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Thermal Ablation Combined With Anlotinib and TQB2450 Solution for HCC

2021年3月2日 更新者:Ping Liang、Chinese PLA General Hospital

Safety and Effectiveness of Thermal Ablation Combined With Anlotinib and TQB2450 Solution for Advanced Hepatocelualr Carcinoma

In this study, investigators aimed to evaluated the efficacy and safety of microwave ablation combined with anlotinib and TQB2450 Solution in patients with advanced hepatocellular carcinoma. Patients were randomly assigned at a one-to-one ratio to receive microwave ablation plus anlotinib and TQB2450 Solution or microwave ablation plus TQB2450 Solution. Primary end points were objective response rate(ORR). Second end points include overall survival, progression-free survival and disease control rate. Safety was assessed in all patients.

研究概览

研究类型

介入性

注册 (预期的)

80

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Beijing
      • Beijing、Beijing、中国、100853
        • Chinese PLA General Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. ECOG PS score: 0-1, Life expectancy of 3 months or more
  2. Subjects must have confirmed diagnosis of HCC
  3. BCLC B and C grade
  4. At least 1 measurable target lesion according to mRECIST
  5. Child-Pugh score A to B
  6. No locoregional therapy within 4 weeks before enrollment for patients with unresectable HCC or tumor progression after locoregional therapy; All toxicities related to prior treatments must be resolved to Grade ≤1
  7. No prior treatment with anti-angiogenic drugs or any anti-PD-1 agent within 4 weeks before enrollment
  8. HBV DNA<500IU/mL
  9. Adequate organ function within 14 days before enrollment
  10. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to the start of study drug. Women must not be breastfeeding. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of study treatment
  11. Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol

Exclusion Criteria:

  1. Prior liver transplant
  2. Any prior (within 1 year) or current clinically significant ascites as measured by physical examination and that requires active paracentesis for control
  3. Prior treatment with an anti-PD-L1
  4. Active autoimmune disease that has required systemic treatment in past 2 years
  5. Known or suspected allergy to Anlotinib and TQB2450 Solution or study drug components;History of severe hypersensitivity reaction to any monoclonal antibody
  6. Has received a live-virus vaccination within 30 days of planned treatment start.
  7. Subjects with CNS metastases are not eligible, unless they have completed local therapy (eg, whole brain radiation therapy [WBRT], surgery or radiosurgery) and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (eg, radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment
  8. Subjects with any active, known, or suspected autoimmune disease; Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  9. HBV DNA ≥ 1000 IU/ml,HCV RNA
  10. New York Heart Association congestive heart failure of grade II or above, unstable angina, myocardial infarction within the past 6 months, or serious cardiac arrhythmia associated with significant cardiovascular impairment within the past 6 months, Prolongation of QTc (Fridericia formula) interval to >480 ms
  11. Dysfunction of blood coagulation (INR>1.5 or APTT>1.5×ULN), Bleeding or thrombotic disorders
  12. Anticoagulants requiring therapeutic INR monitoring, eg, warfarin or similar agents. Antiplatelet agents and low molecular weight heparin are prohibited throughout the study
  13. Active infection (any infection requiring systemic treatment)
  14. History of solid organ or hematologic transplant
  15. Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Anlotinib and TQB2450 solution
Microwave ablation will be performed according to patients' tumor number, size and liver function. Oral anlotinib (12 mg/d) will be administered and its cycle is defined as 2 weeks on-treatment followed by 1 week off-treatment. Patients will be given 1200 mg TQB245 solution intravenously every 3 weeks. The treatment continues until disease progression or treatment intolerance. Anlotinib and TQB2450 solution will be given after 2 weeks of microwave ablation procedure.
Anlotinib is a novel multitarget tyrosine kinase inhibitor, inhibiting tumour angiogenesis and proliferative signalling. TQB2450 solution is a new novel of PD-L1 inhibitor made by Crown Bioscience and CHIATAI TIANQING(CTTQ PHARMA).
有源比较器:TQB2450 Solution
Microwave ablation will be performed according to patients' tumor number, size and liver function. Patients will be given 1200 mg TQB245 solution intravenously every 3 weeks.TQB2450 solution will be given after 2 weeks of microwave ablation procedure.
TQB2450 solution is a new novel of PD-L1 inhibitor made by Crown Bioscience and CHIATAI TIANQING(CTTQ PHARMA).

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
ORR
大体时间:2-year
Objective Response Rate
2-year

次要结果测量

结果测量
措施说明
大体时间
OS
大体时间:2-year
Overall Survival
2-year
PFS
大体时间:2-year
Progression-free Survival
2-year
DCR
大体时间:2-year
Disease Control Rate
2-year
EORTC QLQ C30
大体时间:Change from baseline health related quality of life at 2 years
Impact of treatment on Health Related Quality of Life (HRQoL) for subjects treated using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire. EORTC QLQ C30 scales were grouped and converted to score 0 to 100 according to the scoring manual; a higher score represents a more severe symptom or problem.
Change from baseline health related quality of life at 2 years
EORTC QLQ-HCC18
大体时间:Change from baseline health related quality of life at 2 years
Impact of treatment on Health Related Quality of Life (HRQoL) for subjects treated using HCC-specific EORTC QLQ-HCC18 questionnaire. EORTC QLQ-HCC18 scales were grouped and converted to score 0 to 100 according to the scoring manual; a higher score represents a more severe symptom or problem.
Change from baseline health related quality of life at 2 years
AE
大体时间:2-year
Incidence of Adverse Events
2-year
SAEs
大体时间:2-year
Incidence of Severe Adverse Events
2-year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2021年3月5日

初级完成 (预期的)

2022年12月31日

研究完成 (预期的)

2023年12月31日

研究注册日期

首次提交

2020年11月30日

首先提交符合 QC 标准的

2020年12月7日

首次发布 (实际的)

2020年12月11日

研究记录更新

最后更新发布 (实际的)

2021年3月4日

上次提交的符合 QC 标准的更新

2021年3月2日

最后验证

2021年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • 301jrcsk-lp-yj

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