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临床试验/CTRI/2014/12/005310
CTRI/2014/12/005310已完成4 期

Outcomes of HCC Patients Treated With TACE Followed or Not Followed by Sorafenib and the Influence of Timing to Initiate Sorafenib - OPTMIS

Bayer pharmaceuticals Pvt Ltd0 个研究点目标入组 55 人开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
已完成
入组人数
55

研究概览

简要总结

暂无简介。

研究设计

研究类型
Pms

入排标准

入选标准

  • Patients with histologically/cytologically documented or radiographically diagnosed HCC. Radiographic diagnosis needs typical findings of HCC by radiographic method i.e. on multi-dimensional dynamic CT, CT hepatic arteriography (CTHA)/CT arterial portography (CTAP) or MRI.
  • Patients with BCLC (Barcelona clinic liver cancer staging) stage B or higher.
  • Patients in whom a decision to treat with TACE has been made at time of study enrollment. Patients that have received one TACE in the past also can be enrolled, if the TACE was done at the same site and all required data about such previous TACEs are available. TACE includes both conventional TACE with lipidiol (or similar agents) and chemotherapeutic agent(s) and TACE with DC Beads excluding TAE without chemotherapeutic agent.
  • Patients with unresectable HCC (incurable with curative treatments including resection or ablation or not eligible for resection or local ablation)
  • Patients must have signed an informed consent form
  • Patients must have a life expectancy of at least 8 weeks

排除标准

  • Patients who have received TACE in the past but the data about TACE required in this protocol are not available
  • Patients who received any systemic anti-cancer therapy prior to the first TACE
  • Patients who are treated according to a trial protocol for intervention including a locoregional therapy or systemic therapy
  • Hospice patients
  • All contra-indications according to the local marketing authorization should be considered.

研究者

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