LAUNCH trial

JRCT ID: jRCTs031190017

Registered date:26/04/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Hepatocellular carcinoma
• Date of first enrollment: 26/06/2020
• Target sample size: 62
• Study type: Interventional
• Intervention(s): Lenvatinib

Outcome(s)

Primary Outcome

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

Secondary Outcome

Secondary outcomes of efficacy.
As secondary outcomes of efficacy, we evaluate overall survival (OS), progression free survival (PFS), time to progression (TTP) and objective response rate (ORR). Both RECIST version 1.1 and mRECIST are used for evaluation of efficacy.
Secondary outcomes of safety
As secondary outcomes of safety, we evaluate the discontinuation rate due to adverse events. For evaluation of adverse events, we use "Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Japanese version)"

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients must meet all of the following criteria to be included in this study:
1)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.
2)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).
3)EOCG Performance Status (PS) of 0 or 1.
4)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)
5)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
6)Patients must have measurable lesion with RECIST version 1.1 and modified RECIST (mRECIST).
7)Systemic chemotherapy including lenvatinib, sorafenib, regorafenib has not been administerd(Combination therapy of atezolizumab and bevacizumab is permitted).
8)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).
9)Ages 20 and older (any gender).
10)Patients with written consent after receiving sufficient explanation for this study. The consent is based on free will.

Exclude criteria

Patients who fall under any of the following criteria, will be excluded from the study.
1)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.
2)Patients on kidney dialysis.
3)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.
4)Severe and active infections (CTCAE version 4.0 Grade 3 or higher).
5)History of HIV infection.
6)Portosystemic shunt with hepatic encephalopathy.
7)History of hepatic encephalopathy (Grade2 or higher).
8)Esophageal and gastric varices requiring treatment.
9)History of esophageal and gastric variceal bleeding.
10)Refractory ascites.
11)Detectable HBV-DNA without nucleic acid analog treatment.
12)Thromboembolism (cerebrovascular disorder including transient cerebral ischemic attack, deep vein thrombosis, pulmonary embolism etc.) within 6 months before the start of the study
13)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
14)Gastrointestinal disorders which may affect drug absorption and pharmacokinetics
15)Use of drugs which may affect drug absorption and pharmacokinetics
16)Pregnant or lactating woman; woman of child bearing age unless using effective contraception (In case of suspected pregnancy, pregnancy test should be conducted)
17)Possibility of allergic reaction to the study drug
18)Drug abuse. Health, psychological, social conditions that interfere with the participation of the study or evaluation of the results
19)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.

Related Information

• Primary Sponsor: Kato Naoya
• Secondary Sponsor: Ogasawara Sadahisa
• Source(s) of Monetary Support: Eisai Co., Ltd.