check_circleStudy Completed

Carcinoma, Hepatocellular

Bayer Identifier:

16560

ClinicalTrials.gov Identifier:

NCT01933945

EudraCT Number:

Not Available

EU CT Number:

Not Available
Outcomes of HCC (Hepatocellular carcinoma) patients treated with TACE (transarterial chemoembolization) and early, not early or not at all followed by sorafenib

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

NaN - N/A
  • - 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
  • - 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 summary

Enrollment Goal
1676
Trial Dates
October 2013 - November 2017
Phase
N/A
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locations, Austria
Completed
Many locations, Korea, Republic Of
Completed
Many locations, Singapore
Completed
Many locations, Pakistan
Completed
Many locations, France
Completed
Many locations, Poland
Completed
Many locations, Japan
Completed
Many locations, Canada
Completed
Many locations, Sweden
Completed
Many locations, Denmark
Completed
Many locations, Czech Republic
Completed
Many locations, Hungary
Completed
Many locations, Greece
Completed
Many locations, Brazil
Completed
Many locations, Russia
Completed
Many locations, Slovakia
Completed
Many locations, China
Completed
Many locations, India
Terminated
Many locations, Hong Kong
Completed
Many locations, Thailand
Completed
Many locations, Egypt
Completed
Many locations, Kazakhstan
Terminated
Many locations, Spain
Completed
Many locations, Netherlands
Completed
Many locations, Mexico
Terminated
Many locations, Turkey
Completed
Many locations, Indonesia
Completed
Many locations, Switzerland
Completed
Many locations, Taiwan
Completed
Many locations, Vietnam
Terminated
Many locations, Israel

Primary Outcome

  • Overall survival (OS)
    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.
    date_rangeTime Frame:
    Up to 3 years
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Overall survival from initial TACE
    OS from initial TACE was defined as the time interval from the day of the first TACE to death due to any cause.
    date_rangeTime Frame:
    Up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • Progression-free survival (PFS) from initial TACE
    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.
    date_rangeTime Frame:
    Up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • Time to progression (TTP) from initial TACE
    TTP from initial TACE was defined as the time interval from the day of first TACE to the date of documented progression.
    date_rangeTime Frame:
    Up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • Tumor response according to mRECIST criteria
    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.
    date_rangeTime Frame:
    Up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • Duration of TACE treatment
    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
    date_rangeTime Frame:
    Up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • Number of patients with TEAEs (treatment emergent adverse events)
    Patients were monitored for TEAEs using the NCI-CTCAE Version 4.03.
    date_rangeTime Frame:
    Up to 3 years
    enhanced_encryption
    Safety Issue:
    Yes
  • TACE unsuitability
    TACE unsuitability was determined according to selected guidelines
    date_rangeTime Frame:
    Up to 3 years
  • Time to TACE non-eligibility
    Determined according to the selected guidelines
    date_rangeTime Frame:
    Up to 3 years
  • Deterioration of liver dysfunction
    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])
    date_rangeTime Frame:
    Up to 3 years
  • OS from initiation of sorafenib
    OS from initiation of sorafenib was defined as the time interval measured from start date of sorafenib treatment to death due to any cause.
    date_rangeTime Frame:
    Up to 3 years
  • PFS from initiation of sorafenib
    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.
    date_rangeTime Frame:
    Up to 3 years
  • Tumor status at different visits response according to mRECIST
    mRECIST: modified Response Evaluation Criteria In Solid Tumors
    date_rangeTime Frame:
    Up to 3 years
  • Duration of sorafenib treatment
    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).
    date_rangeTime Frame:
    Up to 3 years
  • TTP from initiation of sorafenib
    TTP from initiation of sorafenib was defined as the time interval from start date of sorafenib treatment to the date of documented progression.
    date_rangeTime Frame:
    Up to 3 years

Trial design

OPTIMIS - Outcomes of HCC patients treated with TACE followed or not followed by sorafenib and the influence of timing to initiate sorafenib
Trial Type
Observational
Intervention Type
Procedure/Surgery
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer products.