NCT05738616招募中3 期
Lenvatinib Combined With Transcatheter Arterial Chemoembolization and Camrelizumab Versus Lenvatinib Combined With Transcatheter Arterial Chemoembolization in Conversion Resection for Advanced Hepatocellular Carcinoma:A Randomized, Open-label, Parallel-controlled, Phase III Study(LEN-TAC Study)
Wen Tianfu1 个研究点 分布在 1 个国家目标入组 196 人开始时间: 2024年5月10日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Compared to systemic therapy alone, conversion therapy is promising to improve the prognosis of patients with advanced hepatocellular carcinoma (HCC). Triple therapy (lenvatinib combined with transcatheter arterial chemoembolization and camrelizumab) may have significant efficacy in conversion therapy for patients with advanced HCC, but its safety and efficacy remain unknown. To address this, we have designed a randomized, open-label, parallel-controlled trial to evaluate the safety and efficacy of lenvatinib combined with transcatheter arterial chemoembolization and camrelizumab versus lenvatinib combined with transcatheter arterial chemoembolization in conversion resection for advanced HCC. Totally 196 patients with BCLC C stage HCC will be rigorously screened and included, and the primary endpoints of the study are overall survival. This study aims to provide valuable insights into new treatment strategies for advanced 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
- •Aged between 18 and 75 years.
- •Patients with HCC who strictly meet the criteria outlined in the Guidelines for the Diagnosis and Treatment of Hepatocellular Carcinoma (2022Edition), or those diagnosed by histopathology or cytology.
- •No prior anticancer therapy for HCC(Excluding patients who have received two or fewer TACE treatments).
- •ECOG PS score of 0-
- •Child-Pugh class A to B.
- •BCLC stage C Patients: tumor localized in one half of the liver with portal vein tumor thrombus (Vp1-Vp4 patients without contralateral portal vein tumor thrombus).
- •At least one radiographically measurable lesion according to mRECIST.
- •For HBsAg-positive patients, HBV-DNA < 2000 IU/ml (10^4 copies/ml) when undergoing PD-1 monoclonal antibody treatment; HCV RNA negative when HCV antibody is positive.
- •Adequate organ function based on laboratory test results.
- •Adequate blood pressure control with up to 3 antihypertensive agents, defined as BP ≤ 150/90 mmHg at screening with no changes in antihypertensive therapy within 1 week prior to Cycle 1/Day
- •Patients expected to survive more than 3 months.
- •Not planning to become pregnant.
排除标准
- •Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed hepatocellular carcinoma, and fibrolamellar cell carcinoma.
- •Extrahepatic metastasis of HCC.
- •Diffuse HCC or intrahepatic tumor burden ≥ 50% (including contralateral portal vein tumor thrombus, superior mesenteric vein tumor thrombus, and inferior vena cava tumor thrombus).
- •Contraindications to TACE or epirubicin.
- •Known hypersensitivity to lenvatinib ingredients.
- •Known hypersensitivity to the active ingredient or excipients of Camrelizumab.
- •Presence of other malignancies.
- •Pregnancy, lactation, or unwillingness to use effective contraceptive measures.
- •Class II or higher myocardial ischemia or infarction, poorly controlled arrhythmia, cardiac insufficiency class III-IV, or LVEF < 50%.
- •Abnormal coagulation function or bleeding tendency.
- •History of psychiatric disorders or substance abuse.
- •HIV infection.
- •Allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- •Active infection.
- •Poor compliance such as floating population.
- •Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents.
- •Active autoimmune disease requiring systemic therapy within 2 years prior to the first dose.
- •Systemic glucocorticoid or immunosuppressive therapy within 7 days prior to the first dose.
- •Clinically uncontrolled pleural/peritoneal effusion.
- •Active chronic hepatitis B or C.
- •Vaccination with live vaccines within 30 days prior to the first dose.
结局指标
主要结局
Overall survival
时间窗: 3-year
Time from randomization to death (any cause).
次要结局
- Disease control rate(2 years)
- Event-free survival(2 years)
- Conversional resection rate(2 years)
- Adverse events(2 years)
- Objective response rate(2 years)
- Overall survival at 2 years(2 years)
研究者
Wen Tianfu
Professor
West China Hospital
研究点 (1)
Loading locations...
相似试验
招募中
不适用
The Comparison of TACE-Lenvatinib With TACE-Lenvatinib-ablation for Intermediate Recurrent Hepatocellular CarcinomaRecurrent Hepatocellular CarcinomaLenvatinibLocal TherapyAblationSystemic TherapyNCT06609850Sun Yat-sen University116
招募中
3 期
Lenvatinib Plus DEB-TACE and HAIC vs. Lenvatinib Plus DEB-TACE for Large HCC With PVTTHepatocellular Carcinoma Non-resectableNCT06492395Second Affiliated Hospital of Guangzhou Medical University178
已完成
不适用
Combined Therapy for Hepatocellular Carcinoma >3-<5 cmHepatocellular CarcinomaNCT04721470Zagazig University278
Unknown
3 期
The Efficacy of Transarterial Chemoinfusion (TAI) Combine Lenvatinib in Advanced Hepatocellular Carcinoma (HCC)Hepatocellular CarcinomaNCT04053985Sun Yat-sen University206
Unknown
2 期
Safety and QoL of Trastuzumab With Lapatinib or Chemiotherapy in MBC and HER2+ Patients Refractory to Anti HER2 TherapiesMetastatic Breast CancerNCT02238509Consorzio Oncotech154