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Phase II study of Lenvatinib plus cisplatin hepatic arterial infusion chemotherapy for biological borderline resectable hepatocellular carcinoma (J-LEOPARD)

J-LEOPARD

Haruki Koichiro

The Jikei University School of Medicine

3-25-8, Nishi-shinbashi, Minato-ku, Tokyo

haruki@jikei.ac.jp

Haruki Koichiro

The Jikei University School of Medicine

3-25-8, Nishi-shinbashi, Minato-ku, Tokyo

+81-3-3433-1111

haruki@jikei.ac.jp

Recruiting

Sept. 18, 2026

Interventional

single arm study

open(masking not used)

historical control

single assignment

treatment purpose

1) Histologically or clinically confirmed hepatocellular carcinoma (except for mixed type).
2) A high-risk score of >= 2 points, based on the following factors: AFP >= 12 ng/mL, tumor diameter >5 cm, number of tumors >=3, and macroscopic vascular invasion (Vp3/Vv2)
3) Technically resectable HCC (in patients with multiple lesions, RFA is acceptable for lesions <=2 cm)
4) Age >=18 years and <80 years.
5) No prior systemic therapy of primary lesion (Prior treatment history (Local therapy such as hepatectomy, RFA, TACE) is not a consideration.
6) Measurable lesions as defined by RECIST version 1.1.
7) ECOG Performance Status (PS) of 0 or 1.
8) Sufficient organ functions
Bone marrow
Neutro >= 1,500 /mm3
Hb >= 8.5 g/dL
PLT >= 75,000 /mm3
Liver
T-Bil <= 2.0 mg/dL
ALB >= 2.8 g/dL
AST/ALT <=150 IU/L
Kidney Cr <= 1.2 mg/dL
Creatinine Clearance >= 50 ml/min
Coagulation
International normalized ratio (PT-INR) <= 2.3
9) Child-Pugh score 5-6 points.
10) Controllable blood pressure by the use of antihypertensive agents with no more than three drugs
11) Procedural cisplatin hepatic arterial infusion chemotherapy is expected to be feasible.
12) Written informed consent has been obtained from the patient.

1) Extrahepatic metastases.
2) Previously treated with lenvatinib or cisplatin for hepatocellular carcinoma.
3) Moderate or greater ascites or pleural effusion unresponsive to treatment.
4) When the proteinuria is 2+ or more in the urinary protein qualitative test, 24-hour urine collection is carried out, and the urinary protein is recognized over 1 g/24 hour. (However, substitution by urinary protein/creatinine ratio is allowed.)
5) Hepatic encephalopathy
6) The following serious complications
Uncontrolled hypertension despite treatment
Difficult-to-control heart failure despite treatment; angina; arrhythmias
Poorly controlled diabetes despite treatment
Myocardial infarction within 6 months of onset
Active double cancers (synchronous double cancers, metachronous double cancers within 3 years of disease-free interval)
Serious psychiatric disorder
History of hypersensitivity to iodine-containing drugs or contrast media.
Serious drug allergy
7) Bleeding or thrombotic disease or a history of gastrointestinal bleeding or active hemoptysis within 28 days before enrollment.
8) Pregnant, breastfeeding, or possibly or intentionally pregnant, or wish to raise a child.
9) Difficult oral intake.
10) HIV positive.
11) Complicated by active infection requiring treatment (except for hepatitis virus).
12) Complicated by pulmonary fibrosis or interstitial pneumonia.
13) Treatment for blood conditions (including blood transfusions, blood products or hematopoietic factors products such as Granulocyte-Colony Stimulating Factor: G-CSF) in the 14 days prior to enrollment.
14) The investigator judges it inappropriate to conduct the study safely.

Both

Biological Borderline Resectable Hepatocellular Carcinoma

Lenvatinib and intra-arterial cisplatin, Surgical resection

Induction therapy

LEOPARD

D006528

C531958, D002945, D013514

Recurrence within 1 year after resection

Resection rate, recurrence beyond Milan criteria within 1 year after resection, disease-free survival, progression-free survival, overall survival, objective response rate, R0 resection rate, tumor-necrosis response (EVANS classification)

+81-3-3433-1111

Sept. 14, 2026

No

none