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临床试验/NCT05557656
NCT05557656尚未招募不适用

A Real World Study of Regogfinib in the Treatment of Advanced Hepatocellular Carcinoma

Zhongda Hospital0 个研究点目标入组 800 人开始时间: 2023年1月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
800
主要终点
Overall survival (OS)

研究概览

简要总结

This is a non-interventional observational study with the primary objective of assessing the efficacy of regorafenib in patients with immediate or advanced stage HCC.

详细描述

  1. Study Objectives Primary Objective: To assess the efficacy of regorafenib in patients with immediate or advanced stage HCC Secondary objective: To assess the safety of regorafenib in patients with immediate or advanced stage HCC
  2. Study Design This is a multicenter, retrospective, real-world study that will collect data from patients treated with regorafenib at medical centers in China.
  3. Data Collection 3.1 Screening Period

The study procedures to be performed at screening include:

  1. . Determine eligible subjects according to the inclusion/exclusion criteria and document the results.
  2. . Collect demographic characteristics (eg, age, sex, weight, BMI, and ECOG score);
  3. . Collect past medical history;
  4. . Collect primary tumor site;
  5. . Collect information on prior treatments: all treatments received since diagnosis of advanced HCC, including each treatment regimen (including first-line therapy), start and end date, duration, best response;
  6. . Collect information on liver function and ECOG score prior to the first dose of regorafenib;
  7. . Collect results of laboratory tests performed prior to and after the first dose of regorafenib, including haematology, biochemistry and genetic testing (if any);
  8. . Collect imaging data: the last imaging procedure performed prior to the first dose of regorafenib, such as CT, PET-CT, MRI, and whole-body bone scan (with at least 1 measurable lesion); and information related to metastases (such as metastases to lymph node, bone and/or lung).

3.2 Data Review Period of Regorafenib Treatment

The following information obtained during each cycle of regorafenib will be collected retrospectively:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with pathologically or clinically confirmed HCC;
  • Patients with Barcelona Clinic Liver Cancer (BCLC) stage B/C;
  • Patients previously treated with regorafenib for at least one 28-day cycle after only one prior systemic therapy.

排除标准

  • Patients with incomplete information that would impact the assessment of primary endpoint;
  • Patients with medical history of other malignant neoplasms.

研究组 & 干预措施

HCC participants who received the treatment of Regorafenib

HCC participants who received the treatment of Regorafenib

干预措施: Regorafenib 40 MG (Drug)

结局指标

主要结局

Overall survival (OS)

时间窗: Time from the start of regorafenib treatment to the date of death from any cause or last follow-up,whichever came first, assessed up to 60 months

Overall survival was defined as the time from the start of regorafenib treatment to the date of death from any cause or last follow-up

次要结局

  • Time to progression (TTP)(Time from the start of regorafenib treatment to the date of the first documentation of disease progression,whichever came first, assessed up to 60 months)
  • Objective response rate (ORR)(Time from the start of regorafenib treatment to the date of the first documentation of objective response,assessed up to 60 months.)
  • Progression-free survival (PFS)(Time from the start of regorafenib treatment to the date of the first documentation of disease progression or death from any cause,whichever came first, assessed up to 60 months.)
  • Adverse events (AEs)(Time from the start of regorafenib treatment to the date of death or last follow up,whichever came first,assessed up to 60 months.)
  • Disease control rate (DCR)(Time from the start of regorafenib treatment to the date of the first documentation of CR or PR or stable,assessed up to 60 months.)

研究者

发起方
Zhongda Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gao-jun Teng

Professor

Zhongda Hospital

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