Drug-eluting Bead Transarterial Chemoembolization Compared With Conventional Transarterial Chemoembolization as the Conversion Therapy for Unresectable Large Hepatocellular Carcinoma: a Multicenter, Prospective, Nonrandomized Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Success rate of conversion to resection
研究概览
简要总结
This study is conducted to evaluate the efficacy of drug-eluting bead transarterial chemoembolization (DEB-TACE) compared with conventional transarterial chemoembolization (cTACE) as the conversion therapy for unresectable large hepatocellular carcinoma (HCC).
详细描述
This is a multicenter, prospective and nonrandomized study to evaluate the efficacy of DEB-TACE (with DC Bead) compared with cTACE as the conversion therapy for unresectable large HCC.
At least 216 patients (≥ 108 patients in each arm) with initially unresectable large HCC (> 7cm) will be enrolled in this study. The patients will receive either DEB-TACE or cTACE as the primary treatment according to their won will. TACE can be repeated on demand based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team, and the technique method of each TACE procedure (i.e. DEB-TACE or cTACE) for the same patient should be consistent. 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 success rate of conversion to resection. The secondary endpoints are objective response rate (ORR) of TACE, progression-free survival (PFS), times of TACE procedure to achieve conversion, conversion time, success rate of surgical resection, tumor recurrence rate after resection, tumor-free survival (TFS) of patients who undergo surgical resection, adverse events (AEs) and overall survival (OS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hepatocellular carcinoma confirmed by histopathology and/or cytology, or diagnosed clinically.
- •The tumor lesion was only localized in one liver lobe.
- •Large HCC with single lesion > 7 cm, or multiple lesions.
- •unresectable HCC evaluated by the surgeon team.
- •The patient is suitable for TACE treatment, which is evaluated by MDT.
- •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 ≥75×109/L, absolute value of neutrophils >1.5×109/L, hemoglobin ≥85 g/L, total bilirubin ≤30 μmol/L, albumin ≥35 g/L, ASL and AST≤5×ULN, creatinine≤1.5×ULN, INR<1.5 or PT/APTT normal range.
- •Patients have the willingness to receive TACE as the conversion therapy for surgical resection.
排除标准
- •Accompanied with tumor thrombus involving the main portal vein, first-order branch or bilateral branches of portal vein.
- •Accompanied with hepatic vein and vena cava tumor thrombus.
- •The extent of the lesion exceeds one liver lobe or extrahepatic metastasis.
- •Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy.
- •Those with organs (heart and kidneys) dysfunction who cannot tolerate TACE treatment and surgical hepatectomy.
- •History of other malignancies.
- •Uncontrollable infection.
- •Patients with active hepatitis B must undergo antiviral therapy to control HBV-DNA <10^3 IU/mL.
- •HCV patients need to complete the anti-HCV therapy before they are enrolled.
- •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. Previous treatment with TACE, intra-arterial infusion chemotherapy, radiotherapy, or systemic therapy
- •Those with bleeding tendency.
结局指标
主要结局
Success rate of conversion to resection
时间窗: 2 years.
The proportion of patients with initially unresectable large HCC who were evaluated by the surgical team as suitable for second-stage surgical resection after TACE treatment.
次要结局
- Time for successful conversion(2 years.)
- Disease-free survival (TFS) of the patients who undergo resection(2 years.)
- Adverse Events (AEs)(3 years.)
- Objective response rate (ORR) of TACE treatment(2 years.)
- Progression-free survival (PFS)(3 years.)
- Times of TACE procedure to achieve conversion(2 years.)
- Overall survival (OS)(3 years.)