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

Bayer

Status: Completed

Conditions: Carcinoma, Hepatocellular

Treatments: Drug: Sorafenib (Nexavar, BAY43-9006); Procedure: TACE (transarterial chemoembolization)

Study type: Observational

Funder types: Industry

Identifiers

NCT01933945

16560

NX1301 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 1,676 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

1,676 participants in 2 patient groups

TACE + early Nexavar

Description:

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).

Treatment:

Drug: Sorafenib (Nexavar, BAY43-9006)

Procedure: TACE (transarterial chemoembolization)

TACE without early Nexavar

Description:

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.

Treatment:

Procedure: TACE (transarterial chemoembolization)