Carcinoma, HepatocellularSUCCESSNCT01839630
Sorafenib Concomitantly Used With TACE (Transarterial Chemoembolization) in uHCC (Unresectable Hepatocellular Carcinoma) Patients in China
An observational study of Carcinoma, Hepatocellular, run by Bayer at 1 site in China.
Trial summary
This study is to obtain the characteristics and treatment pattern of the unresectable HCC patients who are candidates for systemic therapy and in whom a decision to treat with sorafenib from early stage of TACE treatment course (concomitantly use no later than the 3rd TACE procedure) has been made under real-life… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- Sorafenib (Nexavar, BAY43-9006)
- How many people
- 302 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2013to 29 Dec 2016
- 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: Unresectable HCC patients and be candidates for concomitantly systemic therapy with sorafenib + TACE. Considering the local practice and possible clinical benefits, sorafenib should not be initiated later than 7 days after the 3rd TACE course. No prior tartgeted therapy.
Who may be able to join
- Patients with histologically/ cytologically documented or radiographically diagnosed unresectable HCC who are candidates for systemic therapy and for whom a decision to treat with sorafenib has been made. 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 receive the first dose of sorafenib no later than 1 week (<=7days) after the 3rd TACE procedure
- Patients did not receive other prior systemic treatment by using target therapy
- Patients must sign the informed consent form;
- Patients must have a life expectancy of at least 3 months;
- The physician must be willing to complete and submit all CRFs;
- The physician must be willing to submit to a site audit with verification of source documents and validation of data reported;
Who cannot join
- The first dose of sorafenib 7 days after the 3nd TACE procedure
- Exclusion criteria must follow the approved local product information
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on Transarterial Chemoembolization Combined With Sorafenib in Chinese Patients With Unresectable Hepatocellular Carcinoma (SUCCESS)
This study is to obtain the characteristics and treatment pattern of the unresectable HCC patients who are candidates for systemic therapy and in whom a decision to treat with sorafenib from early stage of TACE treatment course (concomitantly use no later than the 3rd TACE procedure) has been made under real-life practice conditions.this study will also conclude the safety and effectiveness of combination in uHCC patients.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- Sorafenib (Nexavar, BAY43-9006)
- Keywords
- Sorafenib, Hepatocellular cancer, TACE combination, Treatment pattern, Safety, Effectiveness
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sorafenib (Nexavar, BAY43-9006)Drug
sorafenib treatment (including dose, duration, modification) and TACE procedure are decided by the investigator
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Sorafenib (Nexavar, BAY43-9006) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summarized patient characteristics
Patient characteristics are hepatic virus infection status, surgery history, tumor size, number of tumor, macroscopic vascular invasion (MVI), extra-hepatic spread (EHS), cirrhosis, ECOG score, Child-Pugh score, BCLC stage, etc.
Measured: up to 3 years
Secondary outcomes (8)
Number of participants with adverse events( AE) and Serious adverse events(SAE) as a measure of safety and tolorability
Measured: up to 3 years
overall survival (OS) by the mRECIST (Modified Response Evaluation Criteria in Solid Tumor) Criteria for treatment of uHCC patients
Measured: up to 3 years
progression-free survival (PFS) by the mRECIST for treatment of uHCC patients
Measured: up to 3 years
time to progression (TTP) by the mRECIST for treatment of uHCC patients
Measured: up to 3 years
response rate (RR) by the mRECIST for treatment of uHCC patients
Measured: up to 3 years
Clinical control Rate (DCR) by the mRECIST for treatment of uHCC patients
Measured: up to 3 years
Clinical benefit rate (CBR) by the mRECIST for treatment of uHCC patients
Measured: up to 3 years
Treatment pattern of Sorafenib
Treatment pattern included: Duration and dosage of Sorafenib treatment; reason for Sorafenib dosage modification/discontinuation; anticancer combination therapy; treatment after radiographic relapse; comorbidities and their impact on disease outcome.
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 posted25 Apr 2013 (estimated)
- Study start30 May 2013
- Primary completion6 Aug 2016
- Study completion29 Dec 2016
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 302 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
- NCT01839630
- Sponsor's protocol ID
- 16608
- Other IDs
- NX1216CN
- Acronym
- SUCCESS
- Status last verified
- Dec 2017
- First submitted
- 23 Nov 2012
- Last updated
- 20 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Transarterial Chemoembolization Combined With Sorafenib in Chinese Patients With Unresectable Hepatocellular Carcinoma (SUCCESS)
- ClinicalTrials.gov ID
- NCT01839630
- Acronym / sponsor ID
- SUCCESS / 16608
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- Sorafenib, Hepatocellular cancer, TACE combination, Treatment pattern, Safety, Effectiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 30 May 2013 (actual)
- Primary completion
- 6 Aug 2016 (actual)
- Study completion
- 29 Dec 2016 (actual)
- First posted
- 25 Apr 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 is to obtain the characteristics and treatment pattern of the unresectable HCC patients who are candidates for systemic therapy and in whom a decision to treat with sorafenib from early stage of TACE treatment course (concomitantly use no later than the 3rd TACE procedure) has been made under real-life practice conditions.this study will also conclude the safety and effectiveness of combination in uHCC patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Sorafenib (Nexavar, BAY43-9006) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Unresectable HCC patients and be candidates for concomitantly systemic therapy with sorafenib + TACE. Considering the local practice and possible clinical benefits, sorafenib should not be initiated later than 7 days after the 3rd TACE course. No prior tartgeted therapy.
Key inclusion criteria (7 listed)
- Patients with histologically/ cytologically documented or radiographically diagnosed unresectable HCC who are candidates for systemic therapy and for whom a decision to treat with sorafenib has been made. 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 receive the first dose of sorafenib no later than 1 week (<=7days) after the 3rd TACE procedure
- Patients did not receive other prior systemic treatment by using target therapy
- Patients must sign the informed consent form;
- Patients must have a life expectancy of at least 3 months;
Key exclusion criteria (2 listed)
- The first dose of sorafenib 7 days after the 3nd TACE procedure
- Exclusion criteria must follow the approved local product information
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 |
|---|---|---|
| Sorafenib (Nexavar, BAY43-9006)sorafenib treatment (including dose, duration, modification) and TACE procedure are decided by the investigator | Drug | Group 1 |
Primary outcome
Summarized patient characteristics
Time frame: up to 3 years
Patient characteristics are hepatic virus infection status, surgery history, tumor size, number of tumor, macroscopic vascular invasion (MVI), extra-hepatic spread (EHS), cirrhosis, ECOG score, Child-Pugh score, BCLC stage, etc.
8 secondary outcomes
Number of participants with adverse events( AE) and Serious adverse events(SAE) as a measure of safety and tolorability
Time frame: up to 3 years
overall survival (OS) by the mRECIST (Modified Response Evaluation Criteria in Solid Tumor) Criteria for treatment of uHCC patients
Time frame: up to 3 years
progression-free survival (PFS) by the mRECIST for treatment of uHCC patients
Time frame: up to 3 years
time to progression (TTP) by the mRECIST for treatment of uHCC patients
Time frame: up to 3 years
response rate (RR) by the mRECIST for treatment of uHCC patients
Time frame: up to 3 years
Clinical control Rate (DCR) by the mRECIST for treatment of uHCC patients
Time frame: up to 3 years
Clinical benefit rate (CBR) by the mRECIST for treatment of uHCC patients
Time frame: up to 3 years
Treatment pattern 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 20 Dec 2017.
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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
1 site in 1 country: 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 1 site in China.
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 7 inclusion and 2 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 20 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Summarized patient characteristics (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 20 Dec 2017.