Clinical trial NCT01933945: Outcomes of HCC (Hepatocellular Carcinoma) Patients Treated With TACE (Transarterial Chemoembolization) and Early, Not Early or Not at All Followed by Sorafenib
Official title: OPTIMIS - Outcomes of HCC Patients Treated With TACE Followed or Not Followed by Sorafenib and the Influence of Timing to Initiate Sorafenib
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Hepatocellular
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-09-02
Enrollment: 1676
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female and male patients with a diagnosis of hepatocellular carcinoma (HCC) will be enrolled in the participating study countries and sites during the enrollment period. All treatment decisions prior inclusion of a patient as well as during the observation must be made by the investigator based on his regular medical practice. Patients must give written informed consent prior to documentation.

During the course of the study, patients will be assigned to one of the following cohorts of special interest:

1. Patients with early start of sorafenib treatment
2. Patients without early start of sorafenib treatment.

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: Up to 3 years
Secondary outcomes:
measure: Overall survival from initial TACE
timeFrame: Up to 3 years
measure: Progression-free survival (PFS) from initial TACE
timeFrame: Up to 3 years
measure: Time to progression (TTP) from initial TACE
timeFrame: Up to 3 years
measure: Tumor response according to mRECIST criteria
timeFrame: Up to 3 years
measure: Duration of TACE treatment
timeFrame: Up to 3 years
measure: Number of patients with TEAEs (treatment emergent adverse events)
timeFrame: Up to 3 years
measure: TACE unsuitability
timeFrame: Up to 3 years
measure: Time to TACE non-eligibility
timeFrame: Up to 3 years
measure: Deterioration of liver dysfunction
timeFrame: Up to 3 years
measure: OS from initiation of sorafenib
timeFrame: Up to 3 years
measure: PFS from initiation of sorafenib
timeFrame: Up to 3 years
measure: Tumor status at different visits response according to mRECIST
timeFrame: Up to 3 years
measure: Duration of sorafenib treatment
timeFrame: Up to 3 years
measure: TTP from initiation of sorafenib
timeFrame: Up to 3 years
Other outcomes:
measure: PFS from TACE non-eligibility
timeFrame: Up to 3 years
measure: TTP from TACE non-eligibility
timeFrame: Up to 3 years
measure: Tumor response from time of TACE non-eligibility by mRECIST
timeFrame: Up 3 years
measure: Switch to sorafenib or other systemic and non-systemic cancer therapy
timeFrame: Up to 3 years
measure: Deviations from recommendations for TACE use
timeFrame: Up to 3 years
measure: Duration of treatment of sorafenib after TACE
timeFrame: Up to 3 years
Locations:
city: Multiple Locations
country: Austria
city: Multiple Locations
country: Brazil
city: Multiple Locations
country: Canada
city: Multiple Locations
country: China
city: Multiple Locations
country: Czechia
city: Multiple Locations
country: Denmark
city: Multiple Locations
country: Egypt
city: Multiple Locations
country: France
city: Multiple Locations
country: Greece
city: Multiple Locations
country: Hong Kong
city: Multiple Locations
country: Hungary
city: Multiple Locations
country: India
city: Multiple Locations
country: Indonesia
city: Multiple Locations
country: Israel
city: Multiple Locations
country: Japan
city: Multiple Locations
country: Kazakhstan
city: Multiple Locations
country: Korea, Republic of
city: Multiple Locations
country: Mexico
city: Multiple Locations
country: Netherlands
city: Multiple Locations
country: Pakistan
city: Multiple Locations
country: Poland
city: Multiple Locations
country: Russian Federation
city: Multiple Locations
country: Singapore
city: Multiple Locations
country: Slovakia
city: Multiple Locations
country: Spain
city: Multiple Locations
country: Sweden
city: Multiple Locations
country: Switzerland
city: Multiple Locations
country: Taiwan
city: Multiple Locations
country: Thailand
city: Multiple Locations
country: Turkey
city: Multiple Locations
country: Vietnam
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: