic Arterial Infusion Chemotherapy Versus Hepatic Arterial Infusion Chemotherapy Alone for Large Hepatocellular Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
This study is conducted to evaluate the efficacy and safety of transarterial chemoembolization with drug-eluting beads (DEB-TACE) plus hepatic artery infusion chemotherapy (HAIC) compared with HAIC alone for unresectable large hepatocellular carcinoma (HCC).
详细描述
This is a multicenter, prospective and randomized study to evaluate the efficacy and safety of DEB-TACE (with CalliSpheres) plus HAIC compared with HAIC alone for unresectable large HCC (>7cm).
230 patients with initially unresectable large HCC (> 7cm) will be enrolled in this study. The patients will receive either DEB-TACE plus HAIC (dTACE-HAIC) or HAIC as the primary treatment using an 1:1 randomization scheme. In the dTACE-HAIC arm, the microcatheter will be reserved at the proper/left/right hepatic artery and chemotherapy drugs (FOLFOX-based regimen) will be intra-arterially administered though the microcatheter. The treatment can be repeated on demand (at a 4-6-week interval usually) based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team. In the HAIC arm, treatment will repeated once every 3 weeks for up to six cycles. During follow-up, the potential resectability of the tumor will be assessed by the multidisciplinary team (MDT). Once the tumors become resectable, curative surgical resection will be recommended for the patients.
The primary end point of this study is overall survival (OS). The secondary endpoints are tumor response (objective response rate and disease control rate), success rate of conversion to resection, progression-free survival (PFS), and adverse events (AEs).
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
- •Patients with HCC confirmed by histology/cytology or diagnosed clinically.
- •The maximum HCC lesion > 7 cm.
- •Unresectable HCC evaluated by the surgeon team.
- •At least one measurable intrahepatic target lesion.
- •Patients without cirrhosis, or with cirrhosis but the liver function of Child-Pugh Class A.
- •ECOG score of performance status ≤ 1 point.
- •Adequate organ and bone marrow function; the blood biochemical examination: platelet count ≥75×10^9/L, leukocyte >3.0×10^9/L, ASL and AST≤5×ULN, creatinine≤1.5×ULN, INR<1.5 or PT/APTT normal range.
- •Life expectancy of at least 3 months.
排除标准
- •Accompanied with tumor thrombus involving the main portal vein or bilateral first-order branch of portal vein.
- •Accompanied with vena cava tumor thrombus.
- •Extrahepatic metastasis.
- •Previous treatment with TACE, HAIC, liver transplantation, resection, ablation, radiotherapy, or systemic therapy.
- •Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy.
- •Those with organs (heart and kidneys) dysfunction who cannot tolerate TACE or HAIC treatment.
- •History of other malignancies.
- •Uncontrollable infection.
- •History of HIV.
- •Allergic to the drugs involved in the research.
- •Patients with gastrointestinal bleeding within 30 days, or other bleeding> CTCAE grade
- •History of organ or cells transplantation.
- •Those with bleeding tendency.
研究组 & 干预措施
Transarterial chemoembolization with drug-eluting beads plus hepatic arterial infusion chemotherapy
Patients will receive the combination treatment of DEB-TACE and HAIC.
干预措施: dTACE-HAIC (Procedure)
Transarterial chemoembolization with drug-eluting beads plus hepatic arterial infusion chemotherapy
Patients will receive the combination treatment of DEB-TACE and HAIC.
干预措施: dTACE-HAIC protocol (Drug)
Hepatic arterial infusion chemotherapy
Patients will receive HAIC treatment alone.
干预措施: HAIC (Procedure)
Hepatic arterial infusion chemotherapy
Patients will receive HAIC treatment alone.
干预措施: HAIC protocol (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: 4 years.
The time from date of randomization to death due to any cause.
次要结局
- Objective response rate (ORR) per mRECIST.(4 years.)
- Disease control rate (DCR) per mRECIST.(4 years.)
- DCR per RECIST 1.1.(4 years.)
- ORR per RECIST 1.1.(4 years.)
- Progression free survival (PFS) per mRECIST.(4 years.)
- Success rate of conversion to resection(4 years.)
- Adverse Events (AEs)(4 years.)
- Progression free survival (PFS) per RECIST 1.1.(4 years.)