TACE Combined With Lenvatinib for Unresectable Hepatocellular Carcinoma：A Multicenter, Single-armed, Prospective, Observational Study (Prolong)
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 主要终点
- Objective response rate（ORR）
研究概览
简要总结
This is a multicenter, prospective, observational study in which subjects will be treated with lenvatinib combined with TACE in un-resectable HCC patients who had not received systematic treatment or TACE treatment in the past.
详细描述
Only 30% of HCC patients received radical resection. Most of the patients are in the advanced stage and can only receive palliative treatment such as TACE or systemic treatment. Lenvatinib is a multi-target receptor tyrosine kinase inhibitor (TKI), which mainly inhibits vascular endothelial growth factor(VEGF) receptor-1, 2, 3; fibroblast growth factors(FGF) receptor-1, 2, 3, 4; platelet derived growth factor receptor(PDGFR)α; RET and KIT and showed significant anti-tumor effect in REFLECT study. The purpose of this study is to explore the efficacy and safety of Lenvatinib and TACE in unresectable HCC patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages of ≥ 18 and ≤ 75 years old.
- •Clinically or histopathologically diagnosed as hepatocellular carcinoma (HCC).
- •China stage IIb-IIIb patients, not suitable for surgical resection.
- •The imaging examination within 2 weeks before interventional therapy showed that there was at least one target lesion that could be measured by CT or MRI, and the lesion was suitable for repeated and accurate measurement.
- •Child-Pugh scores ≤
- •Intended to be treated with TACE combined with lenvatinib.
- •Good organ and bone marrow function: Blood routine: WBC>4.0×109/L、Hb>80g/L, PLT>75×109/L, NEUT>1.5×10⁹/L. Blood coagulation function: International normalized ratio (INR)<1.
- •Hepatic function: serum albumin (ALB)>3.5 g/dl, total bilirubin (TBIL) <1.5 × normal upper limit (ULN) (Eliminate biliary obstruction), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 3 × ULN. Renal dysfunction：serum creatinine (SCR) <1.5× ULN.
- •Agreed to join the clinical trial and sign the informed consent form.
排除标准
- •Hepatobiliary cell carcinoma, mixed cell carcinoma and fibrolamellar hepatocellular carcinoma.
- •With invasion of the main portal vein or vena cava.
- •Received interventional therapy such as TACE within 2 years.
- •Received systematic treatment in the past.
- •Uncontrollable ascites, hepatic encephalopathy or esophagogastric variceal bleeding.
- •Patients with hypertension who cannot be reduced to normal range after antihypertensive treatment (systolic blood pressure > 140mmHg, or diastolic blood pressure > 90 mmHg).
- •Suffering from grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmia or myocardial ischemia or myocardial infarction (The QTc interval ≥ 450ms, QTc interval is calculated by Fridericia formula).
- •There is a history of gastrointestinal bleeding or a clear tendency of gastrointestinal bleeding in the past 3 months, such as esophageal varices at risk of bleeding, local active ulcer lesions, fecal occult blood ≥ (+).
- •Pregnant or lactating women. A fertile patient who is unwilling or unable to use effective contraception.
- •Patients with HIV infection.
- •Suspected allergy to research drugs.
- •Other situations which the researchers considered ineligible for participating in the trial.
研究组 & 干预措施
Lenvatinib and TACE
Patients in Lenvatinib + TACE group will take oral lenvatinib within ten days after TACE.
干预措施: Lenvatinib (Drug)
Lenvatinib and TACE
Patients in Lenvatinib + TACE group will take oral lenvatinib within ten days after TACE.
干预措施: TACE (Procedure)
结局指标
主要结局
Objective response rate（ORR）
时间窗: up to 12 months
The percentage of patients who have best overall response of complete response (CR) or partial response (PR) according to mRECIST.
次要结局
- Intrahepatic ORR and Extrahepatic ORR(up to 12 months)
- Progression-free survival (PFS)(up to 12 months)
- Alpha-fetoprotein (AFP) response rate(up to 12 months)
- Time to progression（TTP）(up to 12 months)
- Adverse events(AEs)(up to 18 months)
研究者
guoliang shao
Vice President of Zhejiang Cancer Hospital
Zhejiang Cancer Hospital