NCT05954897招募中2 期
Lenvatinib, Tislelizumab Combined With RALOX Regimen HAIC in Advanced Hepatocellular Carcinoma: a Phase II, Single-arm, Prospective Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
To evaluate the efficacy and safety of lenvatinib, tislelizumab combined with RALOX regimen HAIC in advanced hepatocellular carcinoma.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older.
- •HCC was diagnosed according to the Criteria for Diagnosis and Treatment of Primary Liver Cancer (2022 Edition) and American Association for the Study of Liver Diseases (AASLD) criteria.
- •Classified as stage C according to the Barcelona Clinic Liver Cancer (BCLC) staging system.
- •A dominant mass in theliver with or without extrahepatic oligometastasis, which was defined as up to three metastatic lesions in up to two organs with the largest diameter of≤3 cm.
- •No prior treatment for HCC.
- •At least one measurable target lesion according to modified Response Evaluation Criteria in Solid Tumors (mRECIST).
- •Performance status (PS) ECOG score ≤
- •Child-Pugh score ≤
- •Subjects voluntarily participate in this study, and sign the informed consent form, cooperate with the follow-up
- •Adequate organ function, defined as: Hb ≥ 90 g/dL; Neu ≥ 1.5 x 10 ^ 9/L; PLT ≥ 75 x 10 ^ 9/L; ALB ≥2.8 g/dL; TBIL ≤2 times the upper limit of normal; AST and ALT ≤ 3 times the upper limit of normal; Cre ≤1.5 x upper limit of normal; APTT≤1.5 times the upper limit of normal.
排除标准
- •Pathologically confirmed diagnosis of fibrolamellar HCC, sarcomatoid HCC, hepatocellular carcinoma-intrahepatic cholangiocarcinoma (HCC-ICC) mixed type;
- •Previous liver transplantation;
- •History of other malignancies;
- •Previous history of severe mental illness;
- •Uncontrollable hepatic encephalopathy, hepatorenal syndrome, ascites, pleural effusion or pericardial effusion;
- •Active bleeding or coagulation abnormalities, bleeding tendency or receiving thrombolytic, anticoagulant or antiplatelet therapy;
- •Other reasons were judged by the investigator to be unable to enroll.
研究组 & 干预措施
Experimental group
Experimental
干预措施: Lenvatinib, Tislelizumab Combined with RALOX Regimen HAIC (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: After the first HAIC treatment, until the disease progresses or dies (during the treatment of the patient) or the toxicity is intolerable，through study completion, an average of 12 months
The proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, including cases of complete remission (CR), partial remission (PR) under mRECIST criteria
次要结局
- Disease control rate(From date of the first HAIC treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months)
- Overall survival(Through study completion, up to 24 months)
- Progression-free survival(From date of the first HAIC treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months)
- Adverse Events(Until the last medication for 30 days (±7 days) or before the start of other anti-tumor therapy (whichever occurs first).)
研究者
研究点 (1)
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