Overview

This trial is active, not recruiting.

Condition carcinoma, hepatocellular
Treatments tace (transarterial chemoembolization), sorafenib (nexavar, bay43-9006)
Sponsor Bayer
Start date June 2013
End date July 2017
Trial size 1701 participants
Trial identifier NCT01933945, 16560, NX1301

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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).
tace (transarterial chemoembolization)
First treatment for all patients included in the study
sorafenib (nexavar, bay43-9006)
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.
tace (transarterial chemoembolization)
First treatment for all patients included in the study

Primary Outcomes

Measure
Overall survival
time frame: Up to 3 years

Secondary Outcomes

Measure
Overall survival from initial TACE
time frame: Up to 3 years
Progression-free survival from initial TACE
time frame: Up to 3 years
Time to progression from initial TACE
time frame: Up to 3 years
Tumor response according to mRECIST criteria
time frame: Up to 3 years
Duration of treatment
time frame: Up to 3 years
Number of patients with TEAEs (treatment emergent adverse events)
time frame: Up to 3 years

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title OPTIMIS - Outcomes of HCC Patients Treated With TACE Followed or Not Followed by Sorafenib and the Influence of Timing to Initiate Sorafenib
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Bayer.