Safety and Efficacy of Lenvatinib and Anti-PD1 Antibody Combined With Radiotherapy Neoadjuvant Tr… (NCT05225116) | Clinical Trial Compass
UnknownPhase 1
Safety and Efficacy of Lenvatinib and Anti-PD1 Antibody Combined With Radiotherapy Neoadjuvant Treatment for Resectable Hepatocellular Carcinoma With PVTT
China20 participantsStarted 2023-01-08
Plain-language summary
Patients with hepatocellular carcinoma with PVTT can benefit from surgical resection and radiotherapy. As the rapid development of systematic treatment in hepatocellular carcinoma, ICIs neoadjuvant therapy is being actively explored .But there is no evidence to prove the safety and efficacy of lenvatinib and anti-PD1 antibody combined with radiotherapy neoadjuvant treatment for resectable hepatocellular carcinoma with PVTT. This study intends to supplement the evidence of benefit in such patients.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Aged 18-70, with no gender limitation;
✓. 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;
✓. BCLC stage C, no distant metastasis;
✓. Patients with PVTT of type VP1-2-3-4 according to Japanese VP Classification;
✓. 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)
✓. ECOG score 0-1;
✓. Child-Pugh score ≤7;
✓. If the patient is HBV antigen positive, HBV DNA \< 500 IU/ mL, conventional antiviral treatment;
Exclusion criteria
✕. Extrahepatic metastasis of primary hepatocellular carcinoma;
What they're measuring
1
Safety(CTCAE v5.0)
Timeframe: up to 5 years
2
Number of patients who complete pre-op treatment and proceed to surgery
✕. Patients who had previously received targeted drugs or immune checkpoint inhibitors;
✕. allergic to Lenvatinib or PD-1 inhibitor ingredients;
✕. 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;
✕. abnormal coagulation function (INR \> 1.5 or prothrombin time (PT) \> ULN+4 seconds or APTT \> 1.5ULN), with bleeding tendency or receiving thrombolytic or anticoagulant therapy;
✕. pregnant or breast-feeding women; Fertile patients unwilling or unable to take effective contraceptive measures;
✕. have a history of mental illness or abuse of psychotropic drugs;