LEOPARD trial

JRCT ID: jRCTs031180019

Registered date:26/09/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Hepatocellular carcinoma
• Date of first enrollment: 16/10/2018
• Target sample size: 35
• Study type: Interventional
• Intervention(s): Lenvatinib and intra-arterial cisplatin

Outcome(s)

• Primary Outcome: Response rate (modified RECIST as assessed by independent radiological review committees)
• Secondary Outcome: Progression-free survival, time to progression, overall survival, adverse events, response rate (RECIST1.1 as assessed by independent radiological review committees), response rate (modified RECIST as assessed by each investigators) and serious adverse events.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

1)Advanced hepatocellular carcinoma (HCC) confirmed histologically or by the typical findings of a hypervascular tumor on computed tomography or angiography
2)Not applicable for surgical resection, liver transplantation, local ablative therapy or TACE
3)No prior systemic chemotherapy for HCC
4)Age 20-79 years old
5)Presence of intrahepatic tumors affecting the prognosis, irrespective of the presence of extrahepatic tumors
6)Presence of measurable lesions
7)Eastern Cooperative Oncology Group Performance Status 0-1
8)Adequate organ functions
9)Child-Pugh score 5-6
10)Controlled hypertension with 3 or less antihypertensive drugs
11)Hepatic arterial infusion chemotherapy with CDDP technically feasible
12)Interval of 4 weeks or more from the last treatment for HCC
13)Life expectation of 12 weeks or over at least
14)Written informed consent

Exclude criteria

1)Prior treatment with sorafenib, lenvatinib or cisplatin (including combined use with TACE)
2)Refractory moderate pleural effusion or ascites
3)Urinary protein excretion of 1 g or over on quantitative examination of a 24-hour urine sample, if qualitative examination for proteinuria reveals a result of 2+ or greater.
4)Hepatic encephalopathy
5)Serious complications
6)Hemorrhagic or thrombotic disease, or history of gastrointestinal bleeding or active hemoptysis.
7)Pregnant or lactating woman; woman of childbearing age unless using effective contraception
8)Oral intake impossible
9)Brain or meningeal metastasis
10)Active infection, excluding hepatitis viral infection
11)HIV-positive
12)Pulmonary fibrosis or interstitial pneumonitis
13)History of blood transfusion or intake of blood-forming medicines, such as G-CSF, within 14 days prior to enrollment
14)Unsatisfactory general condition for participation in the study as judged by the primary physician

Related Information

• Primary Sponsor: Ikeda Masafumi
• Source(s) of Monetary Support: Eisai, Co.Ltd.