Outcomes of HCC (Hepatocellular Carcinoma) Patients Treated With TACE (Transarterial Chemoembolization) and Early, Not Early or Not at All Followed by Sorafenib

• Status: Completed
• Trial end date: 2017-11-10
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Niacinamide; Sorafenib

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.