DEB-TACE in Combination With or Without RALOX-based HAIC for Unresectable Large Hepatocellular Carcinoma: A Randomized, Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS)
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) combined with hepatic artery infusion chemotherapy (HAIC) with oxaliplatin and raltitrexed (RALOX-HAIC) versus DEB-TACE alone for unresectable large hepatocellular carcinoma (HCC).
详细描述
This is a multicenter randomized study to evaluate the efficacy and safety of DEB-TACE plus RALOX-HAIC (DEB-TACE+HAIC) compared with DEB-TACE alone for unresectable large HCC (>7cm).
130 patients with unresectable large HCC (> 7cm) will be enrolled in this study. The patients will receive either DEB-TACE+HAIC or DEB-TACE using an 1:1 randomization scheme. In the DEB-TACE+HAIC arm, the microcatheter will be reserved at the main hepatic tumor-feeding artery and chemotherapy drugs (RALOX-based regimen) will be intra-arterially administered though the microcatheter. In the DEB-TACE arm, patients will be treated with DEB-TACE alone. The treatments can be repeated on demand (at a 4-week interval usually) based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team. 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 progression-free survival (PFS). The secondary endpoints are tumor response (objective response rate and disease control rate), overall survival (OS) , 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
- •HCC confirmed by histology/cytology or diagnosed clinically.
- •At least one measurable intrahepatic target lesion.
- •The largest tumor size > 7 cm.
- •Tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment.
- •Child-Pugh score 5-
- •ECOG performance status ≤
- •Adequate organ and hematologic function with platelet count ≥75×10^9/L, leukocyte >3.0×10^9/L, Neutrophil count ≥1.5×10^9/L, ASL and AST≤5×ULN, creatinine clearance≤1.5×ULN, and prolongation of prothrombin time ≤4 seconds.
排除标准
- •Macrovascular invasion or extrahepatic metastasis.
- •Diffuse HCC.
- •Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy.
- •Previous palliative treatments, including TACE, transcatheter arterial embolization, HAIC, radiation therapy, systemic therapy.
- •Organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment.
- •History of other malignancies.
- •Uncontrollable infection.
- •History of HIV.
- •Gastrointestinal bleeding within 30 days, or other bleeding> CTCAE grade
- •History of organ or cells transplantation.
- •Pregnant or lactating patients.
研究组 & 干预措施
DEB-TACE+HAIC
For DEB-TACE, superselective catheterization is performed and CalliSpheres loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. In patients with huge or bilobar multiple lesions, in order to reduce the risk of complications, the embolization end point was not achieved in the initial TACE but in the second or third TACE session.
After each chemoembolization, the microcatheter is reserved at the main hepatic tumor-feeding artery. The RALOX-based regimen is intra-arterially administered.
During follow-up, the treatment will be repeated on demand (about 4-week interval) based on the evaluation of the follow-up laboratory and imaging examination.
干预措施: DEB-TACE+HAIC (Drug)
DEB-TACE
Superselective catheterization is performed and CalliSpheres loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. In patients with huge or bilobar multiple lesions, in order to reduce the risk of complications, the embolization end point was not achieved in the initial TACE but in the second or third TACE session.
干预措施: DEB-TACE (Drug)
结局指标
主要结局
Progression free survival (PFS)
时间窗: 3 years
The time from date of randomization until the first occurrence of disease progression (according to mRECIST) or death due to any cause, whichever occurs first.
次要结局
- Objective response rate (ORR)(3 years)
- Overall survival (OS)(4 years)
- Adverse Events (AEs)(3 years)
- Disease control rate (DCR)(3 years)