PEARL Trial: Partial TACE Enhancing Anti-tumor Response With Lenvatinib in Unresectable HCC
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- 1-year progression-free survival (PFS) by mRECIST
研究概览
简要总结
This is a single-arm, open-label, phase II clinical trial. Patients with unresectable hepatocellular carcinoma (HCC) who are eligible for lenvatinib treatment will receive partial transarterial chemoembolization (TACE) targeting up to two liver segments containing the largest tumor volume or lesions at risk of rupture, in combination with standard lenvatinib therapy. The partial TACE approach is designed as a liver-function-sparing technique that limits ischemic territory while preserving hepatic reserve.
详细描述
Primary objective:
-1-year progression-free survival (PFS) by mRECIST
Secondary objectives:
- 1-year overall survival (OS)
- Objective response rate (ORR) and disease control rate (DCR) per RECIST v1.1 and mRECIST
- Incidence of hepatic decompensation within 30 days after treatment (defined as: bilirubin > 3 mg/dL, new or worsened ascites, or hepatic encephalopathy)
- Duration of response (DOR)
Exploratory Endpoints:
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of HCC confirmed by histology/cytology or typical imaging features, unsuitable for surgical resection or liver transplantation
- •Age ≥ 20 years at the time of signing informed consent
- •ECOG performance status 0-1
- •BCLC stage B or C (without main portal vein thrombosis)
- •Child-Pugh score 5-7 (Class A or B7) within 28 days of registration
- •Adequate bone marrow, liver, and renal function
- •Blood pressure adequately controlled
- •Ability to understand and sign written informed consent
排除标准
- •Prior systemic therapy for HCC
- •Main portal vein thrombosis
- •Prior locoregional therapy within 4 weeks
- •Uncontrolled hypertension
- •Clinically significant cardiovascular disease within 6 months
- •Pregnancy or breastfeeding
研究组 & 干预措施
Partial TACE Enhancing Anti-tumor Response with Lenvatinib in unresectable HCC
Lenvatinib: Oral administration at 12 mg once daily (body weight ≥ 60 kg) or 8 mg once daily (body weight < 60 kg). Treatment continues until disease progression, unacceptable toxicity, or patient withdrawal.
Partial TACE:
Performed within 4 weeks after starting lenvatinib.
干预措施: Partial transarterial chemoembolization (TACE) (Procedure)
Partial TACE Enhancing Anti-tumor Response with Lenvatinib in unresectable HCC
Lenvatinib: Oral administration at 12 mg once daily (body weight ≥ 60 kg) or 8 mg once daily (body weight < 60 kg). Treatment continues until disease progression, unacceptable toxicity, or patient withdrawal.
Partial TACE:
Performed within 4 weeks after starting lenvatinib.
干预措施: Lenvatinib (Drug)
结局指标
主要结局
1-year progression-free survival (PFS) by mRECIST
时间窗: 1 year after start of study treatment
Percentage of participants alive and free of disease progression at 1 year. Progression-free survival is measured from the start date of study treatment to the date of first documented disease progression according to modified RECIST (mRECIST) or death from any cause, whichever occurs first.
次要结局
- 1-year overall survival (OS)(1 year after start of study treatment)
- Objective response rate (ORR) by mRECIST(Up to 12 months after start of study treatment)
- Objective response rate (ORR) by RECIST v1.1(Up to 12 months after start of study treatment)
- Disease control rate (DCR) by mRECIST(Up to 12 months after start of study treatment)
- Disease control rate (DCR) by RECIST v1.1(Up to 12 months after start of study treatment)
- Duration of response (DOR) by mRECIST(Up to 12 months after start of study treatment)
- Incidence of hepatic decompensation(Within 30 days after treatment)
- Incidence of treatment-emergent adverse events(From first dose of study treatment up to 30 days after the last dose)