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

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ClinicalTrials.gov Identifier: NCT01933945
Recruitment Status : Completed
First Posted : September 2, 2013
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment
Carcinoma, Hepatocellular Procedure: TACE (transarterial chemoembolization) Drug: Sorafenib (Nexavar, BAY43-9006)

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Study Type : Observational
Actual Enrollment : 1676 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: OPTIMIS - Outcomes of HCC Patients Treated With TACE Followed or Not Followed by Sorafenib and the Influence of Timing to Initiate Sorafenib
Actual Study Start Date : October 28, 2013
Actual Primary Completion Date : July 22, 2017
Actual Study Completion Date : November 10, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
TACE + early Nexavar
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).
Procedure: TACE (transarterial chemoembolization)
First treatment for all patients included in the study

Drug: Sorafenib (Nexavar, BAY43-9006)
TACE without early Nexavar
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.
Procedure: TACE (transarterial chemoembolization)
First treatment for all patients included in the study




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01933945


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Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01933945     History of Changes
Other Study ID Numbers: 16560
NX1301 ( Other Identifier: Company internal )
First Posted: September 2, 2013    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action