NCT05225116招募中1 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of patients who complete pre-op treatment and proceed to surgery
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •The major organs meeting the following criteria:
- •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.
- •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.
- •Adequate coagulation function, defined as an international standardized ratio ( (INR) of 2.3 or less.
- •Adequate renal function was defined as creatinine clearance greater than 40 mL/min (mL/min), calculated according to the Cockcroft and Gault formulas.
- •Adequate pancreatic function, defined as amylase and lipase. = 1.5 x ULN.
- •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
- •Patients are expected to survive longer than 3 months.
- •No pregnancy or pregnancy plan.
- •Subjects voluntarily joined the study and signed informed consent with good compliance and follow-up.
排除标准
- •Extrahepatic metastasis of primary hepatocellular carcinoma;
- •Diffuse liver cancer;
- •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;
- •patients with co-HIV infection;
- •a history of liver resection, liver transplantation, interventional therapy, and other malignant tumors;
- •patients with active infection;
- •contraindications to radiotherapy;
- •Patients with poor compliance such as floating population;
- •participants in clinical trials of other experimental drugs or devices within 4 weeks;
- •those considered unsuitable for inclusion by the researcher.
研究组 & 干预措施
Sintilimab+Lenvatinib+Radiotherapy
Experimental
干预措施: Sintilimab (Drug)
Sintilimab+Lenvatinib+Radiotherapy
Experimental
干预措施: Lenvatinib (Drug)
Sintilimab+Lenvatinib+Radiotherapy
Experimental
干预措施: radiotherapy (Radiation)
结局指标
主要结局
Number of patients who complete pre-op treatment and proceed to surgery
时间窗: up to 5 years
Number of patients who complete pre-op treatment and proceed to surgery
Safety(CTCAE v5.0)
时间窗: up to 5 years
Number of patients who reported incidence of grade ≥3 treatment related adverse events.
次要结局
- Major Pathological Response(MPR)(Within 3 months after surgery)
- Objective Response Rate(ORR)(within 1 week before surgery)
- Imaging-pathology Concordance Rate(Within 3 months after surgery)
- PVTT regression rate(Within 3 months after surgery)
- Median Overall survival(mOS)(up to 5 years)
- Recurrence free survival(RFS)(1 year after surgery)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
4 期
Hepatic Resection Versus Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma Complicated by Portal Vein Tumor ThrombosisHepatocellular Carcinoma With PVTTNCT01350206Sun Yat-sen University180
已完成
不适用
ISP-TACE Versus TACE for HCC With PVTTPortal Vein Tumor ThrombosisHCCNCT03108248Zhongda Hospital126
已完成
不适用
Lenvatinib Combined Anti-PD1 Antibody for the Advanced Hepatocellular CarcinomaAnti-PD1 AntibodyLiver DiseasesHepatocellular CarcinomaNCT04627012Sun Yat-sen University600
已完成
不适用
Radioembolization for Hepatocellular Carcinoma With Portal Vein Tumoral ThrombosisHepatocellular CarcinomaNCT04771988IRCCS Azienda Ospedaliero-Universitaria di Bologna17
招募中
2 期
Perioperative Sintilimab Plus Bevacizumab Biosimilar and TACE-HAIC for HCC Patients With PVTT: A Phase-2 Clinical TrialHepatocellular CarcinomaNCT06031285Sun Yat-sen University43