Hepatocellular CarcinomaSORAGO-HCCNCT03644511
Use of Sorafenib and/or Regorafenib in Liver Cancer (Hepatocellular Carcinoma) Subsequent to Another Systemic First-line Treatment
An observational study of Hepatocellular Carcinoma, run by Bayer at 1 site in Germany.
Trial summary
Researchers already did trials that showed Sorafenib and Regorafenib worked for patients with hepatocellular carcinoma (most common liver tumor type). In this trial, they want to learn more about the same patient group in which Sorafenib or Regorafenib is given after other drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Regorafenib (Stivarga, BAY73-4506) and Sorafenib (Nexavar, BAY43-9006)
- How many people
- 3 participants
- Where
- 1 siteGermany
- Study dates
- 24 Jan 2019to 30 Sep 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of patients with HCC in stage BCLC-B (Barcelona Classification of Liver Cancer) or BCLC-C for whom the decision to treat with Nexavar and/or Stivarga as ≥ 2nd-line has been taken by the investigator and the drugs are prescribed in the customary manner in accordance with the terms of the marketing authorization.
Who may be able to join
- Diagnosis of hepatocellular cancer in stage BCLC-B or BCLC-C
- Decision to initiate treatment with Nexavar (sorafenib) and/or Stivarga (regorafenib) as 2nd-line or beyond treatment was made as per investigator's routine treatment practice. Stivarga (regorafenib) must be used according to its indication, i.e. after prior progression under Nexavar (sorafenib) treatment.
Who cannot join
- Patients concurrently participating in an investigational program for the treatment of HCC with interventions outside of routine clinical practice.
- Stivarga (regorafenib) treatment without prior therapy with Nexavar (sorafenib). NOTE: Nexavar (sorafenib) treatment could have been given as treatment for HCC outside of this non-interventional study. In this case Stivarga (regorafenib) would NOT constitute the second-line therapy after direct pretreatment with Nexavar (sorafenib) but e.g. 3rd-line treatment directly after a different drug.
- Contra-indications according to the local marketing authorization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Sorafenib and/or Regorafenib in Hepatocellular Carcinoma (HCC) Subsequent to Another Systemic First-line Treatment
Researchers already did trials that showed Sorafenib and Regorafenib worked for patients with hepatocellular carcinoma (most common liver tumor type).
In this trial, they want to learn more about the same patient group in which Sorafenib or Regorafenib is given after other drugs. Patients participating in this study will be observed until 12 months after the last patient has been enrolled to collect data on how safe the drugs are and how well they are working when used as second line or beyond treatment.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Regorafenib (Stivarga, BAY73-4506), Sorafenib (Nexavar, BAY43-9006)
- Keywords
- HCC, Liver cancer, Live cell carcinoma
- 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.
Regorafenib (Stivarga, BAY73-4506)Drug
Prescribed by physician.
Sorafenib (Nexavar, BAY43-9006)Drug
Prescribed by physician.
| Study group | Role | What they receive |
|---|---|---|
| Patients with HCC | Treated with Nexavar and/or Stivarga as ≥ 2nd-line systemic treatment Receives: Drug: Regorafenib (Stivarga, BAY73-4506); Drug: Sorafenib (Nexavar, BAY43-9006) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of current treatment patterns by means of individual treatment lines in the systemic HCC therapy with regards to Nexavar and Stivarga, i.e. when both drugs are used in ≥ 2nd-line under current practice conditions
Measured: Up to 24 months
Secondary outcomes (6)
Overall Survival (OS) from start of Nexavar or Stivarga therapy and from start of first systemic therapy
Measured: Up to 36 months
Progression free survival (PFS)
Measured: Up to 36 months
Time to progression (TTP)
Measured: Up to 36 months
Duration of Nexavar or Stivarga treatment
Measured: Up to 36 months
Tumor response to treatment
Evaluated by the investigator according to the categories "complete response", "partial response", "stable disease", "progressive disease by clinical judgment", "progressive disease measurement proven", "unknown" and "not applicable", and will be analyzed providing absolute and relative frequencies of the tumor status categories.
Measured: Up to 36 months
Incidence of treatment-emergent adverse events (TEAE)
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start24 Jan 2019
- Primary completion18 Jul 2019
- Study completion30 Sep 2019
Why it stopped: The interest of potential centers is very limited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644511
- Sponsor's protocol ID
- 20215
- Acronym
- SORAGO-HCC
- Status last verified
- Aug 2020
- First submitted
- 22 Aug 2018
- Last updated
- 21 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Sorafenib and/or Regorafenib in Hepatocellular Carcinoma (HCC) Subsequent to Another Systemic First-line Treatment
- ClinicalTrials.gov ID
- NCT03644511
- Acronym / sponsor ID
- SORAGO-HCC / 20215
- Conditions
- Hepatocellular Carcinoma
- Keywords
- HCC, Liver cancer, Live cell carcinoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The interest of potential centers is very limited.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 24 Jan 2019 (actual)
- Primary completion
- 18 Jul 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 23 Aug 2018 (actual)
- 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.
Researchers already did trials that showed Sorafenib and Regorafenib worked for patients with hepatocellular carcinoma (most common liver tumor type).
In this trial, they want to learn more about the same patient group in which Sorafenib or Regorafenib is given after other drugs. Patients participating in this study will be observed until 12 months after the last patient has been enrolled to collect data on how safe the drugs are and how well they are working when used as second line or beyond treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with HCC | – | Drug: Regorafenib (Stivarga, BAY73-4506), Drug: Sorafenib (Nexavar, BAY43-9006)Treated with Nexavar and/or Stivarga as ≥ 2nd-line systemic treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of patients with HCC in stage BCLC-B (Barcelona Classification of Liver Cancer) or BCLC-C for whom the decision to treat with Nexavar and/or Stivarga as ≥ 2nd-line has been taken by the investigator and the drugs are prescribed in the customary manner in accordance with the terms of the marketing authorization.
Key inclusion criteria (2 listed)
- Diagnosis of hepatocellular cancer in stage BCLC-B or BCLC-C
- Decision to initiate treatment with Nexavar (sorafenib) and/or Stivarga (regorafenib) as 2nd-line or beyond treatment was made as per investigator's routine treatment practice. Stivarga (regorafenib) must be used according to its indication, i.e. after prior progression under Nexavar (sorafenib) treatment.
Key exclusion criteria (3 listed)
- Patients concurrently participating in an investigational program for the treatment of HCC with interventions outside of routine clinical practice.
- Stivarga (regorafenib) treatment without prior therapy with Nexavar (sorafenib). NOTE: Nexavar (sorafenib) treatment could have been given as treatment for HCC outside of this non-interventional study. In this case Stivarga (regorafenib) would NOT constitute the second-line therapy after direct pretreatment with Nexavar (sorafenib) but e.g. 3rd-line treatment directly after a different drug.
- Contra-indications according to the local marketing authorization.
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 |
|---|---|---|
| Regorafenib (Stivarga, BAY73-4506)Prescribed by physician. | Drug | Patients with HCC |
| Sorafenib (Nexavar, BAY43-9006)Prescribed by physician. | Drug | Patients with HCC |
Primary outcome
Identification of current treatment patterns by means of individual treatment lines in the systemic HCC therapy with regards to Nexavar and Stivarga, i.e. when both drugs are used in ≥ 2nd-line under current practice conditions
Time frame: Up to 24 months
6 secondary outcomes
Overall Survival (OS) from start of Nexavar or Stivarga therapy and from start of first systemic therapy
Time frame: Up to 36 months
Progression free survival (PFS)
Time frame: Up to 36 months
Time to progression (TTP)
Time frame: Up to 36 months
Duration of Nexavar or Stivarga treatment
Time frame: Up to 36 months
Tumor response to treatment
Time frame: Up to 36 months
Incidence of treatment-emergent adverse events (TEAE)
Time frame: Up to 36 months
Results and safety
The study was stopped early (reason given: The interest of potential centers is very limited.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
- Individual participant dataSharing planned: Undecided. Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hepatocellular Carcinoma, run by Bayer at 1 site in Germany.
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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 21 Aug 2020. 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 Germany. 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 was stopped early (reason given: The interest of potential centers is very limited.). Results are not available in the source record.
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?
Identification of current treatment patterns by means of individual treatment lines in the systemic HCC therapy with regards to Nexavar and Stivarga, i.e. when both drugs are used in ≥ 2nd-line under current practice conditions (time frame: Up to 24 months). 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 21 Aug 2020.