Carcinoma, HepatocellularOPTIMISNCT01933945
Outcomes of HCC (Hepatocellular Carcinoma) Patients Treated With TACE (Transarterial Chemoembolization) and Early, Not Early or Not at All Followed by Sorafenib
An observational study of Carcinoma, Hepatocellular, run by Bayer at 31 sites in 31 countries.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- TACE (transarterial chemoembolization) and Sorafenib (Nexavar, BAY43-9006)
- Type of treatment
- Surgery or procedure
- How many people
- 1,676 participants
- Where
- 31 sitesin 31 countries
- Study dates
- 28 Oct 2013to 10 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
31 sites in 31 countries.
31 sites in 31 countries
About this study
Official title: OPTIMIS - Outcomes of HCC Patients Treated With TACE Followed or Not Followed by Sorafenib and the Influence of Timing to Initiate 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.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- TACE (transarterial chemoembolization), Sorafenib (Nexavar, BAY43-9006)
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACE (transarterial chemoembolization)Procedure or surgery
First treatment for all patients included in the study
Sorafenib (Nexavar, BAY43-9006)Drug
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: TACE (transarterial chemoembolization); 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. Receives: Procedure: TACE (transarterial chemoembolization) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 years
Secondary outcomes (14)
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.
Measured: Up to 3 years
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.
Measured: Up to 3 years
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.
Measured: Up to 3 years
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.
Measured: Up to 3 years
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
Measured: Up to 3 years
Number of patients with TEAEs (treatment emergent adverse events)
Patients were monitored for TEAEs using the NCI-CTCAE Version 4.03.
Measured: Up to 3 years
TACE unsuitability
TACE unsuitability was determined according to selected guidelines
Measured: Up to 3 years
Time to TACE non-eligibility
Determined according to the selected guidelines
Measured: 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])
Measured: 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.
Measured: 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.
Measured: Up to 3 years
Tumor status at different visits response according to mRECIST
mRECIST: modified Response Evaluation Criteria In Solid Tumors
Measured: 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).
Measured: 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.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2013 (estimated)
- Study start28 Oct 2013
- Primary completion22 Jul 2017
- Study completion10 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,676 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01933945
- Sponsor's protocol ID
- 16560
- Other IDs
- NX1301
- Acronym
- OPTIMIS
- Status last verified
- Nov 2018
- First submitted
- 29 Aug 2013
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTIMIS - Outcomes of HCC Patients Treated With TACE Followed or Not Followed by Sorafenib and the Influence of Timing to Initiate Sorafenib
- ClinicalTrials.gov ID
- NCT01933945
- Acronym / sponsor ID
- OPTIMIS / 16560
- Conditions
- Carcinoma, Hepatocellular
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,676 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2013 (actual)
- Primary completion
- 22 Jul 2017 (actual)
- Study completion
- 10 Nov 2017 (actual)
- First posted
- 2 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TACE + early Nexavar | – | Procedure: TACE (transarterial chemoembolization), Drug: Sorafenib (Nexavar, BAY43-9006)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). |
| TACE without early Nexavar | – | Procedure: TACE (transarterial chemoembolization)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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TACE (transarterial chemoembolization)First treatment for all patients included in the study | Procedure or surgery | TACE + early Nexavar, TACE without early Nexavar |
| Sorafenib (Nexavar, BAY43-9006) | Drug | TACE + early Nexavar |
Primary outcome
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.
14 secondary outcomes
Overall survival from initial TACE
Time frame: Up to 3 years
Progression-free survival (PFS) from initial TACE
Time frame: Up to 3 years
Time to progression (TTP) from initial TACE
Time frame: Up to 3 years
Tumor response according to mRECIST criteria
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
TACE unsuitability
Time frame: Up to 3 years
Time to TACE non-eligibility
Time frame: Up to 3 years
Deterioration of liver dysfunction
Time frame: Up to 3 years
OS from initiation of sorafenib
Time frame: Up to 3 years
PFS from initiation of sorafenib
Time frame: Up to 3 years
Tumor status at different visits response according to mRECIST
Time frame: Up to 3 years
Duration of sorafenib treatment
Time frame: Up to 3 years
TTP from initiation of sorafenib
Time frame: Up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
31 sites in 31 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Hepatocellular, run by Bayer at 31 sites in 31 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Austria, Brazil, Canada, China, Czechia and 26 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2018.