Metastatic Colorectal CancerNCT05023720
Real-World Effectiveness of Regorafenib in the Treatment of Patients With Metastatic Colorectal Cancer
An observational study of Metastatic Colorectal Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
Real-World Effectiveness of Regorafenib in the Treatment of Patients with Metastatic Colorectal Cancer- A Retrospective, Observational Study Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- nonintervention
- Type of treatment
- Pill or oral medicine
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2021to 21 Dec 2022
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pathologically proven colorectal adenocarcinoma whose disease progressed after two lines of antitumor therapy were treated with regorafenib alone or in combination.
- Inclusion Criteria:
- Must be a pathologically proven colorectal adenocarcinoma
- Must have been treated with regorafenib
- Regorafenib must be used after two lines of standard antitumor therapy
- Exclusion Criteria:
- Application is less than one course of treatment with regorafenib
- First - or second-line treatment with regorafenib
- Patients with multiple primary cancers
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Henan cancer hosiptal
Zhengzhou, Henan, 450008
Shujun Yang, bachelor
About this study
Official title: Real-World Effectiveness of Regorafenib in the Treatment of Patients With Metastatic Colorectal Cancer-A Retrospective Study
Real-World Effectiveness of Regorafenib in the Treatment of Patients with Metastatic Colorectal Cancer- A Retrospective, Observational Study
Read the detailed description
To analyze the real-world usage pattern, effectiveness and factors associated with the effectiveness of regorafenib in the treatment of patients with metastatic colorectal cancer (mCRC). This retrospective, observational study included clinicopathological and follow-up data of patients with mCRC who were treated with regorafenib from June 2017 to September 2020. Patients with incomplete data were excluded. Overall survival (OS) stratified by combination therapy with programmed cell death ligand-1 (PD-L1) inhibitors, chemotherapy and regorafenib dose was calculated by Kaplan Meier method and log rank test. R software version 4.0 was used for the analysis.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- nonintervention
- Keywords
- metastatic colorectal cancer, regorafenib
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
noninterventionOther
| Study group | Role | What they receive |
|---|---|---|
| Regorafenib group | Patients were given only regorafenib orally Receives: Other: nonintervention | |
| Joint group | The patient was treated with regorafenib orally and in combination with other medications Receives: Other: nonintervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in overall survival between the two groups calculated by Kaplan-Meier
Survival differences between the monotherapy and combination groups
Measured: 2021.7-2022.12
The difference of OS in patients receiving different doses of regorafenib
In the real world, regorafenib was used in different dosages: 40mg,80mg,120mg,160mg,respectively. The difference in overall survival time of patients with different dosage was compared.
Measured: 2021.11-2022.12
Regorafenib in combination with other drugs
In the real world, regorafenib was used in combination with chemotherapy, immunotherapy or other drugs, and the frequency of occurrence of different conditions was analyzed.
Measured: 2021.7-2022.10
Secondary outcomes (1)
Survival differences among the patients with different clinical phenotypes and genotypes
To compare the survival of patients with mCRC by gender, age, tumor site and other genotypes
Measured: 2021.7-2022.10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start20 Jul 2021
- Primary completion21 Dec 2022 (estimated)
- Study completion21 Dec 2022 (estimated)
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 Henan Cancer HospitalThe 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shujun Yang, Henan Cancer Hospital
- Investigators
- Shujun Yang, Study director, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023720
- Sponsor's protocol ID
- YShujun
- Status last verified
- Mar 2022
- First submitted
- 29 Jul 2021
- Last updated
- 1 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Clinical data of the patients
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Effectiveness of Regorafenib in the Treatment of Patients With Metastatic Colorectal Cancer-A Retrospective Study
- ClinicalTrials.gov ID
- NCT05023720
- Acronym / sponsor ID
- YShujun
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- metastatic colorectal cancer, regorafenib
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 21 Dec 2022 (estimated)
- Study completion
- 21 Dec 2022 (estimated)
- First posted
- 26 Aug 2021 (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.
Real-World Effectiveness of Regorafenib in the Treatment of Patients with Metastatic Colorectal Cancer- A Retrospective, Observational Study
Detailed description
To analyze the real-world usage pattern, effectiveness and factors associated with the effectiveness of regorafenib in the treatment of patients with metastatic colorectal cancer (mCRC). This retrospective, observational study included clinicopathological and follow-up data of patients with mCRC who were treated with regorafenib from June 2017 to September 2020. Patients with incomplete data were excluded. Overall survival (OS) stratified by combination therapy with programmed cell death ligand-1 (PD-L1) inhibitors, chemotherapy and regorafenib dose was calculated by Kaplan Meier method and log rank test. R software version 4.0 was used for the analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regorafenib group | – | Other: noninterventionPatients were given only regorafenib orally |
| Joint group | – | Other: noninterventionThe patient was treated with regorafenib orally and in combination with other medications |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pathologically proven colorectal adenocarcinoma whose disease progressed after two lines of antitumor therapy were treated with regorafenib alone or in combination.
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 |
|---|---|---|
| nonintervention | Other | Joint group, Regorafenib group |
Primary outcome
The difference in overall survival between the two groups calculated by Kaplan-Meier
Time frame: 2021.7-2022.12
Survival differences between the monotherapy and combination groups
The difference of OS in patients receiving different doses of regorafenib
Time frame: 2021.11-2022.12
In the real world, regorafenib was used in different dosages: 40mg,80mg,120mg,160mg,respectively. The difference in overall survival time of patients with different dosage was compared.
Regorafenib in combination with other drugs
Time frame: 2021.7-2022.10
In the real world, regorafenib was used in combination with chemotherapy, immunotherapy or other drugs, and the frequency of occurrence of different conditions was analyzed.
1 secondary outcome
Survival differences among the patients with different clinical phenotypes and genotypes
Time frame: 2021.7-2022.10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Individual participant dataSharing planned: Yes. Clinical data of the patients
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CRC
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.
Shujun Yang study director
Henan Cancer Hospital
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 Metastatic Colorectal Cancer, run by Henan Cancer Hospital 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?
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: status not confirmed, as of the sponsor's last update on 1 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shujun Yang, bachelor (13803869419, nkyang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in overall survival between the two groups calculated by Kaplan-Meier (time frame: 2021.7-2022.12). The study lists 3 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 1 Apr 2022.