Combining lenvatinib and anti-PD1 antibody with radiotherapy for liver cancer treatment

Safety and Efficacy of Lenvatinib and Anti-PD1 Antibody Combined With Radiotherapy Neoadjuvant Treatment for Resectable Hepatocellular Carcinoma With PVTT,Prospective, Multicenter, Single-arm Study

This study is testing a new treatment combining lenvatinib, an anti-PD1 antibody, and radiotherapy to see if it helps people with liver cancer before they have surgery.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Beijing Tsinghua Chang Gung Hospital (Academic / other)
• Drugs / interventions: Lenvatinib
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT05225116 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and efficacy of a combination treatment involving lenvatinib, an anti-PD1 antibody, and radiotherapy for patients with resectable hepatocellular carcinoma (HCC) that has portal vein tumor thrombus (PVTT). The study aims to provide evidence for the effectiveness of this neoadjuvant therapy approach, which is currently unproven. Eligible participants will undergo this treatment before surgical resection of their tumors. The trial is designed to assess both the safety profile and the potential benefits of this combined treatment strategy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with resectable hepatocellular carcinoma and specific types of portal vein tumor thrombus.

Not a fit: Patients with distant metastasis or those with severe liver dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve surgical outcomes and overall survival for patients with hepatocellular carcinoma and PVTT.

How similar studies have performed: While the combination of immunotherapy and radiotherapy is being explored in various cancers, this specific approach for hepatocellular carcinoma with PVTT is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Aged 18-70, with no gender limitation;
2. HCC patients who strictly met the clinical diagnostic criteria of The Code for The Diagnosis and Treatment of Primary Liver Cancer (2019 edition) or were confirmed by histopathological or cytological examination;
3. BCLC stage C, no distant metastasis;
4. Patients with PVTT of type VP1-2-3-4 according to Japanese VP Classification;
5. The primary tumor can be resected (the remaining liver has complete vascular structure and sufficient liver volume, in line with the decision-making system of safe liver resection)
6. ECOG score 0-1;
7. Child-Pugh score ≤7;
8. If the patient is HBV antigen positive, HBV DNA \< 500 IU/ mL, conventional antiviral treatment;
9. The major organs meeting the following criteria:

   1. Adequate bone marrow function, defined as: Absolute neutrophil count (ANC ≥ or equal to 1.5 X 10 \^ 9 per liter (/ L)) Hemoglobin (Hb ≥ 8.5 g/dL) Platelet count ≥ 75×10 \^ 9 / L.
   2. Adequate liver function, defined as: Albumin \> 2.8 g/dL Bilirubin is 3.0 mg/dL or less Aspartate aminotransferase (AST), alkaline phosphatase (ALP) and alanine aminotransferase (ALT) are less than or equal to 5 ULN.
   3. Adequate coagulation function, defined as an international standardized ratio ( (INR) of 2.3 or less.
   4. Adequate renal function was defined as creatinine clearance greater than 40 mL/min (mL/min), calculated according to the Cockcroft and Gault formulas.
   5. Adequate pancreatic function, defined as amylase and lipase. = 1.5 x ULN.
10. Adequate control of blood pressure (BP) with up to 3 antihypertensive drugs, defined as BP-lt at screening time; = 150/90 mmHg (mmHg), and there was no change in antihypertensive therapy 1 week prior to cycle 1 / day 1.
11. Patients are expected to survive longer than 3 months.
12. No pregnancy or pregnancy plan.
13. Subjects voluntarily joined the study and signed informed consent with good compliance and follow-up.

Exclusion Criteria:

1. Extrahepatic metastasis of primary hepatocellular carcinoma;
2. Diffuse liver cancer;
3. Patients who had previously received targeted drugs or immune checkpoint inhibitors;
4. allergic to Lenvatinib or PD-1 inhibitor ingredients;
5. Patients with grade II or higher myocardial ischemia or myocardial infarction and poorly controlled arrhythmias (including QTc interval ≥470 ms); Patients with grade III \~ IV cardiac insufficiency according to NYHA standard, or left ventricular ejection fraction (LVEF) \< 50% as indicated by color doppler echocardiography;
6. abnormal coagulation function (INR \> 1.5 or prothrombin time (PT) \> ULN+4 seconds or APTT \&gt; 1.5ULN), with bleeding tendency or receiving thrombolytic or anticoagulant therapy;
7. pregnant or breast-feeding women; Fertile patients unwilling or unable to take effective contraceptive measures;
8. have a history of mental illness or abuse of psychotropic drugs;
9. patients with co-HIV infection;
10. a history of liver resection, liver transplantation, interventional therapy, and other malignant tumors;
11. patients with active infection;
12. contraindications to radiotherapy;
13. Patients with poor compliance such as floating population;
14. participants in clinical trials of other experimental drugs or devices within 4 weeks;
15. those considered unsuitable for inclusion by the researcher.

Where this trial is running

Beijing, Beijing

• Beijing Tsinghua Changgung Hospital — Beijing, Beijing, China (Recruiting)

Study contacts

• Study coordinator: Jiahong Dong, MD

Conditions Hepatocellular Carcinoma