Skip to main content
OpenTrials
Completed

NCT Number: NCT01933945

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TACE (transarterial chemoembolization)

Procedure

First treatment for all patients included in the study

Sorafenib (Nexavar, BAY43-9006)

Drug

Primary outcomes

  1. Overall survival (OS)

    Time frame: Up to 3 years

    Defined as time (in days) from time of TACE non-eligibility to death due to any cause. Patients lost to follow-up or alive at the end of the study will be censored at the last date known to be alive.

Secondary outcomes

  1. Overall survival from initial TACE

    Time frame: Up to 3 years

    OS from initial TACE was defined as the time interval from the day of the first TACE to death due to any cause.

  2. Progression-free survival (PFS) from initial TACE

    Time frame: Up to 3 years

    PFS from initial TACE was defined as the time interval measured from the day of the first TACE to documented (radiological or clinical) progression or death, whichever came first.

  3. Time to progression (TTP) from initial TACE

    Time frame: Up to 3 years

    TTP from initial TACE was defined as the time interval from the day of first TACE to the date of documented progression.

  4. Tumor response according to mRECIST criteria

    Time frame: Up to 3 years

    Tumor response to TACE by modified Response Evaluation Criteria In Solid Tumors (mRECIST) were evaluated according to the categories "Complete Response", "Partial Response", "Stable Disease", and "Not evaluable" by mRECIST for each TACE.

  5. Duration of TACE treatment

    Time frame: Up to 3 years

    Duration of TACE treatment was defined as the time interval from of the day of first TACE to the date of permanent discontinuation of TACE

  6. Number of patients with TEAEs (treatment emergent adverse events)

    Time frame: Up to 3 years

    Patients were monitored for TEAEs using the NCI-CTCAE Version 4.03.

  7. TACE unsuitability

    Time frame: Up to 3 years

    TACE unsuitability was determined according to selected guidelines

  8. Time to TACE non-eligibility

    Time frame: Up to 3 years

    Determined according to the selected guidelines

  9. Deterioration of liver dysfunction

    Time frame: Up to 3 years

    Deteriorations of liver dysfunction were defined as follow: Deterioration of Child Pugh score (A5, A6, B7, B8, B9); Liver dysfunction reported as AE or deterioration of aspartate aminotransferase, alanine aminotransferase or bilirubin (from Grade 1 to Grade 2-5, from Grade 2 to 3-5, Grade 3 to Grade 4 or 5); Any liver related adverse events or deterioration of liver related events according to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03; Change of liver related laboratory data (aspartate aminotransferase, alanine aminotransferase, bilirubin, albumin, prothrombin international normalized ratio [INR])

  10. OS from initiation of sorafenib

    Time frame: Up to 3 years

    OS from initiation of sorafenib was defined as the time interval measured from start date of sorafenib treatment to death due to any cause.

  11. PFS from initiation of sorafenib

    Time frame: Up to 3 years

    PFS from initiation of sorafenib was defined as the time interval measured from the start date of sorafenib treatment to documented (radiological or clinical) progression or death, whichever came first.

  12. Tumor status at different visits response according to mRECIST

    Time frame: Up to 3 years

    mRECIST: modified Response Evaluation Criteria In Solid Tumors

  13. Duration of sorafenib treatment

    Time frame: Up to 3 years

    Duration of sorafenib treatment was defined as the time interval from start date of sorafenib treatment to the date of permanent discontinuation of sorafenib treatment (regardless of the reason for discontinuation including death).

  14. TTP from initiation of sorafenib

    Time frame: Up to 3 years

    TTP from initiation of sorafenib was defined as the time interval from start date of sorafenib treatment to the date of documented progression.

Other outcomes

  1. PFS from TACE non-eligibility

    Time frame: Up to 3 years

    PFS from TACE non-eligibility was defined as the time interval from TACE non-eligibility to documented (radiological or clinical) progression or death, whichever came first.

  2. TTP from TACE non-eligibility

    Time frame: Up to 3 years

    TTP from TACE non-eligibility was defined as the time interval from TACE non-eligibility to the date of documented progression.

  3. Tumor response from time of TACE non-eligibility by mRECIST

    Time frame: Up 3 years

    Planned to be evaluated according to the categories "Complete Response", "Partial Response", "Stable Disease", and "Not evaluable"

  4. Switch to sorafenib or other systemic and non-systemic cancer therapy

    Time frame: Up to 3 years

    Evaluated according to the categories "Before initial TACE", "After one TACE", "After two TACEs", and "After more than two TACEs"

  5. Deviations from recommendations for TACE use

    Time frame: Up to 3 years

    Deviations from recommendations for TACE use in the treatment guidelines for TACE use based on the number of patients for whom the treatment decision for a new TACE was made by the investigator after TACE non-eligibility.

  6. Duration of treatment of sorafenib after TACE

    Time frame: Up to 3 years

    Defined as days from the first sorafenib dose to the date of permanent discontinuation of sorafenib plus one

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

OPTIMIS - Outcomes of HCC Patients Treated With TACE Followed or Not Followed by Sorafenib and the Influence of Timing to Initiate Sorafenib

Acronym: OPTIMIS

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Sep 2, 2013
Registry last updated
Nov 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.