Safety and efficacy of lenvatinib in Child-Pugh A and B patients with advanced hepatocellular carcinoma including high burden of intrahepatic tumor (LAUNCH)

未提供0 个研究点目标入组 62 人开始时间: 2020年6月26日最近更新: 2024年2月20日

适应症

试验速览

阶段: 不适用
状态: 已完成
入组人数: 62
主要终点: Safety

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Non-randomized Controlled Trial
干预模型: Parallel Assignment
主要目的: Treatment Purpose
盲法: Open(masking Not Used)

入排标准

年龄范围: 20age old over 至 No limit（—）
性别: All

入选标准

•Patients must meet all of the following criteria to be included in this study:
•Patients must have been diagnosed with HCC base on either of the following assessments:
•a) Histological or cytological diagnosis of HCC
•b) Radiographic image diagnosis of HCC by the typical findings of a hypervascular tumor on dynamic CT, CTHA/CTAP, dymamic MRI.
•Patients must meet all of the following criteria on treatment of HCC:
•a) Not applicable for surgical resection.
•b) Not applicable for any local therapies (radio frequency ablation, percutaneous ethanol injection, microwave ablation).
•c) Not applicable for transarterial chemoembolization (TACE).
•EOCG Performance Status (PS) of 0 or
•Liver function status is Child-Pugh class A or B (only less than 9).
•a) HCC is classified into Child-Pugh class A to C, employing the added score of 5 clinical parameters.
•b) Child-Pugh classification: A (5-6), B (7-9), and C (10-15)
•Patients must meet all of the following criteria of clinical lab tests.
•a) White blood cell>=2000/uL
•b) Neutrophil>=1000/uL
•c) Hemoglobin>=8.5g/dl
•d) Platelet>=50000/mm3
•e) Total bilirubin<=3.0mg/dl
•f) AST, ALT<=5 times the upper limit of the facility reference
•g) Serum Creatinine<=1.5 times the upper limit of the facility reference
•h) Serum albumin>=2.8g/dl
•i) Prothrombin time (PT-INR)<=2.3
•Patients must have measurable lesion with RECIST version 1.1 and modified RECIST (mRECIST).
•Systemic chemotherapy including lenvatinib, sorafenib, regorafenib has not been administerd(Combination therapy of atezolizumab and bevacizumab is permitted).
•More than four weeks after the last treatment(In the case of combination therapy of atezolizumab and bevacizumab, more than two weeks have passed after the last treatment and adverse events have improved to grade 1 or less).
•Ages 20 and older (any gender).
•Patients with written consent after receiving sufficient explanation for this study. The consent is based on free will.

排除标准

•Patients who fall under any of the following criteria, will be excluded from the study.
•Patients with a history of malignant tumors except for the following cases.
•a) Early stage cancers with a low risk of relapse after appropriate radical treatment such as intraepithelial cervical cancer, basal cell carcinoma, superficial bladder tumor [Ta, Tis and T1] and early gastric cancer.
•b) Malignant tumors that have been given radical treatment for more than three years prior to the study and is considered to have not relapsed since then.
•Patients on kidney dialysis.
•Heart disease which falls under any of the following.
•a) Heart failure of NYHA class 3 or higher.
•b) Coronary artery disease with symptoms. History of myocardial infarction within 24 weeks prior to enrollment.
•c) Arrhythmias requiring control with antiarrhythmic drugs such as beta blocker and digoxin (CTCAE version 4.0 Grade 3 or higher).
•d) Poor control hypertension.
•Severe and active infections (CTCAE version 4.0 Grade 3 or higher).
•History of HIV infection.
•Portosystemic shunt with hepatic encephalopathy.
•History of hepatic encephalopathy (Grade2 or higher).
•Esophageal and gastric varices requiring treatment.
•History of esophageal and gastric variceal bleeding.
•Refractory ascites.
•Detectable HBV-DNA without nucleic acid analog treatment.
•Thromboembolism (cerebrovascular disorder including transient cerebral ischemic attack, deep vein thrombosis, pulmonary embolism etc.) within 6 months before the start of the study
•Patients with the following medical history,
•a) Use of CYP3A4 inducer (rifampicin etc.)
•b) Use of Warfarin
•c) History of gastrointestinal bleeding which needs to be treated within 4 weeks prior to study enrollment
•d) Medical history with invasive surgery within 4 weeks prior to study enrollment
•e) History of homologous organ transplantation
•Gastrointestinal disorders which may affect drug absorption and pharmacokinetics
•Use of drugs which may affect drug absorption and pharmacokinetics
•Pregnant or lactating woman; woman of child bearing age unless using effective contraception (In case of suspected pregnancy, pregnancy test should be conducted)
•Possibility of allergic reaction to the study drug
•Drug abuse. Health, psychological, social conditions that interfere with the participation of the study or evaluation of the results
•Any condition that in the opinion of the investigators could impair the patient's safety or make the study difficult to comply with the protocol by participating in the study.

结局指标

主要结局

Safety

For evaluation of adverse events, we use "Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Japanese version)"

次要结局

overall survival (OS)
progression free survival (PFS)
discontinuation rate due to adverse events
time to progression (TTP)
objective response rate (ORR)

研究者

发起方

未提供

相似试验

The trial to evaluate the safety and efficacy of high dose ambroxol in combination with enzyme replacement therapy in Gaucher disease patientsEndocrine, nutritional and metabolic disease

KCT0003218Asan Medical Center10

已完成

不适用

REGAIN trial (REGAIN trial)Hepatocellular carcinoma