Metastatic Colorectal CancerRegoSeqNCT06137170
A Real-World Study to Learn More About the Order of Different Treatments and Their Effects in People With Metastatic Colorectal Cancer Receiving Their Third and Fourth Line of Treatment
An observational study of Metastatic Colorectal Cancer, run by Bayer at 3 sites in 3 countries.
Trial summary
This is an observational study in which data already collected from people with metastatic colorectal cancer will be studied. Metastatic colorectal cancer (mCRC) is a cancer of the colon (large bowel) or the rectum (lowest part of the bowel just before the anus). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Regorafenib (Stivarga, BAY73-4506)
- How many people
- 121 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Mar 2024to 31 Mar 2025
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: This is a retrospective cohort study of patients aged ≥18 years at the diagnosis of mCRC in real world clinical practice who received sequential treatment with regorafenib followed by TAS (with or without Bevacizumab, R-TAS±BEV) and vice versa (TAS±BEV-R) from January 1, 2019 to December 31, 2022 (inclusion period), or the latest available date that allows at least 3 months of follow-up, at multiple clinical centers in France, Italy, and Spain. The study will use longitudinal patients and clinical data recorded at the centers.
Who may be able to join
- Aged ≥18 years at diagnosis of mCRC
- Histologically confirmed diagnosis of mCRC
- Received sequential treatment with regorafenib followed by TAS with or without Bevacizumab (R-TAS±BEV, without other therapies in-between) and vice versa (TAS±BEV -R without other therapies in-between) from January 1, 2013 to December 31, 2022 (inclusion period), or the latest available date that allows at least 3 months of follow-up
- Have at least 6 months of available data before index date (baseline period) and at least 3 months of follow-up data
Who cannot join
- Patients who had a diagnosis of any other primary cancer (including gastrointestinal stromal tumors (GIST) and hepatocellular carcinoma (HCC)) except non-melanoma skin cancers during baseline
- Patients involved in clinical trials during the study period
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Real-world Sequence of Systemic Therapies and Outcomes in Patients With Metastatic Colorectal Cancer Receiving 3rd and 4th Line of Treatment.
This is an observational study in which data already collected from people with metastatic colorectal cancer will be studied.
Metastatic colorectal cancer (mCRC) is a cancer of the colon (large bowel) or the rectum (lowest part of the bowel just before the anus). Cancer is considered metastatic if it spreads to other parts of the body.
Read more
The study drug, regorafenib, is already approved for doctors to prescribe to people with mCRC. It is an anti-cancer drug that blocks several proteins, called enzymes, which are involved in the growth of cancer. Other approved treatments for mCRC include TAS and bevacizumab. The combination of the anti-cancer drugs trifluridine and tipiracil is called TAS. Both TAS and bevacizumab prevent cancer cells from growing and multiplying.
Some studies have shown that people with mCRC who took TAS along with bevacizumab, lived longer than when TAS was taken alone. This may be especially beneficial for patients who have tried other treatments before. However, there is limited knowledge about how and in which order these drugs are given.
To better understand the impact of the order of taking regorafenib and TAS, with or without bevacizumab, more knowledge is needed about how well these treatments work in people with mCRC in European countries.
The main purpose of this study is to learn more about the effects of treatment in people with mCRC who have already received regorafenib and TAS, with or without bevacizumab, one after the other (also called sequential treatment) in a different order.
To do this, researchers will collect the following information:
- how long participants received sequential treatment for mCRC
- number of participants receiving further treatment for mCRC after the sequential treatment
- number and type of further treatments for mCRC
- how long did participants live (also called overall survival).
The data will come from the participants' information stored in health records from 4 centers in 3 European countries including France, Italy, and Spain. The data will be from people with mCRC who started sequential treatment between January 2013 and December 2022 or until the most recent date that allows researchers to assess the participants' health for at least 3 months.
In this study, only available data from routine care are collected. No visits or tests will be required as part of this study.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Regorafenib (Stivarga, BAY73-4506)
- Medical subject headings
- Colorectal 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
Follow clinical administration.
| Study group | Role | What they receive |
|---|---|---|
| TAS±BEV-R | Eligible patients who started with trifluridine/tipiracil +/- bevacizumab (TAS+/-Bev) first, followed by regorafenib (R), without other therapies in-between. Receives: Drug: Regorafenib (Stivarga, BAY73-4506) | |
| R-TAS±BEV | Eligible patients who started with regorafenib first, followed by TAS+/-Bev without other therapies in-between. Receives: Drug: Regorafenib (Stivarga, BAY73-4506) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of sequential treatment (DoT)
Measured: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Proportion of patients receiving subsequent therapies following sequential treatment during all available follow up after end of sequential treatment
Measured: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Number and type of subsequent therapies
Measured: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Proportion of patients using myelopoiesis supporting therapy
Measured: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Overall Survival (OS)
Measured: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Secondary outcomes (9)
Descriptive analysis of demographic characteristics
Measured: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
ECOG at index (the closest measurement before index date)
Descriptive analysis of clinical characteristics: Descriptive statistics will be calculated. Categorical variables will be summarized using frequency (number of patients [N]) and percentage (%) of total study persons observed in each group. Continuous and count variables will be presented as the mean, standard deviation (SD) and median. As relevant, continuous variables will also be categorized into intervals.
Measured: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Location of primary cancer: left colon, right colon, rectum
Descriptive analysis of clinical characteristics: Descriptive statistics will be calculated. Categorical variables will be summarized using frequency (number of patients [N]) and percentage (%) of total study persons observed in each group. Continuous and count variables will be presented as the mean, standard deviation (SD) and median. As relevant, continuous variables will also be categorized into intervals.
Measured: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
TNM stage at diagnosis
Descriptive analysis of clinical characteristics: Descriptive statistics will be calculated. Categorical variables will be summarized using frequency (number of patients [N]) and percentage (%) of total study persons observed in each group. Continuous and count variables will be presented as the mean, standard deviation (SD) and median. As relevant, continuous variables will also be categorized into intervals.
Measured: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Metastasis location: lung, hepatic, other sites
Descriptive analysis of clinical characteristics: Descriptive statistics will be calculated. Categorical variables will be summarized using frequency (number of patients [N]) and percentage (%) of total study persons observed in each group. Continuous and count variables will be presented as the mean, standard deviation (SD) and median. As relevant, continuous variables will also be categorized into intervals.
Measured: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Molecular diagnostics status
Descriptive analysis of clinical characteristics: Descriptive statistics will be calculated. Categorical variables will be summarized using frequency (number of patients [N]) and percentage (%) of total study persons observed in each group. Continuous and count variables will be presented as the mean, standard deviation (SD) and median. As relevant, continuous variables will also be categorized into intervals.
Measured: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Regorafenib dose at starting treatment and changes during treatment
Descriptive analysis of clinical characteristics: Descriptive statistics will be calculated. Categorical variables will be summarized using frequency (number of patients [N]) and percentage (%) of total study persons observed in each group. Continuous and count variables will be presented as the mean, standard deviation (SD) and median. As relevant, continuous variables will also be categorized into intervals.
Measured: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Biomarkers: KRAS, NRAS & BRAF and MMR/MSI
Measured: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Proportion of patients in the sequential treatment groups who received myelopoiesis supporting therapy, differentiating between prophylactic and for therapeutic purpose
Myelopoiesis supporting therapy including blood / blood cell transfusions, hematopoietic growth factors, e.g., granulocyte colony stimulating factor and erythropoiesis-stimulating agents.
Measured: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Mar 2024
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies 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
- Retrospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06137170
- Sponsor's protocol ID
- 22581
- Acronym
- RegoSeq
- Status last verified
- Feb 2026
- First submitted
- 6 Nov 2023
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later 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.vivli.org 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 member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Sequence of Systemic Therapies and Outcomes in Patients With Metastatic Colorectal Cancer Receiving 3rd and 4th Line of Treatment.
- ClinicalTrials.gov ID
- NCT06137170
- Acronym / sponsor ID
- RegoSeq / 22581
- Conditions
- Metastatic Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 18 Nov 2023 (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.
This is an observational study in which data already collected from people with metastatic colorectal cancer will be studied.
Metastatic colorectal cancer (mCRC) is a cancer of the colon (large bowel) or the rectum (lowest part of the bowel just before the anus). Cancer is considered metastatic if it spreads to other parts of the body.
The study drug, regorafenib, is already approved for doctors to prescribe to people with mCRC. It is an anti-cancer drug that blocks several proteins, called enzymes, which are involved in the growth of cancer. Other approved treatments for mCRC include TAS and bevacizumab. The combination of the anti-cancer drugs trifluridine and tipiracil is called TAS. Both TAS and bevacizumab prevent cancer cells from growing and multiplying.
Some studies have shown that people with mCRC who took TAS along with bevacizumab, lived longer than when TAS was taken alone. This may be especially beneficial for patients who have tried other treatments before. However, there is limited knowledge about how and in which order these drugs are given.
To better understand the impact of the order of taking regorafenib and TAS, with or without bevacizumab, more knowledge is needed about how well these treatments work in people with mCRC in European countries.
The main purpose of this study is to learn more about the effects of treatment in people with mCRC who have already received regorafenib and TAS, with or without bevacizumab, one after the other (also called sequential treatment) in a different order.
To do this, researchers will collect the following information:
- how long participants received sequential treatment for mCRC
- number of participants receiving further treatment for mCRC after the sequential treatment
- number and type of further treatments for mCRC
- how long did participants live (also called overall survival).
The data will come from the participants' information stored in health records from 4 centers in 3 European countries including France, Italy, and Spain. The data will be from people with mCRC who started sequential treatment between January 2013 and December 2022 or until the most recent date that allows researchers to assess the participants' health for at least 3 months.
In this study, only available data from routine care are collected. No visits or tests will be required as part of this study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAS±BEV-R | – | Drug: Regorafenib (Stivarga, BAY73-4506)Eligible patients who started with trifluridine/tipiracil +/- bevacizumab (TAS+/-Bev) first, followed by regorafenib (R), without other therapies in-between. |
| R-TAS±BEV | – | Drug: Regorafenib (Stivarga, BAY73-4506)Eligible patients who started with regorafenib first, followed by TAS+/-Bev without other therapies in-between. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a retrospective cohort study of patients aged ≥18 years at the diagnosis of mCRC in real world clinical practice who received sequential treatment with regorafenib followed by TAS (with or without Bevacizumab, R-TAS±BEV) and vice versa (TAS±BEV-R) from January 1, 2019 to December 31, 2022 (inclusion period), or the latest available date that allows at least 3 months of follow-up, at multiple clinical centers in France, Italy, and Spain. The study will use longitudinal patients and clinical data recorded at the centers.
Key inclusion criteria (4 listed)
- Aged ≥18 years at diagnosis of mCRC
- Histologically confirmed diagnosis of mCRC
- Received sequential treatment with regorafenib followed by TAS with or without Bevacizumab (R-TAS±BEV, without other therapies in-between) and vice versa (TAS±BEV -R without other therapies in-between) from January 1, 2013 to December 31, 2022 (inclusion period), or the latest available date that allows at least 3 months of follow-up
- Have at least 6 months of available data before index date (baseline period) and at least 3 months of follow-up data
Key exclusion criteria (2 listed)
- Patients who had a diagnosis of any other primary cancer (including gastrointestinal stromal tumors (GIST) and hepatocellular carcinoma (HCC)) except non-melanoma skin cancers during baseline
- Patients involved in clinical trials during the study period
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)Follow clinical administration. | Drug | R-TAS±BEV, TAS±BEV-R |
Primary outcome
Duration of sequential treatment (DoT)
Time frame: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Proportion of patients receiving subsequent therapies following sequential treatment during all available follow up after end of sequential treatment
Time frame: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Number and type of subsequent therapies
Time frame: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Proportion of patients using myelopoiesis supporting therapy
Time frame: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Overall Survival (OS)
Time frame: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
9 secondary outcomes
Descriptive analysis of demographic characteristics
Time frame: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
ECOG at index (the closest measurement before index date)
Time frame: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Location of primary cancer: left colon, right colon, rectum
Time frame: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
TNM stage at diagnosis
Time frame: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Metastasis location: lung, hepatic, other sites
Time frame: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Molecular diagnostics status
Time frame: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Regorafenib dose at starting treatment and changes during treatment
Time frame: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Biomarkers: KRAS, NRAS & BRAF and MMR/MSI
Time frame: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Proportion of patients in the sequential treatment groups who received myelopoiesis supporting therapy, differentiating between prophylactic and for therapeutic purpose
Time frame: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
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 2 Mar 2026.
- Individual participant dataSharing planned: No. Availability of this study's data will later 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.vivli.org 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 member 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.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer, run by Bayer at 3 sites in 3 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 4 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 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Italy, Spain. 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?
Duration of sequential treatment (DoT) (time frame: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up). The study lists 5 primary outcomes in all. 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 2 Mar 2026.