LEOPARD-Neo

JRCT ID: jRCTs031230128

Registered date:09/06/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Borderline resectable Hepatocellular carcinoma
• Date of first enrollment: 13/10/2023
• Target sample size: 24
• Study type: Interventional
• Intervention(s): Lenvatinib and intra-arterial cisplatin, Surgical resection

Outcome(s)

• Primary Outcome: Resection rate
• Secondary Outcome: Objective response rate, progression-free survival, overall survival, R0 resection rate, tumor-necrosis response (EVANS classification); incidence adverse event; and serious complications of surgical resection; treatment outcomes by preoperative circulating tumor DNA (ctDNA), perioperative ctDNA monitoring

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

1) Histologically or clinically confirmed hepatocellular carcinoma (except for mixed type).
2) Presence of vascular invasion. (Vascular invasion refers to portal vein tumor thrombosis, hepatic vein tumor thrombus, and bile duct tumor thrombus.)
3) Technically resectable HCC
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) Having measurable lesions
7) ECOG Performance Status 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<=105 IU/L
ALT Male <=210 IU/L Female <=115IU/L
Pancreas
Amylase<= 264U/L
KidneyCr <= 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.

Exclude criteria

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 (diastolic pressure exceeds 100 mmHg)
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.

Related Information

• Primary Sponsor: Ikeda Masafumi
• Secondary Sponsor: Japan Oncology Network in Hepatobiliary and Pancreas
• Source(s) of Monetary Support: Guardant Health AMEA