HAIC Combined With Lenvatinib and Tislelizumab Versus D-TACE Combined With Lenvatinib and Tislelizumab in Advanced Unresectable Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Tumor Response
研究概览
简要总结
Drug-eluting Bead-Transarterial chemoembolization (D-TACE) is the most widely used palliative treatment for hepatocellular carcinoma (HCC) patients. While a number of studies demonstrate poor effect of D-TACE for patients in Advanced Unresectable HCC. The investigators previous study also revealed similar results in Advanced Unresectable HCC patients treated with D-TACE. Recently, the investigators previous study demonstrated that, compared with D-TACE, hepatic arterial infusion chemotherapy (HAIC) may improve tumor response in Advanced Unresectable HCC. Thus, the investigators carried out this prospective nonrandomized control to demonstrate the superiority of HAIC-based combination therapy over D-TACE-based combination therapy.
详细描述
HCC is one of the most common malignant tumors with the worst prognosis. At present, except for liver transplantation, surgical resection is the most effective therapy for patients with HCC. However, many patients are found to have advanced cancer as soon as they were diagnosed and lose the opportunity of radical resection and treatments are limited.More and more clinical research failures have hit the investigators' hard, until a clinical study named IMbrave150, published in the New England Journal of Medicine in 2020. It has opened up a new era of combination therapy, breaking the pattern of only a single mode of advanced liver cancer for more than ten years, making the investigators realize that for the treatment of patients with advanced liver cancer, the single treatment effect is often very limited, and combination therapy is the future.The investigators recent research showed that HAIC Combined With Lenvatinib and Tislelizumab brings good results to patients with advanced HCC.To identify a more effective and safety way for treating potentially resectable HCC patients, this study is designed to compare the safety and efficacy between HAIC-based combination therapy and D-TACE-based combination therapy for those patients in Advanced 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
- •Patients with advanced unresectable hepatocellular carcinoma treated by D- TACE, or HAIC combined with Lenvatinib and Tislelizumab as initial treatment
- •Age between 18 and 75 years
- •Child-Pugh A or B liver function
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Adequate hematologic blood counts (white blood cell count >3ⅹ109/L, absolute neutrophil count >1.5ⅹ109/L, platelet count >10ⅹ109/L, hemoglobin concentration >85 g/L
- •No extrahepatic metastasis
排除标准
- •Severe underlying cardiac, pulmonary, or renal diseases
- •History of a second primary malignant tumor
- •Incomplete medical data
- •Loss to follow-up.
研究组 & 干预措施
HAIC+lenvatinib+tislelizumab
Hepatic Arterial Infusion Chemotherapy Combined With lenvatinib and tislelizumab
干预措施: HAIC (Drug)
HAIC+lenvatinib+tislelizumab
Hepatic Arterial Infusion Chemotherapy Combined With lenvatinib and tislelizumab
干预措施: Lenvatinib (Drug)
HAIC+lenvatinib+tislelizumab
Hepatic Arterial Infusion Chemotherapy Combined With lenvatinib and tislelizumab
干预措施: tislelizumab (Drug)
D-TACE+lenvatinib+tislelizumab
Transarterial chemoembolization with drug-eluting beads Combined With lenvatinib and tislelizumab
干预措施: D-TACE (Drug)
D-TACE+lenvatinib+tislelizumab
Transarterial chemoembolization with drug-eluting beads Combined With lenvatinib and tislelizumab
干预措施: HAIC (Drug)
D-TACE+lenvatinib+tislelizumab
Transarterial chemoembolization with drug-eluting beads Combined With lenvatinib and tislelizumab
干预措施: Lenvatinib (Drug)
结局指标
主要结局
Tumor Response
时间窗: 6-8 weeks
The tumor responses were evaluated by measuring the longest diameter of target lesions according to response evaluation criteria in solid tumors.(RECIST) version 1.1
Overall survival
时间窗: 24months
Overall survival (OS) was measured from the initiation of transarterial therapy to the date of death or the last follow-up.
Progression-free survival
时间窗: 24 months
Progression-free survival (PFS) was measured from the initiation of transarterial therapy to the time of progression or recurrence or last follow-up
Cancer embolism withdraws
时间窗: 6-8 weeks
The degree of thrombosis withdrawal of the portal vein or hepatic vein(VP1-VP4 or I-IV).
次要结局
未报告次要终点
研究者
Wen Li
Attending physician
Second Affiliated Hospital of Nanchang University