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临床试验/NCT05954897
NCT05954897招募中2 期

Lenvatinib, Tislelizumab Combined With RALOX Regimen HAIC in Advanced Hepatocellular Carcinoma: a Phase II, Single-arm, Prospective Study

Guangdong Provincial People's Hospital1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2023年9月1日最近更新:
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

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

申办方类型
Other
责任方
Sponsor

研究点 (1)

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