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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01933945
• Date of registration: 29/08/2013
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: Outcomes of HCC (Hepatocellular Carcinoma) Patients Treated With TACE (Transarterial Chemoembolization) and Early, Not Early or Not at All Followed by Sorafenib OPTIMIS
• Scientific title: OPTIMIS - Outcomes of HCC Patients Treated With TACE Followed or Not Followed by Sorafenib and the Influence of Timing to Initiate Sorafenib
• Date of first enrolment: October 28, 2013
• Target sample size: 1676
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01933945
• Study type: Observational

Countries of recruitment

Austria, Brazil, Canada, China, Czech Republic, Czechia, Denmark, Egypt, France, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Japan, Kazakhstan, Korea, Republic of, Mexico, Netherlands, Pakistan, Poland, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Vietnam

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion 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.



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Carcinoma, Hepatocellular

Intervention(s)

Procedure: TACE (transarterial chemoembolization)

Drug: Sorafenib (Nexavar, BAY43-9006)

Primary Outcome(s)

Overall survival (OS) [Time Frame: Up to 3 years]

Secondary Outcome(s)

TTP from initiation of sorafenib [Time Frame: Up to 3 years]

Deterioration of liver dysfunction [Time Frame: Up to 3 years]

Overall survival from initial TACE [Time Frame: Up to 3 years]

Duration of sorafenib treatment [Time Frame: Up to 3 years]

Progression-free survival (PFS) from initial TACE [Time Frame: Up to 3 years]

TACE unsuitability [Time Frame: Up to 3 years]

PFS from initiation of sorafenib [Time Frame: Up to 3 years]

Tumor response according to mRECIST criteria [Time Frame: Up to 3 years]

Time to progression (TTP) from initial TACE [Time Frame: Up to 3 years]

Tumor status at different visits response according to mRECIST [Time Frame: Up to 3 years]

Duration of TACE treatment [Time Frame: Up to 3 years]

Number of patients with TEAEs (treatment emergent adverse events) [Time Frame: Up to 3 years]

OS from initiation of sorafenib [Time Frame: Up to 3 years]

Time to TACE non-eligibility [Time Frame: Up to 3 years]

Secondary ID(s)

NX1301

16560

Source(s) of Monetary Support

Please refer to primary and secondary sponsors