OPTIMIS - Outcomes of HCC Patients Treated With TACE Followed or Not Followed by Sorafenib and the Influence of Timing to Initiate Sorafenib
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 1,676
- 主要终点
- Overall survival (OS)
研究概览
简要总结
This study will collect data of patients who are treated with TACE followed by sorafenib for hepatocellular carcinoma (HCC) or patients without Sorafenib after TACE. In contrast to a prior observational study on sorafenib (GIDEON study), where pre-treatment with TACE was documented retrospectively, this study will collect more detailed information about the TACE treatment and the status of a patient when treatment with sorafenib is started.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
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.
研究组 & 干预措施
TACE + early Nexavar
Patients with early start of Sorafenib treatment. This cohort comprises all patients where the physician decides at the time of TACE non-eligibility to choose Sorafenib as the next treatment option (regardless of whether TACE treatment is continued or not).
干预措施: TACE (transarterial chemoembolization) (Procedure)
TACE without early Nexavar
Patients without early start of Sorafenib treatment. This cohort comprises all patients where the physician decides at the time of TACE non-eligibility not to choose Sorafenib as the next treatment option. This cohort also includes patients with TACE non-eligibility for whom the decision to treat with Sorafenib is made at a later point in time, patients who are never treated with Sorafenib as well as patients for whom another systemic cancer treatment has been chosen be the physician either at time of TACE non-eligibility or at a later point in time.
干预措施: TACE (transarterial chemoembolization) (Procedure)
TACE + early Nexavar
Patients with early start of Sorafenib treatment. This cohort comprises all patients where the physician decides at the time of TACE non-eligibility to choose Sorafenib as the next treatment option (regardless of whether TACE treatment is continued or not).
干预措施: Sorafenib (Nexavar, BAY43-9006) (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: Up to 3 years
Defined as time (in days) from time of TACE non-eligibility to death due to any cause. Patients lost to follow-up or alive at the end of the study will be censored at the last date known to be alive.
次要结局
- Progression-free survival (PFS) from initial TACE(Up to 3 years)
- Duration of TACE treatment(Up to 3 years)
- TTP from initiation of sorafenib(Up to 3 years)
- Overall survival from initial TACE(Up to 3 years)
- Time to progression (TTP) from initial TACE(Up to 3 years)
- Tumor response according to mRECIST criteria(Up to 3 years)
- Number of patients with TEAEs (treatment emergent adverse events)(Up to 3 years)
- Time to TACE non-eligibility(Up to 3 years)
- OS from initiation of sorafenib(Up to 3 years)
- Tumor status at different visits response according to mRECIST(Up to 3 years)
- Duration of sorafenib treatment(Up to 3 years)
- Deterioration of liver dysfunction(Up to 3 years)
- PFS from initiation of sorafenib(Up to 3 years)
- TACE unsuitability(Up to 3 years)